Back Clinic Herniated Disc Chiropractic Team. A herniated disc refers to a problem with one of the rubbery cushions (discs) between the individual bones (vertebrae) that stack up to make your spine.
A spinal disc has a soft center encased within a tougher exterior. Sometimes called a slipped disc or a ruptured disc, a herniated disc occurs when some of the soft centers push out through a tear in the tougher exterior.
A herniated disc can irritate the surrounding nerves which can cause pain, numbness, or weakness in an arm or leg. On the other hand, many people experience no symptoms from a herniated disk. Most people who have a herniated disc will not need surgery to correct the problem.
Symptoms
Most herniated disks occur in the lower back (lumbar spine), although they can also occur in the neck (cervical spine). Most common symptoms of a herniated disk:
Arm or leg pain: A herniated disk in the lower back, typically an individual will feel the most intense pain in the buttocks, thigh, and calf. It may also involve part of the foot. If the herniated disc is in the neck, the pain will typically be most intense in the shoulder and arm. This pain may shoot into the arm or leg when coughing, sneezing, or moving the spine into certain positions.
Numbness or tingling: A herniated disk can feel like numbness or tingling in the body part served by the affected nerves.
Weakness: Muscles served by the affected nerves tend to weaken. This may cause stumbling or impair the ability to lift or hold items.
Someone can have a herniated disc without knowing. Herniated discs sometimes show up on spinal images of people who have no symptoms of a disc problem. For answers to any questions you may have please call Dr. Jimenez at 915-850-0900
Herniated Disc Pain: Araceli Pizana started chiropractic care with Dr. Alex Jimenez due to chronic back pain symptoms associated with a herniated disc. Before finding the right alternative treatment option with Dr. Jimenez, Mrs. Pizana struggled to perform her everyday activities. Araceli Pizana describes how Dr. Alex Jimenez’s exceptional care for his patients ultimately reflects on his ability to improve her overall well-being. Mrs. Pizana recommends chiropractic care for health and wellness.
Herniated Disc Pain & Chiropractic Treatment
Most healthcare professionals agree that degeneration of the intervertebral discs is the main cause of spinal disc herniation, where trauma and/or injury is considered to be the least probable cause. Disc degeneration occurs both with degenerative disc disease and aging. When the degeneration of the intervertebral discs occurs, the soft gel-like center of the disc, known as the nucleus pulposus, pushes through the outer ring of the disc, known as the annulus fibrosus. A tear in the intervertebral disc is what’s known as a disc herniation. Furthermore, the chemical material released can irritate the surrounding structures of the spine causing herniated disc pain.
Dr. Jimenez has teamed with the top surgeons, clinical specialist, medical researchers and�premiere rehabilitation�providers to bring El Paso the top clinical treatments to our community.��Providing the top non-invasive protocols is our priority.��The clinical insight is what our patients demand in order to give them the appropriate care required.
Our team has takes great�pride in bringing our families and injured patients only�clinically proven treatments protocols. �By teaching complete holistic wellness as a lifestyle,�we also change not only our patients lives but their families as well.� We do this so that we may reach as many El Pasoans who need us, no matter the affordability issues.
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Stress is a result of the human body’s “fight or flight” response, a prehistoric defense mechanism triggered by the sympathetic nervous system (SNS). Stress is an essential component of survival. When stressors activate the fight or flight response, a mixture of chemicals and hormones are secreted into the blood flow, which prepare the body for perceived danger. Although short-term stress is helpful, however, long-term stress can lead to a variety of health issues. Furthermore, stressors in modern society have changed and it’s become more difficult for people to manage their stress and maintain mindfulness.
How Does Stress Affect the Body?
Stress can be experienced through three different channels: emotion; body and environment. Emotional stress involves adverse situations which affect our mind and decision making. Bodily stress includes improper nutrition and a lack of sleep. And finally, environmental stress occurs based on external experiences. When you experience any of these types of stressors, the sympathetic nervous system will trigger the “fight or flight” response, releasing adrenaline and cortisol to increase heart rate and heighten our senses to make us more alert in order to face the situation ahead of us.
However, if perceived stressors are always present, the SNS’s fight or flight response can remain active. Chronic stress can then lead to a variety of health issues, such as anxiety, depression, muscle tension, neck and back pain, digestive problems, weight gain and sleep problems as well as impaired memory and concentration. In addition, muscle tension along the spine due to stress can cause a spinal misalignment, or subluxation, which may in turn lead to disc herniation.
Headache and Disc Herniation from Stress
A herniated disc occurs when the soft, gel-like center of an intervertebral disc pushes through a tear in its outer, cartilage ring, irritating and compressing the spinal cord and/or the nerve roots. Disc herniation commonly occurs in the cervical spine, or neck, and in the lumbar spine, or low back. Symptoms of herniated discs depend on the location of the compression along the spine. Neck pain and back pain accompanied by numbness, tingling sensations and weakness along the upper and lower extremities are some of the most common symptoms associated with disc herniation. Headache and migraine are also common symptoms associated with stress and herniated discs along the cervical spine, as a result of muscle tension and spinal misalignment.
Mindfulness Interventions for Stress Management
Stress management is essential towards improving as well as maintaining overall health and wellness. According to research studies, mindfulness interventions, such as chiropractic care and mindfulness-based stress reduction (MBSR), among others, can safely and effectively help reduce stress. Chiropractic care utilizes spinal adjustments and manual manipulations to carefully restore the original alignment of the spine, relieving pain and discomfort as well as easing muscle tension. Additionally, a chiropractor may include lifestyle modifications to help further improve symptoms of stress.�A balanced spine can help the nervous system respond to stress more effectively. MBSR can also help reduce stress, anxiety and depression.
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If you are experiencing symptoms of stress with headache or migraine as well as neck and back pain associated with disc herniation, mindfulness interventions such as chiropractic care can be a safe and effective treatment for your stress. Dr. Alex Jimenez’s stress management services can help you achieve overall health and wellness. Seeking the proper mindfulness interventions can get you the relief you deserve. The purpose of the following article is to demonstrate the effects of mindfulness-based stress reduction in patients with tension headache. Don’t just treat the symptoms, get to the source of the issue.
Effects of Mindfulness-Based Stress Reduction on Perceived Stress and Psychological Health in Patients with Tension Headache
Abstract
Background: Programs for improving health status of patients with illness related to pain, such as headache, are often still in their infancy. Mindfulness-based stress reduction (MBSR) is a new psychotherapy that appears to be effective in treating chronic pain and stress. This study evaluated efficacy of MBSR in treatment of perceived stress and mental health of client who has tension headache.
Materials and Methods: This study is a randomized clinical trial. Sixty patients with tension type headache according to the International Headache Classification Subcommittee were randomly assigned to the Treatment As Usual (TAU) group or experimental group (MBSR). The MBSR group received eight weekly classmates with 12-min sessions. The sessions were based on MBSR protocol. The Brief Symptom Inventory (BSI) and Perceived Stress Scale (PSS) were administered in the pre- and posttreatment period and at 3 months follow-up for both the groups.
