Randomized Controlled Trial

Back Clinic Randomized Controlled Trial Chiropractic and Functional Medicine Team. A study in which the participants are divided by chance into separate groups that compare different treatments or other interventions. Using the chance to divide people into groups means that the groups will be similar and that the effects of the treatments they receive can be compared more fairly.

At the time of the trial, it is not known which treatment is best. A Randomized Controlled Trial or (RCT) design randomly assigns participants into an experimental group or a control group. As the study is conducted, the only expected difference from the control and experimental groups in a randomized controlled trial (RCT) is the outcome variable being studied.

Advantages

Easier to blind/mask than from observational studies
Good randomization washes out any population bias
Populations of participating individuals are clearly identified
Results can be analyzed with well known statistical tools

Disadvantages

Does not reveal causation
Expensive in time and money
Loss to follow-up attributed to treatment
Volunteer biases: the population that participates may not be representative of the whole

For answers to any questions you may have please call Dr. Jimenez at 915-850-0900

Cognitive-Behavioral Therapy for Auto Accident Injuries in El Paso, TX

by spinedoctors | Back Pain, Chronic Pain, Conditions Treated, Herniated Disc, Neck Pain, Physical Rehabilitation, Randomized Controlled Trial, Research Studies, Stress, Treatments

Being involved in an automobile accident is an undesirable situation which can result in a variety of physical trauma or injury as well as lead to the development of a number of aggravating conditions. Auto accident injuries, such as whiplash, can be characterized by painful symptoms, including chronic neck pain, however, recent research studies have found that emotional distress resulting from an auto collision could manifest into physical symptoms. Stress, anxiety, depression and post traumatic stress disorder, or PTSD, are common psychological issues which may occur as a result of an automobile accident.

The researchers of the research studies also determined that cognitive-behavioral therapy may be an effective treatment for emotional distress and psychological issues which may have developed as a result of the auto accident injuries. Additionally, auto accident injuries may also cause stress, anxiety, depression and even PTSD if left untreated for an extended amount of time. The purpose of the article below is to demonstrate the effects of cognitive-behavioral therapy, together with alternative treatment options like chiropractic care and physical therapy. for auto accident injuries, such as whiplash.

Neck Exercises, Physical and Cognitive Behavioural-Graded Activity as a Treatment for Adult Whiplash Patients with Chronic Neck Pain: Design of a Randomised Controlled Trial

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Abstract

Background

Many patients suffer from chronic neck pain following a whiplash injury. A combination of cognitive, behavioural therapy with physiotherapy interventions has been indicated to be effective in the management of patients with chronic whiplash-associated disorders. The objective is to present the design of a randomised controlled trial (RCT) aimed at evaluating the effectiveness of a combined individual physical and cognitive behavioural-graded activity program on self-reported general physical function, in addition to neck function, pain, disability and quality of life in patients with chronic neck pain following whiplash injury compared with a matched control group measured at baseline and 4 and 12 months after baseline.

Methods/Design

The design is a two-centre, RCT-study with a parallel group design. Included are whiplash patients with chronic neck pain for more than 6 months, recruited from physiotherapy clinics and an out-patient hospital department in Denmark. Patients will be randomised to either a pain management (control) group or a combined pain management and training (intervention)group. The control group will receive four educational sessions on pain management, whereas the intervention group will receive the same educational sessions on pain management plus 8 individual training sessions for 4 months, including guidance in specific neck exercises and an aerobic training programme. Patients and physiotherapists are aware of the allocation and the treatment, while outcome assessors and data analysts are blinded. The primary outcome measures will be Medical Outcomes Study Short Form 36 (SF36), Physical Component Summary (PCS). Secondary outcomes will be Global Perceived Effect (-5 to +5), Neck Disability Index (0-50), Patient Specific Functioning Scale (0-10), numeric rating scale for pain bothersomeness (0-10), SF-36 Mental Component Summary (MCS), TAMPA scale of Kinesiophobia (17-68), Impact of Event Scale (0-45), EuroQol (0-1), craniocervical flexion test (22 mmHg – 30 mmHg), joint position error test and cervical range of movement. The SF36 scales are scored using norm-based methods with PCS and MCS having a mean score of 50 with a standard deviation of 10.

Discussion

The perspectives of this study are discussed, in addition to the strengths and weaknesses.

Trial registration

The study is registered in www.ClinicalTrials.gov identifier NCT01431261.

Background

The Danish National Board of Health estimates that 5-6,000 subjects per year in Denmark are involved in a traffic accident evoking whiplash-induced neck pain. About 43% of those will still have physical impairment and symptoms 6 months after the accident [1]. For Swedish society, including Swedish insurance companies, the economic burden is approximately 320 million Euros [2], and this burden is likely to be comparable to that of Denmark. Most studies suggest that patients with Whiplash-Associated Disorders (WAD) report chronic neck symptoms one year after the injury [3]. The main problems in whiplash patients with chronic neck pain are cervical dysfunction and abnormal sensory processing, reduced neck mobility and stability, impaired cervicocephalic kinaesthetic sense, in addition to local and possibly generalised pain [4,5]. Cervical dysfunction is characterised by reduced function of the deep stabilising muscles of the neck.

Besides chronic neck pain, patients with WAD may suffer from physical inactivity as a consequence of prolonged pain [6,7]. This influences physical function and general health and can result in a poor quality of life. In addition, WAD patients may develop chronic pain followed by sensitisation of the nervous system [8,9], a lowering of the threshold for different sensory inputs (pressure, cold, warm, vibration and electrical impulses) [10]. This can be caused by an impaired central pain inhibition [11] – a cortical reorganisation [12]. Besides central sensitisation, the group with WAD may have poorer coping strategies and cognitive functions, compared with patients with chronic neck pain in general [13-15].

Studies have shown that physical training, including specific exercises targeting the deep postural muscles of the cervical spine, is effective in reducing neck pain [16-18] for patients with chronic neck pain, albeit there is a variability in the response to training with not every patient showing a major change. Physical behavioural-graded activity is a treatment approach with a focus on increasing general physical fitness, reducing fear of movement and increasing psychological function [19,20]. There is insufficient evidence for the long-term effect of treatment of physical and cognitive behavioural-graded activity, especially in chronic neck pain patients. Educational sessions, where the focus is on understanding complex chronic pain mechanisms and development of appropriate pain coping and/or cognitive behavioural strategies, have shown reduced general pain [6,21-26]. A review indicated that interventions with a combination of cognitive, behavioural therapy with physiotherapy including neck exercises is effective in the management of WAD patients with chronic neck pain [27], as also recommended by the Dutch clinical guidelines for WAD [28]. However, the conclusions regarding the guidelines are largely based on studies performed on patients with either acute or sub-acute WAD [29]. A more strict conclusion was drawn for WAD patients with chronic pain in the Bone and Joint Decade 2000-2010 Task Force, stating, that ‘because of conflicting evidence and few high-quality studies, no firm conclusions could be drawn about the most effective non-invasive interventions for patients with chronic WAD” [29,30]. The concept of combined treatment for WAD patients with chronic pain has been used in a former randomised controlled trial [31]. The results indicated that a combination of non-specific aerobic exercises and advice containing standardised pain education and reassurance and encouragement to resume light activity, produced better outcomes than advice alone for patients with WAD 3 months after the accident. The patients showed improvements in pain intensity, pain bothersomeness and functions in daily activities in the group receiving exercise and advice, compared with advice alone. However, the improvements were small and only apparent in the short term.

This project is formulated on the expectation that rehabilitation of WAD patients with chronic neck pain must target cervical dysfunctions, training of physical function and the understanding and management of chronic pain in a combined therapy approach. Each single intervention is based upon former studies that have shown effectiveness [6,18,20,32]. This study is the first to also include the long-term effect of the combined approach in patients with chronic neck pain after whiplash trauma. As illustrated in Figure ?Figure1,1, the conceptual model in this study is based upon the hypothesis that training (including both individually-guided specific neck exercises and graded aerobic training) and education in pain management (based on a cognitive behavioural approach) is better for increasing the patients’ physical quality of life, compared with education in pain management alone. Increasing the physical quality of life includes increasing the general physical function and level of physical activity, decreasing fear of movement, reducing post-traumatic stress symptoms, reducing neck pain and increasing neck function. The effect is anticipated to be found immediately after the treatment (i.e. 4 months; short-term effect) as well as after one year (long-term effect).

Figure 1: Hypothesis of the intervention effect for patients with chronic neck pain after a whiplash accident.

Using a randomised controlled trial (RCT) design, the aim of this study is to evaluate the effectiveness of: graded physical training, including specific neck exercises and general aerobic training, combined with education in pain management (based on a cognitive behavioural approach) versus education in pain management (based on a cognitive behavioural approach), measured on physical quality of life’, physical function, neck pain and neck functions, fear of movement, post-traumatic symptoms and mental quality of life, in patients with chronic neck pain after whiplash injury.

Methods/Design

Trial Design

The study is conducted in Denmark as an RCT with a parallel group design. It will be a two-centre study, stratified by recruitment location. Patients will be randomised to either the Pain Management group (control) or the Pain Management and Training group (intervention). As illustrated in Figure ?Figure2,2, the study is designed to include a secondary data assessment 12 months after baseline; the primary outcome assessment will be performed immediately after the intervention program 4 months after baseline. The study utilises an allocation concealment process, ensuring that the group to which the patient is allocated is not known before the patient is entered into the study. The outcome assessors and data analysts will be kept blinded to the allocation to intervention or control group.

Figure 2: Flowchart of the patients in the study.

Settings

The participants will be recruited from physiotherapy clinics in Denmark and from The Spine Centre of Southern Denmark, Hospital Lilleb�lt via an announcement at the clinics and the Hospital. Using physiotherapy clinics spread across Denmark, the patients will receive the intervention locally. The physiotherapy clinics in Denmark receive patients via referral from their general practitioners. The Spine Centre, a unit specialising in treating patients with musculoskeletal dysfunctions and only treating out-patients, receives patients referred from general practitioners and/or chiropractors.

Study Population

Two hundred adults with a minimum age of 18 years, receiving physiotherapy treatment or having been referred for physiotherapy treatment will be recruited. For patients to be eligible, they must have: chronic neck pain for at least 6 months following a whiplash injury, reduced physical neck function (Neck Disability Index score, NDI, of a minimum of 10), pain primarily in the neck region, finished any medical /radiological examinations, the ability to read and understand Danish and the ability to participate in the exercise program. The exclusion criteria include: neuropathies/ radiculopathies (clinically tested by: positive Spurling, cervical traction and plexus brachialis tests) [33], neurological deficits (tested as in normal clinical practice through a process of examining for unknown pathology), engagement in experimental medical treatment, being in an unstable social and/or working situation, pregnancy, known fractures, depression according to the Beck Depression Index (score > 29) [18,34,35], or other known coexisting medical conditions which could severely restrict participation in the exercise program. The participants will be asked not to seek other physiotherapy or cognitive treatment during the study period.

Intervention

Control

The Pain Management (control) group will receive education in pain management strategies. There will be 4 sessions of 11/2 hours, covering topics regarding pain mechanisms, acceptance of pain, coping strategies, and goal-setting, based upon pain management and cognitive therapy concepts [21,26,36].

Intervention

The Pain Management plus Training (intervention) group will receive the same education in pain management as those in the control group plus 8 treatment sessions (instruction in neck exercises and aerobic training) with the same period of 4 months length. If the treating physiotherapist estimates additional treatments are needed, the treatment can be extended with 2 more sessions. Neck training: The treatment of neck-specific exercises will be progressed through different phases, which are defined by set levels of neck function. At the first treatment session, patients are tested for cervical neuromuscular function to identify the specific level at which to start neck training. A specific individually tailored exercise program will be used to target the neck flexor and extensor muscles. The ability to activate the deep cervical neck flexor muscles of the upper cervical region to increase their strength, endurance and stability function is trained progressively via the craniocervical training method using a biopressure feedback transducer [18,37]. Exercises for neck-eye coordination, neck joint positioning, balance and endurance training of the neck muscles will be included as well, since it has been shown to reduce pain and improve sensorimotor control in patients with insidious neck pain [17,38]. Aerobic training: The large trunk and leg muscles will be trained with a gradually increasing physical training program. Patients will be allowed to select activities such as walking, cycling, stick walking, swimming, and jogging. The baseline for training duration is set by exercising 3 times at a comfortable level, that does not exacerbate pain and aims at a rated perceived exertion (RPE) level of between 11 and 14 on a Borg scale [39]. The initial duration of training is set 20% below the average time of the three trials. Training sessions are carried out every second day with a prerequisite that pain is not worsened, and that RPE is between 9 and 14. A training diary is used. If patients do not experience a relapse, and report an average RPE value of 14 or less, the exercise duration for the following period (1 or 2 weeks) is increased by 2-5 minutes, up to a maximum of 30 minutes. If the RPE level is 15 or higher, the exercise duration will be reduced to an average RPE score of 11 to 14 every fortnight [20,40]. By using these pacing principles, the training will be graded individually by the patient, with a focus on perceived exertion – with the aim of increasing the patient’ s general physical activity level and fitness.

Patients’ compliance will be administered by registration of their participation in the control and intervention group. The patients in the control group will be considered to have completed the pain management if they have attended 3 out of 4 sessions. The patiesnts in the intervention group will be considered to have completed if the patient has attended a minimum of 3 out of 4 pain management sessions and a minimum of 5 out of 8 trainings sessions. Each patient’s home training with neck exercises and aerobic training will be registered by him/her in a logbook. Compliance with 75% of the planned home training will be considered as having completed the intervention.

Physiotherapists

The participating physiotherapists will be recruited via an announcement in the Danish Physiotherapy Journal. The inclusion criteria consist of: being a qualified physiotherapist, working at a clinic and having at least two years of working experience as a physiotherapist, having attended a course in the described intervention and passed the related exam.

Outcome Measures

At baseline the participants’ information on age, gender, height and weight, type of accident, medication, development of symptoms over the last two months (status quo, improving, worsening), expectation of treatment, employment and educational status will be registered. As a primary outcome measure, Medical Outcomes Study Short Form 36 (SF36) – Physical Component Summary (PCS) will be used [41,42]. The PCS scales are scored using norm-based methods [43,44] with a mean score of 50 with a standard deviation of 10. The primary outcome with respect to having an effect, will be calculated as a change from baseline [45]. Secondary outcomes contain data on both clinical tests and patient-reported outcomes. Table ?Table11 presents clinical tests for measuring the intervention effect on neuromuscular control of the cervical muscles, cervical function and mechanical allodynia. Table ?Table22 presents the patient-related outcomes from questionnaires used to test for perceived effect of the treatment, neck pain and function, pain bothersomeness, fear of movement, post-traumatic stress and quality of life and potential treatment modifiers.

Table 1: Clinical outcomes used for measurement of treatment effect on muscle strategy, function and treatment modifiers.

Table 2: Patient reported outcomes used for measured of treatment effect on pain and function.

Patients will be tested at baseline, 4 and 12 months after baseline, except for GPE, which will only be measured 4 and 12 months after baseline.

Power and Sample Size Estimation

The power and sample size calculation is based on the primary outcome, being SF36-PCS 4 months after baseline. For a two-sample pooled t-test of a normal mean difference with a two-sided significance level of 0.05, assuming a common SD of 10, a sample size of 86 per group is required to obtain a power of at least 90% to detect a group mean difference of 5 PCS points [45]; the actual power is 90.3%, and the fractional sample size that achieves a power of exactly 90% is 85.03 per group. In order to adjust for an estimated 15% withdrawal during the study period of 4 months, we will include 100 patients in each group. For sensitivity, three scenarios were applied: firstly, anticipating that all 2 � 100 patients complete the trial, we will have sufficient power (> 80%) to detect a group mean difference as low as 4 PCS points; secondly, we will be able to detect a statistically significant group mean difference of 5 PCS points with sufficient power (> 80%) even with a pooled SD of 12 PCS points. Thirdly and finally, if we aim for a group mean difference of 5 PCS points, with a pooled SD of 10, we will have sufficient power (> 80%) with only 64 patients in each group. However, for logistical reasons, new patients will no longer be included in the study 24 months after the first patient has been included.

Randomisation, Allocation and Blinding Procedures

After the baseline assessment, the participants are randomly assigned to either the control group or the intervention group. The randomisation sequence is created using SAS (SAS 9.2 TS level 1 M0) statistical software and is stratified by centre with a 1:1 allocation using random block sizes of 2, 4, and 6. The allocation sequence will be concealed from the researcher enrolling and assessing participants in sequentially numbered, opaque, sealed and stapled envelopes. Aluminium foil inside the envelope will be used to render the envelope impermeable to intense light. After revealing the content of the envelope, both patients and physiotherapists are aware of the allocation and the corresponding treatment. Outcome assessors and data analysts are however kept blinded. Prior to the outcome assessments, the patients will be asked by the research assistant not to mention the treatment to which they have been allocated.

Statistical Analysis

All the primary data analyses will be carried out according to a pre-established analysis plan; all analyses will be done applying SAS software (v. 9.2 Service Pack 4; SAS Institute Inc., Cary, NC, USA). All descriptive statistics and tests are reported in accordance with the recommendations of the ‘Enhancing the QUAlity and Transparency Of health Research’ (EQUATOR) network; i.e., various forms of the CONSORT statement [46]. Data will be analysed using a two-factor Analysis of Covariance (ANCOVA), with a factor for Group and a factor for Gender, using the baseline value as covariate to reduce the random variation, and increase the statistical power. Unless stated otherwise, results will be expressed as the difference between the group means with 95% confidence intervals (CIs) and associated p-values, based on a General Linear Model (GLM) procedure. All the analyses will be performed using the Statistical Package for Social Sciences (version 19.0.0, IBM, USA) as well as the SAS system (v. 9.2; SAS Institute Inc., Cary, NC, USA). A two-way analysis of variance (ANOVA) with repeated measures (Mixed model) will be performed to test the difference over time between the intervention and the control groups; interaction: Group � Time. An alpha-level of 0.05 will be considered as being statistically significant (p < 0.05, two- sided). The data analysts will be blinded to the allocated interventions for primary analyses.

The baseline scores for the primary and secondary outcomes will be used to compare the control and intervention groups. The statistical analyses will be performed on the basis of the intention-to-treat principle, i.e. patients will be analysed in the treatment group to which they were randomly allocated. In the primary analyses, missing data will be replaced with the feasible and transparent ‘Baseline Observation Carried Forward’ (BOCF) technique, and for sensitivity also a multiple imputation technique will apply.

Secondarily, to relate the results to compliance, a ‘per protocol’ analysis will be used as well. The ‘per protocol’ population he patients who have ‘completed’ the intervention to which they were allocated, according to the principles described in the intervention section above.

Ethical Considerations

The Regional Scientific Ethical Committee of Southern Denmark approved the study (S-20100069). The study conformed to The Declaration of Helsinki 2008 [47] by fulfilling all general ethical recommendations.

All subjects will receive information about the purpose and content of the project and give their oral and written consent to participate, with the possibility to drop out of the project at any time.

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Dr. Alex Jimenez’s Insight

Managing stress, anxiety, depression and symptoms of post traumatic stress disorder, or PTSD, after being involved in an automobile accident can be difficult, especially if the incident caused physical trauma and injuries or aggravated a previously existing condition. In many cases, the emotional distress and the psychological issues caused by the incident may be the source of the painful symptoms. In El Paso, TX, many veterans with PTSD visit my clinic after manifesting worsening symptoms from a previous auto accident injury. Chiropractic care can provide patients the proper stress management environment they need to improve their physical and emotional symptoms. Chiropractic care can also treat a variety of auto accident injuries, including whiplash, head and neck injuries, herniated disc and back injuries.

Discussion

This study will contribute to a better understanding of treating patients with chronic neck pain following a whiplash accident. The knowledge from this study can be implemented into clinical practice, as the study is based on a multimodal approach, mirroring the approach, which in spite of the current lack of evidence, is often used in a clinical physiotherapy setting. The study may also be included in systematic reviews thereby contributing to updating the knowledge about this population and to enhancing evidence-based treatment.

Publishing the design of a study before the study is performed and the results obtained has several advantages. It allows the design to be finalised without its being influenced by the outcomes. This can assist in preventing bias as deviations from the original design can be identified. Other research projects will have the opportunity to follow a similar approach with respect to population, interventions, controls and outcome measurements. The challenges of this study are related to standardising the interventions, treating a non-homogeneous population, defining and standardising relevant outcome measures on a population with long-lasting symptoms and having a population from two different clinical settings. Standardisation of the interventions is obtained by teaching the involved physiotherapists in an instructional course. Population homogeneity will be handled by strict inclusion and exclusion criteria and by monitoring the baseline characteristics of the patients, and differences between groups based on other influences than the intervention/control will be possible to analyse statistically. This research design is composed as an ‘add-on’ design: both groups receive pain education; the intervention group receives additional physical training, including specific neck exercises and general training. Today there is insufficient evidence for the effect of treatment for patients with chronic neck pain following a whiplash accident. All participating patients will be referred for a treatment (control or intervention), as we consider it unethical not to offer some form of treatment, i.e. randomising the control group to a waiting list. The add-on design is chosen as a pragmatic workable solution in such a situation [48].

For whiplash patients with chronic pain, the most responsive disability measures (for the individual patient, not for the group as a whole) are considered to be the Patient Specific Functional Scale and the numerical rating scale of pain bothersomeness [49]. By using these and NDI (the most often used neck disability measure) as secondary outcome measures, it is anticipated that patient-relevant changes in pain and disability can be evaluated. The population will be recruited from and treated at two different clinical settings: the out-patient clinic of The Spine Centre, Hospital Lilleb�lt and several private physiotherapy clinics. To avoid any influence of the different settings on the outcome measures, the population will be block randomised related to the settings, securing equal distribution of participants from each setting to the two intervention groups.

Competing Interests

The authors declare that they have no competing interests.

Authors’ Contributions

IRH drafted the manuscript. IRH, BJK and KS participated in the design of the study. All contributed to the design. RC, IRH; BJK and KS participated in the power and sample size calculation and in describing the statistical analysis as well as the allocation and randomization procedure. All authors read and approved the final manuscript. Suzanne Capell provided writing assistance and linguistic corrections.

Pre-Publication History

The pre-publication history for this paper can be accessed here: www.biomedcentral.com/1471-2474/12/274/prepub

Acknowledgements

This study has received funding from the Research Fund for the Region of Southern Denmark, the Danish Rheumatism Association, the Research Foundation of the Danish Association of Physiotherapy, the Fund for Physiotherapy in Private Practice, and the Danish Society of Polio and Accident Victims (PTU). The Musculoskeletal Statistics Unit at the Parker Institute is supported by grants from the Oak Foundation. Suzanne Capell provided writing assistance and linguistic correction.

The trial is registered in www.ClinicalTrials.gov identifier NCT01431261.

A Randomized Controlled Trial of Cognitive-Behavioral Therapy for the Treatment of PTSD in the context of Chronic Whiplash

Abstract

Objectives

Whiplash-associated disorders (WAD) are common and involve both physical and psychological impairments. Research has shown that persistent posttraumatic stress symptoms are associated with poorer functional recovery and physical therapy outcomes. Trauma-focused cognitive-behavioral therapy (TF-CBT) has shown moderate effectiveness in chronic pain samples. However, to date, there have been no clinical trials within WAD. Thus, this study will report on the effectiveness of TF-CBT in individuals meeting the criteria for current chronic WAD and posttraumatic stress disorder (PTSD).

Method

Twenty-six participants were randomly assigned to either TF-CBT or a waitlist control, and treatment effects were evaluated at posttreatment and 6-month follow-up using a structured clinical interview, self-report questionnaires, and measures of physiological arousal and sensory pain thresholds.

Results

Clinically significant reductions in PTSD symptoms were found in the TF-CBT group compared with the waitlist at postassessment, with further gains noted at the follow-up. The treatment of PTSD was also associated with clinically significant improvements in neck disability, physical, emotional, and social functioning and physiological reactivity to trauma cues, whereas limited changes were found in sensory pain thresholds.

Discussion

This study provides support for the effectiveness of TF-CBT to target PTSD symptoms within chronic WAD. The finding that treatment of PTSD resulted in improvements in neck disability and quality of life and changes in cold pain thresholds highlights the complex and interrelating mechanisms that underlie both WAD and PTSD. Clinical implications of the findings and future research directions are discussed.

In conclusion, being involved in an automobile accident is an undesirable situation which can result in a variety of physical trauma or injury as well as lead to the development of a number of aggravating conditions. However, stress, anxiety, depression and post traumatic stress disorder, or PTSD, are common psychological issues which may occur as a result of an automobile accident. According to research studies, physical symptoms and emotional distress may be closely connected and treating both physical and emotional injuries could help patients achieve overall health and wellness. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

Curated by Dr. Alex Jimenez

Additional Topics: Back Pain

According to statistics, approximately 80% of people will experience symptoms of back pain at least once throughout their lifetimes. Back pain is a common complaint which can result due to a variety of injuries and/or conditions. Often times, the natural degeneration of the spine with age can cause back pain. Herniated discs occur when the soft, gel-like center of an intervertebral disc pushes through a tear in its surrounding, outer ring of cartilage, compressing and irritating the nerve roots. Disc herniations most commonly occur along the lower back, or lumbar spine, but they may also occur along the cervical spine, or neck. The impingement of the nerves found in the low back due to injury and/or an aggravated condition can lead to symptoms of sciatica.

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EXTRA IMPORTANT TOPIC: Managing Workplace Stress

Mindfulness Interventions for Auto Accident Injuries in El Paso, TX

by spinedoctors | Back Pain, Chiropractic, Neck Pain, Physical Rehabilitation, Randomized Controlled Trial, Stress, Treatments

When you’ve been involved in a car crash, the auto accident injuries resulting from the incident may not always have a physical cause. The emotional distress due to trauma or injury from the impact of an automobile accident may often be so immense, it can lead to a variety of painful symptoms. If such stress is not treated immediately, it could result in the development of psychological conditions. Stress, anxiety, depression and in severe cases, PTSD, or post traumatic stress disorder, are some of the most common psychological issues you may end up encountering after a traumatic auto accident.

Anxiety and Irrational Fears

In several cases, the victim of an automobile accident may develop irrational fears as a result of the incident. As a matter of fact, many of these individuals report experiencing anxiety about getting behind the wheel again. For them, the fear of being in another accident may ultimately cause them to avoid driving altogether. For many other individuals still, the irrational fear of suffering a panic attack while on the road may be the cause for them to avert driving entirely. If the anxiety and irrational fears caused by the emotional distress of an auto accident worsen, it may permanently�discourage a person from driving again.

