Back Pain

Back Clinic Back Pain Chiropractic Treatment Team. At the El Paso Back Clinic, we take back pain very seriously.

After diagnosing the root cause of your discomfort/pain, we’ll do everything within our power to cure the area and relieve your symptoms.

Common causes of back pain:
There is an infinite number of forms of back pain, and a variety of injuries and diseases may cause discomfort in this area of the body. One of the most Frequent ones we see one of our patients in East Side El Paso and surrounding areas comprise:

Disc Herniation
Inside the backbone are flexible discs that cushion your bones and absorb shock. Whenever these discs are broken, they may compress a nerve leading to lower extremity numbness. StressWhen a muscle at the trunk is overexerted or hurt, causing stiffness and pain, this type of injury is generally classified as a back strain. This can be the consequence of attempting to lift an item that can result in excruciating pain and impairment and is too heavy. Diagnosing the underlying cause of your pain.

Osteoarthritis
Osteoarthritis is characterized by the slow wearing down of protective cartilage. When the back is affected by this condition, it causes damage to the bones that results in chronic pain, stiffness, and limited mobility. SprainIf ligaments in your spine and back are stretched or torn, it’s called a spine sprain. Typically, this injury causes pain in the region. Spasms cause back muscles to overwork they may start to contract, and can even stay contracted– also called a muscle spasm. Muscle spasms can present with pain and stiffness until the strain resolves.

We want to accomplish the diagnosis straight away, integrating a background and exam along with state-of-the-art imaging, so we can provide you with the most efficient therapy choices. To begin, we will speak with you regarding your symptoms, which will provide us with critical information regarding your underlying condition. We’ll then perform a physical exam, during which we’ll check for posture issues, evaluate your spine and assess your backbone. If we guess injuries, like a disk or neurological injury, we’ll probably order imaging tests to obtain an analysis.

Regenerative remedies to your back pain. At the El Paso Back Clinic, you may be certain that you’re in the best possible hands with our Doctor of Chiropractic and Massage Therapist. Our purpose during your pain treatment isn’t only to relieve your symptoms — but also to avoid a recurrence and to treat your pain.

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

Name: El Paso Back Clinic | Spine Specialists - El Paso, TX
Price range: $$

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

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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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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IMPORTANT TOPIC: EXTRA EXTRA: A Healthier You!

Non-Invasive Treatment Modalities for Back Pain

by Dr Alex Jimenez | Back Pain, Chiropractic, Clinical Case Reports, Conditions Treated, Lower Back Pain, Physical Rehabilitation, Treatments

Attributed from a personal perspective, as a practicing chiropractor with experience on a variety of spinal injuries and conditions, back pain is one of the most common health issues reported among the general population, affecting about 8 out of 10 individuals at some point throughout their lives. While many different types of treatments are currently available to help improve the symptoms of back pain, health care based on clinical and experimental evidence has caused an impact on the type of treatment individuals will receive for their back pain. Many patients in health care are turning to non-invasive treatment modalities for their back pain as a result of growing evidence associated with its safety and effectiveness.

On a further note, non-invasive treatment modalities are defined as conservative procedures which do not require incision into the body, where no break in the skin is created and there is no contact with the mucosa or internal body cavity beyond a natural or artificial body orifice, or the removal of tissue. The clinical and experimental methods and results of a variety of non-invasive treatment modalities on back pain have been described and discussed in detail below.

Abstract

At present, there is an increasing international trend towards evidence-based health care. The field of low back pain (LBP) research in primary care is an excellent example of evidence-based health care because there is a huge body of evidence from randomized trials. These trials have been summarized in a large number of systematic reviews. This paper summarizes the best available evidence from systematic reviews conducted within the framework of the Cochrane Back Review Group on non-invasive treatments for non-specific LBP. Data were gathered from the latest Cochrane Database of Systematic Reviews 2005, Issue 2. The Cochrane reviews were updated with additional trials, if available. Traditional NSAIDs, muscle relaxants, and advice to stay active are effective for short-term pain relief in acute LBP. Advice to stay active is also effective for long-term improvement of function in acute LBP. In chronic LBP, various interventions are effective for short-term pain relief, i.e. antidepressants, COX2 inhibitors, back schools, progressive relaxation, cognitive�respondent treatment, exercise therapy, and intensive multidisciplinary treatment. Several treatments are also effective for short-term improvement of function in chronic LBP, namely COX2 inhibitors, back schools, progressive relaxation, exercise therapy, and multidisciplinary treatment. There is no evidence that any of these interventions provides long-term effects on pain and function. Also, many trials showed methodological weaknesses, effects are compared to placebo, no treatment or waiting list controls, and effect sizes are small. Future trials should meet current quality standards and have adequate sample size.

Keywords: Non-specific low back pain, Non-invasive treatment, Primary care, Effectiveness, Evidence review

Introduction

Low back pain is most commonly treated in primary health care settings. Clinical management of acute as well as chronic low back pain (LBP) varies substantially among health care providers. Also, many different primary health care professionals are involved in the management of LBP, such as general practitioners, physical therapists, chiropractors, osteopaths, manual therapists, and others. There is a need to increase consistency in the management of LBP across professions.

At present, there is an increasing international trend towards evidence-based health care. Within the framework of evidence-based health care, clinicians should conscientiously, explicitly, and judiciously use the best current evidence in making decisions about the care of individual patients. The field of LBP research in primary care is an excellent example of evidence-based health care because there is a huge body of evidence. At present, more than 500 randomized controlled trials (RCTs) have been published, evaluating all types of conservative and alternative treatments for LBP that are commonly used in primary care. These trials have been summarized in a large number of systematic reviews. The Cochrane Back Review Group (CBRG) offers a framework for conducting and publishing systematic reviews in the fields of back and neck pain. However, method guidelines have also been developed and published by the CBRG to improve the quality of reviews in this field and to facilitate comparison across reviews and enhance consistency among reviewers. This paper summarizes the best available evidence from systematic reviews conducted within the framework of the CBRG on non-invasive treatments for non-specific LBP.

Objectives

To determine the effectiveness of non-invasive (pharmaceutical and non-pharmaceutical) interventions compared to placebo (or sham treatment, no intervention and waiting list control) or other interventions for acute, subacute, and chronic non-specific LBP. Trials comparing various types of the same interventions (e.g. various types of NSAIDs or various types of exercises) were excluded. The evidence on complementary and alternative medicine interventions (acupuncture, botanical medicines, massage, and neuroreflexotherapy) has been published elsewhere. Evidence on surgical and other invasive interventions for LBP will be presented in another paper in the same issue of the European Spine Journal.

Methods

The results of systematic reviews conducted within the framework of the CBRG were used. Most of these reviews were published, but preliminary results from one Cochrane review on patient education (A. Engers et al., submitted for publication) that has been submitted for publication were also used. Because no Cochrane review was available, we used two recently published systematic reviews for the evidence summary on antidepressants. The Cochrane review on work conditioning, work hardening, and functional restoration was not taken into account because all trials included in this review were also included in the reviews on exercise therapy and multidisciplinary treatment. The Cochrane reviews were updated with additional trials, if available, using Clinical Evidence as source (www.clinicalevidence.com). This manuscript consists of two parts: one on evidence of pharmaceutical interventions and the other on evidence of non-pharmaceutical interventions for non-specific LBP.

Search Strategy and Study Selection

The following search strategy was used in the Cochrane reviews:

A computer aided search of the Medline and Embase databases since their beginning.
A search of the Cochrane Central Register of Controlled Trials (Central).
Screening references given in relevant systematic reviews and identified trials.
Personal communication with content experts in the field.