Results: The mean of total score of the BSI (global severity index; GSI) in MBSR group was 1.63 � 0.56 before the intervention that was significantly reduced to 0.73 � 0.46 and 0.93 � 0.34 after the intervention and at the follow-up sessions, respectively (P < 0.001). In addition, the MBSR group showed lower scores in perceived stress in comparison with the control group at posttest evaluation. The mean of perceived stress before the intervention was 16.96 � 2.53 and was changed to 12.7 � 2.69 and 13.5 � 2.33 after the intervention and at the follow-up sessions, respectively (P < 0.001). On the other hand, the mean of GSI in the TAU group was 1.77 � 0.50 at pretest that was significantly reduced to 1.59 � 0.52 and 1.78 � 0.47 at posttest and follow-up, respectively (P < 0.001). Also, the mean of perceived stress in the TAU group at pretest was 15.9 � 2.86 and that was changed to 16.13 � 2.44 and 15.76 � 2.22 at posttest and follow-up, respectively (P < 0.001).
Conclusion: MBSR could reduce stress and improve general mental health in patients with tension headache.
Chiropractic care is an effective stress management treatment because it focuses on the spine, which is the base of the nervous system. Chiropractic utilizes spinal adjustments and manual manipulations to carefully restore the alignment of the spine in order to allow the body to naturally heal itself. A spinal misalignment, or subluxation, can create muscle tension along the spine and lead to a variety of health issues, including headache and migraine, as well as disc herniation and sciatica. Chiropractic care can also include lifestyle modifications, such as nutritional advice and exercise recommendations, to further enhance its effects. Mindfulness-based stress reduction can also effectively help with stress management and symptoms.
Introduction
Tension headache constitutes 90% of total headaches. About 3% of the population are suffering from chronic tension headache.[1] Tension headaches are often associated with lower quality of life and high levels of psychological discomforts.[2] In recent years, several meta-analyses evaluating the established pain treatments used today have shown that medical treatments, which may be effective in acute pain, are not effective with chronic pain and may, in fact, be causing further problems. Most of the pain treatments are designed for and useful for acute pain but if used in the long run may create more problems such as substance abuse and avoidance of important activities.[3] A common element in most of the pain treatments is that they emphasize on either avoiding pain or fighting to reduce pain. The pain in tension headache can be intolerable. Painkillers and pain management strategies can increase intolerance and sensitivity to pain. Therefore, the treatments that increase acceptance and tolerance to pain, especially chronic pain, are effective. Mindfulness-based stress reduction (MBSR) is a new psychotherapy that appears to be effective in improving physical performance and psychological well-being in patients with chronic pain.[4,5,6,7,8] In the past two decades, Kabat-Zinn et al. in the US successfully used mindfulness for the relief of pain and illness related to pain.[9] Recent studies on acceptance-based methods, such as mindfulness, show improved performance in patients with chronic pain. Mindfulness modulates the pain using nonelaborative awareness of thoughts, feelings and sensations, and an emotionally distanced relationship with internal and external experience.[10] Studies found that MBSR program can significantly alleviate medical illness related to chronic pains such as fibromyalgia, rheumatoid arthritis, chronic musculoskeletal pain, chronic low back pain, and multiple sclerosis.[7,11,12,13] MBSR has significant changes in pain intensity, anxiety, depression, somatic complaints, well-being, adaptation, quality of sleep, fatigue, and physical functioning.[6,14,15,16,17] But the programs for improving health status of patients with illness related to pain, such as tension headache, are often still in their infancy. Therefore, the study was conducted to assess the effects of MBSR on perceived stress and general mental health in patients with tension headache.
Materials and Methods
This randomized controlled clinical trial was performed in 2012 in Shahid Beheshti Hospital in Kashan City. The Research Ethics Committee of the Kashan University of Medical Sciences approved this study (IRCT No: 2014061618106N1). The participants of the study included adults with tension headache who were referred by the psychiatrists and neurologists in Kashan. The inclusion criteria were as follows: Having tension headache according to the International Headache Classification Subcommittee, willing to participate in the study, not having a medical diagnosis of organic brain disorder or psychotic disorder, and not having a history of psychological treatment during the preceding 6 months. The patients who did not complete the intervention and missed more than two sessions were excluded from the study. The participants, who signed an informed consent form, completed the measures as a pretest. For estimating the sample size, we referred to another study in which changes in mean of scores of fatigue was 62 � 9.5 in the pretreatment period and 54.5 � 11.5 in the posttreatment period.[18] Then, by utilizing the sample size calculation, 33 participants (with attrition risk) in each group with ? = 0.95 and 1 � ? = 0.9 were segregated. After sample size calculation, 66 patients with tension headache were selected via convenient sampling according to the inclusion criteria. Then, the patients were called and invited to participate in the study. If a patient agreed to participate, then he/she was invited to attend the study-briefing session and if not another patient was selected similarly. Then using a random number table, they were assigned either to the experimental group (MBSR) or to the control group that treated as usual. Finally, 3 patients were excluded from each group and 60 patients were included (30 patients in each group). The TAU group was treated only by antidepressant medication and clinical management. The MBSR group received MBSR training in addition to TAU. The patients in MBSR group were trained for 8 weeks by a clinical psychologist with PhD degree. The Brief Symptom Inventory (BSI) and Perceived Stress Scale (PSS) were administered before the first treatment session in the MBSR group, after the eighth session (posttest), and 3 months after the test (follow-up) in both groups. The TAU group was invited to Shahid Beheshti Hospital to fill out the questionnaires. Figure 1 shows a Consolidated Standards of Reporting Trials (CONSORT) diagram depicting the flow of study participants.
Figure 1: CONSORT diagram depicting flow of study participants.
Intervention
The intervention group (MBSR) was trained in Shahid Beheshti Hospital. The eight weekly sessions (120 min) were held according to the standard MBSR protocol as developed by Kabat-Zinn.[11] Additional sessions were held for the participants who had missed one or two sessions. At the end of the training and 3 months later (follow-up), both MBSR and TAU groups were invited to Shahid Beheshti Hospital (the place of MBSR trial) and were instructed to complete the questionnaires. During the MBSR sessions, the participants were trained to be aware of their thoughts, feelings, and physical sensations nonjudgmentally. Mindfulness exercises are taught as two forms of meditation practices � formal and informal. Formal type exercises include trained sitting meditation, body scan, and mindful yoga. In informal meditation, attention and awareness are focused not only on daily activities, but also on thoughts, feelings, and physical sensation even they are problematic and painful. The overall content of the sessions were mentioned in Table 1.
Table 1: Agendas for sessions of mindfulness-based stress reduction.
Measurement Tools
International Headache Classification Subcommittee Diary Scale for Headache
Headache was measured by diary scale for headache.[19] The patients were asked to record the pain severity diary on a 0-10 rating scale. Absence of pain and the most intense disabling headache were characterized by 0 and 10, respectively. The mean of headache severity in a week was calculated by dividing the sum of the severity scores by 7. Moreover, the mean of headache severity in a month was calculated by dividing the sum of the severity scores by 30. The minimum and maximum scores of headache severity were 0 and 10, respectively. Headache diary was given to five patients and a neurologist and a psychiatrist confirmed the content validity of the instrument.[20] The reliability coefficient of Persian version of this scale was calculated as 0.88.[20]
Brief symptom Inventory (BSI)
Psychological symptoms were assessed with the BSI.[21] The inventory consist 53 items and 9 subscales that assess psychological symptoms. Each item scores between 0 and 4 (for example: I have nausea or upset in my stomach). BSI has a global severity index (GSI) achieved a total score of 53 items. The reliability of the test has reported a score of 0.89.[22] In our study, GSI test�retest estimate was .90 based on a sample of 60 patients with tension headache who completed the BSI.