Depression

It is also possible for people who’ve been involved in an auto accident to develop depression following the incident. In the end, you wind up experiencing psychological trauma as a result of physical trauma. There are numerous symptoms of depression which you might readily recognize. These include problems with sleep, losing your appetite, and headaches. As it becomes worse, however, you might end up feeling sad or hopeless all of the time, which could lead to worsening symptoms.

Post Traumatic Stress Disorder (PTSD)

It’s highly possible for individuals involved in an automobile accident to suffer from post traumatic stress disorder, or PTSD. According to the National Center For PTSD, as much as 9 percent of people who experience auto accident injuries end up suffering from PTSD. Moreover, at least 14 percent of car crash survivors who seek mental health care are experiencing PTSD.

A new research study demonstrated that mindfulness interventions might be just as essential to your health as traditional treatment, especially if you’ve got post traumatic stress disorder, or PTSD. Researchers have demonstrated that chiropractic care can lead to a substantial advancement in the mind-body stress component of a patient’s overall health and wellness.

Chiropractic Care for Auto Accident Injuries

Addressing automobile accident injuries, such as whiplash, which also result in anxiety and irrational fears, depression and especially PTSD, demands a multi-disciplinary strategy. Chiropractic is an alternative treatment option which focuses on injuries and/or conditions of the musculoskeletal and nervous system. A chiropractor commonly utilizes spinal adjustments and manual manipulations to carefully correct spinal misalignments, or subluxations, which could be causing pain and discomfort. By releasing pressure and muscle tension, a doctor of chiropractic, or chiropractor, can help reduce stress and emotional distress which could be causing the individual’s anxiety, irrational fears, depression and PTSD. If further help is required, the chiropractor can recommend patients to the best healthcare specialist to help them with their symptoms. The purpose of the following article is to demonstrate the prevalence of PTSD on individuals involved in a traffic collision as well as to show how mindfulness interventions can ultimately help improve as well as manage the stress symptoms people may experience after a car crash.

Prediction of Post Traumatic Stress Disorder by Immediate Reactions to Trauma: a Prospective Study in Road Traffic Accident Victims

Abstract

Road traffic accidents often cause serious physical and psychological sequelae. Specialists of various medical faculties are involved in the treatment of accident victims. Little is known about the factors which might predict psychiatric disorders, e.g. Posttraumatic Stress Disorder (PTSD) after accidents and how psychological problems influence physical treatment. In a prospective study 179 unselected, consecutively admitted road traffic accident victims were assessed a few days after the accident for psychiatric diagnoses, severity of injury and psychopathology. All were inpatients and had to be treated for bone fractures. At 6-months follow-up assessment 152 (85%) of the patients were interviewed again. Of the patients, 18.4% fulfilled the criteria for Posttraumatic Stress Disorder (DSM-III-R) within 6 months after the accident. Patients who developed PTSD were injured more severely and showed more symptoms of anxiety, depression and PTSD a few days after the accident than patients with no psychiatric diagnosis. Patients with PTSD stayed significantly longer in the hospital than the other patients. Multiple regression analysis revealed that the length of hospitalization was due mainly to a diversity of factors such as severity of injury, severity of accident, premorbid personality and psychopathology. Posttraumatic stress disorder is common after road traffic accidents. Patients with PTSD at follow-up can be identified by findings from early assessment. Untreated psychological sequelae such as PTSD cause longer hospitalization and therefore more costs than in non-PTSD patients.

Trauma-Focused Cognitive Behavior Therapy and Exercise for Chronic Whiplash: Protocol of a Randomized Controlled Trial

Abstract

Introduction:�As a consequence of a road traffic crash, persistent pain and disability following whiplash injury are common and incur substantial personal and economic costs. Up to 50% of people who experience a whiplash injury will never fully recover and up to 30% will remain moderately to severely disabled by the condition. The reason as to why symptoms persist past the acute to sub-acute stage and become chronic is unclear, but likely results from complex interactions between structural injury, physical impairments, and psychological and psychosocial factors. Psychological responses related to the traumatic event itself are becoming an increasingly recognised factor in the whiplash condition. Despite this recognition, there is limited knowledge regarding the effectiveness of psychological interventions, either delivered alone or in combination with physiotherapy, in reducing the physical and pain-related psychological factors of chronic whiplash. Pilot study results have shown positive results for the use of trauma-focused cognitive behaviour therapy to treat psychological factors, pain and disability in individuals with chronic whiplash. The results have indicated that a combined approach could not only reduce psychological symptoms, but also pain and disability.
Aims:�The primary aim of this randomised, controlled trial is to investigate the effectiveness of combined trauma-focused cognitive behavioural therapy, delivered by a psychologist, and physiotherapy exercise to decrease pain and disability of individuals with chronic whiplash and post-traumatic stress disorder (PTSD). The trial also aims to investigate the effectiveness of the combined therapy in decreasing post-traumatic stress symptoms, anxiety and depression.
Participants and Setting:�A total of 108 participants with chronic whiplash-associated disorder (WAD) grade II of > 3 months and < 5 years duration and PTSD (diagnosed with the Clinician Administered PTSD Scale (CAPS) according to the DSM-5) will be recruited for the study. Participants will be assessed via phone screening and in person at a university research laboratory. Interventions will take place in southeast Queensland, Australia and southern Denmark.
Intervention:�Psychological therapy will be delivered once a week over 10 weeks, with participants randomly assigned to either trauma-focused cognitive behavioural therapy or supportive therapy, both delivered by a clinical psychologist. Participants will then receive ten sessions of evidence-based physiotherapy exercise delivered over a 6-week period.
Outcome Measures:�The primary outcome measure is neck disability (Neck Disability Index). Secondary outcomes focus on: pain intensity; presence and severity of PTSD (CAPS V and PTSD Checklist 5); psychological distress (Depression, Anxiety Stress Scale 21); patient perceived functionality (SF-12, Tampa Scale of Kinesiophobia, and Patient-Specific Functional Scale); and pain-specific self-efficacy and catastrophising (Pain Self-Efficacy Questionnaire and Pain Catastrophizing Scale). After psychotherapy (10 weeks after randomisation) and physiotherapy (16 weeks after randomisation), as well as at the 6-month and 12-month follow-ups, a blind assessor will measure the outcomes.
Analysis:�All analyses will be conducted on an intention-to-treat basis. The primary and secondary outcomes that are measured will be analysed using linear mixed and logistic regression models. Any effect of site (Australia or Denmark) will be evaluated by including a site-by-treatment group-by-time interaction term in the mixed models analyses. Effect modification will only be assessed for the primary outcome of the Neck Disability Index.
Discussion:�This study will provide a definitive evaluation of the effects of adding trauma-focused cognitive behaviour therapy to physiotherapy exercise for individuals with chronic WAD and PTSD. This study is likely to influence the clinical management of whiplash injury and will have immediate clinical applicability in Australia, Denmark and the wider international community. The study will also have implications for both health and insurance policy makers in their decision-making regarding treatment options and funding.

Introduction

Persistent pain and disability following whiplash injury as a consequence of a road traffic crash (RTC) is common and incurs substantial personal and economic costs. Up to 50% of people who experience a whiplash injury will never fully recover and up to 30% will remain moderately to severely disabled by the condition [1-3]. Less recognised are the mental health issues that accompany this condition. The prevalence of psychiatric disorders has been shown to be 25% for PTSD, 31% for Major Depressive Episode and 20% for Generalised Anxiety Disorder [4-6]. Whiplash injury accounts for the vast majority of any submitted claims as well as the greatest incurred costs in Queensland compulsory third party scheme [7]. In Australia, Whiplash injuries comprise approximately 75% of all survivable RTC injuries [8] with total costs of more than $950 M per annum [9], exceeding costs for both spinal cord and traumatic brain injury [7]. In Denmark, whiplash costs an estimated 300 million USD per annum if loss of work is included [10].

Neck pain is the cardinal symptom of individuals following whiplash injury. It is now generally accepted that there is an initial peripheral injury of some kind to the neck [11] although the specific injured structure in individual patients is difficult to clinically identify with current imaging techniques. The reason as to why symptoms persist past the acute to sub-acute stage and become chronic is not clear but likely results from complex interactions between structural injury, physical impairments, psychological and psychosocial factors [12]. However it is clear that chronic WAD is a heterogeneous and complex condition involving physical impairments such as movement loss, disturbed movement patterns and sensory disturbances [13] as well as pain related psychological responses such as catastrophizing [14, 15], kinesiophobia [16], activity avoidance and poor self-efficacy for pain control [17]. In addition recent studies have shown that posttraumatic stress symptoms or event related distress is common [18-20]. Thus it would seem logical that interventions targeting both the physical and psychological manifestations of the whiplash condition would be of benefit.

In contrast to many common musculoskeletal pain conditions (e.g. low back pain, non-specific neck pain) whiplash related neck pain usually occurs following a traumatic event, namely a motor vehicle crash. Psychological responses related to the traumatic event itself, posttraumatic stress symptoms, are emerging as an important additional psychological factor in the whiplash condition. Recent data indicates that post-traumatic stress symptoms are prevalent in individuals who have sustained whiplash injuries following motor vehicle accidents [18, 20, 21]. The early presence of posttraumatic stress symptoms have been shown to be associated with poor functional recovery from the injury [13, 18]. Recent data from our laboratory have shown that following whiplash injury 17% of individuals will follow a trajectory of initial moderate/severe posttraumatic stress symptoms that persist for at least 12 months and 43% will follow a trajectory of moderate initial symptoms that decrease but remain at mild to moderate (sub-clinical) levels for at least 12 months (the duration of the study) [4]. See Figure 1. These figures are significant as they are similar to the prevalence of PTSD in individuals admitted to hospital following �more severe� motor vehicle injuries [22].

Figure 1 Data from Whiplash Injured Participants

Figure 1: Data from 155 whiplash injured participants measured at 1, 3, 6 & 12 months post-accident. The Posttraumatic Stress Diagnostic Scale (PDS) was measured at each time point. Group based trajectory modelling identified 3 distinct clinical pathways (trajectories). 1. Chronic moderate/severe (17%) 2. Recovering: initial moderate levels of posttraumatic stress decreasing to mild/ moderate levels. 3. Resilient: negligible symptoms throughout2. PDS symptom score Cut-offs: 1�10 mild, 11�20 moderate, 21�35.

Although chronic WAD is a considerable health problem the number of published randomized controlled trials (RCTs) is very limited [23]. A recent systematic review concluded that there is evidence to suggest that exercise programs are modestly effective in relieving whiplash-related pain, at least over the short term [23]. For example, Stewart et al [24] showed only a 2 point (on a 10 point scale) decrease in pain levels immediately after a 6 week functional exercise management intervention that adhered to pain-related CBT principals but with no significant sustained effects at more long term follow-ups of 6 and 12 months. In a preliminary RCT conducted in our laboratory (published in 2007), a more neck specific exercise approach also delivered only modest effects, in that pain and disability scores decreased by just clinically relevant amounts (8�14% on the Neck disability Index) when compared to a single advice session [25].

The systematic review also concluded that there is conflicting evidence regarding the effectiveness of psychological interventions either delivered alone or in combination with physiotherapy [23]. The studies included in the review were of variable quality and mostly utilized CBT in some format to address pain related cognitions and distress [26, 27]. No study specifically targeted PTSD symptoms.

Thus the seemingly logical proposal of interventions to target the physical and pain�related psychological factors of chronic WAD is not working as well as would be anticipated. This expectation is based on more favourable outcomes with such approaches for other musculoskeletal pain conditions such as low back [28].

In an endeavour to understand why exercise rehabilitation approaches are not very effective for chronic WAD, we undertook a NHMRC (570884) funded randomized controlled trial that included effect modifiers of PTSD symptoms and sensory disturbances. In this larger (n=186) multicentre trial, preliminary analysis indicate that only 30% of patients with chronic WAD and a PTSD diagnosis had a clinically relevant change in Neck Disability Index scores (>10% change) compared to 70% of WAD patients without PTSD following an exercise rehabilitation program. All included participants reported moderate or greater levels of pain and disability indicating that the co-morbid presence of PTSD prevents a good response to physical rehabilitation. We could find no modifying effect of any sensory changes. The results of this study lead us to propose that first treating PTSD and then instituting physical rehabilitation will be a more effective intervention to improve health outcomes for chronic WAD.

Trauma-focused CBT is a highly effective treatment for PTSD symptoms [29] and the Australian Guidelines for Treatment of Acute Stress Disorder and PTSD recommend that individually delivered trauma-focused CBT should be provided to people with these conditions [30]. There is data available to indicate that trauma-focused CBT may potentially have an effect not only on PTSD symptoms but also on pain and disability. The results of a recent empirical examination explored directional relationships between PTSD and chronic pain in 323 survivors of accidents [31]. The results indicated a mutual maintenance of pain intensity and posttraumatic stress symptoms at 5 days post injury but by 6 months post injury (chronic stage), PTSD symptoms impacted significantly on pain but not vice versa. Whilst this study did not specifically focus on whiplash injury, it provides indication that addressing PTSD symptoms in the chronic stage of WAD may allow for a decrease in levels of pain thus facilitating the potential effects of more pain/disability focused approaches to management such as exercise and pain-focused CBT.

Based on our findings of the co-occurrence of PTSD and WAD, we conducted a small pilot study with the aim being to test the effects of trauma-focused CBT on psychological factors, pain and disability in individuals with chronic WAD [32]. Twenty-six participants with chronic WAD and a diagnosis of PTSD were randomly assigned to treatment (n = 13) or no-Intervention (n = 13) control. The treatment group underwent 10 weekly sessions of trauma-focused CBT for PTSD. Assessments of PTSD diagnosis, psychological symptoms, disability, and pain symptoms were made at baseline and post-assessment (10-12 weeks). Following the treatment intervention, there was not only a significant reduction in psychological symptoms (PTSD symptom severity; numbers meeting the diagnostic criteria for PTSD; depression, anxiety and stress scores) but also a significant decrease in pain and disability and improvements in physical function, bodily pain and role physical items of the SF36 (Table 1).

Table 1. Results of pilot randomised control trial

	Trauma-focused CBT	No-intervention Control
Neck Disability Index (0-100)*
Baseline	43.7 (15)	42.8 (14.3)
Post intervention	38.7 (12.6)	43.9 (12.9)
SF-36 Physical Function �
Baseline	55.8 (25.9)	55.4 (28.2)
Post intervention	61.5 (20.1)	51.1 (26.3)
SF -36 Bodily Pain �
Baseline	31.2 (17.2)	22.6 (15.5)
Post intervention	41.8 (18)	28.2 (15.8)
Posttraumatic Stress Disorder Diagnosis (SCID-IV)
Baseline	N= 13 (100%)	N= 13 (100%)
Post intervention	N= 5 (39.5%)	N= 12 (92.3%)

* higher score=worse; �higher scores=better

The results of this study indicate that trauma-focused CBT provided to individuals with chronic WAD has positive effects, not only on psychological status but also on pain and disability the cardinal symptoms of this condition. Whilst the mean change of 5% was marginal in terms of a clinical relevance [33], the effect size for change of the NDI was moderate (d=0.4) and shows promise for a greater effect in a larger sample size [34]. Nevertheless our pilot trial findings suggest that trauma-focused CBT alone will not be enough for successful management of chronic WAD and for this reason our proposed trial will combine this approach with exercise. These findings are potentially ground breaking in the area of whiplash management and it is imperative that they are now tested in a full randomised controlled design.

In summary, we have already shown that individuals with chronic WAD and moderate PTSD symptoms do not respond as well to a physical rehabilitation based intervention as those without PTSD symptoms [25]. Our recent pilot study indicates that trauma-focused CBT has a beneficial effect on both psychological status and pain and disability. We propose that by pre-treating the PTSD, PTSD symptoms and pain related disability will decrease allowing the exercise intervention to be more effective than has been seen to date [24, 25]. Therefore our proposed research will address this identified gap in knowledge by being the first to evaluate the efficacy of a combined trauma-focused CBT intervention followed by exercise for chronic WAD.

The primary aim of this project is to investigate the effectiveness of combined trauma-focused CBT and exercise to decrease pain and disability of individuals with chronic whiplash and PTSD. The secondary aims are to investigate the effectiveness of combined trauma-focused CBT and exercise to decrease posttraumatic stress symptoms, anxiety and depression, and to investigate the effectiveness of trauma-focused CBT alone on posttraumatic stress symptoms and pain/disability.

This trial is expected to commence in June 2015 and completed by December 2018.

Design

This study will be a randomised controlled multi-centre trial evaluating 10 weeks of trauma-focused CBT compared with 10 weeks of supported therapy, each followed by a 6 week exercise program. Outcomes will be measured at 10 weeks, 16 weeks, 6 and 12 months post randomisation. A total of 108 people with chronic whiplash disorder (>3 months, <5 years duration) and PTSD (DSM-5 diagnosed with CAPS) will be enrolled in the study. The assessors measuring outcomes will be blinded to the assigned treatment group allocation. The protocol conforms to CONSORT guidelines.

Figure 2 Study Design

Methods

Participants

A total of 108 participants with chronic whiplash associated disorder (WAD) grade II (symptom duration >3 months and <5 years) and PTSD will be recruited from Southeast Queensland and Zealand, Denmark. Participants will be recruited via:

Advertisements (the Danish national health register, newspaper, newsletter and internet): potential participants will be invited to make contact with project staff.
Physiotherapy and General Medical Practices: the study will be promoted in physiotherapy and medical clinics where project staff already have a relationship. Patients deemed to be appropriate for inclusion will be given an information sheet about the project and invited to contact project staff directly.

There is a two-step process to determining inclusion to this study: initial online/telephone interview followed by a screening clinical examination. The initial interview will identify duration of whiplash injury (inclusion criteria) and moderate pain based on NDI scores, and potential exclusion criteria. Likelihood of PTSD will be based on conservative PCL-5 scores, requiring at least one moderate score per symptom and a minimum score of 30 overall. A description of the project will be provided to all volunteers at the point of initial contact. Volunteers deemed likely to be eligible will be invited to attend a screening clinical examination. If more than four weeks passes between the phone interview and clinical screening than the NDI and PCL-5 measures are to be re-administered.

Prior to undertaking the screening clinical examination, volunteers will be provided with participant information and asked to complete informed consent documentation. During the screening examination, participants who have significant co-morbidity such as serious spinal pathology will be identified and excluded from participation. To screen for serious pathology, a diagnostic triage will be conducted following the Motor Accident Authority of NSW Whiplash Guidelines [35]. The screening examination will also include a clinical interview by a research assistant who will administer the Clinician Administered PTSD scale 5 (CAPS 5) to determine the presence and severity of PTSD [36]. The research assistant will also confirm the absence of exclusion criteria such as past history or current presentation of psychosis, bipolar disorder, organic brain disorder and severe depression substance abuse. If participants report a diagnosis of an exclusion criteria the relevant section of SCID-I will be utilised to clarify diagnosis.

During the initial screen or during treatment, if a participant is identified as being at high risk of self-harm or suicide, they will be referred to appropriate care in accordance with the professional standards of psychologists. Participants who meet the inclusion criteria (NDI >30% and PTSD diagnosis) will then be evaluated on all outcome measures for baseline results. It is possible that volunteers invited to attend the screening clinical examination will not meet the inclusion criteria (NDI >30% and PTSD diagnosis) and will therefore be excluded from further participation. Volunteers will be informed of this possibility during the telephone interview and also during the informed consent process. The Interview will be recorded and a random selection will be assessed for consistency

Inclusion Criteria

Chronic WAD Grade II (no neurological deficit or fracture) [37] of at least 3 months duration but less than 5 years duration
At least moderate pain and disability (>30% on the NDI)
A diagnosis of PTSD (DSM-5, APA, 2013) using the CAPS 5
Aged between 18 and 70 years old
Proficient in written English or Danish (depending on country of participation)

Exclusion Criteria

Known or suspected serious spinal pathology (e.g. metastatic, inflammatory or infective diseases of the spine)
Confirmed fracture or dislocation at the time of injury (WAD Grade IV)
Nerve root compromise (at least 2 of the following signs: weakness/reflex changes/sensory loss associated with the same spinal nerve)
Spinal surgery in the last 12 months
A history or current presentation of psychosis, bipolar disorder, organic brain disorder or severe depression.

Sample Size

We are interested in detecting a clinically important difference between the two interventions, given that baseline values for each group are statistically equivalent as a result of the randomisation. Based on a two-sided t-test a sample of 86 (43 per group) will provide 80% power to detect a significant difference at alpha 0.05 between the group means of 10 points on the 100 point NDI (assuming a SD of 16, based on our pilot data and data from recent trials ). Effects smaller than this are unlikely to be considered clinically worthwhile. Allowing for a 20% loss to follow up by 12 months, we would require 54 participants per treatment group.

Intervention

Randomisation

Participants will be randomly allocated to treatment group. The randomisation schedule will be generated by the study biostatistician. Randomisation will be by random permuted blocks of 4 to 8. Consecutively numbered, sealed, opaque envelopes will be used to conceal randomisation. Group allocation will be performed immediately following completion of baseline measures by an independent (non-blinded) research assistant . This same research assistant will arrange all appointment times with the treating practitioners and the blinded assessor for all outcome measures. Participants will be instructed not to reveal details about their treatment to the examiner in order to assist with blinding. Patients will be scheduled to receive their first treatment within one week of randomisation.

Intervention group – Trauma-focused Cognitive-behavioural therapy (CBT)

A psychological intervention that targets PTSD symptoms will consist of 10 weekly 60-90 minute sessions of individually delivered trauma-focused CBT based on the Australian Guidelines for the treatment of Adults with Acute Stress Disorder and PTSD [38] (see Table 2). Session one will focus on providing psycho-education regarding the common symptoms of PTSD, maintaining factors and providing a rationale for various treatment components. Sessions two and three will continue to develop patient�s knowledge of PTSD symptoms and teach anxiety management strategies including deep breathing and progressive muscle relaxation. Cognitive restructuring which involves challenging unhelpful and irrational thoughts and beliefs will commence in session three and continue throughout treatment. Participants will start prolonged exposure in session four which will be paired with relaxation and cognitive challenging. Session six will introduce graded in-vivo exposure. Relapse prevention will also be included in the final two sessions [12]. Participants will be asked to complete a home practice over the course of their sessions which will be recorded and brought to the next session. Treatment will be delivered by registered psychologists with postgraduate clinical training and experience delivering trauma-focused CBT interventions.

Table 2. Overview of CBT program

Session	Overview
1	Introduction and rationale
2	Relaxation training
3	Relaxation training and cognitive challenging
4 and 5	Cognitive challenging and prolonged exposure
6	Prolonged exposure and in vivo exposure
7 and 8	Prolonged exposure and in-vivo exposure
9	Relapse prevention
10	Relapse prevention and end of treatment

Control group – Supportive Therapy

The first session will involve education about trauma and an explanation of the nature of supportive therapy. The following sessions will include discussions of current problems and general problem-solving skills. Home practice will involve diary keeping of current problems and mood states. Supportive therapy will specifically avoid exposure, cognitive restructuring or anxiety management techniques. If the results of the trial are favourable and participants randomised to this intervention still have a PTSD diagnosis at the 12 month follow-up, they will be offered a referral to a clinical psychologist.

Exercise Program

Following the 10 week psychological therapy sessions (intervention or control), All participants will participate in the same exercise program. The 6-week exercise program will be carried out under supervision from a physiotherapist (2 sessions in each of the first four weeks; and 1 session in week 5 and week 6) and will comprise specific exercises to improve the movement and control of the neck and shoulder girdles as well as proprioceptive and co-ordination exercises (see Table 3). The exercises will be tailored by the physiotherapist for each individual participant.

The program begins with a clinical examination of the cervical muscles and the axio-scapular-girdle muscles and includes tests that assess ability to recruit the muscles in a coordinated manner, tests of balance, cervical kinaesthesia and eye movement control and tests of muscle endurance at low levels of maximum voluntary contraction. The specific impairments that are identified are then addressed with an exercise program that is supervised and progressed by the physiotherapist. This specific treatment program has been described in detail [15] and focuses on activating and improving the co-ordination and endurance capacity of the neck flexor, extensor and scapular muscles in specific exercises and functional tasks, and a graded program directed to the postural control system, including balance exercises, head relocation exercises and exercises for eye movement control.

Participants will also perform the exercises at home, once a day. A log book will be completed by participants to record compliance with the exercises. At the same time, the physiotherapist will guide the subject�s return to normal activities.

Physiotherapists will adhere to cognitive-behavioural principles during training and supervision of all exercises [26]. The cognitive behavioural therapy principles include the encouragement of skill acquisition by modelling, setting progressive goals, self-monitoring of progress, and positive reinforcement of progress. Self-reliance will be fostered by encouraging subjects to engage in problem-solving to deal with difficulties rather than seeking reassurance and advice, by encouraging relevant and realistic activity goals, and by encouraging self-reinforcement. Daily physical activity at home will be encouraged and monitored using a diary. Written and illustrated exercise instructions will be provided.

Table 3. Overview of the exercise program

Week	Sessions per week	Components
1	2	�� Baseline & follow-up assessments to guide initial prescription & progression of program �� Exercise to improve cervical and scapular muscle control, kinaesthesia & balance �� Education and advice �� Daily home program including exercise & graded increase of physical activities �� CBT principles such as goal setting, reinforcement used by physiotherapists �� Discharge session to reinforce progress and plan for continued activity
2	2
3	2
4	2
5	1
6	1

Outcome Measures

At the baseline assessment, personal characteristics such as age, gender, level of education, compensation status, accident date and information about symptoms of whiplash will be collected. The following outcome measures will be assessed by a blind assessor at baseline, 10 weeks, 16 weeks, 6 months and 12 months post randomisation.

The Neck Disability Index (NDI) will be the primary outcome measure [21]. The NDI is a valid measure and reliable measure of neck pain related disability [21] and is recommended for use by the Bone and Joint Decade Neck Pain Task Force [7] and at the recent International Whiplash Summit [11, 16].

Secondary outcome measures include:

Average pain intensity over last week (0-10 scale) [39]
Average pain intensity over last 24 hours (0-10 scale) [39]
Patient�s global impression of recovery (-5 to +5 scale) [39]
Clinician administered PTSD scale 5 (CAPS 5) [40].
The PTSD Checklist (PCL-5) [41]
Depression Anxiety Stress Scale-21 (DASS-21) [42]
Generic measure of health status (SF-12) [43]
Patient-generated measure of disability (Patient-Specific Functional Scale) [44]
Physical measures (cervical range of movement, pressure pain threshold, cold pain threshold)
Pain Catastrophizing Scale (PCS) [45]
Pain Self Efficacy Questionnaire (PSEQ) [46]
Tampa Scale of Kinesiophobia (TSK) [47]

Expectations of a beneficial treatment effect will be measured with the Credibility Expectancy Questionnaire (CEQ) [48] at the first and last week of each treatment. Working alliance as reported by the client and the therapist (psych or physio) will also be measured at the first and last week of each treatment using the Working Alliance Inventory (WAI) [49].