Two reviewers independently applied the inclusion criteria to select the potentially relevant trials from the titles, abstracts, and keywords of the references retrieved by the literature search. Articles for which disagreement existed, and articles for which title, abstract, and keywords provided insufficient information for a decision on selection were obtained to assess whether they met the inclusion criteria. A consensus method was used to resolve disagreements between the two reviewers regarding the inclusion of studies. A third reviewer was consulted if disagreements were not resolved in the consensus meeting.

Inclusion Criteria

Study design. RCTs were included in all reviews.

Participants. Participants of trials that were included in the systematic reviews usually had acute (less than 6 weeks), subacute (6�12 weeks), and/or chronic (12 weeks or more) LBP. All reviews included patients with non-specific LBP.

Interventions. All reviews included one specific intervention. Typically any comparison group was allowed, but comparisons with no treatment/placebo/waiting list controls and other interventions were separately presented.

Outcomes. The outcome measures included in the systematic reviews were outcomes of symptoms (e.g. pain), overall improvement or satisfaction with treatment, function (e.g. back-specific functional status), well-being (e.g. quality of life), disability (e.g. activities of daily living, work absenteeism), and side effects. Results were separately presented for short-term and long-term follow-up.

Methodological Quality Assessment

In most reviews, the methodological quality of trials included in the reviews was assessed using the criteria recommended by the CBRG. The studies were not blinded for authors, institutions, or the journals in which the studies were published. The criteria were: (1) adequate allocation concealment, (2) adequate method of randomization, (3) similarity of baseline characteristics, (4) blinding of patients, (5) blinding of care provider, (6) equal co-interventions, (7) adequate compliance, (8) identical timing of outcome assessment, (9) blinded outcome assessment, (10) withdrawals and drop outs adequate, and (11) intention-to-treat analysis. All items were scored as positive, negative, or unclear. High quality was typically defined as fulfilling 6 or more of the 11 quality criteria. We refer readers to the original Cochrane reviews for details of the quality of trials.

Data Extraction

The data that were extracted and presented in tables included characteristics of participants, interventions, outcomes, and results. We refer readers to the original Cochrane reviews for summaries of trial data.

Data Analysis

Some reviews conducted a meta-analysis using statistical methods to analyse and summarize the data. If relevant valid data were lacking (data were too sparse or of inadequate quality) or if data were statistically too heterogeneous (and the heterogeneity could not be explained), statistical pooling was avoided. In these cases, reviewers performed a qualitative analysis. In the qualitative analyses, various levels of evidence were used that took into account the participants, interventions, outcomes, and methodological quality of the original studies. If only a subset of available trials provided sufficient data for inclusion in a meta-analysis (e.g. only some trials reported standard deviations), both a quantitative and qualitative analysis was used.

Dr. Alex Jimenez’s Insight

The purpose of the following research study was to determine which of the various non-invasive treatment modalities used could be safe and most effective towards the prevention, diagnosis and treatment of acute, subacute and chronic non-specific low back pain, as well as general back pain. All of the systematic reviews included participants with some type of non-specific low back pain, or LBP, where each received health care for one specific intervention. The outcome measures included in the systematic reviews were based on symptoms, overall improvement or satisfaction with treatment, function, well-being, disability and side effects. The data of the results was extracted and presented in Tables 1 and 2. The researchers of the study performed a qualitative analysis of all the presented clinical and experimental data before demonstrating it in this article. As a healthcare professional, or patient with back pain, the information in this research study may help determine which non-invasive treatment modality should be considered to achieve the desired recovery outcome measures.

Results

Pharmaceutical Interventions

Antidepressants

There are three reasons for using antidepressants in the treatment of LBP. The first reason is that chronic LBP patients often also cope with depression, and treatment with antidepressants may elevate mood and increase pain tolerance. Second, many antidepressant drugs are sedating, and it has been suggested that part of their value for managing chronic pain syndromes simply could be improving sleep. The third reason for the use of antidepressants in chronic LBP patients is their supposed analgesic action, which occurs at lower doses than the antidepressant effect.

Effectiveness of antidepressants for acute LBP No trials were identified.

Effectiveness of antidepressants for chronic LBP Antidepressants versus placebo. We found two systematic reviews including a total of nine trials. One review found that antidepressants significantly increased pain relief compared with placebo but found no significant difference in functioning [pain: standardized mean difference (SMD) 0.41, 95% CI 0.22�0.61; function: SMD 0.24, 95% CI -0.21 to +0.69]. The other review did not statistically pool data but had similar results.

Adverse effects Adverse effects of antidepressants include dry mouth, drowsiness, constipation, urinary retention, orthostatic hypotension, and mania. One RCT found that the prevalence of dry mouth, insomnia, sedation, and orthostatic symptoms was 60�80% with tricyclic antidepressants. However, rates were only slightly lower in the placebo group and none of the differences were significant. In many trials, the reporting of side effects was insufficient.

Muscle Relaxants

The term �muscle relaxants� is very broad and includes a wide range of drugs with different indications and mechanisms of action. Muscle relaxants can be divided into two main categories: antispasmodic and antispasticity medications.

Antispasmodics are used to decrease muscle spasm associated with painful conditions such as LBP. Antispasmodics can be subclassified into benzodiazepines and non-benzodiazepines. Benzodiazepines (e.g. diazepam, tetrazepam) are used as anxiolytics, sedatives, hypnotics, anticonvulsants, and/or skeletal muscle relaxants. Non-benzodiazepines include a variety of drugs that can act at the brain stem or spinal cord level. The mechanisms of action with the central nervous system are still not completely understood.

Antispasticity medications are used to reduce spasticity that interferes with therapy or function, such as in cerebral palsy, multiple sclerosis, and spinal cord injuries. The mechanism of action of the antispasticity drugs with the peripheral nervous system (e.g. dantrolene sodium) is the blockade of the sarcoplasmic reticulum calcium channel. This reduces calcium concentration and diminishes actin�myosin interaction.

Effectiveness of muscle relaxants for acute LBP Benzodiazepines versus placebo. One study showed that there is limited evidence (one trial; 50 people) that an intramuscular injection of diazepam followed by oral diazepam for 5 days is more effective than placebo for patients with acute LBP on short-term pain relief and better overall improvement, but is associated with substantially more central nervous system side effects.

Non-benzodiazepines versus placebo. Eight studies were identified. One high quality study on acute LBP showed that there is moderate evidence (one trial; 80 people) that a single intravenous injection of 60 mg orphenadrine is more effective than placebo in immediate relief of pain and muscle spasm for patients with acute LBP.

Three high quality and one low quality trial showed that there is strong evidence (four trials; 294 people) that oral non-benzodiazepines are more effective than placebo for patients with acute LBP on short-term pain relief, global efficacy, and improvement of physical outcomes. The pooled RR and 95% CIs for pain intensity was 0.80 (0.71�0.89) after 2�4 days (four trials; 294 people) and 0.58 (0.45�0.76) after 5�7 days follow-up (three trials; 244 people). The pooled RR and 95% CIs for global efficacy was 0.49 (0.25�0.95) after 2�4 days (four trials; 222 people) and 0.68 (0.41�1.13) after 5�7 days follow-up (four trials; 323 people).

Antispasticity drugs versus placebo. Two high quality trials showed that there is strong evidence (two trials; 220 people) that antispasticity muscle relaxants are more effective than placebo for patients with acute LBP on short-term pain relief and reduction of muscle spasm after 4 days. One high quality trial also showed moderate evidence on short-term pain relief, reduction of muscle spasm, and overall improvement after 10 days.

Effectiveness of muscle relaxants for chronic LBP Benzodiazepines versus placebo. Three studies were identified. Two high quality trials on chronic LBP showed that there is strong evidence (two trials; 222 people) that tetrazepam 50 mg t.i.d. is more effective than placebo for patients with chronic LBP on short-term pain relief and overall improvement. The pooled RRs and 95% CIs for pain intensity were 0.82 (0.72�0.94) after 5�7 days follow-up and 0.71 (0.54�0.93) after 10�14 days. The pooled RR and 95% CI for overall improvement was 0.63 (0.42�0.97) after 10�14 days follow-up. One high quality trial showed that there is moderate evidence (one trial; 50 people) that tetrazepam is more effective than placebo on short-term decrease of muscle spasm.