Perceived Stress Scale (PSS)
Perceived stress was assessed using the PSS,[21,23] a 10-item scale that assesses the degree of uncontrollable and unpredictable situations of life during the past month (for example: Felt that you were unable to control the important things in your life?). Respondents report the prevalence of an item within the last month on a 5-point scale, ranging from 0 (never) to 4 (very often). Scoring is completed by reverse scoring of four positively worded items[4,5,7,8] and summing all item scores. The scale scores range from 0-40. Higher scores indicate higher levels of stress. It assumes that people depending on their coping resources evaluate level of threatening or challenging events. A higher score indicates a greater degree of perceived stress. Adequate test�retest reliability and convergent and discriminate validity have also been reported.[19] In our study, Cronbach’s alpha coefficients for assessing internal consistency of this scale were calculated to be 0.88.
The repeated measures analysis of variance was performed to compare the MBSR and TAU groups on measures of perceived stress and GSI at pretreatment, posttreatment, and 3-month follow-up. Also, Chi-square test was used to compare the demographics in the two groups. P value less than 0.05 was considered significant in all tests.
Results
Among 66 subjects, 2 participants from the MBSR group were excluded because of missing more than 2 sessions. Also, three participants were excluded because of did not complete the questionnaires in post-test or follow-up who one of them were from MBSR group and three participants from TAU group. Table 2 showed demographic characteristics of the subjects and results of the randomization check. The results of t-test for differences between the MBSR and TAU groups in age variable and Chi-square test in other variables showed that there was no significant difference between demographic variables in two groups and the subjects were randomly assigned to two groups.
Table 2: Demographic characteristics of the subjects a,b.
Table 3 provides the mean scores and standard deviations of the dependent variables (perceived stress and GSI) and comparison of outcome measures at pretreatment period, post-treatment period, and 3-month follow-up.
Table 3: Means, standard deviations, and comparison of outcome measures at pretreatment, posttreatment, and follow-up stages in the MBSR and TAU groups a,b.
Table 3 shows the more reduction in received stress and GSI in the intervention group (MBSR) compared to TAU group, while the reduction in received stress and GSI were not observed in the TAU group. The results revealed the significant effect of time and interaction between time and type of treatment on the changes of scores (P < 0.001).
Figures ?2 and ?3 present mean received stress and GSI scores for MBSR and TAU groups at posttest and follow-up stages.
Figure 2: CONSORT diagram depicting flow of study participants.
Figure 3: Mean of perceived stress in MBSR and control groups in pretest, posttest, and follow-up.
Discussion
This study compared efficacy of MBSR and Treatment As Usual (TAU) in perceived stress and mental health of patients with tension headache. Although MBSR is recognized as an effective treatment for stress symptoms and pain, there is a need to examine its efficacy for the treatment of mental health problems in patients with tension headache, which is one of the common complaints in the population.
The findings of our study demonstrate enhanced general mental health in the GSI index of BSI. In some study, significant improvements by MBSR intervention were reported on all indexes of the 36-item Short Form Health Survey (SF-36).[20,24] Studies showed significant reduction in psychological problems in the Symptom Checklist-90-Revised (SCL-90-R) subscale such as anxiety and depression by MBSR after intervention and 1-year follow-up.[5] Reibel et al. showed MBSR in patients with chronic pain reported a decrease in medical symptoms such as anxiety, depression, and pain.[5] It has been shown that tension headache and anxiety are accompanied with deficits in controlled cognitive processing such as sustained attention and working memory.[25] Negative emotions may amplify suffering associated with pain perception.
MBSR implements the following mechanisms to improve the patient’s mental status: First, mindfulness leads to increased awareness for what is happening in each moment, with an accepting attitude, without getting caught up in habitual thoughts, emotions, and behavior patterns. The increased awareness then gives rise to new ways to respond and cope in relation to oneself and the world around.[3] Mindfulness establishes a sense of self that is greater than one’s thoughts, feelings, and bodily sensation such as pain. Mindfulness exercises, learned clients develop an �observer�self�. With this ability, they can observe their thoughts and feelings in a nonreactive and nonjudgmental way that previously avoided, that previously avoided thoughts and feelings be observed in a nonreactive and nonjudgmental way. The clients learn to notice thoughts without necessarily acting on them, being controlled by them, or believing them.[3]
Second, mindfulness helps the client develop persistence in taking steps in valued directions that are important to them. Most clients with chronic pain want to become pain free rather than living the vital lives of their choice. But the MBSR program trained them to engage in valued action despite the the pain. Studies have shown attention and emotional reaction to pain has an important role in becoming persistent the pain.[26] Emotional and cognitive components can modulate attention to pain and worry about it that could intensify pain and disrupt the patients activities.[27,28]
Third, findings from some studies indicate that MBSR can alter the function of the brain that is responsible for affect regulation and the areas that govern how we react to stressful impulses, and this in turn may normalize body functions such as breathing, heart rate, and immune function.[29,30] Mindfulness practice reduces reactivity to distressing thoughts and feelings that comorbid and strengthen pain perception.[31] Also mindfulness may lessen psychophysiological activation related to stress and mood dysfunction by strengthening positive reappraisal and emotion regulation skills.[32]
The strength of this study is the use of a new effective psychotherapy in reducing the stress on a complaint that is less studied, but it is a common medical problem. The implications of our study are using a simple psychotherapy that does not make too much cognitive demand and is readily usable as a coping skill for the patient with tension headache. Therefore, the health-care professionals related to this complaint and the patient will be able to use this treatment. Also, MBSR will change the patient’s lifestyle who would be exacerbated by his/her problem. The main limitation of this study was the lack of comparison between MBSR and the gold standard psychotherapies such as cognitive behavior therapy (CBT). It is suggested that future studies need to compare the efficacy of MBSR and other traditional and newer cognitive behavioral therapies in patients with tension headache.
Conclusion
Our study supports the hypothesis that patients suffering from tension headache can enhance their general mental health by participating in the MBSR program. In summary, the results of the present study suggest that MBSR can reduce pain-related anxiety and interference in daily activities in the short term. The unique features of mindfulness exercises are easy training and no need to complex cognitive abilities.
Financial support and sponsorship: Nil.
Conflicts of interest: There are no conflicts of interest.
Author’s Contribution
AO contributed in the conception of the work, conducting the study, and agreed for all aspects of the work. FZ contributed in the conception of the work, revising the draft, approval of the final version of the manuscript and agreed for all aspects of the work.
Acknowledgments
Authors are grateful to the staff of Shahid Beheshti Hospital and participants. Authors also express their gratitude to Kabat-Zinn from the Center for Mindfulness (CFM) at the University of Massachusetts who graciously provided electronic copies of the MBSR guidelines.