Monitoring of Treatment Sites

Treatment sites will be located in areas easily accessible by public transport. Attempts will be made to have both the psychology and exercise sessions held at the same site. Prior to commencement of the trial, psychologists and physiotherapists at each treatment site will be provided with the appropriate therapist protocol. Psychologists will be trained to implement the CBT program and the supported therapy by senior investigators at a one day workshops. Physiotherapists will be trained by senior investigators to implement the exercise program at a one day workshop.

Prior to starting the trial, the different treatment provider sites and therapists will be provided with a copy of the trial and treatment protocols. Both psychological therapies will be conducted according to a procedural manual. Therapists will be required to record each session as well as complete a checklist of adherence to the protocol. A random sample of these recordings and checklists will be evaluated and ongoing supervision provided by a psychologist on the research team. Physiotherapy exercises will be based on a previous exercise trial for chronic WAD [25]. An audit of the physiotherapy sessions will be conducted twice during the intervention by a senior investigator expert in this area. A handover will occur between psychologist and physiotherapist to maintain continuity of care.

Adverse Events

Apart from the usual ethics committee based provisions for reporting of adverse effects, practitioners will be requested to report any adverse event to the Chief Investigators. Also at the 16 week follow-up, information about adverse effects of treatment will be sought from all subjects using open-ended questioning. At 6 and 12 months follow-up, data relating to the number of recurrences of neck pain, and the number of health care contacts will also be collected.

Statistical Analysis

The study biostatistician will analyse the data in a blinded manner. All analyses will be conducted on an intention to treat basis. The primary and secondary outcomes measured at 10 weeks, 16 weeks, 6 months, and 12 months will be analysed using linear mixed and logistic regression models that will include their respective baseline scores as a covariate, subjects as a random effect and treatment conditions as fixed factors. Diagnostics will be used to examine assumptions, including homogeneity of variances. Effect sizes will be calculated for all measures with an effect size of 0.2 considered small, 0.5 medium and 0.8 large. Alpha will be set at 0.05. Any effect of site (Qld or Denmark) will be evaluated by including a site-by-treatment group-by-time interaction term to the mixed models analyses. Effect modification will only be assessed for the primary outcome of NDI.

Funding

The trial is funded by a NHMRC Project grant 1059310.
The Council of the Danish Victims Fund Project grant 14-910-00013

Potential Significance

This project addresses a problem of major importance to human health. Whiplash is an enormous health burden for both Australia and all countries where there are motor vehicles. Current conservative approaches to the management of chronic WAD have been shown to be only marginally effective. One reason for this may be due to the lack of attention of current practice to the psychological status of whiplash injured patients. This study will provide a definitive evaluation of the effects of adding trauma-focused CBT to exercise for individuals with chronic WAD and PTSD.

This study is likely to influence the clinical management of whiplash injury and will have immediate clinical applicability. Any intervention that may improve health outcomes for individuals with chronic whiplash will have far reaching effects in both Australia and internationally. Our study will also have implications for both health and insurance policy makers in their decision making regarding treatment options and funding. A search of the WHO International Clinical Trials Registry Platform Search Portal on 2/3/13 revealed no planned or completed trial that would duplicate our work.

Conflict of Interest Declaration

The authors declare no conflict of interest.

Role of Psychosocial Stress in Recovery from Common Whiplash

Abstract

It is widely accepted that psychosocial factors are related to illness behaviour and there is some evidence that they may influence the rate of recovery from post-traumatic disorders. The abilities of psychosocial stress, somatic symptoms, and subjectively assessed cognitive impairment to predict delayed recovery from common whiplash were investigated in a follow-up study. 78 consecutive patients referred 7.2 (SD 4.5) days after they had sustained common whiplash in car accidents were assessed for psychosocial stress, negative affectivity, personality traits, somatic complaints, and cognitive impairment by semistructured interview and by several standardised tests. On examination 6 months later 57 patients were fully recovered and 21 had persisting symptoms. The groups’ scores for the independent variables assessed at the baseline examination were compared. Stepwise regression analysis showed that psychosocial factors, negative affectivity, and personality traits were not significant in predicting the outcome. However, initial neck pain intensity, injury-related cognitive impairment, and age were significant factors predicting illness behaviour. This study, which was based on a random sample and which considered many other possible predictive factors as well as psychosocial status, does not support previous findings that psychosocial factors predict illness behaviour in post-trauma patients.

Dr Jimenez White Coat

Dr. Alex Jimenez’s Insight

Being involved in an automobile accident can be a traumatic experience for anyone. From physical injuries and financial problems, to emotional distress, an auto accident can place a heavy burden on those individuals who’ve experienced it, especially if the auto accident injuries begin to take a toll on the mind. Many patients visit my chiropractic office with anxiety, irrational fears, depression and PTSD after being involved in an automobile accident. Learning to trust again to receive chiropractic care can be challenging, but through careful and effective spinal adjustments and manual manipulations, our staff can provide patients with the sense of safety they need to continue treatment and achieve overall health and wellness.

In conclusion,�automobile accidents can cause a variety of physical injuries and conditions, such as whiplash, back pain and headaches, as well as financial issues, however, auto accident injuries and complications can also lead to emotional distress. According to evidence-based research studies, like the one above, emotional distress has been connected to chronic pain symptoms. Fortunately, researchers have conducted numerous research studies to demonstrate how mindfulness interventions, like chiropractic care, can help reduce emotional distress and improve painful symptoms. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

Curated by Dr. Alex Jimenez

Additional Topics: Back Pain

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EXTRA IMPORTANT TOPIC: Managing Workplace Stress

Effectiveness of Mindfulness on Herniated Discs & Sciatica in El Paso, TX

by spinedoctors | Conditions Treated, Herniated Disc, Physical Rehabilitation, Randomized Controlled Trial, Spinal Decompression Treatments, Stress, Treatments

Chronic low back pain is the second most common cause of disability in the United States. Approximately 80 percent of the population will experience back pain at least once throughout their lifetime. The most prevalent causes of chronic low back pain include: herniated discs, sciatica, injuries from lifting heavy objects or any other non-specific spine injury. However, people will often react differently to their symptoms. These differing responses are due to people’s psychological attitudes and outlooks.

Chronic Low Back Pain and the Mind

Stress has been associated with increased pain but your own personal health beliefs and coping strategies can influence your own perception of pain as well. That’s because psychological vulnerabilities can alter your brain and intensify the pain. Additionally, the pain itself can rewire the brain.�When pain first occurs, it impacts the pain-sensitivity brain circuits. When pain becomes persistent, the associated brain activity switches from the pain circuits to circuits that process emotions. That’s why it’s believed that stress, anxiety and depression can cause as well as worsen chronic low back pain.

Managing the Scourge of Chronic Low Back Pain

Fortunately, several stress management methods and techniques can help improve chronic low back pain. Mindfulness is the most common treatment with the best supporting evidence towards improving and managing chronic pain.�A recent study demonstrated that mindfulness-based stress reduction, or MBSR, including mindfulness meditation and other mindfulness interventions, can help reduce back pain and enhance psychological control by increasing brain blood flow to the frontal lobe. Practicing mindfulness involves activating a brain relaxation pathway by intentionally ignoring mental “chatter” and focusing on your breathing.�Cognitive behavioral therapy, or CBT can also be helpful for chronic low back pain. Cognitive behavioral therapy can prevent an acute injury from progressing to chronic low back pain. Hypnosis may also help relieve chronic low back pain. However, CBT and hypnosis have weaker evidence to support their effectiveness on back pain.

Mind Over Matter

So while it may seem that chronic low back pain is all “in your head”, research studies have demonstrated that stress can influence painful symptoms.��Mind� includes �matter,� especially when you consider that the physical �matter� of the brain plays a major role in mindset changes. This is especially true when it comes to the brain-based changes related to low back pain. The purpose of the article below is to demonstrate the effectiveness of mindfulness meditation on chronic low back pain.

Effectiveness of Mindfulness Meditation on Pain and Quality of Life of Patients with Chronic Low Back Pain

Abstract

Background and aim: Recovery of patients with chronic low back pain (LBP) is depended on several physical and psychological factors. Therefore, the authors aimed to examine the efficacy of mindfulness based stress reduction (MBSR) as a mind-body intervention on quality of life and pain severity of female patients with nonspecific chronic LBP (NSCLBP).
Methods: Eighty-eight patients diagnosed as NSCLBP by physician and randomly assigned to experimental (MBSR+ usual medical care) and the control group (usual medical care only). The subjects assessed in 3 times frames; before, after and 4 weeks after intervention by Mac Gil pain and standard brief quality of life scales. Data obtained from the final sample analyzed by ANCOVA using SPSS software.
Results: The findings showed MBSR was effective in reduction of pain severity and the patients who practiced 8 sessions meditation reported significantly lower pain than patients who only received usual medical care. There was a significant effect of the between subject factor group (F [1, 45] = 16.45, P < 0.001) and (F [1, 45] = 21.51, P < 0.001) for physical quality of life and (F [1, 45] = 13.80, P < 0.001) and (F [1, 45] = 25.07, P < 0.001) mental quality of life respectively.
Conclusion: MBSR as a mind-body therapy including body scan, sitting and walking meditation was effective intervention on reduction of pain severity and improvement of physical and mental quality of life of female patients with NSCLBP.
Keywords: Chronic low back pain, mindfulness based stress reduction, pain, quality of life, SF-12

Introduction

In nonspecific low back pain (NSLBP) the pain is not related to conditions such as fractures, spondylitis, direct trauma, or neoplastic, infectious, vascular, metabolic, or endocrine-related although it is a cause of limitation in daily activities due to actual pain or fear of pain.[1] Unfortunately, the majority of LBP patients (80�90%) suffers from nonspecific LBP which leads to considerable pain-related disability and limitation in daily activities.[1,2] Chronic LBP is not only prevalent, but is also a source of great physical disability, role impairment, and diminished psychological well-being and quality of life.[1]

Prior to the current accepted biopsychosocial model, the biomedical model dominated all illness conceptualizations for almost 300 years and still dominates in the popular imagination. First proposed by Engel (1977) the biopsychosocial model acknowledges biological processes but also highlights the importance of experiential and psychological factors in pain. The famous gate control theory of pain[3] also proposed that the brain plays a dynamic role in pain perception as opposed to being a passive recipient of pain signals. They suggested psychological factors can inhibit or enhance sensory flow of pain signals and thus influence the way brain ultimately responds to painful stimulation.[4] If mind processes can change the way the brain processes pain then this holds tremendous potential for psychological intervention to produce reduced pain signals from the brain.

Kabat-Zinn’s et al. (1986) described the process of pain reduction in his paper on mindfulness and meditation. The process of pain reduction occurred by �an attitude of detached observation toward a sensation when it becomes prominent in the field of awareness and to observe with similar detachment the accompanying but independent cognitive processes which lead to evaluation and labeling of the sensation as painful, as hurt.� Thus, by �uncoupling� the physical sensation, from the emotional and cognitive experience of pain, the patient is able to reduce the pain.[5] The patients� descriptions of distraction from pain, identifying maladaptive coping strategies toward pain and heightened awareness of pain sensation leading to behavioral changes are examples of how pain is unassociated with emotion, cognition, and sensation [Figure 1]. Therefore recently these theories attracted several researchers who are working on pain.

Figure 1: Consort diagram.

Mindfulness meditation has roots in Buddhist Vipassana philosophy and practice and has been independently adopted within clinical psychology in Western societies.[6,7,8,9] Recently in Netherlands Veehof et al. conducted a systematic review of controlled and noncontrolled studies on effectiveness of acceptance-based interventions such as mindfulness-based stress reduction program, acceptance and commitment therapy for chronic pain. Primary outcomes measured were pain intensity and depression. Secondary outcomes measured were anxiety, physical well-being and quality of life.[10] Twenty-two studies randomized controlled studies clinical controlled studies without randomization and noncontrolled studies were included totaling 1235 patients with chronic pain. An effect size on pain of (0.37) was found in the controlled studies. The effect on depression was (0.32). The authors concluded that ACT and mindfulness interventions had similar effects to other cognitive-behavioral therapy interventions and that these types of interventions may be a useful alternative or adjunct to current therapies. Chiesa and Serretti also conducted another systematic review on 10 mindfulness interventions.[11] The main findings were that these interventions produced small nonspecific effects in terms of reducing chronic pain and symptoms of depression. When compared to active control groups (support and education) no additional significant effects were noted.

In summary, there is a need for further studies into the specific effects of mindfulness studies on chronic pain. Regarding as the researcher knowledge efficacy of mindfulness has not been explored on quality of life of chronic pain patients in Iran. The authors aimed to examine the impact of mindfulness based stress reduction (MBSR) protocol designed for pain management on quality of life and pain of a homogeneous sample of females with nonspecific chronic LBP (NSCLBP) in comparison of the usual medical care group.

Methods

Sampling

Out of initial female samples aged 30�45 (n = 155) who diagnosed as chronic NSLBP by physicians in physiotherapy centers of Ardebil-Iran at least 6 months before. Only 88 met inclusion criteria and gave consent to participate in the research program. Patients were randomly assigned in small groups to receive MBSR plus medical usual care (experimental group) and medical usual care (control group). Some patients dropped during and after the treatment. The final sample of the study comprised of 48 females.

Inclusion Criteria

Age 30�45 years
Being under medical treatments like physiotherapy and medicine
Medical problem-history of NSCLBP and persisting pain for at least 6 months
Language – Persian
Gender – female
Qualification – educated at least up to high school
Consent and willingness to alternative and complementary therapies for pain management.

Exclusion Criteria

History of spine surgery
Combination with other chronic disease
Psychotherapy in the last 2 years excluded
Unavailability in next 3 months.

The proposal of study approved by the scientific committee of �Panjab University,� psychology department and all patients signed consent to participate in the present study. The study approved in India (in the university which researcher done her PhD), but conducted in Iran because researcher is from Iran originally and there was language and culture difference problem. Approval from Institutional Ethics Committee of physiotherapy center of Ardebil was obtained in Iran also to carry out the research.

Design

The study made use of the pre-post quasi time series experimental design to assess the efficacy of MBSR in 3 times frames (before-after-4 weeks after the program). A MBSR program administered one session per week for explaining techniques, practice, and feedback and share their experience for 8 weeks beside 30�45 min� daily home practice [Table 1]. The intervention was conducted in three groups included 7�9 participants in each group. The process of framing the program was based on the quid lines provided by Kabat-Zinn, Morone (2008a, 2008b and 2007)[6,12,13,14] and some adaptation done for the patients involved in the study. The control group was not offered any type of intervention in the research project. Consequently, they underwent the normal routines in healthcare including physiotherapy and medicine.

Table 1: Content of MBSR sessions.

Intervention

The sessions conducted in a private physiatrist clinic near to physiotherapy centers. Sessions took 8 weeks, and each session lasted for 90 min. Meditation transformed the patients� awareness through the techniques of breathing and mindfulness. The intervention was conducted in small groups included 7�9 participants in each group. Table 1 for details of session’s content which prepared according books and previous studies.[6,12,13,14]

Assessments

The questionnaire completed by patients before the intervention, after intervention and 4 weeks after the interventions. The receptor of physiotherapy centers conducted the assessment. The receptors trained before conducting the assessment, and they were blind for the hypothesis of the study. The following are used for assessment of participants:

McGill Pain Questionnaire

The main component of this scale consists of 15 descriptive adjectives, 11 sensory including: Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot-burning, Aching, Heavy, Tender, Splitting, and four affective including: Tiring-exhausting, Sickening, Fearful, Punishing-cruel, which are rated by the patients according to their severity on a four point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe), yielding three scores. The sensory and affective scores are calculated by adding sensory and affective item values separately, and the total score is the sum of the two above-mentioned scores. In this study, we just used pain rating index with total scores. Adelmanesh et al.,[15] translated and validated Iran version of this questionnaire.

Quality of Life (SF-12)

The quality of life assessed by the validated SF-12 Health Survey.[16] It was developed as a shorter, quicker-to-complete alternative to the SF-36v2 Health Survey and measures the same eight health constructs. The constructs are: Physical functioning; role physical; bodily pain; general health; vitality; social functioning; role emotional; and mental health. Items have five response choices (for example: All of the time, most of the time, some of the time, a little of the time, none of the time), apart from two questions for which there are three response choices (for the physical functioning domain). Four items are reverse scored. Summed raw scores in the eight domains are transformed to convert the lowest possible score to zero and the highest possible score to 100. Higher scores represent better health and well-being. The standard form SF-12 uses a time frame of the past 4 weeks.[16]

The Iranian version of SF-12 in Montazeri et al. (2011) study showed satisfactory internal consistency for both summary measures, that are the Physical Component Summary (PCS) and the Mental Component Summary (MCS); Cronbach’s ? for PCS-12 and MCS-12 was 0.73 and 0.72, respectively. The known – group comparison showed that the SF-12 discriminated well between men and women and those who differed in age and educational status (P < 0.001) 2.5.[17]

Statistical Analysis

The SPSS 20 (Armonk, NY: IBM Corp) was used to analysis of data. For descriptive analysis mean, standard deviation (SD) used. For performing ANCOVA, the pretest scores were used as covariates.

Results

The mean age was 40.3, SD = 8.2. 45% of females were working and the rest were a house wife. 38% had two children, 55% one child and the rest did have children. All were married and from middle-income families. 9.8% of patients reported very low physical quality of life, and the rest were low (54.8%) and moderate (36.4%). This was 12.4%, 40% and 47.6% very low, low and medium levels of mental quality of life in patients participated in our study (n = 48). The mean and SD of patients in MBSR and control group showed a decrease in pain and increase in mental and physical quality of life [Table 2].

Table 2: Mean and SD of patients in pain, mental and physical quality of life in baseline, after intervention and 4 weeks after intervention.

Comparative Results

Pain. The results indicated that after adjusting for pretest scores, there was a significant effect of the between subject factor group (F [1, 45] =110.4, P < 0.001) and (F [1, 45] =115.8, P < 0.001). Adjusted post-test scores suggest that the intervention had an effect on increasing the pain scores of the NSCLBP patients who received the MBSR as compared to those who were in the control group and did not receive any mind-body therapy [Table 3].

Table 3: The result of comparison of pain and quality of life of MBSR and control group after intervention (time 1) and 4 weeks after intervention (time 2).

Quality of life. The results shows that after adjusting for pretest scores, there was a significant effect of the between subject factor group (F [1, 45] =16.45, P < 0.001) and (F [1, 45] =21.51, P < 0.001). Adjusted post-test scores suggest that the intervention had an effect on increasing the physical quality of life scores of the NSCLBP patients who received the MBSR as compared to those who were in the control group and did not receive any mind-body therapy [Table 3].

The results also showed that after adjusting for pretest scores, there was a significant effect of the between subject factor group (F [1, 45] =13.80, P < 0.001) and (F [1, 45] =25.07, P < 0.001). Adjusted post-test scores suggest that the intervention had an effect on increasing the mental quality of life scores of the NSCLBP patients who received the MBSR as compared to those who were in the control group and did not receive any psychological therapy [Table 3].

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Dr. Alex Jimenez’s Insight

Mindfulness is the psychological process which involves�activating a brain relaxation pathway by intentionally ignoring mental “chatter”, bringing one’s attention to experiences occurring in the present moment and focusing on your breathing. Mindfulness can commonly be achieved through the practice of meditation and stress management methods and techniques. According to research studies, mindfulness is an effective treatment option which can help decrease chronic low back pain. Researchers have previously compared mindfulness-based stress reduction, or MBSR, with cognitive behavioral therapy to determine whether these mindfulness interventions could improve chronic low back pain. The following article was also conducted to determine if mindfulness meditation is an effective treatment option for chronic low back pain. The results of both research studies were promising, demonstrating that mindfulness can be more effective for chronic low back pain than traditional treatment options as well as the use of drugs and/or medication.

Discussion

The results showed that the experimental group who were subjected to the MBSR showed a significant improvement in their overall pain severity, physical and mental quality of life scores due to the training received as compared to the control group who received only usual medical care. The program reduced pain perception and enhanced both physical and mental quality of life and impacted on the experimental group clearly in comparison of the usual medical care. Baranoff et al., 2013,[18] Nykl�cek and Kuijpers, 2008,[19] and Morone (2) et al., 2008[20] reported the same results.

Kabat-Zinn et al. believed the process of pain reduction occurred by �uncoupling� the physical sensation, from the emotional and cognitive experience of pain, the patient is able to reduce the pain.[21] In the current study, the participants uncoupled the different components of the experience of pain. Breathing exercise distract their mind from pain to breathing and mindful living made them aware about maladaptive coping strategies.

In the first session, information given about the fundamentals of mindfulness, describing the mindfulness supporting attitudes included being nonjudgmental toward thought, emotions or sensations as they arise, patience, nonstriving, compassion, acceptance and curiosity gave them a wisdom and believe that they are suffering from painful thoughts more than the pain itself.

Furthermore, during body scan practice they learned to see their real body conditions, as it truly was, without trying to change the reality. Accepting their chronic illness condition helped them see the other possible abilities in their social and emotional roles. In fact the body scan practice helped them change the relationship with their body and pain. Through direct experience in body scan, one realizes the interconnection between the state of the mind and the body, and thereby increases patients� self-control over their life. Mindful living techniques also improved their quality of life by teaching them to pay more attention to their daily life necessities, which led to the experience of subtle positive emotions, like peace and joy, self-esteem and confidence. Furthermore, they appreciated positive things. Once they learned to see the persistent pain objectively and observe other sensations in their body, they applied the same principles through mindful living techniques in their everyday life. As a result, they learned how to manage their health and began to engage in their duties mindfully.

A number of research studies such as Plews-Ogan et al.,[22] Grossman et al.,[23] and Sephton et al., (2007)[24] showed effectiveness of mindfulness meditation program on quality of life of patients with chronic pain conditions.

Conclusion

All together the result of this study and previous studies highlighted the effectiveness of complementary and alternative treatment for patients with chronic LBP. Regarding the considerable role of quality of life in professional and personal life designing the effective psychotherapies especially for enhancement of quality of life of patients with chronic LBP strongly suggested by the authors.

This study involved with several limitations such as ununiformed usual care received by patients. The provided physiotherapy sessions or methods and medicine prescribed by different physicians in slightly different manner. Although some patients commonly dose not completed physiotherapy sessions. The sample size was small and it was only limited to three centers. This is suggested for future researchers to conduct study with considering physiologic variables such as MRI, NMR and neurologic signals to test the efficacy of MBSR to decrease pain sufferer.

In conclusion, more evidence-based larger scale researches with longer-term follow-up need to be done to increase the therapeutic weight and value of MBSR as a part of complementary alternative medicine being preventive and rehabilitation method among CLBP patients.

Acknowledgement

We are thankful from patients who were corporate with us. Dr. Afzalifard and staff of physiotherapy centers of Ardebil.

Footnotes

Source of support: Nil.
Conflict of interest: None declared.

In conclusion,�mindfulness�is the most prevalent treatment with the best supporting evidence towards improving and managing chronic low back pain. Mindfulness interventions, such as mindfulness-based stress reduction and cognitive behavioral therapy, have demonstrated to be effective for chronic low back pain. Furthermore, mindfulness meditation was also demonstrated to effectively help improve as well as manage chronic low back pain caused by stress. However, further research studies are still required to determine a solid outcome measure for mindfulness interventions and chronic pain. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

Curated by Dr. Alex Jimenez

Additional Topics: Back Pain

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EXTRA IMPORTANT TOPIC: Managing Workplace Stress

Effects of Stress Management Treatment for Low Back Pain in El Paso, TX

by spinedoctors | Chiropractic, Physical Rehabilitation, Randomized Controlled Trial, Stress, Treatments

Chiropractic care is a well-known alternative treatment option commonly used for a variety of injuries and/or conditions, including low back pain and sciatica. Of course, not all pain is physical nor does it always have a physical cause. Stress, anxiety and depression affects millions of people each year. While many patients require prescription drug therapy to treat their mental health issues, others may be able to control and treat they symptoms with a holistic approach. Chiropractic care is an effective stress management treatment which can help reduce symptoms associated with stress, such as low back pain and sciatica.

How Does Stress Affect the Body?

There are 3 major categories of stress: bodily, environmental and emotional.

Bodily stress: Caused by lack of sleep, disease, trauma or injury, and an improper nutrition.
Environmental stress: Caused by loud noises (sudden or sustained), pollution and world events, such as war and politics.
Emotional stress: Caused by a variety of life events, such as moving homes, starting a new job and regular personal interactions. In contrast to the other two categories of stress, however, people can have some control over their emotional stress. Such can depend on the individual’s own attitude.

Stress can affect the human body in a variety of ways, both positively and negatively, physically and emotionally. Although short-term stress can be helpful, long-term stress can cause many cumulative health issues on both the mind and body. Stress activates the “fight or flight” response, a defense mechanism triggered by the sympathetic nervous system to prepare the body for perceived danger by increasing heart rate and breathing as well as the senses, by way of instance, eyesight can become more acute. Once the stressor goes away, the central nervous system relays the message to the body and the vitals return to normal.

In several instances, the central nervous system can fail to relay the signal to the body when it is time to return to its relaxed state. Many people also experience persistent, recurrent stress, referred to as chronic stress. Either occurrence takes a toll on the human body. This type of stress can often lead to pain, anxiety, irritability and depression.

Managing Your Stress

Chronic stress can cause painful symptoms, such as low back pain and sciatica, which can then cause more stress. Pain generally contributes to mood issues, such as anxiety and depression, clouded thought processes, and an inability to concentrate. Individuals with chronic stress who experience painful symptoms may feel unable to perform and engage in regular activities.

Stress management treatment can help people improve as well as manage their chronic stress and its associated symptoms. Chiropractic care can help reduce pain and muscle tension, further decreasing stress. The central nervous system can also benefit from the effects of chiropractic treatment. The central nervous system, or CNS, helps regulate mood, as well as full-body health and wellness, meaning that a balanced central nervous system can help enhance overall well-being.

Benefits of Chiropractic Care

Chiropractic care is a holistic treatment approach, designed to return the body to the original state it needs to maintain the muscles and joints functioning properly. Chronic stress can cause muscle tension along the back, which can eventually lead to spinal misalignments. A misalignment of the spine, or a subluxation, can contribute to a variety of symptoms, including nausea and vomiting, headaches and migraines, stress and digestive issues. A chiropractor utilized spinal adjustments and manual manipulations to release pressure and decrease the inflammation around the spine to improve nerve function and allow the body to heal itself naturally. Alleviating pain can ultimately help decrease stress and enhance overall health and wellness. Chiropractic care can also include massage as well as counseling to help control stress, anxiety and depression.