Non-benzodiazepines versus placebo. Three studies were identified. One high quality trial showed that there is moderate evidence (one trial; 107 people) that flupirtin is more effective than placebo for patients with chronic LBP on short-term pain relief and overall improvement after 7 days, but not on reduction of muscle spasm. One high quality trial showed that there is moderate evidence (one trial; 112 people) that tolperisone is more effective than placebo for patients with chronic LBP on short-term overall improvement after 21 days, but not on pain relief and reduction of muscle spasm.

Adverse effects Strong evidence from all eight trials on acute LBP (724 people) showed that muscle relaxants are associated with more total adverse effects and central nervous system adverse effects than placebo, but not with more gastrointestinal adverse effects; RRs and 95% CIs were 1.50 (1.14�1.98), 2.04 (1.23�3.37), and 0.95 (0.29�3.19), respectively. The most commonly and consistently reported adverse events involving the central nervous system were drowsiness and dizziness. For the gastrointestinal tract this was nausea. The incidence of other adverse events associated with muscle relaxants was negligible.

NSAIDs

The rationale for the treatment of LBP with NSAIDs is based both on their analgesic potential and their anti-inflammatory action.

Effectiveness of NSAIDs for acute LBP NSAIDs versus placebo. Nine studies were identified. Two studies reported on LBP without radiation, two on sciatica, and the other five on a mixed population. There was conflicting evidence that NSAIDs provide better pain relief than placebo in acute LBP. Six of the nine studies which compared NSAIDs with placebo for acute LBP reported dichotomous data on global improvement. The pooled RR for global improvement after 1 week using the fixed effects model was 1.24 (95% CI 1.10�1.41), indicating a statistically significant effect in favour of NSAIDs compared to placebo. The pooled RR (three trials) for analgesic use using the fixed effects model was 1.29 (95% CI 1.05�1.57), indicating significantly less use of analgesics in the NSAIDs group.

NSAIDs versus paracetamol/acetaminophen. There were no differences between NSAIDs and paracetamol reported in two studies, but one study reported better outcomes for two of the four types of NSAIDs. There is conflicting evidence that NSAIDs are more effective than paracetamol for acute LBP.

NSAIDs versus other drugs. Six studies reported on acute LBP, of which five did not find any differences between NSAIDs and narcotic analgesics or muscle relaxants. Group sizes in these studies ranged from 19 to 44 and, therefore, these studies simply may have lacked power to detect a statistically significant difference. There is moderate evidence that NSAIDs are not more effective than other drugs for acute LBP.

Effectiveness of NSAIDs for chronic LBP NSAIDs versus placebo. One small cross-over study (n=37) found that naproxen sodium 275 mg capsules (two capsules b.i.d.) decreased pain more than placebo at 14 days.

COX2 inhibitors versus placebo. Four additional trials were identified. There is strong evidence that COX2 inhibitors (etoricoxib, rofecoxib and valdecoxib) decreased pain and improved function compared with placebo at 4 and 12 weeks, but effects were small.

Adverse effects NSAIDs may cause gastrointestinal complications. Seven of the nine studies which compared NSAIDs with placebo for acute LBP reported data on side effects. The pooled RR for side effects using the fixed effects model was 0.83 (95% CI 0.64�1.08), indicating no statistically significant difference. One systematic review of the harms of NSAIDs found that ibuprofen and diclofenac had the lowest gastrointestinal complication rate, mainly because of the low doses used in practice (pooled OR for adverse effects vs. placebo 1.30, 95% CI 0.91�1.80). COX2 inhibitors have been shown to have less gastrointestinal side effects in osteoarthritis and rheumatoid arthritis studies. However, increased cardiovascular risk (myocardial infarction and stroke) has been reported with long-term use.

Non-Pharmaceutical Interventions

Advice to Stay Active

Effectiveness of advice to stay active for acute LBP Stay active versus bed rest. The Cochrane review found four studies that compared advice to stay active as single treatment with bed rest. One high quality study showed that advice to stay active significantly improved functional status and reduced sick leave after 3 weeks compared with advice to rest in bed for 2 days. It also found a significant reduction of pain intensity in favour of the stay active group at intermediate follow-up (more than 3 weeks). The low quality studies showed conflicting results. The additional trial (278 people) found no significant differences in pain intensity and functional disability between advice to stay active and bed rest after 1 month. However, it found that advice to stay active significantly reduced sick leave compared with bed rest up to day 5 (52% with advice to stay active vs. 86% with bed rest; P<0.0001).

Stay active versus exercise. One trial found short-term improvement in functional status and reduction in sick leave in favour of advice to stay active. A significant reduction in sick leave in favour of the stay active group was also reported at long-term follow-up.

Effectiveness of advice to stay active for chronic LBP No trials identified.

Adverse effects No trials reported side effects.

Back Schools

The original �Swedish back school� was introduced by Zachrisson Forsell in 1969. It was intended to reduce the pain and prevent recurrences. The Swedish back school consisted of information on the anatomy of the back, biomechanics, optimal posture, ergonomics, and back exercises. Four small group sessions were scheduled during a 2-week period, with each session lasting 45 min. The content and length of back schools has changed and appears to vary widely today.

Effectiveness of back schools for acute LBP Back schools versus waiting list controls or �placebo� interventions. Only one trial compared back school with placebo (shortwaves at the lowest intensity) and showed better short-term recovery and return to work for the back school group. No other short- or long-term differences were found.

Back schools versus other interventions. Four studies (1,418 patients) showed conflicting evidence on the effectiveness of back schools compared to other treatments for acute and subacute LBP on pain, functional status, recovery, recurrences, and return to work (short-, intermediate-, and long-term follow-up).

Effectiveness of back schools for chronic LBP Back schools versus waiting list controls or �placebo� interventions. There is conflicting evidence (eight trials; 826 patients) on the effectiveness of back schools compared to waiting list controls or placebo interventions on pain, functional status, and return to work (short-, intermediate-, and long-term follow-up) for patients with chronic LBP.

Back schools versus other treatments. Six studies were identified comparing back schools with exercises, spinal or joint manipulation, myofascial therapy, and some kind of instructions or advice. There is moderate evidence (five trials; 1,095 patients) that a back school is more effective than other treatments for patients with chronic LBP for pain and functional status (short- and intermediate-term follow-up). There is moderate evidence (three trials; 822 patients) that there is no difference in long-term pain and functional status.

Adverse effects None of the trials reported any adverse effects.

Bed Rest

One rationale for bed rest is that many patients experience relief of symptoms in a horizontal position.

Effectiveness of bed rest for acute LBP Twelve trials were included in the Cochrane review. Some trials were on a mixed population of patients with acute and chronic LBP or on a population of patients with sciatica.

Bed rest versus advice to stay active. Three trials (481 patients) were included in this comparison. The results of two high quality trials showed small but consistent and significant differences in favour of staying active, at 3- to 4-week follow-up [pain: SMD 0.22 (95% CI 0.02�0.41); function: SMD 0.31 (95% CI 0.06�0.55)], and at 12-week follow-up [pain: SMD 0.25 (95% CI 0.05�0.45); function: SMD 0.25 (95% CI 0.02�0.48)]. Both studies also reported significant differences in sick leave in favour of staying active. There is strong evidence that advice to rest in bed is less effective than advice to stay active for reducing pain and improving functional status and speeding-up return to work.

Bed rest versus other interventions. Three trials were included. Two trials compared advice to rest in bed with exercises and found strong evidence that there was no difference in pain, functional status, or sick leave at short- and long-term follow-up. One study found no difference in improvement on a combined pain, disability, and physical examination score between bed rest and manipulation, drug therapy, physiotherapy, back school, or placebo.