In conclusion,�while short-term stress is helpful, long-term stress can eventually lead to a variety of health issues, including anxiety and depression as well as neck and back pain, headache and disc herniation. Fortunately, mindfulness interventions, such as chiropractic care and mindfulness-based stress reduction (MBSR) are safe and effective stress management alternative treatment options. Finally, the article above demonstrated evidence-based results that MBSR could reduce stress and improve general mental health in patients with tension headache. 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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Being involved in an automobile accident is an undesirable situation which can result in a variety of physical trauma or injury as well as lead to the development of a number of aggravating conditions. Auto accident injuries, such as whiplash, can be characterized by painful symptoms, including chronic neck pain, however, recent research studies have found that emotional distress resulting from an auto collision could manifest into physical symptoms. Stress, anxiety, depression and post traumatic stress disorder, or PTSD, are common psychological issues which may occur as a result of an automobile accident.
The researchers of the research studies also determined that cognitive-behavioral therapy may be an effective treatment for emotional distress and psychological issues which may have developed as a result of the auto accident injuries. Additionally, auto accident injuries may also cause stress, anxiety, depression and even PTSD if left untreated for an extended amount of time. The purpose of the article below is to demonstrate the effects of cognitive-behavioral therapy, together with alternative treatment options like chiropractic care and physical therapy. for auto accident injuries, such as whiplash.
Neck Exercises, Physical and Cognitive Behavioural-Graded Activity as a Treatment for Adult Whiplash Patients with Chronic Neck Pain: Design of a Randomised Controlled Trial
Abstract
Background
Many patients suffer from chronic neck pain following a whiplash injury. A combination of cognitive, behavioural therapy with physiotherapy interventions has been indicated to be effective in the management of patients with chronic whiplash-associated disorders. The objective is to present the design of a randomised controlled trial (RCT) aimed at evaluating the effectiveness of a combined individual physical and cognitive behavioural-graded activity program on self-reported general physical function, in addition to neck function, pain, disability and quality of life in patients with chronic neck pain following whiplash injury compared with a matched control group measured at baseline and 4 and 12 months after baseline.
Methods/Design
The design is a two-centre, RCT-study with a parallel group design. Included are whiplash patients with chronic neck pain for more than 6 months, recruited from physiotherapy clinics and an out-patient hospital department in Denmark. Patients will be randomised to either a pain management (control) group or a combined pain management and training (intervention)group. The control group will receive four educational sessions on pain management, whereas the intervention group will receive the same educational sessions on pain management plus 8 individual training sessions for 4 months, including guidance in specific neck exercises and an aerobic training programme. Patients and physiotherapists are aware of the allocation and the treatment, while outcome assessors and data analysts are blinded. The primary outcome measures will be Medical Outcomes Study Short Form 36 (SF36), Physical Component Summary (PCS). Secondary outcomes will be Global Perceived Effect (-5 to +5), Neck Disability Index (0-50), Patient Specific Functioning Scale (0-10), numeric rating scale for pain bothersomeness (0-10), SF-36 Mental Component Summary (MCS), TAMPA scale of Kinesiophobia (17-68), Impact of Event Scale (0-45), EuroQol (0-1), craniocervical flexion test (22 mmHg – 30 mmHg), joint position error test and cervical range of movement. The SF36 scales are scored using norm-based methods with PCS and MCS having a mean score of 50 with a standard deviation of 10.
Discussion
The perspectives of this study are discussed, in addition to the strengths and weaknesses.
The Danish National Board of Health estimates that 5-6,000 subjects per year in Denmark are involved in a traffic accident evoking whiplash-induced neck pain. About 43% of those will still have physical impairment and symptoms 6 months after the accident [1]. For Swedish society, including Swedish insurance companies, the economic burden is approximately 320 million Euros [2], and this burden is likely to be comparable to that of Denmark. Most studies suggest that patients with Whiplash-Associated Disorders (WAD) report chronic neck symptoms one year after the injury [3]. The main problems in whiplash patients with chronic neck pain are cervical dysfunction and abnormal sensory processing, reduced neck mobility and stability, impaired cervicocephalic kinaesthetic sense, in addition to local and possibly generalised pain [4,5]. Cervical dysfunction is characterised by reduced function of the deep stabilising muscles of the neck.
Besides chronic neck pain, patients with WAD may suffer from physical inactivity as a consequence of prolonged pain [6,7]. This influences physical function and general health and can result in a poor quality of life. In addition, WAD patients may develop chronic pain followed by sensitisation of the nervous system [8,9], a lowering of the threshold for different sensory inputs (pressure, cold, warm, vibration and electrical impulses) [10]. This can be caused by an impaired central pain inhibition [11] – a cortical reorganisation [12]. Besides central sensitisation, the group with WAD may have poorer coping strategies and cognitive functions, compared with patients with chronic neck pain in general [13-15].
Studies have shown that physical training, including specific exercises targeting the deep postural muscles of the cervical spine, is effective in reducing neck pain [16-18] for patients with chronic neck pain, albeit there is a variability in the response to training with not every patient showing a major change. Physical behavioural-graded activity is a treatment approach with a focus on increasing general physical fitness, reducing fear of movement and increasing psychological function [19,20]. There is insufficient evidence for the long-term effect of treatment of physical and cognitive behavioural-graded activity, especially in chronic neck pain patients. Educational sessions, where the focus is on understanding complex chronic pain mechanisms and development of appropriate pain coping and/or cognitive behavioural strategies, have shown reduced general pain [6,21-26]. A review indicated that interventions with a combination of cognitive, behavioural therapy with physiotherapy including neck exercises is effective in the management of WAD patients with chronic neck pain [27], as also recommended by the Dutch clinical guidelines for WAD [28]. However, the conclusions regarding the guidelines are largely based on studies performed on patients with either acute or sub-acute WAD [29]. A more strict conclusion was drawn for WAD patients with chronic pain in the Bone and Joint Decade 2000-2010 Task Force, stating, that ‘because of conflicting evidence and few high-quality studies, no firm conclusions could be drawn about the most effective non-invasive interventions for patients with chronic WAD” [29,30]. The concept of combined treatment for WAD patients with chronic pain has been used in a former randomised controlled trial [31]. The results indicated that a combination of non-specific aerobic exercises and advice containing standardised pain education and reassurance and encouragement to resume light activity, produced better outcomes than advice alone for patients with WAD 3 months after the accident. The patients showed improvements in pain intensity, pain bothersomeness and functions in daily activities in the group receiving exercise and advice, compared with advice alone. However, the improvements were small and only apparent in the short term.
This project is formulated on the expectation that rehabilitation of WAD patients with chronic neck pain must target cervical dysfunctions, training of physical function and the understanding and management of chronic pain in a combined therapy approach. Each single intervention is based upon former studies that have shown effectiveness [6,18,20,32]. This study is the first to also include the long-term effect of the combined approach in patients with chronic neck pain after whiplash trauma. As illustrated in Figure ?Figure1,1, the conceptual model in this study is based upon the hypothesis that training (including both individually-guided specific neck exercises and graded aerobic training) and education in pain management (based on a cognitive behavioural approach) is better for increasing the patients’ physical quality of life, compared with education in pain management alone. Increasing the physical quality of life includes increasing the general physical function and level of physical activity, decreasing fear of movement, reducing post-traumatic stress symptoms, reducing neck pain and increasing neck function. The effect is anticipated to be found immediately after the treatment (i.e. 4 months; short-term effect) as well as after one year (long-term effect).