A Holistic Care Approach

Most chiropractors will utilize other treatment methods and techniques, such as physical therapy, exercise, and nutrition advice, to further increase the stress management effects of chiropractic care. These lifestyle changes affect every area of your well-being. Furthermore, the purpose of the article below is to demonstrate the effects of mindfulness-based stress reduction compared to cognitive-behavioral therapy and usual care on stress with associated symptoms of chronic low back pain and sciatica.

Effects of Mindfulness-Based Stress Reduction vs Cognitive-Behavioral Therapy and Usual Care on Back Pain and Functional Limitations among Adults with Chronic Low Back Pain: A Randomized Clinical Trial

Abstract

Importance

Mindfulness-based stress reduction (MBSR) has not been rigorously evaluated for young and middle-aged adults with chronic low back pain.

Objective

To evaluate the effectiveness for chronic low back pain of MBSR versus usual care (UC) and cognitive-behavioral therapy (CBT).

Design, Setting, and Participants

Randomized, interviewer-blind, controlled trial in integrated healthcare system in Washington State of 342 adults aged 20�70 years with CLBP enrolled between September 2012 and April 2014 and randomly assigned to MBSR (n = 116), CBT (n = 113), or UC (n = 113).

Interventions

CBT (training to change pain-related thoughts and behaviors) and MBSR (training in mindfulness meditation and yoga) were delivered in 8 weekly 2-hour groups. UC included whatever care participants received.

Main Outcomes and Measures

Co-primary outcomes were the percentages of participants with clinically meaningful (?30%) improvement from baseline in functional limitations (modified Roland Disability Questionnaire [RDQ]; range 0 to 23) and in self-reported back pain bothersomeness (0 to 10 scale) at 26 weeks. Outcomes were also assessed at 4, 8, and 52 weeks.

Results

Among 342 randomized participants (mean age, 49 (range, 20�70); 225 (66%) women; mean duration of back pain, 7.3 years (range 3 months to 50 years), <60% attended 6 or more of the 8 sessions, 294 (86.0%) completed the study at 26 weeks and 290 (84.8%) completed the study 52weeks. In intent-to-treat analyses, at 26 weeks, the percentage of participants with clinically meaningful improvement on the RDQ was higher for MBSR (61%) and CBT (58%) than for UC (44%) (overall P = 0.04; MBSR versus UC: RR [95% CI] = 1.37 [1.06 to 1.77]; MBSR versus CBT: 0.95 [0.77 to 1.18]; CBT versus UC: 1.31 [1.01 to 1.69]. The percentage of participants with clinically meaningful improvement in pain bothersomeness was 44% in MBSR and 45% in CBT, versus 27% in UC (overall P = 0.01; MBSR versus UC: 1.64 [1.15 to 2.34]; MBSR versus CBT: 1.03 [0.78 to 1.36]; CBT versus UC: 1.69 [1.18 to 2.41]). Findings for MBSR persisted with little change at 52 weeks for both primary outcomes.

Conclusions and Relevance

Among adults with chronic low back pain, treatment with MBSR and CBT, compared with UC, resulted in greater improvement in back pain and functional limitations at 26 weeks, with no significant differences in outcomes between MBSR and CBT. These findings suggest that MBSR may be an effective treatment option for patients with chronic low back pain.

Introduction

Low back pain is a leading cause of disability in the U.S. [1]. Despite numerous treatment options and greatly increased medical care resources devoted to this problem, the functional status of persons with back pain in the U.S. has deteriorated [2, 3]. There is need for treatments with demonstrated effectiveness that are low-risk and have potential for widespread availability.

Psychosocial factors play important roles in pain and associated physical and psychosocial disability [4]. In fact, 4 of the 8 non-pharmacologic treatments recommended for persistent back pain include �mind-body� components [4]. One of these, cognitive-behavioral therapy (CBT), has demonstrated effectiveness for various chronic pain conditions [5�8] and is widely recommended for patients with chronic low back pain (CLBP). However, patient access to CBT is limited. Mindfulness-Based Stress Reduction (MBSR) [9], another �mind-body� approach, focuses on increasing awareness and acceptance of moment-to-moment experiences, including physical discomfort and difficult emotions. MBSR is becoming increasingly popular and available in the U.S. Thus, if demonstrated beneficial for CLBP, MBSR could offer another psychosocial treatment option for the large number of Americans with this condition. MBSR and other mindfulness-based interventions have been found helpful for a range of conditions, including chronic pain [10�12]. However, only one large randomized clinical trial (RCT) has evaluated MBSR for CLBP [13], and that trial was limited to older adults.

This RCT compared MBSR with CBT and usual care (UC). We hypothesized that adults with CLBP randomized to MBSR would show greater short- and long-term improvement in back pain-related functional limitations, back pain bothersomeness, and other outcomes, as compared with those randomized to UC. We also hypothesized that MBSR would be superior to CBT because it includes yoga, which has been found effective for CLBP [14].

Methods

Study Design, Setting, and Participants

We previously published the Mind-Body Approaches to Pain (MAP) trial protocol [15]. The primary source of participants was Group Health (GH), a large integrated healthcare system in Washington State. Letters describing the trial and inviting participation were mailed to GH members who met the electronic medical record (EMR) inclusion/exclusion criteria, and to random samples of residents in communities served by GH. Individuals who responded to the invitations were screened and enrolled by telephone (Figure 1). Potential participants were told that they would be randomized to one of �two different widely-used pain self-management programs that have been found helpful for reducing pain and making it easier to carry out daily activities� or to continued usual care plus $50. Those assigned to MBSR or CBT were not informed of their treatment allocation until they attended the first session. We recruited participants from 6 cities in 10 separate waves.

Figure 1: Flow of participants through trial comparing mindfulness-based stress reduction with cognitive-behavioral therapy and usual care for chronic low back pain.

We recruited individuals 20 to 70 years of age with non-specific low back pain persisting at least 3 months. Persons with back pain associated with a specific diagnosis (e.g., spinal stenosis), with compensation or litigation issues, who would have difficulty participating (e.g., unable to speak English, unable to attend classes at the scheduled time and location), or who rated pain bothersomeness <4 and/or pain interference with activities <3 on 0�10 scales were excluded. Inclusion and exclusion criteria were assessed using EMR data for the previous year (for GH enrollees) and screening interviews. Participants were enrolled between September 2012 and April 2014. Due to slow enrollment, after 99 participants were enrolled, we stopped excluding persons 64�70 years old, GH members without recent visits for back pain, and patients with sciatica. The trial protocol was approved by the GH Human Subjects Review Committee. All participants gave informed consent.

Randomization

Immediately after providing consent and completing the baseline assessment, participants were randomized in equal proportions to MBSR, CBT, or UC. Randomization was stratified by the baseline score (?12 versus ?13, 0�23 scale) of one of the primary outcome measures, the modified Roland Disability Questionnaire (RDQ) [16]. Participants were randomized within these strata in blocks of 3, 6, or 9. The stratified randomization sequence was generated by the study biostatistician using R statistical software [17], and the sequence was stored in the study recruitment database and concealed from study staff until randomization.

Interventions

All participants received any medical care they would normally receive. Those randomized to UC received $50 but no MBSR training or CBT as part of the study and were free to seek whatever treatment, if any, they desired.

The interventions were comparable in format (group), duration (2 hours/week for 8 weeks, although the MBSR program also included an optional 6-hour retreat), frequency (weekly), and number of participants per group [See reference 15 for intervention details]. Each intervention was delivered according to a manualized protocol in which all instructors were trained. Participants in both interventions were given workbooks, audio CDs, and instructions for home practice (e.g., meditation, body scan, and yoga in MBSR; relaxation and imagery in CBT). MBSR was delivered by 8 instructors with 5 to 29 years of MBSR experience. Six of the instructors had received training from the Center for Mindfulness at the University of Massachusetts Medical School. CBT was delivered by 4 licensed Ph.D.-level psychologists experienced in group and individual CBT for chronic pain. Checklists of treatment protocol components were completed by a research assistant at each session and reviewed weekly by a study investigator to ensure all treatment components were delivered. In addition, sessions were audio-recorded and a study investigator monitored instructors� adherence to the protocol in person or via audio-recording for at least one session per group.

MBSR was modelled closely after the original MBSR program [9], with adaptation of the 2009 MBSR instructor�s manual [18] by a senior MBSR instructor. The MBSR program does not focus specifically on a particular condition such as pain. All classes included didactic content and mindfulness practice (body scan, yoga, meditation [attention to thoughts, emotions, and sensations in the present moment without trying to change them, sitting meditation with awareness of breathing, walking meditation]). The CBT protocol included CBT techniques most commonly applied and studied for CLBP [8, 19�22]. The intervention included (1) education about chronic pain, relationships between thoughts and emotional and physical reactions, sleep hygiene, relapse prevention, and maintenance of gains; and (2) instruction and practice in changing dysfunctional thoughts, setting and working towards behavioral goals, relaxation skills (abdominal breathing, progressive muscle relaxation, guided imagery), activity pacing, and pain coping strategies. Between-session activities included reading chapters of The Pain Survival Guide [21]. Mindfulness, meditation, and yoga techniques were proscribed in CBT; methods to challenge dysfunctional thoughts were proscribed in MBSR.

Follow-Up

Trained interviewers masked to treatment group collected data by telephone at baseline (before randomization) and 4 (mid-treatment), 8 (post-treatment), 26 (primary endpoint), and 52 weeks post-randomization. Participants were compensated $20 for each interview.

Measures

Sociodemographic and back pain information was obtained at baseline (Table 1). All primary outcome measures were administered at each time-point; secondary outcomes were assessed at all time-points except 4 weeks.

Table 1: Baseline characteristics of participants by treatment group.

Co�primary Outcomes

Back pain-related functional limitation was assessed by the RDQ [16], modified to 23 (versus the original 24) items and to ask about the past week rather than today only. Higher scores (range 0�23) indicate greater functional limitation. The original RDQ has demonstrated reliability, validity, and sensitivity to clinical change [23]. Back pain bothersomeness in the past week was measured by a 0�10 scale (0 = �not at all bothersome,� 10 = �extremely bothersome�). Our primary analyses examined the percentages of participants with clinically meaningful improvement (?30% improvement from baseline) [24] on each measure. Secondary analyses compared the adjusted mean change from baseline between groups.

Secondary Outcomes

Depressive symptoms were assessed by the Patient Health Questionnaire-8 (PHQ-8; range, 0�24; higher scores indicate greater severity) [25]. Anxiety was measured using the 2-item Generalized Anxiety Disorder scale (GAD-2; range, 0�6; higher scores indicate greater severity) [26]. Characteristic pain intensity was assessed as the mean of three 0�10 ratings (current back pain and worst and average back pain in the previous month; range, 0�10; higher scores indicate greater intensity) from the Graded Chronic Pain Scale [27]. The Patient Global Impression of Change scale [28] asked participants to rate their improvement in pain on a 7-point scale (�completely gone, much better, somewhat better, a little better, about the same, a little worse, and much worse�). Physical and mental general health status were assessed with the 12-item Short-Form Health Survey (SF-12) (0�100 scale; lower scores indicate poorer health status) [29]. Participants were also asked about their use of medications and exercise for back pain during the previous week.

Adverse Experiences

Adverse experiences were identified during intervention sessions and by follow-up interview questions about significant discomfort, pain, or harm caused by the intervention.

Sample Size

A sample size of 264 participants (88 in each group) was chosen to provide adequate power to detect meaningful differences between MBSR and CBT and UC at 26 weeks. Sample size calculations were based on the outcome of clinically meaningful improvement (?30% from baseline) on the RDQ [24]. Estimates of clinically meaningful improvement in the intervention and UC groups were based on unpublished analyses of data from our previous trial of massage for CLBP in a similar population [30]. This sample size provided adequate power for both co-primary outcomes. The planned sample size provided 90% power to detect a 25% difference between MBSR and UC in the proportion with meaningful improvement on the RDQ, and ?80% power to detect a 20% difference between MBSR and CBT, assuming 30% of UC participants and 55% of CBT participants showed meaningful improvement. For meaningful improvement in pain bothersomeness, the planned sample size provided ?80% power to detect a 21.8% difference between MBSR and UC, and a 16.7% difference between MBSR and CBT, assuming 47.5% in UC and 69.3% in CBT showed meaningful improvement.

Allowing for an 11% loss to follow-up, we planned to recruit 297 participants (99 per group). Because observed follow-up rates were lower than expected, an additional wave was recruited. A total of 342 participants were randomized to achieve a target sample size of 264 with complete outcome data at 26 weeks.

Statistical Analysis

Following the pre-specified analysis plan [15], differences among the three groups on each primary outcome were assessed by fitting a regression model that included outcome measures from all four time-points after baseline (4, 8, 26, and 52 weeks). A separate model was fit for each co-primary outcome (RDQ and bothersomeness). Indicators for time-point, randomization group, and the interactions between these variables were included in each model to estimate intervention effects at each time-point. Models were fit using generalized estimating equations (GEE) [31], which accounted for possible correlation within individuals. For binary primary outcomes, we used a modified Poisson regression model with a log link and robust sandwich variance estimator [32] to estimate relative risks. For continuous measures, we used linear regression models to estimate mean change from baseline. Models adjusted for age, sex, education, pain duration (<1 year versus ?1 year since experiencing a week without back pain), and the baseline score on the outcome measure. Evaluation of secondary outcomes followed a similar analytic approach, although models did not include 4-week scores because secondary outcomes were not assessed at 4 weeks.

We evaluated the statistical significance of intervention effects at each time-point separately. We decided a priori to consider MBSR successful only if group differences were significant at the 26-week primary endpoint. To protect against multiple comparisons, we used the Fisher protected least-significant difference approach [33], which requires that pairwise treatment comparisons are made only if the overall omnibus test is statistically significant.

Because our observed follow-up rates differed across intervention groups and were lower than anticipated (Figure 1), we used an imputation method for non-ignorable nonresponse as our primary analysis to account for possible non-response bias. The imputation method used a pattern mixture model framework using a 2-step GEE approach [34]. The first step estimated the GEE model previously outlined with observed outcome data adjusting for covariates, but further adjusting for patterns of non-response. We included the following missing pattern indicator variables: missing one outcome, missing one outcome and assigned CBT, missing one outcome and assigned MBSR, and missing ?2 outcomes (no further interaction with group was included because very few UC participants missed ?2 follow-up time-points). The second step estimated the GEE model previously outlined, but included imputed outcomes from step 1 for those with missing follow-up times. We adjusted the variance estimates to account for using imputed outcome measures for unobserved outcomes.

All analyses followed an intention-to-treat approach. Participants were included in the analysis by randomization assignment, regardless of level of intervention participation. All tests and confidence intervals were 2-sided and statistical significance was defined as a P-value ? 0.05. All analyses were performed using the statistical package R version 3.0.2 [17].

Results

Figure 1 depicts participant flow through the study. Among 1,767 individuals expressing interest in study participation and screened for eligibility, 342 were enrolled and randomized. The main reasons for exclusion were inability to attend treatment sessions, pain lasting <3 months, and minimal pain bothersomeness or interference with activities. All but 7 participants were recruited from GH. Almost 90% of participants randomized to MBSR and CBT attended at least 1 session, but only 51% in MBSR and 57% in CBT attended at least 6 sessions. Only 26% of those randomized to MBSR attended the 6-hour retreat. Overall follow-up response rates ranged from 89.2% at 4 weeks to 84.8% at 52 weeks, and were higher in the UC group.

At baseline, treatment groups were similar in sociodemographic and pain characteristics except for more women in UC and fewer college graduates in MBSR (Table 1). Over 75% reported at least one year since a week without back pain and most reported pain on at least 160 of the previous 180 days. The mean RDQ score (11.4) and pain bothersomeness rating (6.0) indicated moderate levels of severity. Eleven percent reported using opioids for their pain in the past week. Seventeen percent had at least moderate levels of depression (PHQ-8 scores ?10) and 18% had at least moderate levels of anxiety (GAD-2 scores ?3).

Co-Primary Outcomes

At the 26-week primary endpoint, the groups differed significantly (P = 0.04) in percent with clinically meaningful improvement on the RDQ (MBSR 61%, UC 44%, CBT 58%; Table 2a). Participants randomized to MBSR were more likely than those randomized to UC to show meaningful improvement on the RDQ (RR = 1.37; 95% CI, 1.06�1.77), but did not differ significantly from those randomized to CBT. The overall difference among groups in clinically meaningful improvement in pain bothersomeness at 26 weeks was also statistically significant (MBSR 44%, UC 27%, CBT 45%; P = 0.01). Participants randomized to MBSR were more likely to show meaningful improvement when compared with UC (RR = 1.64; 95% CI, 1.15�2.34), but not when compared with CBT (RR = 1.03; 95% CI, 0.78�1.36). The significant differences between MBSR and UC, and non-significant differences between MBSR and CBT, in percent with meaningful function and pain improvement persisted at 52 weeks, with relative risks similar to those at 26 weeks (Table 2a). CBT was superior to UC for both primary outcomes at 26, but not 52, weeks. Treatment effects were not apparent before end of treatment (8 weeks). Generally similar results were found when the primary outcomes were analyzed as continuous variables, although more differences were statistically significant at 8 weeks and the CBT group improved more than the UC group at 52 weeks (Table 2b).

Table 2A: Co-primary outcomes: Percentage of participants with clinically meaningful improvement in chronic low back pain by treatment group and relative risks comparing treatment groups (Adjusted Imputed Analyses).

Table 2B: Co-primary outcomes: Mean (95% CI) change in chronic low back pain by treatment group and mean (95% CI) differences between treatment groups (Adjusted Imputed Analyses).

Secondary Outcomes

Mental health outcomes (depression, anxiety, SF-12 Mental Component) differed significantly across groups at 8 and 26, but not 52, weeks (Table 3). Among these measures and time-points, participants randomized to MBSR improved more than those randomized to UC only on the depression and SF-12 Mental Component measures at 8 weeks. Participants randomized to CBT improved more than those randomized to MBSR on depression at 8 weeks and anxiety at 26 weeks, and more than the UC group at 8 and 26 weeks on all three measures.

Table 3: Secondary outcomes by treatment group and between-group comparisons (Adjusted Imputed Analyses).

The groups differed significantly in improvement in characteristic pain intensity at all three time-points, with greater improvement in MBSR and CBT than in UC and no significant difference between MBSR and CBT. No overall differences in treatment effects were observed for the SF-12 Physical Component score or self-reported use of medications for back pain. Groups differed at 26 and 52 weeks in self-reported global improvement, with both the MBSR and CBT groups reporting greater improvement than the UC group, but not differing significantly from each other.

Adverse Experiences

Thirty of the 103 (29%) participants attending at least 1 MBSR session reported an adverse experience (mostly temporarily increased pain with yoga). Ten of the 100 (10%) participants who attended at least one CBT session reported an adverse experience (mostly temporarily increased pain with progressive muscle relaxation). No serious adverse events were reported.

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Dr. Alex Jimenez’s Insight

Stress management treatment includes a combination of stress management methods and techniques as well as lifestyle changes to help improve and manage stress and its associated symptoms. Because every person responds to stress in a wide variety of ways, treatment for stress will often vary greatly depending on the specific symptoms the individual is experiencing and according to their grade of severity. Chiropractic care is an effective stress management treatment which helps reduce chronic stress and its associated symptoms by reducing pain and muscle tension on the structures surrounding the spine. A spinal misalignment, or subluxation, can create stress and other symptoms, such as low back pain and sciatica. Furthermore, the results of the article above demonstrated that mindfulness-based stress reduction, or MBSR, is an effective stress management treatment for adults with chronic low back pain.

Discussion

Among adults with CLBP, both MBSR and CBT resulted in greater improvement in back pain and functional limitations at 26 and 52 weeks, as compared with UC. There were no meaningful differences in outcomes between MBSR and CBT. The effects were moderate in size, which has been typical of evidence-based treatments recommended for CLBP [4]. These benefits are remarkable given that only 51% of those randomized to MBSR and 57% of those randomized to CBT attended ?6 of the 8 sessions.

Our findings are consistent with the conclusions of a 2011 systematic review [35] that �acceptance-based� interventions such as MBSR have beneficial effects on the physical and mental health of patients with chronic pain, comparable to those of CBT. They are only partially consistent with the only other large RCT of MBSR for CLBP [13], which found that MBSR, as compared with a time- and attention-matched health education control group, provided benefits for function at post-treatment (but not at 6-month follow-up) and for average pain at 6-month follow-up (but not post-treatment). Several differences between our trial and theirs (which was limited to adults ?65 years and had a different comparison condition) could be responsible for differences in findings.

Although our trial lacked a condition controlling for nonspecific effects of instructor attention and group participation, CBT and MBSR have been shown to be more effective than control and active interventions for pain conditions. In addition to the trial of older adults with CLBP [14] that found MBSR to be more effective than a health education control condition, a recent systematic review of CBT for nonspecific low back pain found CBT to be more effective than guideline-based active treatments in improving pain and disability at short- and long-term follow-ups [7]. Further research is needed to identify moderators and mediators of the effects of MBSR on function and pain, evaluate benefits of MBSR beyond one year, and determine its cost-effectiveness. Research is also needed to identify reasons for session non-attendance and ways to increase attendance, and to determine the minimum number of sessions required.

Our finding of increased effectiveness of MBSR at 26�52 weeks relative to post-treatment for both primary outcomes contrasts with findings of our previous studies of acupuncture, massage, and yoga conducted in the same population as the current trial [30, 36, 37]. In those studies, treatment effects decreased between the end of treatment (8 to 12 weeks) and long-term follow-up (26 to 52 weeks). Long-lasting effects of CBT for CLBP have been reported [7, 38, 39]. This suggests that mind-body treatments such as MBSR and CBT may provide patients with long-lasting skills effective for managing pain.

There were more differences between CBT and UC than between MBSR and UC on measures of psychological distress. CBT was superior to MBSR on the depression measure at 8 weeks, but the mean difference between groups was small. Because our sample was not very distressed at baseline, further research is needed to compare MBSR to CBT in a more distressed patient population.

Limitations of this study must be acknowledged. Study participants were enrolled in a single healthcare system and generally highly educated. The generalizability of findings to other settings and populations is unknown. About 20% of participants randomized to MBSR and CBT were lost to follow-up. We attempted to correct for bias from missing data in our analyses by using imputation methods. Finally, the generalizability of our findings to CBT delivered in an individual rather than group format is unknown; CBT may be more effective when delivered individually [40]. Study strengths include a large sample with adequate statistical power to detect clinically meaningful effects, close matching of the MBSR and CBT interventions in format, and long-term follow-up.

Conclusions

Acknowledgments

Funding/Support: Research reported in this publication was supported by the National Center for Complementary & Integrative Health of the National Institutes of Health under Award Number R01AT006226. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Role of sponsor: The study funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.

Footnotes

Ncbi.nlm.nih.gov/pmc/articles/PMC4914381/

Contributor Information

Daniel C. Cherkin, Group Health Research Institute; Departments of Health Services and Family Medicine, University of Washington.
Karen J. Sherman, Group Health Research Institute; Department of Epidemiology, University of Washington.
Benjamin H. Balderson, Group Health Research Institute, University of Washington.
Andrea J. Cook, Group Health Research Institute; Department of Biostatistics, University of Washington.
Melissa L. Anderson, Group Health Research Institute, University of Washington.
Rene J. Hawkes, Group Health Research Institute, University of Washington.
Kelly E. Hansen, Group Health Research Institute, University of Washington.
Judith A. Turner, Departments of Psychiatry and Behavioral Sciences and Rehabilitation Medicine, University of Washington.

In conclusion,�chiropractic care is recognized as an effective stress management treatment for low back pain and sciatica. Because chronic stress can cause a variety of health issues over time, improving as well as managing stress accordingly is essential towards achieving overall health and wellness. Additionally, as demonstrated in the article above comparing the effects of mindfulness-based stress reduction with cognitive-behavioral therapy and usual care for stress with associated chronic low back pain, mindfulness-based stress reduction, or MBSR, is effective as a stress management treatment. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

Curated by Dr. Alex Jimenez

Additional Topics: Back Pain

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EXTRA IMPORTANT TOPIC: Managing Workplace Stress

Stress Management Techniques for Chronic Pain in El Paso, TX

by spinedoctors | Chronic Pain, Conditions Treated, Randomized Controlled Trial, Treatments

In the modern world, it’s easy to find circumstances to stress about. Whether it involves work, financial issues, health emergencies, relationship problems, media stimulation and/or other factors, stress can begin to weigh in on our overall health and wellness if not managed properly. Also, we often tend to create stress ourselves through poor nutrition and a lack of sleep.

In fact, more than three-fourths of the population in the United States experiences stress on a regular basis, where one-third of those individuals characterize their stress levels as “extreme”. Although short-term stress can be helpful, long-term stress can lead to a variety of health issues. Stress has been considered the cause of so many diseases, healthcare professionals estimate it accounts for half of the country’s healthcare-related expenses, according to the U.S. News & World Report.

How Stress Affects the Body

Stress signals the sympathetic nervous system to trigger the “fight or flight” response, a defense mechanism which prepares the body for perceived danger by causing the heart rate, blood volume and blood pressure to rise. This diverts blood away from the digestive system and limbs. The adrenal glands also secrete a special mixture of hormones and chemicals, including adrenaline, epinephrine and norepinephrine, which could affect an individual’s well-being if they’re constantly being secreted into the body.

Also, chronic stress can cause muscle tension. Excess muscle tension along the neck and back may result in the misalignment of the spine, known as a subluxation, ultimately interfering with the proper function of the nervous system and causing symptoms of back pain and sciatica. Fortunately, a variety of stress management techniques, including chiropractic care and mindfulness meditation, can help reduce chronic pain, commonly associated with chronic stress.

Chiropractic Care for Stress

Chiropractic care is a well-known, alternative treatment option utilized to treat a variety of injuries and conditions associated with the musculoskeletal and nervous system.�Correcting spinal misalignments is the first step for reducing stress. If there is a subluxation in the spine, the nervous system may often not be able to properly send signals throughout the rest of the body. By using spinal adjustments and manual manipulations, a doctor of chiropractic can carefully realign the spine,�releasing muscle tension, soothing irritated spinal nerves and improving blood flow, changes which could will alert the brain to switch off the “fight or flight” response so that the body can return to a more relaxed state.