Short bed rest versus longer bed rest. One trial in patients with sciatica reported no significant difference in pain intensity between 3 and 7 days of bed rest, measured 2 days after the end of treatment.

Effectiveness of bed rest for chronic LBP There were no trials identified.

Adverse effects No trials reported adverse effects.

Behavioural Treatment

The treatment of chronic LBP not only focuses on removing the underlying organic pathology, but also tries to reduce disability through the modification of environmental contingencies and cognitive processes. In general, three behavioural treatment approaches can be distinguished: operant, cognitive, and respondent. Each of these approaches focus on the modification of one of the three response systems that characterize emotional experiences: behaviour, cognition, and physiological reactivity.

Operant treatments include positive reinforcement of healthy behaviours and consequent withdrawal of attention towards pain behaviours, time-contingent instead of pain-contingent pain management, and spousal involvement. The operant treatment principles can be applied by all health care disciplines involved with the patient.

Cognitive treatment aims to identify and modify patients� cognitions regarding their pain and disability. Cognition (the meaning of pain, expectations regarding control over pain) can be modified directly by cognitive restructuring techniques (such as imagery and attention diversion), or indirectly by the modification of maladaptive thoughts, feelings, and beliefs.

Respondent treatment aims to modify the physiological response system directly, e.g. by reduction of muscular tension. Respondent treatment includes providing the patient with a model of the relationship between tension and pain, and teaching the patient to replace muscular tension by a tension-incompatible reaction, such as the relaxation response. Electromyographic (EMG) biofeedback, progressive relaxation, and applied relaxation are frequently used.

Behavioural techniques are often applied together as part of a comprehensive treatment approach. This so-called cognitive�behavioural treatment is based on a multidimensional model of pain that includes physical, affective, cognitive, and behavioural components. A large variety of behavioural treatment modalities are used for chronic LBP because there is no general consensus about the definition of operant and cognitive methods. Furthermore, behavioural treatment often consists of a combination of these modalities or is applied in combination with other therapies (such as medication or exercises).

Effectiveness of behavioural therapy for acute LBP One RCT (107 people) identified by the review found that cognitive�behavioural therapy reduced pain and perceived disability after 9�12 months compared with traditional care (analgesics plus back exercises until pain had subsided).

Effectiveness of behavioural therapy for chronic LBP Behavioural treatment versus waiting list controls. There is moderate evidence from two small trials (total of 39 people) that progressive relaxation has a large positive effect on pain (1.16; 95% CI 0.47�1.85) and behavioural outcomes (1.31; 95% CI 0.61�2.01) in the short-term. There is limited evidence that progressive relaxation has a positive effect on short-term back-specific and generic functional status.

There is moderate evidence from three small trials (total of 88 people) that there is no significant difference between EMG biofeedback and waiting list control on behavioural outcomes in the short-term. There is conflicting evidence (two trials; 60 people) on the effectiveness of EMG versus waiting list control on general functional status.

There is conflicting evidence from three small trials (total of 153 people) regarding the effect of operant therapy on short-term pain intensity, and moderate evidence that there is no difference [0.35 (95% CI -0.25 to 0.94)] between operant therapy and waiting list control for short-term behavioural outcomes. Five studies compared combined respondent and cognitive therapy with waiting list controls. There is strong evidence from four small trials (total of 134 people) that combined respondent and cognitive therapy has a medium sized, short-term positive effect on pain intensity. There is strong evidence that there are no differences [0.44 (95% CI -0.13 to 1.01)] on short-term behavioural outcomes.

Behavioural treatment versus other interventions. There is limited evidence (one trial; 39 people) that there are no significant differences between behavioural treatment and exercise on pain intensity, generic functional status and behavioural outcomes, either post-treatment, or at 6- or 12-month follow-up.

Adverse effects None reported in the trials.

Exercise Therapy

Exercise therapy is a management strategy that is widely used in LBP; it encompasses a heterogeneous group of interventions ranging from general physical fitness or aerobic exercise, to muscle strengthening, to various types of flexibility and stretching exercises.

Effectiveness of exercise therapy for acute LBP Exercise versus no treatment. The pooled analysis failed to show a difference in short-term pain relief between exercise therapy and no treatment, with an effect of -0.59 points/100 (95% CI -12.69 to 11.51).

Exercise versus other interventions. Of 11 trials involving 1,192 adults with acute LBP, 10 had non-exercise comparisons. These trials provide conflicting evidence. The pooled analysis showed that there was no difference at the earliest follow-up in pain relief when compared to other conservative treatments: 0.31 points (95% CI -0.10 to 0.72). Similarly, there was no significant positive effect of exercise on functional outcomes. Outcomes show similar trends at short-, intermediate-, and long-term follow-up.

Effectiveness of exercise therapy for subacute LBP Exercise versus other interventions. Six studies involving 881 subjects had non-exercise comparisons. Two trials found moderate evidence of reduced work absenteeism with a graded activity intervention compared to usual care. The evidence is conflicting regarding the effectiveness of other exercise therapy types in subacute LBP compared to other treatments.

Effectiveness of exercise therapy for chronic LBP Exercise versus other interventions. Thirty-three exercise groups in 25 trials on chronic LBP had non-exercise comparisons. These trials provide strong evidence that exercise therapy is at least as effective as other conservative interventions for chronic LBP. Two exercise groups in high quality studies and nine groups in low quality studies found exercise more effective than comparison treatments. These studies, mostly conducted in health care settings, commonly used exercise programs that were individually designed and delivered (as opposed to independent home exercises). The exercise programs commonly included strengthening or trunk stabilizing exercises. Conservative care in addition to exercise therapy was often included in these effective interventions, including behavioural and manual therapy, advice to stay active, and education. One low quality trial found a group-delivered aerobics and strengthening exercise program resulted in less improvement in pain and function outcomes than behavioural therapy. Of the remaining trials, 14 (2 high quality and 12 low quality) found no statistically significant or clinically important differences between exercise therapy and other conservative treatments; 4 of these trials were inadequately powered to detect clinically important differences on at least one outcome. Trials were rated low quality most commonly because of inadequate assessor blinding.

Meta-analysis of pain outcomes at the earliest follow-up included 23 exercise groups with an independent comparison and adequate data. Synthesis resulted in a pooled weighted mean improvement of 10.2 points (95% CI 1.31�19.09) for exercise therapy compared to no treatment, and 5.93 points (95% CI 2.21�9.65) compared to other conservative treatment [vs. all comparisons 7.29 points (95% CI 3.67�0.91)]. Smaller improvements were seen in functional outcomes with an observed mean positive effect of 3.15 points (95% CI -0.29 to 6.60) compared to no treatment, and 2.37 points (95% CI 0.74�4.0) versus other conservative treatment at the earliest follow-up [vs. all comparisons 2.53 points (95% CI 1.08�3.97)].

Adverse effects Most trials did not report any side effects. Two studies reported cardiovascular events that were considered not to be caused by the exercise therapy.

Lumbar Supports

Lumbar supports are provided as treatment to people suffering from LBP with the aim of making the impairment and disability vanish or decrease. Different desired functions have been suggested for lumbar supports: (1) to correct deformity, (2) to limit spinal motion, (3) to stabilize part of the spine, (4) to reduce mechanical uploading, and (5) miscellaneous effects: massage, heat, placebo. However, at the present time the putative mechanisms of action of a lumbar support remain a matter of debate.

Effectiveness of lumbar supports for acute LBP No trials were identified.

Effectiveness of lumbar supports for chronic LBP No RCT compared lumbar supports with placebo, no treatment, or other treatments for chronic LBP.