Figure 1: Hypothesis of the intervention effect for patients with chronic neck pain after a whiplash accident.
Using a randomised controlled trial (RCT) design, the aim of this study is to evaluate the effectiveness of: graded physical training, including specific neck exercises and general aerobic training, combined with education in pain management (based on a cognitive behavioural approach) versus education in pain management (based on a cognitive behavioural approach), measured on physical quality of life’, physical function, neck pain and neck functions, fear of movement, post-traumatic symptoms and mental quality of life, in patients with chronic neck pain after whiplash injury.
Methods/Design
Trial Design
The study is conducted in Denmark as an RCT with a parallel group design. It will be a two-centre study, stratified by recruitment location. Patients will be randomised to either the Pain Management group (control) or the Pain Management and Training group (intervention). As illustrated in Figure ?Figure2,2, the study is designed to include a secondary data assessment 12 months after baseline; the primary outcome assessment will be performed immediately after the intervention program 4 months after baseline. The study utilises an allocation concealment process, ensuring that the group to which the patient is allocated is not known before the patient is entered into the study. The outcome assessors and data analysts will be kept blinded to the allocation to intervention or control group.
Figure 2: Flowchart of the patients in the study.
Settings
The participants will be recruited from physiotherapy clinics in Denmark and from The Spine Centre of Southern Denmark, Hospital Lilleb�lt via an announcement at the clinics and the Hospital. Using physiotherapy clinics spread across Denmark, the patients will receive the intervention locally. The physiotherapy clinics in Denmark receive patients via referral from their general practitioners. The Spine Centre, a unit specialising in treating patients with musculoskeletal dysfunctions and only treating out-patients, receives patients referred from general practitioners and/or chiropractors.
Study Population
Two hundred adults with a minimum age of 18 years, receiving physiotherapy treatment or having been referred for physiotherapy treatment will be recruited. For patients to be eligible, they must have: chronic neck pain for at least 6 months following a whiplash injury, reduced physical neck function (Neck Disability Index score, NDI, of a minimum of 10), pain primarily in the neck region, finished any medical /radiological examinations, the ability to read and understand Danish and the ability to participate in the exercise program. The exclusion criteria include: neuropathies/ radiculopathies (clinically tested by: positive Spurling, cervical traction and plexus brachialis tests) [33], neurological deficits (tested as in normal clinical practice through a process of examining for unknown pathology), engagement in experimental medical treatment, being in an unstable social and/or working situation, pregnancy, known fractures, depression according to the Beck Depression Index (score > 29) [18,34,35], or other known coexisting medical conditions which could severely restrict participation in the exercise program. The participants will be asked not to seek other physiotherapy or cognitive treatment during the study period.
Intervention
Control
The Pain Management (control) group will receive education in pain management strategies. There will be 4 sessions of 11/2 hours, covering topics regarding pain mechanisms, acceptance of pain, coping strategies, and goal-setting, based upon pain management and cognitive therapy concepts [21,26,36].
Intervention
The Pain Management plus Training (intervention) group will receive the same education in pain management as those in the control group plus 8 treatment sessions (instruction in neck exercises and aerobic training) with the same period of 4 months length. If the treating physiotherapist estimates additional treatments are needed, the treatment can be extended with 2 more sessions. Neck training: The treatment of neck-specific exercises will be progressed through different phases, which are defined by set levels of neck function. At the first treatment session, patients are tested for cervical neuromuscular function to identify the specific level at which to start neck training. A specific individually tailored exercise program will be used to target the neck flexor and extensor muscles. The ability to activate the deep cervical neck flexor muscles of the upper cervical region to increase their strength, endurance and stability function is trained progressively via the craniocervical training method using a biopressure feedback transducer [18,37]. Exercises for neck-eye coordination, neck joint positioning, balance and endurance training of the neck muscles will be included as well, since it has been shown to reduce pain and improve sensorimotor control in patients with insidious neck pain [17,38]. Aerobic training: The large trunk and leg muscles will be trained with a gradually increasing physical training program. Patients will be allowed to select activities such as walking, cycling, stick walking, swimming, and jogging. The baseline for training duration is set by exercising 3 times at a comfortable level, that does not exacerbate pain and aims at a rated perceived exertion (RPE) level of between 11 and 14 on a Borg scale [39]. The initial duration of training is set 20% below the average time of the three trials. Training sessions are carried out every second day with a prerequisite that pain is not worsened, and that RPE is between 9 and 14. A training diary is used. If patients do not experience a relapse, and report an average RPE value of 14 or less, the exercise duration for the following period (1 or 2 weeks) is increased by 2-5 minutes, up to a maximum of 30 minutes. If the RPE level is 15 or higher, the exercise duration will be reduced to an average RPE score of 11 to 14 every fortnight [20,40]. By using these pacing principles, the training will be graded individually by the patient, with a focus on perceived exertion – with the aim of increasing the patient’ s general physical activity level and fitness.
Patients’ compliance will be administered by registration of their participation in the control and intervention group. The patients in the control group will be considered to have completed the pain management if they have attended 3 out of 4 sessions. The patiesnts in the intervention group will be considered to have completed if the patient has attended a minimum of 3 out of 4 pain management sessions and a minimum of 5 out of 8 trainings sessions. Each patient’s home training with neck exercises and aerobic training will be registered by him/her in a logbook. Compliance with 75% of the planned home training will be considered as having completed the intervention.
Physiotherapists
The participating physiotherapists will be recruited via an announcement in the Danish Physiotherapy Journal. The inclusion criteria consist of: being a qualified physiotherapist, working at a clinic and having at least two years of working experience as a physiotherapist, having attended a course in the described intervention and passed the related exam.
Outcome Measures
At baseline the participants’ information on age, gender, height and weight, type of accident, medication, development of symptoms over the last two months (status quo, improving, worsening), expectation of treatment, employment and educational status will be registered. As a primary outcome measure, Medical Outcomes Study Short Form 36 (SF36) – Physical Component Summary (PCS) will be used [41,42]. The PCS scales are scored using norm-based methods [43,44] with a mean score of 50 with a standard deviation of 10. The primary outcome with respect to having an effect, will be calculated as a change from baseline [45]. Secondary outcomes contain data on both clinical tests and patient-reported outcomes. Table ?Table11 presents clinical tests for measuring the intervention effect on neuromuscular control of the cervical muscles, cervical function and mechanical allodynia. Table ?Table22 presents the patient-related outcomes from questionnaires used to test for perceived effect of the treatment, neck pain and function, pain bothersomeness, fear of movement, post-traumatic stress and quality of life and potential treatment modifiers.
Table 1: Clinical outcomes used for measurement of treatment effect on muscle strategy, function and treatment modifiers.
Table 2: Patient reported outcomes used for measured of treatment effect on pain and function.
Patients will be tested at baseline, 4 and 12 months after baseline, except for GPE, which will only be measured 4 and 12 months after baseline.