Furthermore, a chiropractor can also recommend lifestyle modifications, together with spinal adjustments and manual manipulations, to help reduce stress. Nutritional supplementation, rehabilitative exercises, deep-tissue massage, relaxation techniques and posture changes recommended by a chiropractor are several stress management techniques which can help improve symptoms of chronic pain associated with stress. The following article is a systematic review and meta-analysis demonstrating the use of mindfulness medication for chronic pain, including back pain and sciatica.

Mindfulness Meditation for Chronic Pain: Systematic Review and Meta-analysis

Abstract

Background: Chronic pain patients increasingly seek treatment through mindfulness meditation.
Purpose: This study aims to synthesize evidence on efficacy and safety of mindfulness meditation interventions for the treatment of chronic pain in adults.
Method: We conducted a systematic review on randomized controlled trials (RCTs) with meta-analyses using the Hartung-Knapp-Sidik-Jonkman method for random-effects models. Quality of evidence was assessed using the GRADE approach. Outcomes included pain, depression, quality of life, and analgesic use.
Results: Thirty-eight RCTs met inclusion criteria; seven reported on safety. We found low-quality evidence that mindfulness meditation is associated with a small decrease in pain compared with all types of controls in 30 RCTs. Statistically significant effects were also found for depression symptoms and quality of life.
Conclusions: While mindfulness meditation improves pain and depression symptoms and quality of life, additional well-designed, rigorous, and large-scale RCTs are needed to decisively provide estimates of the efficacy of mindfulness meditation for chronic pain.
Electronic supplementary material: The online version of this article (doi:10.1007/s12160-016-9844-2) contains supplementary material, which is available to authorized users.
Keywords: Chronic pain, Mindfulness, Meditation, Systematic review

Introduction

Chronic pain, often defined as pain lasting longer than 3 months or past the normal time for tissue healing [1], can lead to significant medical, social, and economic consequences, relationship issues, lost productivity, and larger health care costs. The Institute of Medicine recognizes pain as a significant public health problem that costs our nation at least $560�635 billion annually, including costs of health care and lost productivity [2]. Further, chronic pain is frequently accompanied by psychiatric disorders such as pain medication addiction and depression that make treatment complicated [3]. The high prevalence and refractory nature of chronic pain, in conjunction with the negative consequences of pain medication dependence, has led to increased interest in treatment plans that include adjunctive therapy or alternatives to medication [4]. One such modality that pain patients are using is mindfulness meditation. Based on ancient Eastern meditation practices, mindfulness facilitates an attentional stance of detached observation. It is characterized by paying attention to the present moment with openness, curiosity, and acceptance [5, 6]. Mindfulness meditation is thought to work by refocusing the mind on the present and increasing awareness of one�s external surroundings and inner sensations, allowing the individual to step back and reframe experiences. Current research using neuroimaging to elucidate neurological mechanisms underlying effects of mindfulness has focused on brain structures such as the posterior cingulate cortex, which appear to be involved in self-referential processing [7, 8]. Clinical uses of mindfulness include applications in substance abuse [9], tobacco cessation [10], stress reduction [11], and treatment of chronic pain [12�14].

Early mindfulness studies in pain patients showed promising outcomes on pain symptoms, mood disturbance, anxiety, and depression, as well as pain-related drug utilization [5]. Numerous systematic reviews on the effects of mindfulness meditation have been published in recent years. Of those that report pain outcomes, several have focused on specific types of pain such as low back pain [13], fibromyalgia [15], or somatization disorder [16]. Others were not limited to RCTs [14, 17]. There have been several comprehensive reviews focused on controlled trials of mindfulness interventions for chronic pain including a review [4] that showed improvements in depressive symptoms and coping, another review [18] on mindfulness for chronic back pain, fibromyalgia, and musculoskeletal pain that showed small positive effects for pain, and the most recent review [19] on various pain conditions which found improvements in pain, pain acceptance, quality of life, and functional status. Authors of these reviews echoed concerns that there is limited evidence for efficacy of mindfulness-based interventions for patients with chronic pain because of methodological issues. They have concluded that additional high-quality research was needed before a recommendation for the use of mindfulness meditation for chronic pain symptoms could be made.

The purpose of this study was to conduct a systematic review and meta-analysis of the effects and safety of mindfulness meditation, as an adjunctive or monotherapy to treat individuals with chronic pain due to migraine, headache, back pain, osteoarthritis, or neuralgic pain compared with treatment as usual, waitlists, no treatment, or other active treatments. Pain was the primary outcome, and secondary outcomes included depression, quality of life, and analgesic use. The systematic review protocol is registered in an international registry for systematic reviews (PROSPERO 2015:CRD42015025052).

Methods

Search Strategy

We searched the electronic databases PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, and Cochrane Central Register of Controlled Trials (CENTRAL) for English-language-randomized controlled trials from inception through June 2016. We combined pain conditions and design terms with the following mindfulness search terms: �Mindfulness� [Mesh]) or �Meditation� [Mesh] or mindfulness* or mindfulness-based or MBSR or MBCT or M-BCT or meditation or meditat* or Vipassana or satipa??h?na or anapanasati or Zen or Pranayama or Sudarshan or Kriya or zazen or shambhala or buddhis*.� In addition to this search and the reference mining of all included studies identified through it, we reference mined prior systematic reviews and retrieved all studies included therein.

Eligibility Criteria

Parallel group, individual or cluster RCTs of adults who report chronic pain were included. Studies where the author defined chronic pain and studies in patients reporting pain for a minimum of 3 months were included. Studies were required to involve mindfulness meditation, either as an adjunctive or monotherapy; studies testing other meditation interventions such as yoga, tai chi, qigong, and transcendental meditation techniques without reference to mindfulness were excluded. Mindfulness interventions that did not require formal meditation, such as acceptance and commitment therapy (ACT) were also excluded. Only studies that reported pain measures or change in analgesic use were included. Dissertations and conference abstracts were excluded.

Procedures

Two independent reviewers screened titles and abstracts of retrieved citations�following a pilot session to ensure similar interpretation of the inclusion and exclusion criteria. Citations judged as potentially eligible by one or both reviewers were obtained as full text. The full text publications were then dually screened against the specified inclusion criteria. The flow of citations throughout this process was documented in an electronic database, and reasons for exclusion of full-text publications were recorded. Data abstraction was also conducted in dual. Risk of bias was assessed using the Cochrane Risk of Bias tool [20]. Other biases related to the US Preventive Services Task Force�s (USPSTF) criteria for internal validity of included studies were assessed [21, 22]. These criteria were used to rate the quality of evidence as good, fair, or poor for each included study.

Meta-Analytic Techniques

When sufficient data were available and statistical heterogeneity was below agreed thresholds [20], we performed meta-analysis to pool efficacy results across included studies for the outcomes of interest and present a forest plot for the main meta-analysis. We used the Hartung-Knapp-Sidik-Jonkman method for random effects meta-analysis using unadjusted means and measures of dispersion [23�25]. For studies reporting multiple pain outcomes, we used specific pain measures, such as the McGill Pain Questionnaire (MPQ) for the main meta-analysis rather than the pain subscale of the SF-36, and average or general pain measures rather than situational measures such as pain at the time of assessment. Due to the small number of adverse events reported, quantitative analysis was not conducted. We conducted subgroup analyses and meta-regressions to address whether there were differences in effect sizes between different interventions types, populations, or when used as monotherapy versus an adjunctive therapy. The quality of the body of evidence was assessed using the GRADE approach [22, 26] by which a determination of high, moderate, low, or very low was made for each major outcome [27].

Results

Description of Included Studies

We identified 744 citations through searches of electronic databases and 11 additional records identified through other sources (see Figure 1). Full texts were obtained for 125 citations identified as potentially eligible by two independent reviewers; 38 RCTs met inclusion criteria. Details of study characteristics are displayed in Table ?1 and effects for individual studies are displayed in Table ?2.

Table 1: Characteristics of included studies.

Table 2: Effects for individual studies.

In total, studies assigned 3536 participants; sample sizes ranged from 19 to 342. Fifteen studies reported an a priori power calculation with targeted sample size achieved, ten studies did not report information about a power calculation, and three studies were unclear in the reporting of a power calculation. Ten studies noted there was insufficient power; the authors considered these pilot studies. The majority of the studies were conducted in North America or Europe. The mean age of participants ranged from 30 (SD, 9.08) to 78 years (SD, 7.1. Eight studies included only female participants.

Medical conditions reported included fibromyalgia in eight studies and back pain in eight studies. (Categories are not mutually exclusive; some studies included patients with different conditions.) Osteoarthritis was reported in two studies and rheumatoid arthritis in three. Migraine headache was reported in three studies and another type of headache in five studies. Three studies reported irritable bowel syndrome (IBS). Eight studies reported other causes of pain and three studies did not specify a medical condition or source of chronic pain.

The total length of the interventions ranged from 3 to 12 weeks; the majority of interventions (29 studies) were 8 weeks in length. Twenty-one studies were conducted on mindfulness-based stress reduction (MBSR) and six on mindfulness-based cognitive therapy (MBCT). Eleven additional studies reported results on other types of mindfulness training. Thirteen RCTs provided the mindfulness intervention as monotherapy, and eighteen utilized a mindfulness intervention as adjunctive therapy, specifying that all participants received this in addition to other treatment such as medication. Seven of the studies were unclear as to whether the mindfulness intervention was monotherapy or adjunctive therapy. Nineteen RCTs used treatment as usual as comparators, thirteen used passive comparators, and ten used education/support groups as comparators. Beyond these common comparators, one study each used stress management, massage, a multidisciplinary pain intervention, relaxation/stretching, and nutritional information/food diaries as comparators; two studies used cognitive-behavioral therapy. Several studies had two comparison arms.

Study Quality and Risk of Bias

The study quality for each included study is displayed in Table ?1. Eleven studies obtained a �good� quality rating [28�38]. Fourteen studies were judged to be of fair quality, primarily due to being unclear in some aspects of the methods [39�52]. Thirteen studies were judged to be poor; ten primarily due to issues with completeness of reporting outcome data such as inadequate or missing intention to treat (ITT) analysis and/or less than 80 % follow-up [53�62] and three due to unclear methods [63�65]. Details of the quality ratings and risk of bias for each included study is displayed in Electronic Supplementary Material 1.

Measures

Studies reported patient pain measures such as the Visual Analog Scale, the SF-36 pain subscale, and McGill Pain Questionnaire. Secondary outcome measures included depression symptoms (e.g., Beck Depression Inventory, Patient Health Questionnaire), physical and mental health-related quality of life (e.g., SF-36 mental and physical components), and functional impairment/disability (e.g., Roland-Morris Disability Questionnaire, Sheehan Disability Scale).

Chronic Pain Treatment Response

Thirty RCTs reported continuous outcome data on scales assessing chronic pain [29, 31�33, 36, 39�49, 51�60, 62�64, 66].

Eight studies met screening inclusion criteria but did not contribute to the meta-analysis because they did not report poolable data [28, 30, 34, 35, 38, 50, 61, 65]. Their study characteristics are displayed in Table ?1, and study level effects along with the reasons they were not in pooled analyses are displayed in Table ?2.

Pain scales and comparators varied from study to study. The median follow-up time was 12 weeks, with a range of 4 to 60 weeks. Figure ?2 displays the results of meta-analysis using data at the longest follow-up for each study. The pooled analysis indicates a statistically significant effect of mindfulness meditation compared with treatment as usual, passive controls, and education/support groups (SMD, 0.32; 95 % CI, 0.09, 0.54; 30 RCTs). Substantial heterogeneity was detected (I 2 = 77.6 %). There was no evidence of publication bias (Begg�s p = 0.26; Egger�s test p = 0.09). To investigate whether the treatment estimate is robust when excluding poor-quality studies and to explore the possible source of the substantial heterogeneity, we conducted a sensitivity analysis including only fair or good quality studies. The improvement remained significant, the effect size was smaller (SMD, 0.19; 95 % CI, 0.03, 0.34; 19 RCTs), and there was less heterogeneity (I 2 = 50.5 %). Meta-regressions showed that changes in pain outcomes in good- (p = 0.42) and fair-quality (p = 0.13) studies were not significantly different from changes in poor-quality studies.

Figure 2: Mindfulness meditation effects on chronic pain.

In subgroup analyses, the effect was not statistically significant at 12 weeks or less (SMD, 0.25; 95 % CI, ?0.13, 0.63; 15 RCTs; I 2 = 82.6 %) but was significant for follow-up periods beyond 12 weeks (SMD, 0.31; 95 % CI, 0.04, 0.59; 14 RCTs, I 2 = 69.0 %). Begg�s test was not statistically significant (p = 0.16) but Egger�s test showed evidence of publication bias (p = 0.04). The quality of evidence that mindfulness meditation is associated with a decrease in chronic pain compared with control is low overall and for both short- and long-term follow-up due to inconsistency, heterogeneity, and possible publication bias. A detailed table displays the quality of evidence for findings for each major outcome in Electronic Supplementary Material 2.

In order to present clinically meaningful results, we calculated the percent change in pain symptoms from baseline to follow-up for mindfulness meditation and comparison groups for each study and displayed findings in Table ?2. We then calculated the overall weighted mean percent change for mindfulness meditation groups versus comparison groups for effects of meditation for pain at longest follow-up. The mean percent change in pain for meditation groups was ?0.19 % (SD, 0.91; min, ?0.48; max, 0.10) while the mean percent change in pain for control groups was ?0.08 % (SD, 0.74; min, ?0.35; max, 0.11). The p value for the difference between groups was significant (p = 0.0031).

Depression

Depression outcomes were reported in 12 RCTs [29, 31, 33, 34, 45, 46, 48, 49, 51�53, 56]. Overall, meditation significantly lowered depression scores as compared with treatment as usual, support, education, stress management, and waitlist control groups (SMD, 0.15; 95 % CI, 0.03, 0.26; 12 RCTs; I 2 = 0 %). No heterogeneity was detected. The quality of evidence was rated as high due to lack of heterogeneity, consistent study results, and precision of effect (small confidence intervals).

Quality of Life

Sixteen studies reported mental health-related quality of life; the effect of mindfulness meditation was significant in the pooled analysis as compared with treatment as usual, support groups, education, stress management, and waitlist controls (SMD, 0.49; 95 % CI, 0.22, 0.76; I 2, 74.9 %). [32�34, 45�49, 52, 54, 56, 59, 60, 62�64]. Sixteen studies measured physical health-related quality of life [32�34, 36, 45�49, 52, 54, 56, 60, 62�64]. Pooled analyses showed a significant effect of mindfulness meditation as compared with treatment as usual, support groups, education, stress management, and waitlist controls (SMD, 0.34; 95 % CI, 0.03, 0.65; I 2, 79.2 %). Both quality-of-life analyses detected substantial heterogeneity, and the quality of evidence was rated as moderate for mental health (small confidence intervals, more consistent results) and low for physical health-related quality of life.

Functional Impairment (Disability Measures)

Four studies reported poolable disability scores from the Roland-Morris Disability Questionnaire and the Sheehan Disability Scale [33, 36, 47, 55]. The difference between the mindfulness and comparison groups in follow-up was not statistically significant (SMD, 0.30; 95 % CI, ?0.02, 0.62; I 2 = 1.7 %), although the results approached significance. No heterogeneity was detected. The quality of evidence was rated low due to imprecision and small total sample size.

Analgesic Use

Only four studies reported use of analgesics as an outcome. In a study of MBSR for treatment of chronic pain due to failed back surgery syndrome [55], at 12-week follow-up, the analgesic medication logs of the intervention group documented a decrease in analgesic use compared with those in the control group (?1.5 (SD = 1.8) vs. 0.4 (SD = 1.1), p = <0.001). A study of mindfulness meditation and cognitive-behavioral therapy vs. usual care for low back pain [35] reported that the mean morphine equivalent dose (mg/day) of opioids was not significantly different between groups at both 8 and 26 weeks. Likewise, a trial of MBSR for back pain [38] found no significant difference between groups in self-reported use of pain medication. Finally, a trial of mindfulness-oriented recovery enhancement (MORE) for chronic pain of various etiologies [44] found intervention participants significantly more likely to no longer meet criteria for opioid use disorder immediately following treatment (p = 0.05); however, these effects were not sustained at 3-month follow-up.

Adverse Events

Only 7 of the 38 included RCTs reported on adverse events. Four stated no adverse events occurred [36, 47, 50, 57]; one described that two participants experienced temporary strong feelings of anger toward their pain condition and two of the participants experienced greater anxiety [46]; two studies recorded mild side effects from yoga and progressive muscle relaxation [35, 38].

Study Characteristic Moderators

Meta-regressions were run to determine if changes in pain outcomes systematically differed by several subcategories. There was no difference in effect on pain between MBSR (16 studies) and MBCT (4 studies; p = 0.68) or other types of mindfulness interventions (10 studies; p = 0.68). When comparing MBSR (16 studies) to all other interventions (14 studies), there was also no difference in effect (p = 0.45). As stated in more detail above, medical conditions reported included fibromyalgia, back pain, arthritis, headache, and irritable bowel syndrome (IBS). Meta-regressions did not suggest differences between headache (six studies) and other conditions (p = 0.93), back pain (eight studies) and other conditions (p = 0.15), and fibromyalgia (eight studies) and other conditions (p = 0.29). Gender composition (% male) had no association with effect on pain (p = 0.26). The total length of the intervention program ranged from 3 to 12 weeks (mean was 8 weeks). Meta-regression did not suggest differences between high-frequency interventions and medium- (p = 0.16) or low-frequency (p = 0.44) interventions. No systematic difference in effect on pain between adjunctive therapy and monotherapy (p = 0.62) or between adjunctive therapy and interventions where this was unclear (p = 0.10) was found. Finally, there was no systematic difference in effect whether the comparator was treatment as usual, waitlist, or another intervention (p = 0.21).

Dr Jimenez White Coat

Dr. Alex Jimenez’s Insight

Chronic stress is a massive issue in the United States and it has had a detrimental impact on the overall health and wellness of the American population. Stress can affect different areas of the body. Stress can increase heart rate and cause rapid breathing, or hyperventilation, as well as muscle tension. Additionally, stress triggers the “fight or flight” response, which causes the sympathetic nervous system to release a mixture of hormones and chemicals into the body. Fortunately, chiropractic care can help with stress management. Chiropractic treatment activates the parasympathetic system which calms the “fight or flight” response. Furthermore, chiropractic care can help reduce muscle tension, improving chronic pain symptoms.

Discussion

In sum, mindfulness meditation was associated with a small effect of improved pain symptoms compared with treatment as usual, passive controls, and education/support groups in a meta-analysis of 30 randomized controlled trials. However, there was evidence of substantial heterogeneity among studies and possible publication bias resulting in a low quality of evidence. The efficacy of mindfulness meditation on pain did not differ systematically by type of intervention, medical condition, or by length or frequency of intervention. Mindfulness meditation was associated with statistically significant improvement in depression, physical health-related quality of life, and mental health-related quality of life. Quality of evidence was high for depression, moderate for mental health-related quality of life, and low for physical health-related quality of life. Only four studies reported on change in analgesic use; results were mixed. Adverse events in the included RCTs were rare and not serious, but the vast majority of studies did not collect adverse events data.

This review has several methodological strengths: an a priori research design, duplicate study selection and data abstraction of study information, a comprehensive search of electronic databases, risk of bias assessments, and comprehensive quality of evidence assessments used to formulate review conclusions. One limitation is that we did not contact individual study authors; results reported in the review are based on published data. We excluded conference abstracts which do not contain enough data to evaluate study quality. In addition, we included only studies published in English.

The included studies had many limitations. Thirteen of the thirty-eight studies were rated as poor quality, primarily due to lack of ITT, poor follow-up, or poor reporting of methods for randomization and concealment of allocation. The authors of ten studies reported inadequate statistical power to detect differences in pain outcomes between mindfulness meditation and the comparator; the authors considered these pilot studies. Ten other studies did not report a power calculation. Sample sizes were small; 15 studies randomized fewer than 50 participants.

More well-designed, rigorous, and large RCTs are needed in order to develop an evidence base that can more decisively provide estimates of its effectiveness. Studies should enroll samples large enough to detect statistical differences in outcomes and should follow-up with participants for 6 to 12 months in order to assess the long-term effects of meditation. Adherence to mindfulness practice and simultaneous use of other therapies should be monitored frequently. Intervention characteristics, including the optimal dose, have also not yet conclusively been established. In order to detect intervention specific effects, studies need to have attention-matched controls. Smaller trials may be conducted to answer these questions. Other outcomes that were outside the scope of this review may be important to explore. As the impact of mindfulness may be related to the appraisal of the pain, it may be useful for future trials to focus primary outcomes on symptoms associated with pain such as quality of life, pain-related interference, pain tolerance, analgesic, and related issues such as opioid craving. Future publications on RCTs of mindfulness meditation should adhere to Consolidated Standards of Reporting Trials (CONSORT) standards.

Only three RCTs attributed minor adverse events to mindfulness meditation. However, only 7 of the 38 included RCTs mentioned whether adverse events were monitored and collected. Thus quality of evidence for adverse events reported in RCTs is inadequate for a comprehensive assessment. Given published reports of adverse events during meditation, including psychosis [67], future trials should actively collect adverse events data. In addition, a systematic review of observational studies and case reports would shed additional light on adverse events during mindfulness meditation.

Further research examining the effect of mindfulness meditation on chronic pain should also focus on better understanding whether there is a minimum frequency or duration of meditation practice for it to be effective. While recent studies have yielded similar positive effects of mindfulness for pain, these effects tend to be small to medium and based on a body of evidence that is, at best, of moderate quality. A potential way to advance research on chronic pain would be to improve intervention and control group descriptions, identify different effects of various components of complex interventions, and work toward a standard criterion for assessing therapeutic gain [68]. Head-to-head trials that compare mindfulness interventions of a similar category but with variations in components or dose may be helpful to tease out the most effective elements of these interventions [69].

Similar to previous reviews in this area, we conclude that while mindfulness meditation interventions showed significant improvements for chronic pain, depression, and quality of life, the weaknesses in the body of evidence prevent strong conclusions. The available evidence did not yield consistent effects for pain outcomes, and few studies were available for forms of mindfulness meditation other than MBSR. Quality of evidence for the efficacy of mindfulness interventions in reducing chronic pain is low. There was higher quality evidence of the efficacy of mindfulness meditation on depression and mental health-related quality-of-life outcomes. This review is consistent with previous reviews concluding that more well-designed, rigorous, and large RCTs are needed in order to develop an evidence base that can more decisively provide estimates of the efficacy of mindfulness meditation for chronic pain. In the meantime, chronic pain continues to pose a tremendous burden on society and individuals. A novel therapeutic approach for chronic pain management such as mindfulness meditation would likely be welcomed by patients suffering from pain.

Electronic Supplementary Material

Ncbi.nlm.nih.gov/pmc/articles/PMC5368208/

Compliance with Ethical Standards

Funding and Disclaimer

The systematic review was sponsored by the Department of Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury (contract number 14-539.2). The findings and conclusions in this manuscript are those of the authors and do not necessarily represent the views of the Department of Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury.

Authors Statement of Conflict of Interest and Adherence to Ethical Standards Authors

Authors Hilton, Hempel, Ewing, Apaydin, Xenakis, Newberry, Colaiaco, Maher, Shanman, Sorbero, and Maglione declare that they have no conflict of interest. All procedures, including the informed consent process, were conducted in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000.

In conclusion,�stress can ultimately affect our overall health and wellness if not managed properly. Fortunately, several stress management techniques, including chiropractic care and mindfulness meditation, can help reduce stress as well as improve chronic pain associated with stress. Chiropractic treatment is an important stress management technique because it can calm the “fight or flight” response associated with chronic stress. The article above also demonstrated how mindfulness meditation can be a fundamental stress management technique for improving overall health and wellness. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

Curated by Dr. Alex Jimenez

Additional Topics: Back Pain

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EXTRA IMPORTANT TOPIC: Managing Workplace Stress

Chiropractic & Stress Management for Back Pain in El Paso, TX

by spinedoctors | Back Pain, Chiropractic, Randomized Controlled Trial, Treatments

Stress is a reality of contemporary living. In a society where work hours are increasing and the media is constantly overloading our senses with the most regent tragedy, it’s no wonder why so many people experience higher levels of stress on a regular basis. Fortunately, more healthcare professionals are implementing stress management methods and techniques as a part of a patient’s treatment. While stress is a natural response which helps prepare the body for danger, constant stress can have negative effects on the body, causing symptoms of back pain and sciatica. But, why does too much stress negatively affect the human body?

First, it’s important to understand how the body perceives stress. There are three basic “channels” through which we perceive stress: environment, body, and emotions. Environmental stress is rather self-explanatory; if you’re walking down a quiet road and you hear a loud bang nearby, your body will perceive that as an immediate danger. That is an environmental stressor. Pollution could be another example of environmental stress because it externally affects the body the more one is exposed to it.

Stress through the body includes disease, lack of sleep and/or improper nutrition. Emotional stress is a little different, since it involves the way our brains interpret certain things. For instance, if someone you work with is being passive-aggressive, you might become stressed. Thoughts such as, “is he mad at me for some reason” or “they must be having a tough morning”, could be perceived as emotional stress. What is unique about emotional stress, however, is that we have control on just how much of it we experience, much more so than environmental or body stressors.

Now that we understand how the body can perceive stress in a variety of ways, we can discuss what effects constant stress can have on our overall health and wellness. When the body is placed under stress, through any of the above mentioned channels, the body’s fight or flight response is triggered. The sympathetic nervous system, or SNS, becomes stimulated, which in turn makes the heart beats faster and all of the body’s senses become more intense. This is a leftover defense mechanism from prehistoric times; that is the reason we’ve survived to today, instead of all becoming lunch for hungry predators out in the wild.

Unfortunately, the real issue is that in contemporary society, people often become overstressed and the human body is unable to differentiate between an immediate threat and a simple societal issue. Over the years many research studies have been conducted to estimate the effect of chronic stress on the human body, with such effects as hypertension, increased risk for heart disease and damage to muscle tissue as well as symptoms of back pain and sciatica.

According to several other research studies, combining stress management methods and techniques with a variety of treatment options can help more effectively improve symptoms and can promote a faster recovery. Chiropractic care is a well-known alternative treatment option utilized to treat a variety of injuries and/or conditions of the musculoskeletal and nervous systems. Because chiropractic treatment focuses on the spine, the root of the nervous system, chiropractic can also help with stress. Among the effects of stress is strain, which may consequently lead to subluxation or misalignment of the spine. Spinal adjustment and manual manipulations can help ease muscle tension, which in turn eases the strain on specific areas of the spine and helps ease subluxation. A balanced spine is a crucial element of handling personal stress. As mentioned before, proper nutrition and sufficient sleep is also a crucial part of stress management, which is chiropractic care offers lifestyle modification advice to further improve the patient’s stress levels as well as decrease their symptoms.