Effectiveness of lumbar supports for a mixed population of acute, subacute, and chronic LBP Four studies included a mix of patients with acute, subacute, and chronic LBP. One study did not give any information about the duration of the LBP complaints of the patients. There is moderate evidence that a lumbar support is not more effective in reducing pain than other types of treatment. Evidence on overall improvement and return to work was conflicting.

Adverse effects Potential adverse effects associated with prolonged lumbar support use include decreased strength of the trunk musculature, a false sense of security, heat, skin irritation, skin lesions, gastrointestinal disorders and muscle wasting, higher blood pressure and higher heart rates, and general discomfort.

Multidisciplinary Treatment Programmes

Multidisciplinary treatments for back pain evolved from pain clinics. Initially, multidisciplinary treatments focused on a traditional biomedical model and in the reduction of pain. Current multidisciplinary approaches to chronic pain are based on a multifactorial biopsychosicial model of interrelating physical, psychological, and social/occupational factors. The content of multidisciplinary programs varies widely and, at present, it is unclear what the optimal content is and who should be involved.

Effectiveness of multidisciplinary treatment for subacute LBP No trials identified.

Effectiveness of multidisciplinary treatment for subacute LBP Multidisciplinary treatment versus usual care. Two RCTs on subacute LBP were included. The study population in both studies consisted of workers on sick leave. In one study the patients in the intervention group returned to work sooner (10 weeks) compared with the control group (15 weeks) (P=0.03). The intervention group also had fewer sick leave during follow-up than the control group (mean difference=-7.5 days, 95% CI -15.06 to 0.06). There was no statistically significant difference in pain intensity between the intervention and control group, but subjective disability had decreased significantly more in the intervention group than in the control group (mean difference=-1.2, 95% CI -1.984 to -0.416). In the other study, the median duration of absence from regular work was 60 days for the group with a combination of occupational and clinical intervention, 67 days with the occupational intervention group, 131 days with the clinical intervention group, and 120.5 days with the usual care group (P=0.04). Return to work was 2.4 times faster in the group with both an occupational and clinical intervention (95% CI 1.19�4.89) than the usual care group, and 1.91 times faster in the two groups with occupational intervention than the two groups without occupational interventions (95% CI 1.18�3.1). There is moderate evidence that multidisciplinary treatment with a workplace visit and comprehensive occupational health care intervention is effective with regard to return to work, sick leave, and subjective disability for patients with subacute LBP.

Effectiveness of multidisciplinary treatment for chronic LBP Multidisciplinary treatment versus other interventions. Ten RCTs with a total of 1,964 subjects were included in the Cochrane review. Three additional papers reported on long-term outcomes of two of these trials. All ten trials excluded patients with significant radiculopathy or other indication for surgery. There is strong evidence that intensive multidisciplinary treatment with a functional restoration approach improves function when compared with inpatient or outpatient non-multidisciplinary treatments. There is moderate evidence that intensive multidisciplinary treatment with a functional restoration approach reduces pain when compared with outpatient non-multidisciplinary rehabilitation or usual care. There is contradictory evidence regarding vocational outcomes. Five trials evaluating less intensive multidisciplinary treatment programmes could not demonstrate beneficial effects on pain, function, or vocational outcomes when compared with non-multidisciplinary outpatient treatment or usual care. One additional RCT was found that showed no difference between multidisciplinary treatment and usual care on function and health related quality of life after 2 and 6 months.

The reviewed studies provide evidence that intensive (>100 h of therapy) MBPSR with a functional restoration approach produces greater improvements in pain and function for patients with disabling chronic LBP than non-multidisciplinary rehabilitation or usual care. Less intensive treatments did not seem effective.

Adverse effects No adverse effects were reported.

Spinal Manipulation

Spinal manipulation is defined as a form of manual therapy which involves movement of a joint past its usual end range of motion, but not past its anatomic range of motion. Spinal manipulation is usually considered as that of long lever, low velocity, non-specific type manipulation as opposed to short lever, high velocity, specific adjustment. Potential hypotheses for the working mechanism of spinal manipulation are: (1) release for the entrapped synovial folds, (2) relaxation of hypertonic muscle, (3) disruption of articular or periarticular adhesion, (4) unbuckling of motion segments that have undergone disproportionate displacement, (5) reduction of disc bulge, (6) repositioning of miniscule structures within the articular surface, (7) mechanical stimulation of nociceptive joint fibres, (8) change in neurophysiological function, and (9) reduction of muscle spasm.

Effectiveness of spinal manipulation for acute LBP Spinal manipulation versus sham. Two trials were identified. Patients receiving treatment that included spinal manipulation had statistically significant and clinically important short-term improvements in pain (10-mm difference; 95% CI 2�17 mm) compared with sham therapy. However, the improvement in function was considered clinically relevant but not statistically significant (2.8-mm difference on the Roland Morris scale; 95% CI -0.1 to 5.6).

Spinal manipulation versus other therapies. Twelve trials were identified. Spinal manipulation resulted in statistically significant more short-term pain relief compared with other therapies judged to be ineffective or possibly even harmful (4-mm difference; 95% CI 1�8 mm). However, the clinical significance of this finding is questionable. The point estimate of improvement in short-term function for treatment with spinal manipulation compared with the ineffective therapies was considered clinically significant but was not statistically significant (2.1-point difference on the Roland Morris scale; 95% CI -0.2 to 4.4). There were no differences in effectiveness between patients treated with spinal manipulation and those treated with any of the conventionally advocated therapies.

Effectiveness of spinal manipulation for chronic LBP Spinal manipulation versus sham. Three trials were identified. Spinal manipulation was statistically significantly more effective compared with sham manipulation on short-term pain relief (10 mm; 95% CI 3�17 mm) and long-term pain relief (19 mm; 95% CI 3�35 mm). Spinal manipulation was also statistically significantly more effective on short-term improvement of function (3.3 points on the Roland and Morris Disability Questionnaire (RMDQ); 95% CI 0.6�6.0).

Spinal manipulation versus other therapies. Eight trials were identified. Spinal manipulation was statistically significantly more effective compared with the group of therapies judged to be ineffective or perhaps harmful on short-term pain relief (4 mm; 95% CI 0�8), and short-term improvement in function (2.6 points on the RMDQ; 95% CI 0.5�4.8). There were no differences in short- and long-term effectiveness compared with other conventionally advocated therapies such as general practice care, physical or exercise therapy, and back school.

Adverse effects In the RCTs identified by the review that used a trained therapist to select people and perform spinal manipulation, the risk of serious complications was low. An estimate of the risk of spinal manipulation causing a clinically worsened disk herniation or cauda equina syndrome in a patient presenting with lumbar disk herniation is calculated from published data to be less than 1 in 3.7 million.

Traction

Lumbar traction uses a harness (with velcro strapping) that is put around the lower rib cage and around the iliacal crest. Duration and level of force exerted through this harness can be varied in a continuous or intermittent mode. Only in motorized and bed rest traction can the force be standardized. With other techniques total body weight and the strength of the patient or therapist determine the forces exerted. In the application of traction force, consideration must be given to counterforces such as lumbar muscle tension, lumbar skin stretch and abdominal pressure, which depend on the patient�s physical constitution. If the patient is lying on the traction table, the friction of the body on the table provides the main counterforce during traction. The exact mechanism through which traction might be effective is unclear. It has been suggested that spinal elongation, through decreasing lordosis and increasing intervertebral space, inhibits nociceptive impulses, improves mobility, decreases mechanical stress, reduces muscle spasm or spinal nerve root compression (due to osteophytes), releases luxation of a disc or capsule from the zygo-apophysial joint, and releases adhesions around the zygo-apophysial joint and the annulus fibrosus. So far, the proposed mechanisms have not been supported by sufficient empirical information.