Power and Sample Size Estimation
The power and sample size calculation is based on the primary outcome, being SF36-PCS 4 months after baseline. For a two-sample pooled t-test of a normal mean difference with a two-sided significance level of 0.05, assuming a common SD of 10, a sample size of 86 per group is required to obtain a power of at least 90% to detect a group mean difference of 5 PCS points [45]; the actual power is 90.3%, and the fractional sample size that achieves a power of exactly 90% is 85.03 per group. In order to adjust for an estimated 15% withdrawal during the study period of 4 months, we will include 100 patients in each group. For sensitivity, three scenarios were applied: firstly, anticipating that all 2 � 100 patients complete the trial, we will have sufficient power (> 80%) to detect a group mean difference as low as 4 PCS points; secondly, we will be able to detect a statistically significant group mean difference of 5 PCS points with sufficient power (> 80%) even with a pooled SD of 12 PCS points. Thirdly and finally, if we aim for a group mean difference of 5 PCS points, with a pooled SD of 10, we will have sufficient power (> 80%) with only 64 patients in each group. However, for logistical reasons, new patients will no longer be included in the study 24 months after the first patient has been included.
Randomisation, Allocation and Blinding Procedures
After the baseline assessment, the participants are randomly assigned to either the control group or the intervention group. The randomisation sequence is created using SAS (SAS 9.2 TS level 1 M0) statistical software and is stratified by centre with a 1:1 allocation using random block sizes of 2, 4, and 6. The allocation sequence will be concealed from the researcher enrolling and assessing participants in sequentially numbered, opaque, sealed and stapled envelopes. Aluminium foil inside the envelope will be used to render the envelope impermeable to intense light. After revealing the content of the envelope, both patients and physiotherapists are aware of the allocation and the corresponding treatment. Outcome assessors and data analysts are however kept blinded. Prior to the outcome assessments, the patients will be asked by the research assistant not to mention the treatment to which they have been allocated.
Statistical Analysis
All the primary data analyses will be carried out according to a pre-established analysis plan; all analyses will be done applying SAS software (v. 9.2 Service Pack 4; SAS Institute Inc., Cary, NC, USA). All descriptive statistics and tests are reported in accordance with the recommendations of the ‘Enhancing the QUAlity and Transparency Of health Research’ (EQUATOR) network; i.e., various forms of the CONSORT statement [46]. Data will be analysed using a two-factor Analysis of Covariance (ANCOVA), with a factor for Group and a factor for Gender, using the baseline value as covariate to reduce the random variation, and increase the statistical power. Unless stated otherwise, results will be expressed as the difference between the group means with 95% confidence intervals (CIs) and associated p-values, based on a General Linear Model (GLM) procedure. All the analyses will be performed using the Statistical Package for Social Sciences (version 19.0.0, IBM, USA) as well as the SAS system (v. 9.2; SAS Institute Inc., Cary, NC, USA). A two-way analysis of variance (ANOVA) with repeated measures (Mixed model) will be performed to test the difference over time between the intervention and the control groups; interaction: Group � Time. An alpha-level of 0.05 will be considered as being statistically significant (p < 0.05, two- sided). The data analysts will be blinded to the allocated interventions for primary analyses.
The baseline scores for the primary and secondary outcomes will be used to compare the control and intervention groups. The statistical analyses will be performed on the basis of the intention-to-treat principle, i.e. patients will be analysed in the treatment group to which they were randomly allocated. In the primary analyses, missing data will be replaced with the feasible and transparent ‘Baseline Observation Carried Forward’ (BOCF) technique, and for sensitivity also a multiple imputation technique will apply.
Secondarily, to relate the results to compliance, a ‘per protocol’ analysis will be used as well. The ‘per protocol’ population he patients who have ‘completed’ the intervention to which they were allocated, according to the principles described in the intervention section above.
Ethical Considerations
The Regional Scientific Ethical Committee of Southern Denmark approved the study (S-20100069). The study conformed to The Declaration of Helsinki 2008 [47] by fulfilling all general ethical recommendations.
All subjects will receive information about the purpose and content of the project and give their oral and written consent to participate, with the possibility to drop out of the project at any time.
Dr. Alex Jimenez’s Insight
Managing stress, anxiety, depression and symptoms of post traumatic stress disorder, or PTSD, after being involved in an automobile accident can be difficult, especially if the incident caused physical trauma and injuries or aggravated a previously existing condition. In many cases, the emotional distress and the psychological issues caused by the incident may be the source of the painful symptoms. In El Paso, TX, many veterans with PTSD visit my clinic after manifesting worsening symptoms from a previous auto accident injury. Chiropractic care can provide patients the proper stress management environment they need to improve their physical and emotional symptoms. Chiropractic care can also treat a variety of auto accident injuries, including whiplash, head and neck injuries, herniated disc and back injuries.
Discussion
This study will contribute to a better understanding of treating patients with chronic neck pain following a whiplash accident. The knowledge from this study can be implemented into clinical practice, as the study is based on a multimodal approach, mirroring the approach, which in spite of the current lack of evidence, is often used in a clinical physiotherapy setting. The study may also be included in systematic reviews thereby contributing to updating the knowledge about this population and to enhancing evidence-based treatment.
Publishing the design of a study before the study is performed and the results obtained has several advantages. It allows the design to be finalised without its being influenced by the outcomes. This can assist in preventing bias as deviations from the original design can be identified. Other research projects will have the opportunity to follow a similar approach with respect to population, interventions, controls and outcome measurements. The challenges of this study are related to standardising the interventions, treating a non-homogeneous population, defining and standardising relevant outcome measures on a population with long-lasting symptoms and having a population from two different clinical settings. Standardisation of the interventions is obtained by teaching the involved physiotherapists in an instructional course. Population homogeneity will be handled by strict inclusion and exclusion criteria and by monitoring the baseline characteristics of the patients, and differences between groups based on other influences than the intervention/control will be possible to analyse statistically. This research design is composed as an ‘add-on’ design: both groups receive pain education; the intervention group receives additional physical training, including specific neck exercises and general training. Today there is insufficient evidence for the effect of treatment for patients with chronic neck pain following a whiplash accident. All participating patients will be referred for a treatment (control or intervention), as we consider it unethical not to offer some form of treatment, i.e. randomising the control group to a waiting list. The add-on design is chosen as a pragmatic workable solution in such a situation [48].
For whiplash patients with chronic pain, the most responsive disability measures (for the individual patient, not for the group as a whole) are considered to be the Patient Specific Functional Scale and the numerical rating scale of pain bothersomeness [49]. By using these and NDI (the most often used neck disability measure) as secondary outcome measures, it is anticipated that patient-relevant changes in pain and disability can be evaluated. The population will be recruited from and treated at two different clinical settings: the out-patient clinic of The Spine Centre, Hospital Lilleb�lt and several private physiotherapy clinics. To avoid any influence of the different settings on the outcome measures, the population will be block randomised related to the settings, securing equal distribution of participants from each setting to the two intervention groups.
Competing Interests
The authors declare that they have no competing interests.
Authors’ Contributions
IRH drafted the manuscript. IRH, BJK and KS participated in the design of the study. All contributed to the design. RC, IRH; BJK and KS participated in the power and sample size calculation and in describing the statistical analysis as well as the allocation and randomization procedure. All authors read and approved the final manuscript. Suzanne Capell provided writing assistance and linguistic corrections.