The purpose of the article below is to demonstrate the research study process developed to compare complementary and alternative medicine with conventional mind-body therapies for chronic back pain. The randomized controlled trial was carefully conducted and the details behind the research study have been recorded below. As with other research studies, further evidence-based information may be required to effectively determine the effect of stress management with treatment for back pain.

Comparison of Complementary and Alternative Medicine with Conventional Mind�Body Therapies for Chronic Back Pain: Protocol for the Mind�Body Approaches to Pain (MAP) Randomized Controlled Trial

Abstract

Background

The self-reported health and functional status of persons with back pain in the United States have declined in recent years, despite greatly increased medical expenditures due to this problem. Although patient psychosocial factors such as pain-related beliefs, thoughts and coping behaviors have been demonstrated to affect how well patients respond to treatments for back pain, few patients receive treatments that address these factors. Cognitive-behavioral therapy (CBT), which addresses psychosocial factors, has been found to be effective for back pain, but access to qualified therapists is limited. Another treatment option with potential for addressing psychosocial issues, mindfulness-based stress reduction (MBSR), is increasingly available. MBSR has been found to be helpful for various mental and physical conditions, but it has not been well-studied for application with chronic back pain patients. In this trial, we will seek to determine whether MBSR is an effective and cost-effective treatment option for persons with chronic back pain, compare its effectiveness and cost-effectiveness compared with CBT and explore the psychosocial variables that may mediate the effects of MBSR and CBT on patient outcomes.

Methods/Design

In this trial, we will randomize 397 adults with nonspecific chronic back pain to CBT, MBSR or usual care arms (99 per group). Both interventions will consist of eight weekly 2-hour group sessions supplemented by home practice. The MBSR protocol also includes an optional 6-hour retreat. Interviewers masked to treatment assignments will assess outcomes 5, 10, 26 and 52 weeks postrandomization. The primary outcomes will be pain-related functional limitations (based on the Roland Disability Questionnaire) and symptom bothersomeness (rated on a 0 to 10 numerical rating scale) at 26 weeks.

Discussion

If MBSR is found to be an effective and cost-effective treatment option for patients with chronic back pain, it will become a valuable addition to the limited treatment options available to patients with significant psychosocial contributors to their pain.

Trial Registration

Clinicaltrials.gov Identifier: NCT01467843.

Keywords: Back pain, Cognitive-behavioral therapy, Mindfulness meditation

Background

Identifying cost-effective treatments for chronic low back pain (CLBP) remains a challenge for clinicians, researchers, payers and patients. About $26 billion is spent annually in the United States in direct costs of medical care for back pain [1]. In 2002, the estimated costs of lost worker productivity due to back pain were $19.8 billion [2]. Despite numerous options for evaluating and treating back pain, as well as the greatly increased medical care resources devoted to this problem, the health and functional status of persons with back pain in the United States has deteriorated [3]. Furthermore, both providers and patients are dissatisfied with the status quo [4-6] and continue to search for better treatment options.

There is substantial evidence that patient psychosocial factors, such as pain-related beliefs, thoughts and coping behaviors, can have a significant impact on the experience of pain and its effects on functioning [7]. This evidence highlights the potential value of treatments for back pain that address both the mind and the body. In fact, four of the eight nonpharmacologic treatments recommended by the American College of Physicians and the American Pain Society guidelines for persistent back pain include �mind�body� components [8]. One of these treatments, cognitive-behavioral therapy (CBT), includes mind�body components such as relaxation training and has been found to be effective for a variety of chronic pain problems, including back pain [9-13]. CBT has become the most widely applied psychosocial treatment for patients with chronic back pain. Another mind�body therapy, mindfulness-based stress reduction (MBSR) [14,15], focuses on teaching techniques to increase mindfulness. MBSR and related mindfulness-based interventions have been found to be helpful for a broad range of mental and physical health conditions, including chronic pain [14-19], but they have not been well-studied for chronic back pain [20-24]. Only a few small pilot trials have evaluated the effectiveness of MBSR for back pain [25,26] and all reported improvements in pain intensity [27] or patients� acceptance of pain [28,29].

Further research on the comparative effectiveness and cost-effectiveness of mind�body therapies should be a priority in back pain research for the following reasons: (1) the large personal and societal impact of chronic back pain, (2) the modest effectiveness of current treatments, (3) the positive results of the few trials in which researchers have evaluated mind�body therapies for back pain and (4) the growing popularity and safety, as well as the relatively low cost, of mind�body therapies. To help fill this knowledge gap, we are conducting a randomized trial to evaluate the effectiveness, comparative effectiveness and cost-effectiveness of MBSR and group CBT, compared with usual medical care only, for patients with chronic back pain.

Specific Aims

Our specific aims and their corresponding hypotheses are outlined below.

1. To determine whether MBSR is an effective adjunct to usual medical care for persons with CLBP
Hypothesis 1: Individuals randomized to the MBSR course will show greater short-term (8 and 26 weeks) and long-term (52 weeks) improvement in pain-related activity limitations, pain bothersomeness and other health-related outcomes than those randomized to continued usual care alone.
2. To compare the effectiveness of MBSR and group CBT in decreasing back pain�related activity limitations and pain bothersomeness
Hypothesis 2: MBSR will be more effective than group CBT in decreasing pain-related activity limitations and pain bothersomeness in both the short term and long term. The rationale for this hypothesis is based on (1) the modest effectiveness of CBT for chronic back pain found in past studies, (2) the positive results of the limited initial research evaluating MBSR for chronic back pain and (3) growing evidence that an integral part of MBSR training (but not CBT training)�yoga�is effective for chronic back pain.
3. To identify the mediators of any observed effects of MBSR and group CBT on pain-related activity limitations and pain bothersomeness
Hypothesis 3a: The effects of MBSR on activity limitations and pain bothersomeness will be mediated by increases in mindfulness and acceptance of pain.
Hypothesis 3b: The effects of CBT on activity limitations and pain bothersomeness will be mediated by changes in pain-related cognition (decreases in catastrophizing, beliefs that one is disabled by pain and beliefs that pain signals harm, as well as increases in perceived control over pain and self-efficacy for managing pain) and changes in coping behaviors (increased use of relaxation, task persistence and coping self-statements and decreased use of rest).
4. To compare the cost-effectiveness of MBSR and group CBT as adjuncts to usual care for persons with chronic back pain
Hypothesis 4: Both MBSR and group CBT will be cost-effective adjuncts to usual care.

We will also explore whether certain patient characteristics predict or moderate treatment effects. For example, we will explore whether patients with higher levels of depression are less likely to improve with both CBT and MBSR or whether such patients are more likely to benefit from CBT than from MBSR (that is, whether depression level is a moderator of treatment effects).

Methods/Design

Overview

We are conducting a randomized clinical trial in which individuals with CLBP are randomly assigned to group CBT, a group MBSR course or usual care alone (Figure 1). Participants will be followed for 52 weeks after randomization. Telephone interviewers masked to participants� treatment assignments will assess outcomes 4, 8, 26 and 52 weeks postrandomization. The primary outcomes we will assess are pain-related activity limitations and pain bothersomeness. Participants will be informed that the study researchers are comparing �two different widely used pain self-management programs that have been found helpful for reducing pain and making it easier to carry out daily activities�.

Figure 1: Flowchart of the trial protocol. CBT, Cognitive-behavioral therapy; MBSR, Mindfulness-based stress reduction.

The protocol for this trial has been approved by the Human Subjects Review Committee of the Group Health Cooperative (250681-22). All participants will be required to give their informed consent before enrollment in this study.

Study Sample and Setting

The primary source of participants for this trial will be the Group Health Cooperative (GHC), a group-model, not-for-profit health-care organization that serves over 600,000 enrollees through its own primary care facilities in Washington state. As needed to achieve recruitment goals, direct mailings will be sent to persons 20 to 70 years of age living in the areas served by the GHC.

Inclusion and Exclusion Criteria

We are recruiting individuals from 20 to 70 years of age whose back pain has persisted for at least 3 months. The inclusion and exclusion criteria were developed to maximize the enrollment of appropriate patients while screening out patients who have low back pain of a specific nature (for example, spinal stenosis) or a complicated nature or who would have difficulty completing the study measures or interventions (for example, psychosis). Reasons for exclusion of GHC members were identified on the basis of (1) automated data recorded (using the International Classification of Diseases, Ninth Revision coding system), during all visits over the course of the previous year and (2) eligibility interviews conducted by telephone. For non-GHC members, reasons for exclusion were identified on the basis of telephone interviews. Tables 1 and ?2 list the inclusion and exclusion criteria, respectively, as well as the rationale for each criterion and the information sources.

In addition, we require that participants be willing and able to attend the CBT or MBSR classes during the 8-week intervention period if assigned to one of those treatments, and to respond to the four follow-up questionnaires so that we can assess outcomes.

Recruitment Procedures

Because the study intervention involves classes, we are recruiting participants in ten cohorts consisting of up to forty-five individuals each. We are recruiting participants from three main sources: (1) GHC members who have made visits to their primary care providers for low back pain and whose pain has persisted for at least 3 months, (2) GHC members who have not made a visit to their primary care provider for back pain but who are between the ages of 20 and 70 years and who respond to our nontargeted GHC mailing or our ad in GHC�s twice-yearly magazine and (3) community residents between the ages of 20 and 70 years who respond to a direct mail recruitment postcard.

For the targeted GHC population, a programmer will use GHC�s administrative and clinical electronic databases to identify potentially eligible members with a visit in the previous 3 to 15 months to a provider that resulted in a diagnosis consistent with nonspecific low back pain. These GHC members are mailed a letter and consent checklist that explains the study and eligibility requirements. Members interested in participating sign and return a statement indicating their willingness to be contacted. A research specialist then calls the potential participant to ask questions; determine eligibility; clarify risks, benefits and expected commitment to the study; and request informed consent. After informed consent has been obtained from the individual, the baseline telephone assessment is conducted.

For the nontargeted GHC population (that is, GHC members without visits with back pain diagnoses received within the previous 3 to 15 months but who could possibly have low back pain), a programmer uses administrative and clinical electronic databases to identify potentially eligible members who were not included in the targeted sample described in the preceding paragraph. This population also includes GHC members who respond to an ad in the GHC magazine. The same methods used for the targeted population are then used to contact and screen the potential participants, obtain their informed consent and collect baseline data.

With regard to community residents, we have purchased lists of the names and addresses of a randomly selected sample of people living within our recruitment area who are between 20 and 70 years of age. The people on the list are sent direct mail postcards describing the study including information regarding how to contact study staff if interested in participating. Once an interested person has contacted the research team the same process detailed above is followed.

To ensure that all initially screened study participants remain eligible at the time the classes begin, those who consent more than 14 days prior to the start of the intervention classes will be recontacted approximately 0 to 14 days prior to the first class to reconfirm their eligibility. The primary concern is to exclude persons who no longer have at least moderate baseline ratings of pain bothersomeness and pain-related interference with activities. Those individuals who remain eligible and give their final informed consent will be administered the baseline questionnaire.

Randomization

After completing the baseline assessment, participants will be randomized in equal proportions to the MBSR, CBT or usual care group. Those randomized to the MBSR or CBT group will not be informed of their type of treatment until they arrive at the first classes, which will occur simultaneously in the same building. The intervention group will be assigned on the basis of a computer-generated sequence of random numbers using a program which ensures that allocation cannot be changed after randomization. To ensure balance on a key baseline prognostic factor, randomization will be stratified based on our primary outcome measurement instrument: the modified version of the Roland Disability Questionnaire (RDQ) [30,31]. We will stratify participants into two activity limitations groups: moderate (RDQ score ?12 on a 0 to 23 scale) and high (RDQ scores ?13). Participants will be randomized within these strata in blocks of varying size (three, six or nine) to ensure a balanced but unpredictable assignment of participants. During recruitment, the study biostatistician will receive aggregated counts of participants randomized to each group to assure that the preprogrammed randomization algorithm is functioning properly.

Study Treatments

Both the group CBT and MBSR class series consist of eight weekly 2-hour sessions supplemented by home activities.

Mindfulness-Based Stress Reduction

Mindfulness-based stress reduction, a 30-year-old treatment program developed by Jon Kabat-Zinn, is well-described in the literature [32-34]. The authors of a recent meta-analysis found that MBSR had moderate effect sizes for improving the physical and mental well-being of patients with a variety of health conditions [16]. Our MBSR program is closely modeled on the original one and includes eight weekly 2-hour classes (summarized in Table 3), a 6-hour retreat between weeks 6 and 7 and up to 45 minutes per day of home practice. Our MBSR protocol was adapted by a senior MBSR instructor from the 2009 MBSR instructor�s manual used at the University of Massachusetts [35]. This manual permits latitude in how instructors introduce mindfulness and its practice to participants. The handouts and home practice materials are standardized for this study.

Table 3 Content of CBT and MBSR Class Sessions

Table 3: Content of cognitive-behavioral therapy and mindfulness-based stress reduction class sessions.

Participants will be given a packet of information during the first class that includes a course outline and instructor contact information; information about mindfulness, meditation, communication skills and effects of stress on the body, emotions and behavior; homework assignments; poems; and a bibliography. All sessions will include mindfulness exercises, and all but the first will include yoga or other forms of mindful movement. Participants will be given audio recordings of the mindfulness and yoga techniques, which will have been recorded by their own instructors. Participants will be asked to practice the techniques discussed in each class daily for up to 45 minutes throughout the intervention period and after classes end. They will also be assigned readings to complete before each class. Time will be devoted in each class to a review of challenges that participants have had in practicing what they learned in previous classes and with their homework. An optional day of practice on the Saturday between the sixth and seventh classes will be offered. This 6-hour �retreat� will be held with the participants in silence and only the instructor speaking. This will provide participants an opportunity to deepen what they have learned in class.

Cognitive-Behavioral Therapy

CBT for chronic pain is well-described in the literature and has been found to be modestly to moderately effective in improving chronic pain problems [9-13]. There is no single, standardized CBT intervention for chronic pain, although all CBT interventions are based on the assumption that both cognition and behavior influence adaptation to chronic pain and that maladaptive cognition and behavior can be identified and changed to improve patient functioning [36]. CBT emphasizes active, structured techniques to teach patients how to identify, monitor and change maladaptive thoughts, feelings and behaviors, with a focus on helping patients to acquire skills that they can apply to a variety of problems and collaboration between the patient and therapist. A variety of techniques are taught, including training in pain coping skills (for example, use of positive coping self-statements, distraction, relaxation and problem-solving). CBT also promotes setting and working toward behavioral goals.

Both individual and group formats have been used in CBT. Group CBT is often an important component of multidisciplinary pain treatment programs. We will use a group CBT format because it has been found to be efficacious [37-40], is more resource-efficient than individual therapy and provides patients with the potential benefits deriving from contact with, and support and encouragement from, others with similar experiences and problems. In addition, using group formats for both MBSR and CBT will eliminate intervention format as a possible explanation for any differences observed between the two therapies.

For this study, we developed a detailed therapist�s manual with content specific for each session, as well as a participant�s workbook containing materials for use in each session. We developed the therapist�s manual and participant�s workbooks based on existing published resources as well as on materials we have used in prior studies [39-47].

The CBT intervention (Table 3) will consist of eight weekly 2-hour sessions that will provide (1) education about the role of maladaptive automatic thoughts (for example, catastrophizing) and beliefs (for example, one�s ability to control pain, hurt equals harm) common in people with depression, anxiety and/or chronic pain and (2) instruction and practice in identifying and challenging negative thoughts, the use of thought-stopping techniques, the use of positive coping self-statements and goal-setting, relaxation techniques and coping with pain flare-ups. The intervention will also include education about activity pacing and scheduling and about relapse prevention and maintenance of gains. Participants will be given audio recordings of relaxation and imagery exercises and asked to set goals regarding their relaxation practice. During each session, participants will complete a personal action plan for activities to be completed between sessions. These plans will be used as logs for setting specific home practice goals and checking off activities completed during the week to be reviewed at the next week�s session.

Usual Care

The usual care group will receive whatever medical care they would normally receive during the study period. To minimize possible disappointment with not being randomized to a mind�body treatment, participants in this group will receive $50 compensation.

Class Sites

The CBT and MBSR classes will be held in facilities close to concentrations of GHC members in Washington state (Bellevue, Bellingham, Olympia, Seattle, Spokane and Tacoma).

Instructors

All MBSR instructors will have received either formal training in teaching MBSR from the Center for Mindfulness at the University of Massachusetts or equivalent training. They will themselves be practitioners of both mindfulness and a body-oriented discipline (for example, yoga), will have taught MBSR previously and will have made mindfulness a core component of their lives. The CBT intervention will be conducted by doctorate-level clinical psychologists with previous experience in providing CBT to patients with chronic pain.

Training and Monitoring of Instructors

All CBT instructors will be trained in the study protocol for the CBT intervention by the study�s clinical psychologist investigators (BHB and JAT), who are very experienced in administering CBT to patients with chronic pain. BHB will supervise the CBT instructors. One of the investigators (KJS) will train the MBSR instructors in the adapted MBSR protocol and supervise them. Each instructor will attend weekly supervision sessions, which will include discussion of positive experiences, adverse events, concerns raised by the instructor or participants and protocol fidelity. Treatment fidelity checklists highlighting the essential components for each session were created for both the CBT and MBSR arms. A trained research specialist will use the fidelity checklist during live observation of every session. The research specialist will provide feedback to the supervisor to facilitate weekly supervision of the instructors. In addition, all sessions will be audio-recorded. The supervisors will listen to a random sample and requested portions of sessions and will monitor them using the fidelity checklist. Feedback will be provided to the instructors during their weekly supervision sessions. Treatment fidelity will be monitored in both intervention groups by KJS and BHB with assistance from research specialists. In addition, they will review and rate on the fidelity checklist a random sample of the recorded sessions.

Participant Retention and Adherence to Home Practice

Participants will receive a reminder call before the first class and whenever they miss a class. They will be asked to record their daily home practice on weekly logs. Questions about their home practice during the prior week will also be included in all follow-up interviews. To maintain interviewer blinding, adherence questions will be asked after all outcome data have been recorded.

Measures

We will assess a variety of participant baseline characteristics, including sociodemographic characteristics, back pain history and expectations of the helpfulness of the mind�body treatments for back pain (Table 4).

We will assess a core set of outcomes for patients with spinal disorders (back-related function, pain, general health status, work disability and patient satisfaction) [48] that are consistent with the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials recommendations for clinical trials of chronic pain treatment efficacy and effectiveness [49]. We will measure both short-term outcomes (8 and 26 weeks) and long-term outcomes (52 weeks). We will also include a brief, 4-week, midtreatment assessment to permit analyses of the hypothesized mediators of the effects of MBSR and CBT on the primary outcomes. The primary study endpoint is 26 weeks. Participants will be paid $20 for each follow-up interview completed to maximize response rates.

Co�Primary Outcome Measures

The co�primary outcome measures will be back-related activity limitations and back pain bothersomeness.

Back-related activity limitations will be measured with the modified RDQ, which asks whether 23 specific activities have been limited due to back pain (yes or no) [30]. We have further modified the RDQ to ask a question about the previous week rather than just �today�. The original RDQ has been found to be reliable, valid and sensitive to clinical changes [31,48,50-53], and it is appropriate for telephone administration and use with patients with moderate activity limitations [50].

Back pain bothersomeness will be measured by asking participants to rate how bothersome their back pain has been during the previous week on a 0 to 10 scale (0?=?�not at all bothersome� and 10?=?�extremely bothersome�). On the basis of data compiled from a similar group of GHC members with back pain, we found this bothersomeness measure to be highly correlated with a 0 to 10 measure of pain intensity (r?=?0.8 to 0.9; unpublished data (DCC and KJS) and with measures of function and other outcome measures [54]. The validity of numerical rating scales of pain has been well-documented, and such scales have demonstrated sensitivity in detecting changes in pain after treatment [55].

We will analyze and report these co�primary outcomes in two ways. First, for our primary endpoint analyses, we will compare the percentages of participants in the three treatment groups who achieve clinically meaningful improvement (?30% improvement from baseline) [56,57] at each time point (with 26-week follow-up being the primary endpoint). We will then examine, in a secondary outcome analysis, the adjusted mean differences between groups on these measures at the time of follow-up.

Secondary Outcome Measures

The secondary outcomes that we will measure are depressive symptoms, anxiety, pain-related activity interference, global improvement with treatment, use of medications for back pain, general health status and qualitative outcomes.

Depressive symptoms will be assessed with the Patient Health Questionnaire-8 (PHQ-8) [58]. With the exception of the elimination of a question about suicidal ideation, the PHQ-8 is identical to the PHQ-9, which has been found to be reliable, valid and responsive to change [59,60].

Anxiety will be measured with the 2-item Generalized Anxiety Disorder scale (GAD-2), which has demonstrated high sensitivity and specificity in detecting generalized anxiety disorder in primary care populations [61,62].

Pain-related activity interference with daily activities will be assessed using three items from the Graded Chronic Pain Scale (GCPS). The GCPS has been validated and shown to have good psychometric properties in a large population survey and in large samples of primary care patients with pain [63,64]. Participants will be asked to rate the following three items on a 0 to 10 scale: their current back pain (back pain �right now�), their worst back pain in the previous month and their average pain level over the previous month.

Global improvement with treatment will be measured with the Patient Global Impression of Change scale [65]. This single question asks participants to rate their improvement with treatment on a 7-point scale that ranges from �very much improved� to �very much worse,� with �no change� used as the midpoint. Global ratings of improvement with treatment provide a measure of overall clinical benefit from treatment and are considered one of the core outcome domains in pain clinical trials [49].

Use of medications and exercise for back pain during the previous week will be assessed with the 8-, 26- and 52-week questionnaires.

General health status will be assessed with the 12-item Short Form Health Survey (SF-12) [66], a widely used instrument that yields summary scores for physical and mental health status. The SF-12 will also be used to calculate quality-adjusted life-years (QALYs) using the Short Form Health Survey in 6 dimensions in the cost-effectiveness analyses [67].

Qualitative outcomes will be measured with open-ended questions. We have included open-ended questions in our previous trials and found that they yield valuable insights into participants� feelings about the value of specific components of the interventions and the impact of the interventions on their lives. We therefore will include open-ended questions about these issues at the end of the 8-, 26- and 52-week follow-up interviews.

Measures Used in Mediator Analyses

In the MBSR arm, we will evaluate the mediating effects of increased mindfulness (measured with the Nonreactivity, Observing, Acting with Awareness, and Nonjudging subscales of the Five Facet Mindfulness Questionnaire short form [68-70]) and increased pain acceptance (measured with the Chronic Pain Acceptance Questionnaire [71,72]) on the primary outcomes. In the CBT arm, we will evaluate the mediating effects of improvements in pain beliefs and/or appraisals (measured with the Patient Self-Efficacy Questionnaire [73]; the Survey of Pain Attitudes 2-item Control, Disability, and Harm scales [74-76]; and the Pain Catastrophizing Scale [77-80]) and changes in the use of pain coping strategies (measured with the Chronic Pain Coping Inventory 2-item Relaxation scale and the complete Activity Pacing scale [81,82]) on the primary outcomes. Although we expect the effects of MBSR and CBT on outcomes to be mediated by different variables, we will explore the effects of all potential mediators on outcomes in both treatment groups.

Measures Used in the Cost-Effectiveness Analyses

Direct costs will be estimated using cost data extracted from the electronic medical records for back-related services provided or paid by GHC and from patient reports of care not covered by GHC. Indirect costs will be estimated using the Work Productivity and Activity Impairment questionnaire [83]. The effectiveness of the intervention will be derived from the SF-12 general health status measure [84].

Data Collection, Quality Control and Confidentiality

Data will be collected from participants by trained telephone interviewers using a computer-assisted telephone interview (CATI) version of the questionnaires to minimize errors and missing data. Questions about experiences with specific aspects of the interventions (for example, yoga, meditation, instruction in coping strategies) that would unmask interviewers to treatment groups will be asked at each time point after all other outcomes have been assessed. We will attempt to obtain outcome data from all participants in the trial, including those who never attend or drop out of the classes, those who discontinue enrollment in the health plan and those who move away. Participants who do not respond to repeated attempts to obtain follow-up data by telephone will be mailed a questionnaire including only the two primary outcome measures and offered $10 for responding.

We are will collect information at every stage of recruitment, randomization and treatment so that we can report patient flow according to the CONSORT (Consolidated Standards of Reporting Trials) guidelines [85]. To maintain the confidentiality of patient-related information in the database, unique participant study numbers will be used to identify patient outcomes and treatment data. Study procedures are in place to ensure that all masked personnel will remain masked to treatment group.

Protection of Human Participants and Assessment of Safety

Protection of Human Participants

The GHC Institutional Review Board (IRB) approved this study.

Safety Monitoring

This trial will be monitored for safety by an independent Data and Safety Monitoring Board (DSMB) composed of a primary care physician experienced in mindfulness, a biostatistician and a clinical psychologist with experience in treating patients with chronic pain.

Adverse Experiences

We will collect data on adverse experiences (AEs) from several sources: (1) reports from the CBT and MBSR instructors of any participants� experiences of concern to them; (2) the 8-, 26- and 52-week CATI follow-up interviews in which the participants are asked about any harm they felt during the CBT or MBSR treatment and any serious health problems they had had during the respective time periods; and (3) spontaneous reports from participants. The project coinvestigators and a GHC primary care internist will review AE reports from all sources weekly. Any serious AEs will be reported promptly to the GHC IRB and the DSMB. AEs that are not serious will be recorded and included in regular DSMB reports. Any identified deaths of participants will be reported to the DSMB chair within 7 days of discovery, regardless of attribution.

Stopping Rules

The trial will be stopped only if the DSMB believes that there is an unacceptable risk of serious AEs in one or more of the treatment arms. In this case, the DSMB can decide to terminate one of the arms of the trial or the entire trial.

Statistical Issues

Sample Size and Detectable Differences

Our sample size was chosen to ensure adequate power to detect a statistically significant difference between each of the two mind�body treatment groups and the usual care group, as well as power to detect a statistically significant difference between the two mind�body treatment groups. Because we considered patient activity limitations to be the more consequential of our two co�primary outcome measures, we based our sample size calculations on the modified RDQ [30]. We specified our sample size on the basis of the expected percentage of patients with a clinically meaningful improvement measured with the RDQ at the 26-week assessment (that is, at least 30% relative to baseline) [57].