Thirteen of the studies identified in the Cochrane review included a homogeneous population of LBP patients with radiating symptoms. The remaining studies included a mix of patients with and without radiation. There were no studies exclusively involving patients who had no radiating symptoms.

Five studies included solely or primarily patients with chronic LBP of more than 12 weeks; in one study patients were all in the subacute range (4�12 weeks). In 11 studies the duration of LBP was a mixture of acute, subacute, and chronic. In four studies duration was not specified.

Effectiveness of traction for acute LBP No RCTs included primarily people with acute LBP. One study was identified that included patients with subacute LBP, but this population consisted of a mix of patients with and without radiation.

Effectiveness of traction for chronic LBP One trial found that continuous traction is not more effective on pain, function, overall improvement, or work absenteeism than placebo. One RCT (42 people) found no difference in effectiveness between standard physical therapy including continuous traction and the same program without traction. One RCT (152 people) found no significant difference between lumbar traction plus massage and interferential treatment in pain relief, or improvement of disability 3 weeks and 4 months after the end of treatment. This RCT did not exclude people with sciatica, but no further details of the proportion of people with sciatica were reported. One RCT (44 people) found that autotraction is more effective than mechanical traction on global improvement, but not on pain and function, in chronic LBP patients with or without radiating symptoms. However, this trial had several methodological problems that may be associated with biased results.

Adverse effects Little is known about the adverse effects of traction. Only a few case reports are available, which suggest that there is some danger for nerve impingement in heavy traction, i.e. lumbar traction forces exceeding 50% of the total body weight. Other risks described for lumbar traction are respiratory constraints due to the traction harness or increased blood pressure during inverted positional traction. Other potential adverse effects of traction include debilitation, loss of muscle tone, bone demineralization, and thrombophlebitis.

Transcutaneous Electrical Nerve Stimulation

Transcutaneous electrical nerve stimulation (TENS) is a therapeutic non-invasive modality mainly used for pain relief by electrically stimulating peripheral nerves via skin surface electrodes. Several types of TENS applications, differing in intensity and electrical characteristics, are used in clinical practice: (1) high frequency, (2) low frequency, (3) burst frequency, and (4) hyperstimulation.

Effectiveness of TENS for acute LBP: No trials were identified.

Effectiveness of TENS for chronic LBP The Cochrane review included two RCTs of TENS for chronic LBP. The results of one small trial (N=30) showed a significant decrease in subjective pain intensity with active TENS treatment compared to placebo over the course of the 60-min treatment session. The pain reduction seen at the end of stimulation was maintained for the entire 60-min post-treatment time interval assessed (data not shown). Longer term follow-up was not conducted in this study. The second trial (N=145) demonstrated no significant difference between active TENS and placebo for any of the outcomes measured, including pain, functional status, range of motion, and use of medical services.

Adverse effects In a third of the participants in one trial, minor skin irritation occurred at the site of electrode placement. These adverse effects were observed equally in the active TENS and placebo groups. One participant randomized to placebo TENS developed severe dermatitis 4 days after beginning therapy and was required to withdraw (Tables 1, ?2).

Table 1: Effectiveness of conservative interventions for acute non-specific low back pain.

Table 2: Effectiveness of conservative interventions for chronic non-specific low back pain.

Discussion

The best available evidence for conservative treatments for non-specific LBP summarized in this paper shows that some interventions are effective. Traditional NSAIDs, muscle relaxants, and advice to stay active are effective for short-term pain relief in acute LBP. Advice to stay active is also effective for long-term improvement of function in acute LBP. In chronic LBP, various interventions are effective for short-term pain relief, i.e. antidepressants, COX2 inhibitors, back schools, progressive relaxation, cognitive�respondent treatment, exercise therapy, and intensive multidisciplinary treatment. Several treatments are also effective for short-term improvement of function in chronic LBP, namely COX2 inhibitors, back schools, progressive relaxation, exercise therapy, and multidisciplinary treatment. There is no evidence that any of these interventions provides long-term effects on pain and function. Also, many trials showed methodological weaknesses, effects are compared to placebo, no treatment or waiting list controls, and effect sizes are small. Future trials should meet current quality standards and have adequate sample size. However, in summary, there is evidence that some interventions are effective while evidence for many other interventions is lacking or there is evidence that they are not effective.

During the last decade, various clinical guidelines on the management of acute LBP in primary care have been published that have used this evidence. At present, guidelines exist in at least 12 different countries: Australia, Denmark, Finland, Germany, Israel, the Netherlands, New Zealand, Norway, Sweden, Switzerland, the United Kingdom, and the United States. Since the available evidence is international, one would expect that each country�s guidelines would give more or less similar recommendations regarding diagnosis and treatment. Comparison of clinical guidelines for the management of LBP in primary care from 11 different countries showed that the content of the guidelines regarding therapeutic interventions is quite similar. However, there were also some discrepancies in recommendations across guidelines. Differences in recommendations between guidelines may be due to incompleteness of the evidence, different levels of evidence, magnitude of effects, side effects and costs, differences in health care systems (organization/financial), or differences in membership of guidelines committees. More recent guidelines may have included more recently published trials and, therefore, may end up with slightly different recommendations. Also, guidelines may have been based on systematic reviews that included trials in different languages; the majority of existing reviews have considered only studies published in a few languages, and several, only those published in English. Recommendations in guidelines are not only based on scientific evidence, but also on consensus. Guideline committees may consider various arguments differently, such as the magnitude of the effects, potential side effects, cost-effectiveness, and current routine practice and available resources in their country. Especially as we know that effects in the field of LBP, if any, are usually small and short-term effects only, interpretation of effects may vary among guideline committees. Also, guideline committees may differently weigh other aspects such as side effects and costs. The constitution of the guideline committees and the professional bodies they represent may introduce bias�either for or against a particular treatment. This does not necessarily mean that one guideline is better than the other or that one is right and the other is wrong. It merely shows that when translating the evidence into clinically relevant recommendations more aspects play a role, and that these aspects may vary locally or nationally.

Recently European guidelines for the management of LBP were developed to increase consistency in the management of non-specific LBP across countries in Europe. The European Commission has approved and funded this project called �COST B13�. The main objectives of this COST action were developing European guidelines for the prevention, diagnosis and treatment of non-specific LBP, ensuring an evidence-based approach through the use of systematic reviews and existing clinical guidelines, enabling a multidisciplinary approach, and stimulating collaboration between primary health care providers and promoting consistency across providers and countries in Europe. Representatives from 13 countries participated in this project that was conducted between 1999 and 2004. The experts represented all relevant health professions in the field of LBP: anatomy, anaesthesiology, chiropractic, epidemiology, ergonomy, general practice, occupational care, orthopaedic surgery, pathology, physiology, physiotherapy, psychology, public health care, rehabilitation, and rheumatology. Within this COST B13 project four European guidelines were developed on: (1) acute LBP, (2) chronic LBP, (3) prevention of LBP, and (4) pelvic girdle pain. The guidelines will soon be published as a supplement to the European Spine Journal.

Contributor Information

Maurits W. van Tulder, Bart Koes, Antti Malmivaara: Ncbi.nlm.nih.gov

In conclusion,�the clinical and experimental evidence above for non-invasive treatment modalities on back pain demonstrated that several of the treatments are safe and effective. While the results of a variety of the methods used to improve back pain symptoms were proven to be efficient, many other treatment modalities requires additional evidence and others were reported to not be effective towards improving symptoms of back pain.�The main objective of the research study was to determine the safest and most effective guideline for the prevention, diagnosis and treatment of non-specific back 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: Sciatica

Sciatica is referred to as a collection of symptoms rather than a single type of injury or condition. The symptoms are characterized as radiating pain, numbness and tingling sensations from the sciatic nerve in the lower back, down the buttocks and thighs and through one or both legs and into the feet. Sciatica is commonly the result of irritation, inflammation or compression of the largest nerve in the human body, generally due to a herniated disc or bone spur.