This study has received funding from the Research Fund for the Region of Southern Denmark, the Danish Rheumatism Association, the Research Foundation of the Danish Association of Physiotherapy, the Fund for Physiotherapy in Private Practice, and the Danish Society of Polio and Accident Victims (PTU). The Musculoskeletal Statistics Unit at the Parker Institute is supported by grants from the Oak Foundation. Suzanne Capell provided writing assistance and linguistic correction.
A Randomized Controlled Trial of Cognitive-Behavioral Therapy for the Treatment of PTSD in the context of Chronic Whiplash
Abstract
Objectives
Whiplash-associated disorders (WAD) are common and involve both physical and psychological impairments. Research has shown that persistent posttraumatic stress symptoms are associated with poorer functional recovery and physical therapy outcomes. Trauma-focused cognitive-behavioral therapy (TF-CBT) has shown moderate effectiveness in chronic pain samples. However, to date, there have been no clinical trials within WAD. Thus, this study will report on the effectiveness of TF-CBT in individuals meeting the criteria for current chronic WAD and posttraumatic stress disorder (PTSD).
Method
Twenty-six participants were randomly assigned to either TF-CBT or a waitlist control, and treatment effects were evaluated at posttreatment and 6-month follow-up using a structured clinical interview, self-report questionnaires, and measures of physiological arousal and sensory pain thresholds.
Results
Clinically significant reductions in PTSD symptoms were found in the TF-CBT group compared with the waitlist at postassessment, with further gains noted at the follow-up. The treatment of PTSD was also associated with clinically significant improvements in neck disability, physical, emotional, and social functioning and physiological reactivity to trauma cues, whereas limited changes were found in sensory pain thresholds.
Discussion
This study provides support for the effectiveness of TF-CBT to target PTSD symptoms within chronic WAD. The finding that treatment of PTSD resulted in improvements in neck disability and quality of life and changes in cold pain thresholds highlights the complex and interrelating mechanisms that underlie both WAD and PTSD. Clinical implications of the findings and future research directions are discussed.
In conclusion, being involved in an automobile accident is an undesirable situation which can result in a variety of physical trauma or injury as well as lead to the development of a number of aggravating conditions. However, stress, anxiety, depression and post traumatic stress disorder, or PTSD, are common psychological issues which may occur as a result of an automobile accident. According to research studies, physical symptoms and emotional distress may be closely connected and treating both physical and emotional injuries could help patients achieve overall health and wellness. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .
Curated by Dr. Alex Jimenez
Additional Topics: Back Pain
According to statistics, approximately 80% of people will experience symptoms of back pain at least once throughout their lifetimes. Back pain is a common complaint which can result due to a variety of injuries and/or conditions. Often times, the natural degeneration of the spine with age can cause back pain. Herniated discs occur when the soft, gel-like center of an intervertebral disc pushes through a tear in its surrounding, outer ring of cartilage, compressing and irritating the nerve roots. Disc herniations most commonly occur along the lower back, or lumbar spine, but they may also occur along the cervical spine, or neck. The impingement of the nerves found in the low back due to injury and/or an aggravated condition can lead to symptoms of sciatica.
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Chronic low back pain is the second most common cause of disability in the United States. Approximately 80 percent of the population will experience back pain at least once throughout their lifetime. The most prevalent causes of chronic low back pain include: herniated discs, sciatica, injuries from lifting heavy objects or any other non-specific spine injury. However, people will often react differently to their symptoms. These differing responses are due to people’s psychological attitudes and outlooks.
Chronic Low Back Pain and the Mind
Stress has been associated with increased pain but your own personal health beliefs and coping strategies can influence your own perception of pain as well. That’s because psychological vulnerabilities can alter your brain and intensify the pain. Additionally, the pain itself can rewire the brain.�When pain first occurs, it impacts the pain-sensitivity brain circuits. When pain becomes persistent, the associated brain activity switches from the pain circuits to circuits that process emotions. That’s why it’s believed that stress, anxiety and depression can cause as well as worsen chronic low back pain.
Managing the Scourge of Chronic Low Back Pain
Fortunately, several stress management methods and techniques can help improve chronic low back pain. Mindfulness is the most common treatment with the best supporting evidence towards improving and managing chronic pain.�A recent study demonstrated that mindfulness-based stress reduction, or MBSR, including mindfulness meditation and other mindfulness interventions, can help reduce back pain and enhance psychological control by increasing brain blood flow to the frontal lobe. Practicing mindfulness involves activating a brain relaxation pathway by intentionally ignoring mental “chatter” and focusing on your breathing.�Cognitive behavioral therapy, or CBT can also be helpful for chronic low back pain. Cognitive behavioral therapy can prevent an acute injury from progressing to chronic low back pain. Hypnosis may also help relieve chronic low back pain. However, CBT and hypnosis have weaker evidence to support their effectiveness on back pain.
Mind Over Matter
So while it may seem that chronic low back pain is all “in your head”, research studies have demonstrated that stress can influence painful symptoms.��Mind� includes �matter,� especially when you consider that the physical �matter� of the brain plays a major role in mindset changes. This is especially true when it comes to the brain-based changes related to low back pain. The purpose of the article below is to demonstrate the effectiveness of mindfulness meditation on chronic low back pain.
Effectiveness of Mindfulness Meditation on Pain and Quality of Life of Patients with Chronic Low Back Pain
Abstract
Background and aim: Recovery of patients with chronic low back pain (LBP) is depended on several physical and psychological factors. Therefore, the authors aimed to examine the efficacy of mindfulness based stress reduction (MBSR) as a mind-body intervention on quality of life and pain severity of female patients with nonspecific chronic LBP (NSCLBP).
Methods: Eighty-eight patients diagnosed as NSCLBP by physician and randomly assigned to experimental (MBSR+ usual medical care) and the control group (usual medical care only). The subjects assessed in 3 times frames; before, after and 4 weeks after intervention by Mac Gil pain and standard brief quality of life scales. Data obtained from the final sample analyzed by ANCOVA using SPSS software.
Results: The findings showed MBSR was effective in reduction of pain severity and the patients who practiced 8 sessions meditation reported significantly lower pain than patients who only received usual medical care. There was a significant effect of the between subject factor group (F [1, 45] = 16.45, P < 0.001) and (F [1, 45] = 21.51, P < 0.001) for physical quality of life and (F [1, 45] = 13.80, P < 0.001) and (F [1, 45] = 25.07, P < 0.001) mental quality of life respectively.
Conclusion: MBSR as a mind-body therapy including body scan, sitting and walking meditation was effective intervention on reduction of pain severity and improvement of physical and mental quality of life of female patients with NSCLBP.