Because of multiple comparisons, we will use Fisher�s protected least significant difference test [86], first analyzing if there is any significant difference among all three groups (using the omnibus ?2 likelihood ratio test) for each outcome and each time point. If we find a difference, we will then test for pairwise differences between groups. We will need 264 participants (88 in each group) to achieve 90% power to find either mind�body treatment different from usual care on the RDQ. This assumes that 30% of the usual care group and 55% of each mind�body treatment group will have clinically meaningful improvement on the RDQ at 26 weeks, rates of improvement that are similar to those we observed in a similar back pain population in an evaluation of complementary and alternative treatments for back pain [87]. We will have at least 80% power to detect a significant difference between MBSR and CBT on the RDQ if MBSR is at least 20 percentage points more effective than CBT (that is, 75% of the MBSR group versus 55% of the CBT group).

Our other co�primary outcome is the pain bothersomeness rating. With a total sample size of 264 participants, we will have 80% power to detect a difference between a mind�body treatment group and usual care on the bothersomeness rating scale, assuming that 47.5% of usual care and 69.3% of each mind�body treatment group have 30% or more improvement from baseline on the pain bothersomeness rating scale. We will have at least 80% power to detect a significant difference between MBSR and CBT on the bothersomeness rating scale if MBSR is at least 16.7 percentage points more effective than CBT (that is, 87% of the MBSR group versus 69.3% of the CBT group).

When analyzing the primary outcomes as continuous measures, we will have 90% power to detect a 2.4-point difference between usual care and either mind�body treatment on the modified RDQ scale scores and a 1.1-point difference between usual care and either mind�body treatment on the pain bothersomeness rating scale (assumes normal approximation to compare two independent means with equal variances and a two-sided P?=?0.05 significance level with standard deviations of 5.2 and 2.4 for RDQ and pain bothersomeness measures, respectively [88]. Assuming an 11% loss to follow-up (slightly higher than that found in our previous back pain trials), we plan to recruit a sample of 297 participants (99 per group).

Both of the co�primary outcomes will be tested at the P?<?0.05 level at each time point because they address separate scientific questions. Analyses of both outcomes at all follow-up time points will be reported, imposing a more stringent requirement than simply reporting a sole significant outcome.

Statistical Analyses

Primary Analyses

In our comparisons of treatments based on the outcome measures, we will analyze outcomes assessed at all follow-up time points in a single model, adjusting for possible correlation within individuals and treatment group cohorts using generalized estimating equations [89]. Because we cannot reasonably make an assumption regarding constant or linear group differences over time, we will include an interaction term between treatment groups and time points. We plan to adjust for baseline outcome values, sex and age, as well as other baseline characteristics found to differ significantly by treatment group or follow-up outcomes, to improve precision and power of our statistical tests. We will conduct the following set of analyses for both the continuous outcome score and the binary outcome (clinically significant change from baseline), including all follow-up time points (4, 8, 26 and 52 weeks). The MBSR treatment will be deemed successful only if the 26-week time point comparisons are significant. The other time points will be considered secondary evaluations.

We will use an intent-to-treat approach in all analyses; that is, the assessment of individuals will be analyzed by randomized group, regardless of participation in any classes. This analysis minimizes biases that often occur when participants who do not receive the assigned treatments are excluded from analysis. The regression model will be in the following general form:

Regression Model General Form

where yt is the response at follow-up time t, baseline is the prerandomization value of the outcome measure, treatment includes dummy variables for the MBSR and CBT groups, time is a series of dummy variables indicating the follow-up times and z is a vector of covariates representing other variables adjusted for. (Note that ?1, ?2, ?3 and ?4 are vectors.) The referent group in this model is the usual care group. For binary and continuous outcomes, we will use appropriate link functions (for example, logit for binary). For each follow-up time point at which the omnibus ?2 test is statistically significant, we will go on to test whether there is a difference between MBSR and usual care to address aim 1 and a difference between MBSR and CBT to address aim 2. We will also report the comparison of CBT to usual care. When determining whether MBSR is an effective treatment for back pain, we will require that aim 1, the comparison of MBSR to usual care, must be observed.

On the basis of our previous back pain trials, we expect at least an 89% follow-up and, if that holds true, our primary analysis will be a complete case analysis, including all observed follow-up outcomes. However, we will adjust for all baseline covariates that are predictive of outcome, their probability of being missing and differences between treatment groups. By adjusting for these baseline covariates, we assume that the missing outcome data in our model are missing at random (given that baseline data are predictive of missing data patterns) instead of missing completely at random. We will also conduct sensitivity analysis using an imputation method for nonignorable nonresponses to evaluate whether our results are robust enough to compensate for different missing data assumptions [90].

Mediator Analyses If MBSR or CBT is found to be effective (relative to usual care and/or to each other) in improving either primary outcome at 26 or 52 weeks, we will move to aim 3 to identify the mediators of the effects of MBSR and group CBT on the RDQ and pain bothersomeness scale. We will perform the series of mediation analyses separately for the two primary outcomes (RDQ and pain bothersomeness scale scores) and for each separate treatment comparator of interest (usual care versus CBT, usual care versus MBSR and CBT versus MBSR). We will conduct separate mediator analyses for the 26- and 52-week outcomes (if MBSR or CBT is found to be effective at those time points).

Next, we describe in detail the mediator analysis for the 26-week time point. A similar analysis will be conducted for the 52-week time point. We will apply the framework of the widely used approach of Baron and Kenny [91]. Once we have demonstrated the association between the treatment and the outcome variable (the �total effect� of the treatment on the outcome), the second step will be to demonstrate the association between the treatment and each putative mediator. We will construct a regression model for each mediator with the 4- or 8-week score of the mediator as the dependent variable and the baseline score of the mediator and treatment indicator as independent variables. We will conduct this analysis for each potential mediator and will include as potential mediators in the following step only those that have a P-value ?0.10 for the relationship with the treatment. The third step will be to demonstrate the reduction of the treatment effect on the outcome after removing the effect of the mediators. We will construct a multimediator inverse probability weighted (IPW) regression model [92]. This approach will allow us to estimate the direct effects of treatment after rebalancing the treatment groups with respect to the mediators. Specifically, we will first model the probability of the treatment effects, given the mediators (that is, all mediators that were found to be associated with treatment in step 2), using logistic regression and adjusting for potential baseline confounders. Using this model, we will obtain the estimated probability that each person received the observed treatment, given the observed mediator value. We will then use an IPW regression analysis to model the primary outcomes on treatment status while adjusting for the baseline levels of the outcome and mediator. Comparing the weighted model with the unweighted model will allow us to estimate how much of the direct effect of treatment on the associated outcome can be explained by each potential mediator. The inclusion in step 3 of all mediators found to be significant in step 2 will enable us to examine whether the specific variables that we hypothesized would differentially mediate the effects of MBSR versus CBT in fact mediate the effects of each treatment independently of the effects of the other �process variables�.

Cost-Effectiveness Analyses

A societal perspective cost�utility analysis (CUA) will be performed to compare the incremental societal costs revealed for each treatment arm (direct medical costs paid by GHC and the participant plus productivity costs) to incremental effectiveness in terms of change in participants� QALYs [93]. This analysis will be possible only for study participants recruited from GHC. This CUA can be used by policymakers concerned with the broad allocation of health-related resources [94,95]. For the payer perspective, direct medical costs (including intervention costs) will be compared to changes in QALYs. This CUA will help us to determine whether it makes economic sense for MBSR to be a reimbursed service among this population. A bootstrap methodology will be used to estimate confidence intervals [96]. In secondary analyses conducted to assess the sensitivity of the results to different cost outcome definitions, such as varying assumptions of wage rates used to value productivity and the inclusion of non-back-related health-care resource utilization [97] in the total cost amounts, will also be considered. In cost-effectiveness analyses, we will use intention to treat and adjust for health-care utilization costs in the one calendar year prior to enrollment and for baseline variables that might be associated with treatment group or outcome, such as medication use, to control for potential confounders. We expect there will be minimal missing data, but sensitivity analyses (as described above for the primary outcomes) will also be performed to assess cost measures.

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Dr. Alex Jimenez’s Insight

Stress is the body’s response to physical or psychological pressure. Several factors can trigger stress, which in turn activates the “fight or flight” response, a defense mechanism which prepares the body for perceived danger. When stressed, the sympathetic nervous system becomes stimulated and secretes a complex combination of hormones and chemicals. Short-term stress can be helpful, however long-term stress has been connected to a variety of health issues, including back pain and sciatica symptoms. According to research studies, stress management has become an essential addition for many treatment options because stress reduction may help improve treatment outcome measures. Chiropractic care uses spinal adjustments and manual manipulations together with lifestyle modifications to treat the spine, the root of the nervous system, as well as to promote decreased stress levels through proper nutrition, fitness and sleep.

Discussion

In this trial, we will seek to determine whether an increasingly popular approach for dealing with stress�mindfulness-based stress reduction�is an effective and cost-effective treatment option for persons with chronic back pain. Because of its focus on the mind as well as the body, MBSR has the potential to address some of the psychosocial factors that are important predictors of poor outcomes. In this trial, we will compare the effectiveness and cost-effectiveness of MBSR with that of CBT, which has been found to be effective for back pain but is not widely available. The study will also explore psychosocial variables that may mediate the effects of MBSR and CBT on patient outcomes. If MBSR is found to be an effective and cost-effective treatment option for persons with chronic back pain, it will be a valuable addition to the treatment options available for patients with significant psychosocial contributors to this problem.

Trial Status

Recruitment started in August 2012 and was completed in April 2014.

Abbreviations

AE: Adverse event; CAM: Complementary and alternative medicine; CATI: Computer-assisted telephone interview; CBT: Cognitive-behavioral therapy; CLBP: Chronic low back pain; CUA: Cost�utility analysis; DSMB: Data and Safety Monitoring Board; GHC: Group Health Cooperative; ICD-9: International Classification of Diseases Ninth Revision; IPW: Inverse probability weighting; IRB: Institutional Review Board; MBSR: Mindfulness-based stress reduction; NCCAM: National Center for Complementary and Alternative Medicine; QALY: Quality-adjusted life-year.

Competing Interests

The authors declare that they have no competing interests.

Authors� Contributions

DC and KS conceived of the trial. DC, KS, BB, JT, AC, BS, PH, RD and RH participated in refining the study design and implementation logistics and in the selection of outcome measures. AC developed plans for the statistical analyses. JT and AC developed plans for the mediator analyses. BS, BB and JT developed the materials for the CBT intervention. PH developed plans for the cost-effectiveness analyses. DC drafted the manuscript. All authors participated in the writing of the manuscript and read and approved the final manuscript.

Acknowledgements

The National Center for Complementary and Alternative Medicine (NCCAM) provided funding for this trial (grant R01 AT006226). The design of this trial was reviewed and approved by NCCAM�s Office of Clinical and Regulatory Affairs.

In conclusion, environmental, bodily and emotional stressors can trigger the “fight or flight response” in charge of preparing the the human body for danger. Although stress is essential to increase our performance, chronic stress can have a negative impact in the long-run, manifesting symptoms associated with back pain and sciatica. Chiropractic care utilizes a variety of treatment procedures, along with stress management methods and techniques, to help reduce stress as well as improve and manage symptoms associated with injuries and/or conditions of the musculoskeletal and nervous systems.�Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

Curated by Dr. Alex Jimenez

Additional Topics: Back Pain

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IMPORTANT TOPIC: EXTRA EXTRA: A Healthier You!

Stress Management & Low Back Pain in El Paso, TX

by spinedoctors | Back Pain, Physical Rehabilitation, Randomized Controlled Trial, Research Studies, Treatments

People experience stress on a regular basis. From worries about finances or employment to problems with your kids or significant other, even concerns about the condition of the world, can register as stressors for many individuals. Stress causes both acute (immediate) and chronic (long-term) health issues, including low back pain, a common symptom frequently reported by many patients who suffer from constant stress. Fortunately, several holistic treatment approaches, including chiropractic care, can help alleviate both the feelings and effect of stress, ultimately guiding people through proper stress management methods.

Symptoms of Stress

Stress triggers the body’s fight or flight response. The adrenaline surge you experience after hearing a loud sound is simply one of the remaining characteristics of our ancestors, afraid that that loud noise came from something which wanted to eat them.

Stress causes a number of physical changes in the body, starting with the brain. The heart rate increases and starts directing blood to the other extremities. Hearing and eyesight become more acute. And the adrenal glands begin secreting adrenaline as a means of preparing the body for physical exertion. This is exactly what the “flight or fight response” really means.

If you are walking alone at night and hear footsteps behind you, the fight of flight response can be incredibly effective towards your safety. However, if you experience prolonged stress, this sort of physical reaction contributes to a variety of health issues, such as high blood pressure, diabetes, a compromised immune system and muscle tissue damage. That’s because your body doesn’t recognize that there are different kinds of stress; it only knows that stress represents danger and it reacts accordingly.

Stress Management with Chiropractic Care

Chiropractic care can help improve as well as manage many symptoms of stress. This is because the spine is the root of the nervous system. Spinal adjustments and manual manipulations calm the fight or flight response by activating the parasympathetic system. Additionally, chiropractic can relieve pain and muscular tension, improve circulation, and correct spinal misalignments. These benefits all combine to ease the symptoms of stress, which reduces how stressed the patient feels.

A Well-Rounded Strategy

Chiropractors guide their patients through an assortment of stress management procedures, including dietary changes, exercise, meditation, and relaxation methods. A healthy diet can help the body handle an assortment of issues, including stress. Following a diet rich in fruits and vegetables, lean proteins, and complex carbohydrates, with minimal processed and prepackaged foods, can significantly improve overall health and wellness. Exercise is an effective stress reliever. The energy you expend through exercise relieves tension as well as the energy of stress. It also releases endorphins, which help elevate mood. Yoga is an especially effective kind of physical activity for relieving stress.

Meditation can be performed in a variety of ways and it can be practiced by various healthcare professionals. For some, writing in a journal is a kind of meditation, while others are more conventional in their strategy. Many relaxation techniques are closely linked to meditation, such as breathing exercises, releasing muscle tension, and listening to calming music or nature sounds.

Breathing exercises are simple and offer immediate stress relief. Begin with inhaling slowly and deeply through your nose, while counting to six and extending your stomach. Hold your breath for a count of four, then release the breath through your mouth, counting to six again. Repeat the cycle for three to five occasions.
Release muscle tension through a technique known as “progressive muscle relaxation”. Find a comfortable position, either sitting with your feet on the ground, or lying on your back. Work your way through each muscle group, beginning at your toes or your head, tensing the muscle for a count of five, and then releasing. Wait 30 minutes and then proceed to the next muscle group. Wondering how to tense the muscles of your face? For the face, raise your eyebrows as large as you can and feel the tension in your forehead and scalp. For the central portion of your own face, squint your eyes and wrinkle your nose and mouth. Finally, for the lower face, clench your teeth and pull back the corners of your mouth.
Soothing sounds like instrumental music or nature sounds help relax the body and the brain.

Maintaining a balanced lifestyle while also incorporating chiropractic care as a stress management strategy is an effective way to help improve and cope with the symptoms of stress. Reducing stress can ultimately help maintain your overall well-being.

Mindfulness-Based Stress Reduction and Cognitive-Behavioral Therapy for Chronic Low Back Pain: Similar Effects on Mindfulness, Catastrophizing, Self-Efficacy and Acceptance in a Randomized Controlled Trial

Abstract

Cognitive-behavioral therapy (CBT) is believed to improve chronic pain problems by decreasing patient catastrophizing and increasing patient self-efficacy for managing pain. Mindfulness-based stress reduction (MBSR) is believed to benefit chronic pain patients by increasing mindfulness and pain acceptance. However, little is known about how these therapeutic mechanism variables relate to each other or whether they are differentially impacted by MBSR versus CBT. In a randomized controlled trial comparing MBSR, CBT, and usual care (UC) for adults aged 20-70 years with chronic low back pain (CLBP) (N = 342), we examined (1) baseline relationships among measures of catastrophizing, self-efficacy, acceptance, and mindfulness; and (2) changes on these measures in the 3 treatment groups. At baseline, catastrophizing was associated negatively with self-efficacy, acceptance, and 3 aspects of mindfulness (non-reactivity, non-judging, and acting with awareness; all P-values <0.01). Acceptance was associated positively with self-efficacy (P < 0.01) and mindfulness (P-values < 0.05) measures. Catastrophizing decreased slightly more post-treatment with MBSR than with CBT or UC (omnibus P = 0.002). Both treatments were effective compared with UC in decreasing catastrophizing at 52 weeks (omnibus P = 0.001). In both the entire randomized sample and the sub-sample of participants who attended ?6 of the 8 MBSR or CBT sessions, differences between MBSR and CBT at up to 52 weeks were few, small in size, and of questionable clinical meaningfulness. The results indicate overlap across measures of catastrophizing, self-efficacy, acceptance, and mindfulness, and similar effects of MBSR and CBT on these measures among individuals with CLBP.

Keywords: chronic back pain, self-efficacy, mindfulness, acceptance, catastrophizing, CBT, MBSR

Introduction

Cognitive-behavioral therapy (CBT) has been demonstrated effective, and is widely recommended, for chronic pain problems.[20] Mindfulness-based interventions (MBIs) also show promise for patients with chronic pain[12,14,25,44,65] and their use by this population is increasing. Understanding the mechanisms of action of psychosocial treatments for chronic pain and commonalities in these mechanisms across different therapies is critical to improving the effectiveness and efficiency of these treatments.[27,52] Key mechanisms of action of CBT for chronic pain include decreased catastrophizing and increased self-efficacy for managing pain.[6-8,56] Increased mindfulness is considered a central mechanism of change in MBIs,[14,26,30] which also increase pain acceptance.[16,21,27,38,59] However, little is known about the associations among pain catastrophizing, self-efficacy, acceptance, and mindfulness prior to psychosocial treatment or about differences in effects of CBT versus MBIs on these variables.

There is some evidence suggesting significant associations among these therapeutic mechanism variables. Evidence regarding relationships between catastrophizing and mindfulness is mixed. Some studies[10,18,46] have found negative associations between measures of pain catastrophizing and mindfulness. However, others found no significant relationship[19] or associations (inverse) between catastrophizing and some aspects of mindfulness (non-judging, non-reactivity, and acting with awareness) but not others (e.g., observing).[18] Catastrophizing has also been reported to be associated negatively with pain acceptance.[15,22,60] In a pain clinic sample, general acceptance of psychological experiences was associated negatively with catastrophizing and positively with mindfulness.[19] Pain self-efficacy has been observed to be correlated positively with acceptance and negatively with catastrophizing.[22]

Further suggesting overlap across mechanisms of different psychosocial treatments for chronic pain, increases in mindfulness[10] and acceptance[1,64] have been found after cognitive-behavioral pain treatments, and reductions in catastrophizing have been observed after mindfulness-based pain management programs.[17,24,37] Little research has examined effects of MBIs for chronic pain on self-efficacy, although a small pilot study of migraine patients found greater increases in self-efficacy with Mindfulness-Based Stress Reduction (MBSR) training than with usual care.[63] We were unable to identify any studies of the relationships among all these therapeutic mechanism variables or of changes in all these variables with CBT versus an MBI for chronic pain.

The aim of this study was to replicate and extend prior research by using data from a randomized controlled trial (RCT) comparing MBSR, CBT, and usual care (UC) for chronic low back pain (CLBP)[12] to examine: (1) baseline relationships among measures of mindfulness and pain catastrophizing, self-efficacy, and acceptance; and (2) short- and long-term changes on these measures in the 3 treatment groups. Based on theory and previous research, we hypothesized that: (1) at baseline, catastrophizing would be inversely related to acceptance, self-efficacy, and 3 dimensions of mindfulness (non-reactivity, non-judging, acting with awareness), but not associated with the observing dimension of mindfulness; (2) at baseline, acceptance would be associated positively with self-efficacy; and (3) from baseline to 26 and 52 weeks, acceptance and mindfulness would increase more with MBSR than with CBT and UC, and catastrophizing would decrease more and self-efficacy would increase more with CBT than with MBSR and UC.

Methods

Setting, Participants and Procedures

Study participants were enrolled in an RCT comparing group MBSR, group CBT, and UC for non-specific chronic back pain between September 2012 and April 2014. We previously reported details of the study methods,[13] Consolidated Standards of Reporting Trials (CONSORT) flow diagram,[12] and outcomes.[12] In brief, participants were recruited from Group Health, an integrated healthcare system in Washington State, and from mailings to residents of communities served by Group Health. Eligibility criteria included age 20 – 70 years, back pain for at least 3 months, patient-rated bothersomeness of pain during the previous week ?4 (0 – 10 scale), and patient-rated pain interference with activities during the previous week ?3 (0 – 10 scale). We used International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM)43 diagnostic codes from electronic medical records (EMR) of visits in the previous year and telephone screening to exclude patients with specific causes of low back pain. Exclusion criteria also included pregnancy, spine surgery in the previous 2 years, disability compensation or litigation, fibromyalgia or cancer diagnosis, other major medical condition, plans to see a medical specialist for back pain, inability to read or speak English, and participation in a �mind-body� treatment for back pain in the past year. Potential participants were told that they would be randomized to one of �two different widely-used pain self-management programs that have been found helpful for reducing pain and making it easier to carry out daily activities� or to continued usual care. Those assigned to MBSR or CBT were unaware of the specific treatment they would receive until the first intervention session. The study was approved by the Group Health institutional review board and all participants provided informed consent.

Participants were randomized to the MBSR, CBT, or UC conditions. Randomization was stratified based on the baseline value of the primary outcome, a modified version of the Roland Disability Questionnaire (RDQ),[42] into 2 back pain-related physical limitation stratification groups: moderate (RDQ score ?12 on the 0 – 23 scale) and high (RDQ scores ?13). To mitigate possible disappointment with not being randomized to CBT or MBSR, participants randomized to UC received $50 compensation. Data were collected from participants in computer-assisted telephone interviews by trained survey staff. All participants were paid $20 for each interview completed.

Measures

Participants provided descriptive information at the screening and baseline interviews, and completed the study measures at baseline (before randomization) and 8 (post-treatment), 26 (the primary study endpoint), and 52 weeks post-randomization. Participants also completed a subset of the measures at 4 weeks, but these data were not examined for the current report.

Descriptive Measures and Covariates

The screening and baseline interviews assessed, among other variables not analyzed for the present study, sociodemographic characteristics (age, gender, race, ethnicity, education, work status); pain duration (defined as length of time since a period of 1 or more weeks without low back pain); and number of days with back pain in the past 6 months. In this report, we describe the sample at baseline on these measures and on the primary outcome measures in the RCT: the modified Roland-Morris Disability Questionnaire (RDQ)[42] and a numerical rating of back pain bothersomeness. The RDQ, a widely-used measure of back pain-related functional limitations, asks whether 24 specific activities are limited today by back pain (yes or no).[45] We used a modified version that included 23 items[42] and asked about the previous week rather than today only. Back pain bothersomeness was measured by participants� ratings of how bothersome their back pain was during the previous week on a 0 to 10 numerical rating scale (0 = �not at all bothersome� and 10 = �extremely bothersome�). The covariates for the current report were the same as those in our prior analyses of the interventions� effects on the outcomes:[12] age, gender, education, and pain duration (less than one year versus at least one year since experiencing 1 week without low back pain). We decided a priori to control for these variables because of their potential to affect the therapeutic mechanism measures, participant response to treatment, and/or likelihood of obtaining follow-up information.

Measures of Potential Therapeutic Mechanisms

Mindfulness. Mindfulness has been defined as the awareness that emerges through purposeful, non-judgmental attention to the present moment.[29] We administered 4 subscales of the Five Facet Mindfulness Questionnaire-Short Form (FFMQ-SF):[5] Observing (noticing internal and external experiences; 4 items); Acting with Awareness (attending to present moment activities, as contrasted to behaving automatically while attention is focused elsewhere; 5 items); Non-reactivity (non-reactivity to inner experiences: allowing thoughts and feelings to arise and pass away without attachment or aversion; 5 items); and Non-judging (non-judging of inner experiences: engaging in a non-evaluative stance towards thoughts, emotions, and feelings; 5-item scale; however, one question [�I make judgments about whether my thoughts are good or bad�] inadvertently was not asked.). The FFMQ-SF has been demonstrated to be reliable, valid, and sensitive to change.[5] Participants rated their opinion of what generally is true for them in terms of their tendency to be mindful in their daily lives (scale from 1 = �never or very rarely true� to 5 = �very often or always true�). For each scale, the score was calculated as the mean of the answered items and thus the possible range was 1-5, with higher scores indicating higher levels of the mindfulness dimension. Prior studies have used sum scores rather than means, but we elected to use mean scores given the greater ease of interpretation.

Pain catastrophizing. The Pain Catastrophizing Scale (PCS) is a 13-item measure assessing pain-related catastrophizing, including rumination, magnification, and helplessness.[50] Participants rated the degree to which they had certain thoughts and feelings when experiencing pain (scale from 0 = �not at all� to 4 = �all the time�). Item responses were summed to yield a total score (possible range = 0-52). Higher scores indicate greater endorsement of catastrophic thinking in response to pain.

Pain acceptance. The Chronic Pain Acceptance Questionnaire-8 (CPAQ-8), an 8-item version of the 20-item Chronic Pain Acceptance Questionnaire (CPAQ), has been shown to be reliable and valid.[22,23] It has 2 scales: Activity Engagement (AE; engagement in life activities in a normal manner even while pain is being experienced) and Pain Willingness (PW; disengagement from attempts to control or avoid pain). Participants rated items on a scale from 0 (�never true�) to 6 (�always true�). Item responses were summed to create scores for each subscale (possible range 0-24) and the overall questionnaire (possible range 0-48). Higher scores indicate greater activity engagement/pain willingness/pain acceptance. Prior research suggests that the 2 subscales are moderately correlated and that each makes an independent contribution to the prediction of adjustment in people with chronic pain.[22]

Pain self-efficacy. The Pain Self-efficacy Questionnaire (PSEQ) consists of 10 items assessing individuals� confidence in their ability to cope with their pain and engage in activities despite their pain, each rated on a scale from 0 = �not at all confident� to 6 = �completely confident.�[39] The questionnaire has been demonstrated to be valid, reliable, and sensitive to change.[39] Item scores are summed to yield a total score (possible range 0-60); higher scores indicate greater self-efficacy.

Interventions

The 2 interventions were comparable in format (group), duration, frequency, and number of participants per group cohort. Both the MBSR and CBT interventions consisted of 8 weekly 2-hour sessions supplemented by home activities. For each intervention, we developed a therapist/instructor’s manual and participant’s workbook, both with structured and detailed content for each session. In each intervention, participants were assigned home activities and there was emphasis on incorporating intervention content in their daily lives. Participants were given materials to read at home and CDs with relevant content for home practice (e.g., meditation, body scan, and yoga in MBSR; relaxation and imagery exercises in CBT). We previously published detailed descriptions of both interventions,[12,13] but describe them briefly here.