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IMPORTANT TOPIC: EXTRA EXTRA: Treating Sciatica Pain

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Prescription Painkillers Most Common Treatment For Back Pain

by Dr Alex Jimenez | Back Pain, Chiropractic, Chronic Back Pain, Spine Care, Treatments

Chiropractor, Dr. Alexander Jimenez�Finds Prescription Painkillers Most Common Treatment for Patients Seeking Care for Back Pain
More than half of Americans suffer from back pain, as well as for those that seek treatment, doctors turn most often to prescription drugs
Ann Arbor, MI, May 19, 2017 � Many Americans (51 percent) have experienced back pain in the last 12 months, and of the 58% of those who sought treatment from a medical professional, 40 percent said they were recommended prescription painkillers, according to the Truven Health Analytics-NPR Health Poll.
Truven Health Analytics�, element of the IBM Watson Health business, and NPR run a national poll that is bimonthly to gauge opinions and attitudes on a broad variety of health�issues.

Following Are The Poll�s Findings:

Back Pain Plagues�Americans: Fifty one percent of Americans said they’ve endured from back pain in the last 12 months, and 46 percent of people who experienced pain said they are still in distress. Over half (58 percent) of back pain sufferers sought attention, with 70 percent visiting a medical doctor and 14 percent seeing a chiropractor.
Prescription Pain Killers are the Most Common Treatment: Of the 70 percent of back pain sufferers who sought care from a medical doctor, 40 percent were prescribed prescription pain killers, a rate that tended to decrease with increasing age of the patient. Other treatments prescribed were exercise/physical therapy (31 percent), shots (20 percent), massage (17 percent), steroids (17 percent), over-the-counter painkillers (13 percent), operation (12 percent), or another form of treatment (37 percent).
Almost a Third Stay in Pain with Treatment: Among all respondents, 25 percent said their back pain remained the same and five percent said their pain got worse. Forty-five percent said their pain improved, and 25 percent said it went away entirely.

�Experiencing back pain is extremely common among Americans, and there are a number of factors that may contribute to it, some of which are treatable without prescription pain killers, � said Anil Jain, MD, Vice-President and Chief Health Informatics Officer, Value-Based Care, IBM Watson Health. �These data reveal that when care is sought by the patients, they are generally prescribed painkillers. Compounding this challenge, back pain sufferers that are prescribed opioids for pain may be particularly at risk for dependency and addiction. Checking inappropriate opioid prescriptions for long-term pain is a focus of efforts by suppliers to fight the current opioid epidemic.�

To date, the Truven Health Analytics-NPR Health Survey has investigated numerous health topics, including vaccines generic drugs, data privacy, narcotic painkillers, and sports-related concussions. NPR archives reports on the surveys online in the Photos health blog here. Truven Health keeps a library of survey results here.

The Truven Health Analytics-NPR Health Poll is powered by the Truven Health PULSE� survey, an independently funded, nationally representative, multimodal poll that collects information about health-related behaviours and approaches and healthcare use from 80, 000 U.S. homes annually.
The results represent responses from 3, 002 survey participants interviewed from March 1 � 16 , 2017. The margin of error is /- 1.8 percentage points.

About NPR

NPR is an award winning, multimedia news organization and an influential force in American life. In collaboration with more than 900 independent public radio stations nationwide, NPR strives to generate a more educated public�one challenged and invigorated by way of a deeper understanding and grasp of ideas, events and cultures.
About Truven Health Analytics, section of the IBM Watson Health Company

Truven Health Analytics�, a part of the IBM Watson Health� company, supplies market-leading performance development solutions built on advanced analytics, data integrity and domain expertise. For over 40 years, our insights and alternatives have already been providing hospitals and clinicians, employers and health plans, state and government services, life sciences companies and policymakers, the facts they must make confident choices that directly alter the health and well-being of people and organizations in america and around the world. The firm was acquired by IBM in 2016 to help form a new business, Watson Health. Watson Health aspires to improve lives and give expectation by presenting innovation to deal with the world�s most pressing health challenges through cognitive insights and data.

Chiropractic Treatment for Low Back Pain Symptoms

by Dr Alex Jimenez | Back Pain, Chiropractic, Conditions Treated, Lower Back Pain, Spine Care, Treatments

Seeing a doctor of chiropractic, otherwise referred to as DC, chiropractic physician or a chiropractor, can be a beneficial step towards effectively treating low back pain. Below is a quick description of how they help patients resolve their low back pain and what chiropractors do.

What to Expect from a Chiropractor

Chiropractors use a number of treatments made to manipulate joints, the back, and tissues of the body to relieve pain and improve functional ability. Normally, this could be referred to as spinal manipulative therapy (SMT), but you will find several other chiropractic treatment approaches.

A chiropractor tailors her or his treatment strategy depending on the individual needs of a patient, using a traditional philosophy of starting off together with the more natural, less-invasive treatments before moving on to even more aggressive techniques.

At every stage through the procedure, chiropractors preserve a rigorous emphasis on proactively communicating together with the patient exactly what’s going to happen. The chiropractor makes certain the patient comprehends everything that occurs during evaluation, an investigation, and also the proposed procedures, so that you can instruct the patient and receive direct acceptance to start the treatment process.

This emphasis on informed consent is essential because some chiropractic techniques may carry material hazard, which means there could a danger, however, trivial, that an injury could be maybe caused by a particular process.

Nevertheless, a chiropractor also informs a patient of the potential risks attached to abstaining in the process, entirely. Nevertheless, none of this is meant to scare a patient. Make sure that the patient, who has full control over his / her body can make an informed choice and constantly it’s simply thought to remove mistakes.

Chiropractic Procedures

A chiropractor will examine a patient thoroughly prior to making any type of identification or treatment plan. The evaluation can include various aspects, including:

Health history

Look in the characteristics of the pain, keeping an eye out for “red flags,” which suggest that additional diagnostic testing ought to be ran in order to exclude any potentially serious medical problems that may be connected with neck or low back pain-like neurological disorders, fractures, diseases, and tumors.

You will find lots of reasons why low back pain happens. A chiropractor will find out those motives to configure the most appropriate treatment.

Physical examination, including orthopedic and neurological evaluations
Analyze sensory nerves, the reflexes, joints, muscles, as well as other areas of the body.

Advanced Diagnostic Testing

Lab and imaging evaluations aren’t recommended for nonspecific LBP, however they might be required if there are signs of a serious underlying condition.

Severity and Duration of Afflictions

A chiropractor looks at the symptoms and afflictions of sickness or an injury and rationally classifies them based by how serious they are, and the way long they continue.

Symptoms are subdivided into levels of severity: mild, moderate, or serious. In terms of duration, pain (and other symptoms) might be referred to as:

Acute – lasts for less than 6 weeks
Subacute – persists between 6 and 12 weeks
Long-Term – persists for at least 12 weeks
Perennial/flare up – the same symptom(s) reoccurs sporadically or because of exacerbating the original harm

In case a patient is suffering from acute or subacute low back pain, a normal chiropractic therapeutic trial is 2 to 3 weekly sessions over the course of 2 to 4 weeks, going up to 12 complete sessions per trial. Often, this can be sufficient to entirely solve the pain. Other times, additional treatments may be necessary, especially if a patient is struggling with other issues.

Result measurements certainly are a useful tool to get a chiropractor since they could help determine in the event the treatments are showing significant progress.

Some ways a chiropractor can quantify the outcomes of the treatments include:

Having a patient speed the pain
So a patient can characterize the positioning and nature of the pain, using a pain diagram
Searching for increases (or declines) in day-to-day living practices, as in the capacity to work (employment), exercise and sleep.
Testing practical capacity, such as weightlifting ability, strength, flexibility, and endurance

Some patients’ low back pain may have lasted into and beyond the 12-week mark, which makes it long-term pain. During assessment, chiropractors will look for signs to determine if a patient is at an increased risk of developing long-term pain- the “yellow flags” of chronicity so to speak.

The scope of our information is limited to chiropractic and spinal injuries and conditions. To discuss options on the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .

By Dr. Alex Jimenez

Additional Topics: What is Chiropractic?

Chiropractic care is an well-known, alternative treatment option utilized to prevent, diagnose and treat a variety of injuries and conditions associated with the spine, primarily subluxations or spinal misalignments. Chiropractic focuses on restoring and maintaining the overall health and wellness of the musculoskeletal and nervous systems. Through the use of spinal adjustments and manual manipulations, a chiropractor, or doctor of chiropractic, can carefully re-align the spine, improving a patient�s strength, mobility and flexibility.

Different Chiropractic Treatment Modalities for Back Pain

by Dr Alex Jimenez | Back Pain, Chiropractic, Spine Care, Treatments

Chiropractic care focuses on the diagnosis, treatment and prevention of a variety of injuries and conditions associated with the musculoskeletal and nervous system. Specializing on the spine and its surrounding structures, chiropractic treatment commonly utilizes spinal adjustments and manual manipulations to restore the proper function of the body, however, many chiropractors use other therapies to treat patients.

The following are other common therapeutic treatment methods that chiropractors can additionally offer along with a brief description of each.

Rehabilitation Stretches

After an individual has experienced an injury or aggravated a previous condition, rehabilitation stretches can be essential to prevent the formation of scar tissue. Even after the damage has healed, maintaining a regular program of stretches recommended by a healthcare professional or chiropractor can help maintain and improve flexibility and mobility as well as help protect the tissues from suffering further injury. Your chiropractor will instruct you on the best stretching techniques for you depending on your specific injury or condition and they will supervise you throughout the process.

Rehabilitation Exercises

Together with the recommended set of stretches, a healthcare specialist or chiropractor can follow up by recommending specific exercises to strengthen the structures surrounding the spine of patients with neck and back complications. Strengthening exercises can help eliminate symptoms of pain as well as help prevent the degeneration of the muscles, promotes joint health and can increase strength, stability and range of motion to protect the body from suffering further injuries or aggravating conditions.

Your chiropractor will demonstrate how to do the exercises and supervise you until you are comfortable doing them on your own. It’s fundamental to keep up with your exercises as recommended by your healthcare provides. Research studies have demonstrated that individuals who follow their specific exercise instructions carefully heal faster than those who do not.

Traction

Many chiropractors utilize traction devices to apply traction to different areas of the body in order to distract different regions of the spine. This treatment helps separate the vertebrae, decompressing the discs to reduce and eliminate nerve root pressure.

Soft-Tissue Manual Therapy

Many chiropractors will utilize a variety of hands-on soft tissue therapies to help improve the function of the soft tissues, including muscles, ligaments, tendons and joint capsules. Soft-tissue manual therapies such as the pin and stretch, best known as the active release technique, or ART, and instrument-assisted soft tissue mobilization, best known as the Graston technique, are some of the most common soft-tissue manual therapies used.

Muscular Stimulation

Muscle stimulation is performed by transmitting light electrical pulses to specific areas of the body through electrodes placed against the skin. There’s a variety of electrical stimulation therapies available. Several types can be more beneficial towards eliminating pain, reducing inflammation and for treating muscle spasms while others may actually cause muscles to contract in order to reduce muscle atrophy. Some forms of electrical muscular stimulation can have a combination of benefits and effects.

TENS

A transcutaneous electric nerve stimulation or TENS unit is a small, battery-powered, portable muscle stimulation machine which can be utilized at home to help control pain. Variable intensities of electric current can be utilized by healthcare professionals to control the symptoms of pain. This treatment is recommended to help patients get through periods of severe or acute pain caused by their specific type of injury or condition. TENS units are generally not recommended for chronic pain, however. As a matter of fact, a 2009 report from the American Academy of Neurology determined that transcutaneous electric nerve stimulation units may not be effective for treating chronic low back pain.

Ultrasound

Therapeutic ultrasound is a form of deep heat therapy created by sound waves. When applied to soft tissues and joints, the sound waves function as a form of micro-massage which helps decrease pain, reduce swelling, stiffness and spasms as well as increase blood flow.

Ice and Heat Therapy

The application of ice and heat have been used for many years to treat many painful injuries and conditions. Ice therapy is often recommended to reduce swelling and help control pain immediately after an injury. Heat therapy is often recommended to relax the muscles, increase circulation, and can provide relief to patients with chronic pain. According to the patient’s condition, a combination of ice and heat can be used.

Nutritional Counseling

Research studies have concluded that following an improper diet and nutrition can provide imbalances in the body which may contribute to a variety of serious illnesses, such as heart disease, stroke, diabetes, and even cancer. Many chiropractors are especially trained in diet and nutritional counseling. Your chiropractor can design a nutritional program depending on your needs in order to help you maintain overall health and wellness as well as to minimize the risk of developing these serious health conditions.

Lifestyle Modification Counseling

Good health is much more than the absence of pain or disease. The lifestyle choices you make on a daily basis can greatly affect your entire well-being. Over time, a lifestyle of unhealthy lifestyle choices can ultimately lead to a wide array of health complications. Examples of lifestyle choices and behaviors that can have negative effects on your health include:

lack of regular exercise
smoking
poor diet
excessive mental stress
over-reliance on medication
excessive consumption of alcohol
poor posture
improper lifting

A healthcare specialist or chiropractor will discuss a patient’s lifestyle choices and habits in order to help them identify which of them could be considered an unhealthy health habit. These can then be altered and modified using practical strategies.

Chiropractic care focuses on using much more than spinal adjustments and manual manipulations to ensure the patient achieves their health goals. Doctors of chiropractic use a variety of treatment modalities to help the body naturally heal itself and return the patient to healthier life.

By Dr. Alex Jimenez

The Injury & Trauma Rehabilitation Specialists

PUSHasRx® Trauma Rehabilitation Center

Health, Wellness & Nutrition Specialists

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

Methods/Design

Discussion

Trial Registration

Background

Specific Aims

Methods/Design

Overview

Study Sample and Setting

Inclusion and Exclusion Criteria

Recruitment Procedures

Randomization

Study Treatments

Mindfulness-Based Stress Reduction

Cognitive-Behavioral Therapy

Usual Care

Class Sites

Instructors

Training and Monitoring of Instructors

Participant Retention and Adherence to Home Practice

Measures

Co�Primary Outcome Measures

Secondary Outcome Measures

Measures Used in Mediator Analyses

Measures Used in the Cost-Effectiveness Analyses

Data Collection, Quality Control and Confidentiality

Protection of Human Participants and Assessment of Safety

Protection of Human Participants

Safety Monitoring

Adverse Experiences

Stopping Rules

Statistical Issues

Sample Size and Detectable Differences

Statistical Analyses

Primary Analyses

Cost-Effectiveness Analyses

Dr. Alex Jimenez’s Insight

Discussion

Trial Status

Abbreviations

Competing Interests

Authors� Contributions

Acknowledgements

Additional Topics: Back Pain

Blank

References

Close Accordion

Symptoms of Stress

Stress Management with Chiropractic Care

A Well-Rounded Strategy

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

Introduction

Methods

Setting, Participants and Procedures

Measures

Descriptive Measures and Covariates

Measures of Potential Therapeutic Mechanisms

Interventions

MBSR

CBT

Usual Care

Instructors/Therapists and Treatment Fidelity Monitoring

Statistical Analyses

Dr. Alex Jimenez’s Insight

Results

Characteristics of the Study Sample

Baseline Associations Between Therapeutic Mechanism Measures

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

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

Discussion

Summary

Acknowledgements

Footnotes

Additional Topics: Back Pain