MBSR

The MBSR intervention was modeled closely after the original program developed by Kabat-Zinn[28] and based on the 2009 MBSR instructor’s manual.[4] It consisted of 8 weekly sessions and an optional 6-hour retreat between the 6th and 7th sessions. The protocol included experiential training in mindfulness meditation and mindful yoga. All sessions included mindfulness exercises (e.g., body scan, sitting meditation) and mindful movement (most commonly, yoga).

CBT

The group CBT protocol included the techniques most commonly applied in CBT for CLBP[20,58] and used in prior studies.[11,33,41,51,53-55,57,61] The intervention included: (1) education about (a) chronic pain, (b) maladaptive thoughts (including catastrophizing) and beliefs (e.g., inability to control pain, hurt equals harm) common among individuals with chronic pain, (c) the relationships between thoughts and emotional and physical reactions, (d) sleep hygiene, and (e) relapse prevention and maintenance of gains; and (2) instruction and practice in identifying and challenging unhelpful thoughts, generating alternative appraisals that are more accurate and helpful, setting and working towards behavioral goals, abdominal breathing and progressive muscle relaxation techniques, activity pacing, thought-stopping and distraction techniques, positive coping self-statements, and coping with pain flare-ups. None of these techniques were included in the MBSR intervention, and mindfulness, meditation, and yoga techniques were not included in CBT. CBT participants were also given a book (The Pain Survival Guide[53]) and asked to read specific chapters between sessions. During each session, participants completed a personal action plan for activities to do between sessions.

Usual Care

Patients assigned to UC received no MBSR training or CBT as part of the study and received whatever health care they would customarily receive during the study period.

Instructors/Therapists and Treatment Fidelity Monitoring

As previously reported,[12] all 8 MBSR instructors received formal training in teaching MBSR from the Center for Mindfulness at the University of Massachusetts or equivalent training and had extensive previous experience teaching MBSR. The CBT intervention was conducted by 4 Ph.D.-level licensed psychologists with previous experience providing individual and group CBT to patients with chronic pain. Details of instructor training and supervision and treatment fidelity monitoring were provided previously.[12]

Statistical Analyses

We used descriptive statistics to summarize the observed baseline characteristics by randomization group, separately for the entire randomized sample and the subsample of participants who attended 6 or more of the 8 intervention classes (MBSR and CBT groups only). To examine the associations between the therapeutic mechanism measures at baseline, we calculated Spearman rho correlations for each pair of measures.

To estimate changes over time in the therapeutic mechanism variables, we constructed linear regression models with the change from baseline as the dependent variable, and included all post-treatment time points (8, 26, and 52 weeks) in the same model. A separate model was estimated for each therapeutic mechanism measure. Consistent with our approach for analyzing outcomes in the RCT,[12] we adjusted for age, gender, education, and baseline values of pain duration, pain bothersomeness, the modified RDQ, and the therapeutic mechanism measure of interest in that model. To estimate the treatment effect (difference between groups in change on the therapeutic mechanism measure) at each time point, the models included main effects for treatment group (CBT, MBSR, and UC) and time point (8, 26, and 52 weeks), and terms for the interactions between these variables. We used generalized estimating equations (GEE)[67] to fit the regression models, accounting for possible correlation between repeated measures from individual participants. To account for potential bias caused by differential attrition across treatment groups, our primary analysis used a 2-step GEE modeling approach to impute missing data on the therapeutic mechanism measures. This approach uses a pattern mixture model framework for non-ignorable non-response and adjusts the variance estimates in the final outcome model parameters to account for using imputed data.[62] We also, as a sensitivity analysis, conducted the regression analyses again with observed rather than imputed data to evaluate whether using imputed data had a substantial effect on the results and to allow direct comparison to other published studies.

The primary analysis included all randomized participants, using an intent-to-treat (ITT) approach. We repeated the regression analyses using the subsample of participants who were randomized to MBSR or CBT and who attended at least 6 of the 8 sessions of their assigned treatment (�as-treated� or �per protocol� analysis). For descriptive purposes, using regression models for the ITT sample with imputed data, we estimated mean scores (and their 95% confidence intervals [CI]) on the therapeutic mechanism variables at each time point adjusted for age, gender, education, and baseline values of pain duration, pain bothersomeness, and the modified RDQ.

To provide context for interpreting the results, we used t-tests and chi-square tests to compare the baseline characteristics of participants who did versus did not complete at least 6 of the 8 intervention sessions (MBSR and CBT groups combined). We compared intervention participation by group, using a chi-square test to compare the proportions of participants randomized to MBSR versus CBT who completed at least 6 of the 8 sessions.

Dr. Alex Jimenez’s Insight

Stress is primarily a part of the “fight or flight” response which helps the body effectively prepare for danger. When the body enters�a state of mental or emotional strain or tension due to adverse or very demanding circumstances,�a complex mix of hormones and chemicals, such as adrenaline, cortisol and norepinephrine, are secreted in order to prepare the body for physical and psychological action.�While short-term stress provides us with the necessary amount of edge required to improve our overall performance, long-term stress has been associated to a variety of health issues, including low back pain and sciatica. Stress management methods and techniques, including meditation and chiropractic care, have been demonstrated to help improve treatment outcomes of low back pain and sciatica. The following article discusses several types of stress management treatments and describes their effect on overall health and wellness.

Results

Characteristics of the Study Sample

As previously reported,[12] among 1,767 individuals who expressed interest in the study and were screened for eligibility, 1,425 were excluded (most commonly due to pain not present for more than 3 months and inability to attend the intervention sessions). The remaining 342 individuals enrolled and were randomized. Among the 342 individuals randomized, 298 (87.1%), 294 (86.0%), and 290 (84.8%) completed the 8-, 26-, and 52-week assessments, respectively.

Table 1 shows the characteristics of the sample at baseline. Among all participants, the mean age was 49 years, 66% were female, and 79% reported having had back pain for at least one year without a pain-free week. On average, PHQ-8 scores were at the threshold for mild depressive symptom severity.[32] Mean scores on the Pain Catastrophizing Scale (16-18) were below the various cut-points suggested for clinically relevant catastrophizing (e.g., 24,47 3049). Pain Self-Efficacy Scale scores were somewhat higher on average (about 5 points on the 0-60 scale) in our sample as compared with the primary care patients with low back pain enrolled in an RCT evaluating group CBT in England,[33] and about 15 points higher than among individuals with chronic pain attending a mindfulness-based pain management program in England.[17]

About half of participants randomized to MBSR (50.9%) or CBT (56.3%) attended at least 6 sessions of their assigned treatment; the difference between treatments was not statistically significant (chi-square test, P = 0.42). At baseline, those randomized to MBSR and CBT who completed at least 6 sessions, as compared to those who did not, were significantly older (mean [SD] = 52.2 [10.9] versus 46.5 [13.0] years) and reported significantly lower levels of pain bothersomeness (mean [SD] = 5.7 [1.3] versus 6.4 [1.7]), disability (mean [SD] RDQ = 10.8 [4.5] versus 12.7 [5.0]), depression (mean [SD] PHQ-8 = 5.2 [4.1] versus 6.3 [4.3]), and catastrophizing (mean [SD] PCS = 15.9 [10.3] versus 18.9 [9.8]), and significantly greater pain self-efficacy (mean [SD] PSEQ = 47.8 [8.3] versus 43.2 [10.3]) and pain acceptance (CPAQ-8 total score mean [SD] = 31.3 [6.2] versus 29.0 [6.7]; CPAQ-8 Pain Willingness mean [SD] = 12.3 [4.1] versus 10.9 [4.8]) (all P-values < 0.05). They did not differ significantly on any other variable shown in Table 1.

Baseline Associations Between Therapeutic Mechanism Measures

Table 2 shows the Spearman correlations between the therapeutic mechanism measures at baseline. Our hypotheses about the baseline relationships among these measures were confirmed. Catastrophizing was correlated negatively with 3 dimensions of mindfulness (non-reactivity rho = ?0.23, non-judging rho = ?0.30, and acting with awareness rho = ?0.21; all P-values < 0.01), but not associated with the observing dimension of mindfulness (rho = ?0.01). Catastrophizing was also correlated negatively with acceptance (total CPAQ-8 score rho = ?0.55, Pain Willingness subscale rho = ?0.47, Activity Engagement subscale rho = ?0.40) and pain self-efficacy (rho = ?0.57) (all P-values < 0.01). Finally, pain self-efficacy was correlated positively with pain acceptance (total CPAQ-8 score rho = 0.65, Pain Willingness subscale rho = 0.46, Activity Engagement subscale rho = 0.58; all P-values < 0.01).

Treatment Group Differences in Changes on Therapeutic Mechanism Measures Among all Randomized Participants

Table 3 shows the adjusted mean changes from baseline in each study group and the adjusted mean differences between treatment groups on the therapeutic mechanism measures at each follow-up in the entire randomized sample. Figure 1 shows the adjusted mean PCS scores for each group at each time point. Contrary to our hypothesis that catastrophizing would decrease more with CBT than with MBSR, catastrophizing (PCS score) decreased significantly more from pre- to post-treatment in the MBSR group than in the CBT group (MBSR versus CBT adjusted mean [95% CI] difference in change = ?1.81 [?3.60, ?0.01]). Catastrophizing also decreased significantly more in MBSR than in UC (MBSR versus UC adjusted mean [95% CI] difference in change = ?3.30 [?5.11, ?1.50]), whereas the difference between CBT and UC was not significant. At 26 weeks, the treatment groups did not differ significantly in change in catastrophizing from baseline. However, at 52 weeks, both the MBSR and the CBT groups showed significantly greater decreases than did the UC group, and there was no significant difference between MBSR and CBT.

Figure 1: Adjusted mean Pain Catastrophizing Scale (PCS) scores (and 95% confidence intervals) at baseline (pre-randomization), 8 weeks (post-treatment), 26 weeks, and 52 weeks for participants randomized to CBT, MBSR, and UC. Estimated means are adjusted for participant age, gender, education, whether or not at least 1 year since week without pain, and baseline RDQ and pain bothersomeness.

Figure 2 shows the adjusted mean PSEQ scores for each group at each time point. Our hypothesis that self-efficacy would increase more with CBT than with MBSR and with UC was only partially confirmed. Self-efficacy (PSEQ scores) did increase significantly more from pre- to post-treatment with CBT than with UC, but not with CBT relative to the MBSR group, which also increased significantly more than did the UC group (adjusted mean [95% CI] difference in change on PSEQ from baseline for CBT versus UC = 2.69 [0.96, 4.42]; CBT versus MBSR = 0.34 [?1.43, 2.10]; MBSR versus UC = 3.03 [1.23, 4.82]) (Table 3). The omnibus test for differences across groups in self-efficacy change was not significant at 26 or 52 weeks.

Figure 2: Adjusted mean Pain Self-Efficacy Questionnaire (PSEQ) scores (and 95% confidence intervals) at baseline (pre-randomization), 8 weeks (post-treatment), 26 weeks, and 52 weeks for participants randomized to CBT, MBSR, and UC. Estimated means are adjusted for participant age, gender, education, whether or not at least 1 year since week without pain, and baseline RDQ and pain bothersomeness.

Our hypothesis that acceptance would increase more with MBSR than with CBT and with UC was generally not confirmed. The omnibus test for differences across groups was not significant for the total CPAQ-8 or the Activity Engagement subscale at any time point (Table 3). The test for the Pain Willingness subscale was significant at 52 weeks only, when both the MBSR and CBT groups showed greater increases as compared with UC, but not as compared with each other (adjusted mean [95% CI] difference in change for MBSR versus UC = 1.15 [0.05, 2.24]; CBT versus UC = 1.23 [0.16, 2.30]).

Our hypothesis that mindfulness would increase more with MBSR than with CBT was partially confirmed. Both the MBSR and CBT groups showed greater increases as compared with UC on the FFMQ-SF Non-reactivity scale at 8 weeks (MBSR versus UC = 0.18 [0.01, 0.36]; CBT versus UC = 0.28 [0.10, 0.46]), but differences at later follow-ups were not statistically significant (Table 3, Figure 3). There was a significantly greater increase on the Non-judging scale with MBSR versus CBT (adjusted mean [95% CI] difference in change = 0.29 [0.12, 0.46]) as well as between MBSR and UC (0.32 [0.13, 0.50]) at 8 weeks, but no significant difference between groups at later time points (Figure 4). The omnibus test for differences among groups was not significant for the Acting with Awareness or Observing scales at any time point.

Figure 3 Adjusted Mean FFMQ-SF Non Reactivity Scores

Figure 3: Adjusted mean Five Facet Mindfulness Questionnaire-Short Form (FFMQ-SF) Non-reactivity scores (and 95% confidence intervals) at baseline (pre-randomization), 8 weeks (post-treatment), 26 weeks, and 52 weeks for participants randomized to CBT, MBSR, and UC. Estimated means are adjusted for participant age, gender, education, whether or not at least 1 year since week without pain, and baseline RDQ and pain bothersomeness.

Figure 4 Adjusted Mean FFMQ-SF Non Judging Scores

Figure 4: Adjusted mean Five Facet Mindfulness Questionnaire-Short Form (FFMQ-SF) Non-judging scores (and 95% confidence intervals) at baseline (pre-randomization), 8 weeks (post-treatment), 26 weeks, and 52 weeks for participants randomized to CBT, MBSR, and UC. Estimated means are adjusted for participant age, gender, education, whether or not at least 1 year since week without pain, and baseline RDQ and pain bothersomeness.

The sensitivity analyses using observed rather than imputed data yielded almost identical results, with 2 minor exceptions. The difference between MBSR and CBT in change in catastrophizing at 8 weeks, although similar in magnitude, was no longer statistically significant due to slight confidence interval changes. Second, the omnibus test for the CPAQ-8 Pain Willingness scale at 52 weeks was no longer statistically significant (P = 0.07).

Treatment Group Differences in Changes on Therapeutic Mechanism Measures Among Participants Randomized to CBT or MBSR Who Completed at Least 6 Sessions

Table 4 shows the adjusted mean change from baseline and adjusted mean between-group differences on the therapeutic mechanism measures at 8, 26, and 52 weeks for participants who were randomized to MBSR or CBT and completed 6 or more sessions of their assigned treatment. The differences between MBSR and CBT were similar in size to those in the ITT sample. There were only a few differences in statistical significance of the comparisons. In contrast to the results using the ITT sample, the difference between MBSR and CBT in catastrophizing (PCS) at 8 weeks was no longer statistically significant and at 52 weeks, the CBT group increased significantly more than did the MBSR group on the FFMQ-SF Observing scale (adjusted mean difference in change from baseline for MBSR versus CBT = ?0.30 [?0.53, ?0.07]). The sensitivity analyses using observed rather than imputed data yielded no meaningful differences in results.

Discussion

In this analysis of data from an RCT comparing MBSR, CBT, and UC for CLBP, our hypotheses that MBSR and CBT would differentially affect measures of constructs believed to be therapeutic mechanisms generally were not confirmed. For example, our hypothesis that mindfulness would increase more with MBSR than with CBT was confirmed for only 1 of 4 measured facets of mindfulness (non-judging). Another facet, acting with awareness, increased more with CBT than with MBSR at 26 weeks. Both differences were small. Increased mindfulness after a CBT-based multidisciplinary pain program[10] was reported previously; our findings further support a view that both MBSR and CBT increase mindfulness in the short-term. We found no long-term effects of either treatment relative to UC on mindfulness.

Also contrary to hypothesis, catastrophizing decreased more post-treatment with MBSR than with CBT. However, the difference between treatments was small and not statistically significant at later follow-ups. Both treatments were effective compared with UC in decreasing catastrophizing at 52 weeks. Although previous studies demonstrated reductions in catastrophizing after both CBT[35,48,56,57] and mindfulness-based pain management programs,[17,24,37] ours is the first to demonstrate similar decreases for both treatments, with effects up to 1 year.

Increased self-efficacy has been shown to be associated with improvements in pain intensity and functioning,[6] and an important mediator of CBT benefits.[56] However, contrary to our hypothesis, pain self-efficacy did not increase more with CBT than with MBSR at any time point. Compared with UC, there were significantly greater increases in self-efficacy with both MBSR and CBT post-treatment. These results mirror previous findings of positive effects of CBT, including group CBT for back pain,[33] on self-efficacy.[3,56,57] Little research has examined self-efficacy changes after MBIs for chronic pain, although self-efficacy increased more with MBSR than with usual care for patients with migraines in a pilot study[63] and more with MBSR than with health education for CLBP in an RCT.[37] Our findings add to knowledge in this area by indicating that MBSR has short-term benefits for pain self-efficacy similar to those of CBT.

Prior uncontrolled studies found equivalent increases in pain acceptance after group CBT and Acceptance and Commitment Therapy64 (which, unlike traditional CBT, specifically fosters pain acceptance), and increased acceptance after CBT-based multidisciplinary pain treatment.[1,2] In our RCT, acceptance increased in all groups over time, with only 1 statistically significant difference among the 3 groups across the 3 acceptance measures and 3 follow-up time points (a greater increase with both MBSR and CBT than with UC on the Pain Willingness subscale at 52 weeks). This suggests that acceptance may increase over time regardless of treatment, although this needs to be confirmed in additional research.

Two possibilities could explain our previously-reported findings of generally similar effectiveness of MBSR and CBT for CLBP:[12] (1) the treatment effects on outcomes were due to different, but equally effective, therapeutic mechanisms, or (2) the treatments had similar effects on the same therapeutic mechanisms. Our current findings support the latter view. Both treatments may improve pain, function, and other outcomes through different strategies that decrease individuals� views of their pain as threatening and disruptive and encourage activity participation despite pain. MBSR and CBT differ in content, but both include relaxation techniques (e.g., progressive muscle relaxation in CBT, meditation in MBSR, breathing techniques in both) and strategies to decrease the threat value of pain (education and cognitive restructuring in CBT, accepting experiences without reactivity or judgment in MBSR). Thus, although CBT emphasizes learning skills for managing pain and decreasing negative emotional responses, and MBSR emphasizes mindfulness and meditation, both treatments may help patients relax, react less negatively to pain, and view thoughts as mental processes rather than as accurate representations of reality, thereby resulting in decreased emotional distress, activity avoidance, and pain bothersomeness.

Our analyses also revealed overlap among measures of different constructs believed to mediate the effects of MBSR and CBT on chronic pain outcomes. As hypothesized, prior to treatment, pain catastrophizing was associated negatively with pain self-efficacy, pain acceptance, and 3 dimensions of mindfulness (non-reactivity, non-judging, and acting with awareness), and pain acceptance was associated positively with pain self-efficacy. Pain acceptance and self-efficacy were also associated positively with measures of mindfulness. Our results are consistent with prior observations of negative associations between measures of catastrophizing and acceptance,[15,19,60] negative correlations between measures of catastrophizing and mindfulness,[10,46,18] and positive associations between measures of pain acceptance and mindfulness.[19]

As a group, to the extent that these measures reflect their intended constructs, these findings support a view of catastrophizing as inversely associated with two related constructs that reflect participation in customary activities despite pain but differ in emphasis on disengagement from attempts to control pain: pain acceptance (disengagement from attempts to control pain and participation in activities despite pain) and self-efficacy (confidence in ability to manage pain and participate in customary activities). The similarity of some questionnaire items further supports this view and likely contributes to the observed associations. For example, both the CPAQ-8 and the PSEQ contain items about doing normal activities despite pain. Furthermore, there is an empirical and conceptual basis for a view of catastrophizing (focus on pain with highly negative cognitive and affective responses) as also inversely associated with mindfulness (i.e., awareness of stimuli without judgment or reactivity), and for viewing mindfulness as consistent with, but distinct from, acceptance and self-efficacy. Further work is needed to clarify the relationships between these theoretical constructs and the extent to which their measures assess (a) constructs that are related but theoretically and clinically distinct versus (b) different aspects of an overarching theoretical construct.

It remains possible that MBSR and CBT differentially affect important mediators not assessed in this study. Our results highlight the need for further research to more definitively identify the mediators of the effects of MBSR and CBT on different pain outcomes, develop measures that assess these mediators most comprehensively and efficiently, better understand the relationships among therapeutic mechanism variables in affecting outcomes (e.g., decreased catastrophizing may mediate the effect of mindfulness on disability[10]), and refine psychosocial treatments to more effectively and efficiently impact these mediators. Research is also needed to identify patient characteristics associated with response to different psychosocial interventions for chronic pain.

Several study limitations warrant discussion. Participants had low baseline levels of psychosocial distress (e.g., catastrophizing, depression) and we studied group CBT, which has demonstrated efficacy,[33,40,55] resource-efficiency, and potential social benefits, but which may be less effective than individual CBT.[36,66] The results may not generalize to more distressed populations (e.g., pain clinic patients), which would have more room to improve on measures of maladaptive functioning and greater potential for treatments to differentially affect these measures, or to comparisons of MBSR with individual CBT.

Only somewhat over half of the participants randomized to MBSR or CBT attended at least 6 of the 8 sessions. Results could differ in studies with higher rates of treatment adherence; however, our results in �as-treated� analyses generally mirrored those of ITT analyses. Treatment adherence has been shown to be associated with benefits from both CBT for chronic back pain[31] and MBSR.[9] Research is needed to identify ways to increase MBSR and CBT session attendance, and to determine whether treatment effects on therapeutic mechanism and outcome variables are strengthened with greater adherence and practice.

Finally, our measures may not have adequately captured the intended constructs. For example, our mindfulness and pain acceptance measures were short forms of original measures; although these short forms have demonstrated reliability and validity, the original measures or other measures of these constructs might perform differently. Lauwerier et al.[34] note several problems with the CPAQ-8 Pain Willingness scale, including under-representation of pain willingness items. Furthermore, pain acceptance is measured differently across different pain acceptance measures, possibly reflecting differences in definitions.[34]

In sum, this is the first study to examine relationships among measures of key hypothesized mechanisms of MBSR and CBT for chronic pain – mindfulness and pain catastrophizing, self-efficacy, and acceptance – and to examine changes in these measures among participants in an RCT comparing MBSR and CBT for chronic pain. The catastrophizing measure was inversely associated with moderately inter-related measures of acceptance, self-efficacy, and mindfulness. In this sample of individuals with generally low levels of psychosocial distress at baseline, MBSR and CBT had similar short- and long-term effects on these measures. Measures of catastrophizing, acceptance, self-efficacy, and mindfulness may tap different aspects of a continuum of cognitive, affective, and behavioral responses to pain, with catastrophizing and activity avoidance at one end of the continuum and continued participation in usual activities and lack of negative cognitive and affective reactivity to pain at the other. Both MBSR and CBT may have therapeutic benefits by helping individuals with chronic pain shift from the former to the latter. Our results suggest the potential value of refining both measures and models of mechanisms of psychosocial pain treatments to more comprehensively and efficiently capture key constructs important in adaptation to chronic pain.

Summary

MBSR and CBT had similar short- and long-term effects on measures of mindfulness and pain catastrophizing, self-efficacy, and acceptance.

Acknowledgements

Research reported in this publication was supported by the National Center for Complementary & Integrative Health of the National Institutes of Health under Award Number R01AT006226. Preliminary results related to this study were presented in a poster at the 34th annual meeting of the American Pain Society, Palm Springs, May 2015 (Turner, J., Sherman, K., Anderson, M., Balderson, B., Cook, A., and Cherkin, D.: Catastrophizing, pain self-efficacy, mindfulness, and acceptance: Relationships and changes among individuals receiving CBT, MBSR, or usual care for chronic back pain).

Footnotes

Conflict of interest statement: Judith Turner receives royalties from PAR, Inc. on sales of the Chronic Pain Coping Inventory (CPCI) and CPCI/Survey of Pain Attitudes (SOPA) score report software. The other authors report no conflicts of interest.

In conclusion, stress is part of an essential response necessary to keep our body’s on edge in the case of danger, however, constant stress when there’s no real danger can become a real issue for many individuals, especially when symptoms of low back pain, among others begin to manifest. The purpose of the article above was to determine the effectiveness of stress management in the treatment of low back pain. Ultimately, stress management was concluded to help with treatment. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

Curated by Dr. Alex Jimenez

Additional Topics: Back Pain

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The Injury & Trauma Rehabilitation Specialists

PUSHasRx® Trauma Rehabilitation Center

Health, Wellness & Nutrition Specialists

Neck Exercises, Physical and Cognitive Behavioural-Graded Activity as a Treatment for Adult Whiplash Patients with Chronic Neck Pain: Design of a Randomised Controlled Trial

Abstract

Background

Methods/Design

Discussion

Trial registration

Background

Methods/Design

Trial Design

Settings

Study Population

Intervention

Control

Intervention

Physiotherapists

Outcome Measures

Power and Sample Size Estimation

Randomisation, Allocation and Blinding Procedures

Statistical Analysis

Ethical Considerations

Dr. Alex Jimenez’s Insight

Discussion

Competing Interests

Authors’ Contributions

Pre-Publication History

Acknowledgements

A Randomized Controlled Trial of Cognitive-Behavioral Therapy for the Treatment of PTSD in the context of Chronic Whiplash

Abstract

Objectives

Method

Results

Discussion

Additional Topics: Back Pain

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References

Close Accordion

Anxiety and Irrational Fears

Depression

Post Traumatic Stress Disorder (PTSD)

Chiropractic Care for Auto Accident Injuries

Prediction of Post Traumatic Stress Disorder by Immediate Reactions to Trauma: a Prospective Study in Road Traffic Accident Victims

Abstract

Trauma-Focused Cognitive Behavior Therapy and Exercise for Chronic Whiplash: Protocol of a Randomized Controlled Trial

Abstract

Introduction

Design

Methods

Participants

Inclusion Criteria

Exclusion Criteria

Sample Size

Intervention

Randomisation

Intervention group – Trauma-focused Cognitive-behavioural therapy (CBT)

Control group – Supportive Therapy

Exercise Program

Outcome Measures

Monitoring of Treatment Sites

Adverse Events

Statistical Analysis

Funding

Potential Significance

Conflict of Interest Declaration

Role of Psychosocial Stress in Recovery from Common Whiplash

Abstract

Dr. Alex Jimenez’s Insight

Additional Topics: Back Pain

Blank

References

Close Accordion

Chronic Low Back Pain and the Mind

Managing the Scourge of Chronic Low Back Pain

Mind Over Matter

Effectiveness of Mindfulness Meditation on Pain and Quality of Life of Patients with Chronic Low Back Pain

Abstract

Introduction

Methods