Keywords:Chronic low back pain, mindfulness based stress reduction, pain, quality of life, SF-12
Introduction
In nonspecific low back pain (NSLBP) the pain is not related to conditions such as fractures, spondylitis, direct trauma, or neoplastic, infectious, vascular, metabolic, or endocrine-related although it is a cause of limitation in daily activities due to actual pain or fear of pain.[1] Unfortunately, the majority of LBP patients (80�90%) suffers from nonspecific LBP which leads to considerable pain-related disability and limitation in daily activities.[1,2] Chronic LBP is not only prevalent, but is also a source of great physical disability, role impairment, and diminished psychological well-being and quality of life.[1]
Prior to the current accepted biopsychosocial model, the biomedical model dominated all illness conceptualizations for almost 300 years and still dominates in the popular imagination. First proposed by Engel (1977) the biopsychosocial model acknowledges biological processes but also highlights the importance of experiential and psychological factors in pain. The famous gate control theory of pain[3] also proposed that the brain plays a dynamic role in pain perception as opposed to being a passive recipient of pain signals. They suggested psychological factors can inhibit or enhance sensory flow of pain signals and thus influence the way brain ultimately responds to painful stimulation.[4] If mind processes can change the way the brain processes pain then this holds tremendous potential for psychological intervention to produce reduced pain signals from the brain.
Kabat-Zinn’s et al. (1986) described the process of pain reduction in his paper on mindfulness and meditation. The process of pain reduction occurred by �an attitude of detached observation toward a sensation when it becomes prominent in the field of awareness and to observe with similar detachment the accompanying but independent cognitive processes which lead to evaluation and labeling of the sensation as painful, as hurt.� Thus, by �uncoupling� the physical sensation, from the emotional and cognitive experience of pain, the patient is able to reduce the pain.[5] The patients� descriptions of distraction from pain, identifying maladaptive coping strategies toward pain and heightened awareness of pain sensation leading to behavioral changes are examples of how pain is unassociated with emotion, cognition, and sensation [Figure 1]. Therefore recently these theories attracted several researchers who are working on pain.
Figure 1: Consort diagram.
Mindfulness meditation has roots in Buddhist Vipassana philosophy and practice and has been independently adopted within clinical psychology in Western societies.[6,7,8,9] Recently in Netherlands Veehof et al. conducted a systematic review of controlled and noncontrolled studies on effectiveness of acceptance-based interventions such as mindfulness-based stress reduction program, acceptance and commitment therapy for chronic pain. Primary outcomes measured were pain intensity and depression. Secondary outcomes measured were anxiety, physical well-being and quality of life.[10] Twenty-two studies randomized controlled studies clinical controlled studies without randomization and noncontrolled studies were included totaling 1235 patients with chronic pain. An effect size on pain of (0.37) was found in the controlled studies. The effect on depression was (0.32). The authors concluded that ACT and mindfulness interventions had similar effects to other cognitive-behavioral therapy interventions and that these types of interventions may be a useful alternative or adjunct to current therapies. Chiesa and Serretti also conducted another systematic review on 10 mindfulness interventions.[11] The main findings were that these interventions produced small nonspecific effects in terms of reducing chronic pain and symptoms of depression. When compared to active control groups (support and education) no additional significant effects were noted.
In summary, there is a need for further studies into the specific effects of mindfulness studies on chronic pain. Regarding as the researcher knowledge efficacy of mindfulness has not been explored on quality of life of chronic pain patients in Iran. The authors aimed to examine the impact of mindfulness based stress reduction (MBSR) protocol designed for pain management on quality of life and pain of a homogeneous sample of females with nonspecific chronic LBP (NSCLBP) in comparison of the usual medical care group.
Methods
Sampling
Out of initial female samples aged 30�45 (n = 155) who diagnosed as chronic NSLBP by physicians in physiotherapy centers of Ardebil-Iran at least 6 months before. Only 88 met inclusion criteria and gave consent to participate in the research program. Patients were randomly assigned in small groups to receive MBSR plus medical usual care (experimental group) and medical usual care (control group). Some patients dropped during and after the treatment. The final sample of the study comprised of 48 females.
Inclusion Criteria
Age 30�45 years
Being under medical treatments like physiotherapy and medicine
Medical problem-history of NSCLBP and persisting pain for at least 6 months
Language – Persian
Gender – female
Qualification – educated at least up to high school
Consent and willingness to alternative and complementary therapies for pain management.
Exclusion Criteria
History of spine surgery
Combination with other chronic disease
Psychotherapy in the last 2 years excluded
Unavailability in next 3 months.
The proposal of study approved by the scientific committee of �Panjab University,� psychology department and all patients signed consent to participate in the present study. The study approved in India (in the university which researcher done her PhD), but conducted in Iran because researcher is from Iran originally and there was language and culture difference problem. Approval from Institutional Ethics Committee of physiotherapy center of Ardebil was obtained in Iran also to carry out the research.
Design
The study made use of the pre-post quasi time series experimental design to assess the efficacy of MBSR in 3 times frames (before-after-4 weeks after the program). A MBSR program administered one session per week for explaining techniques, practice, and feedback and share their experience for 8 weeks beside 30�45 min� daily home practice [Table 1]. The intervention was conducted in three groups included 7�9 participants in each group. The process of framing the program was based on the quid lines provided by Kabat-Zinn, Morone (2008a, 2008b and 2007)[6,12,13,14] and some adaptation done for the patients involved in the study. The control group was not offered any type of intervention in the research project. Consequently, they underwent the normal routines in healthcare including physiotherapy and medicine.
Table 1: Content of MBSR sessions.
Intervention
The sessions conducted in a private physiatrist clinic near to physiotherapy centers. Sessions took 8 weeks, and each session lasted for 90 min. Meditation transformed the patients� awareness through the techniques of breathing and mindfulness. The intervention was conducted in small groups included 7�9 participants in each group. Table 1 for details of session’s content which prepared according books and previous studies.[6,12,13,14]
Assessments
The questionnaire completed by patients before the intervention, after intervention and 4 weeks after the interventions. The receptor of physiotherapy centers conducted the assessment. The receptors trained before conducting the assessment, and they were blind for the hypothesis of the study. The following are used for assessment of participants:
McGill Pain Questionnaire
The main component of this scale consists of 15 descriptive adjectives, 11 sensory including: Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot-burning, Aching, Heavy, Tender, Splitting, and four affective including: Tiring-exhausting, Sickening, Fearful, Punishing-cruel, which are rated by the patients according to their severity on a four point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe), yielding three scores. The sensory and affective scores are calculated by adding sensory and affective item values separately, and the total score is the sum of the two above-mentioned scores. In this study, we just used pain rating index with total scores. Adelmanesh et al.,[15] translated and validated Iran version of this questionnaire.
Quality of Life (SF-12)
The quality of life assessed by the validated SF-12 Health Survey.[16] It was developed as a shorter, quicker-to-complete alternative to the SF-36v2 Health Survey and measures the same eight health constructs. The constructs are: Physical functioning; role physical; bodily pain; general health; vitality; social functioning; role emotional; and mental health. Items have five response choices (for example: All of the time, most of the time, some of the time, a little of the time, none of the time), apart from two questions for which there are three response choices (for the physical functioning domain). Four items are reverse scored. Summed raw scores in the eight domains are transformed to convert the lowest possible score to zero and the highest possible score to 100. Higher scores represent better health and well-being. The standard form SF-12 uses a time frame of the past 4 weeks.[16]
The Iranian version of SF-12 in Montazeri et al. (2011) study showed satisfactory internal consistency for both summary measures, that are the Physical Component Summary (PCS) and the Mental Component Summary (MCS); Cronbach’s ? for PCS-12 and MCS-12 was 0.73 and 0.72, respectively. The known – group comparison showed that the SF-12 discriminated well between men and women and those who differed in age and educational status (P < 0.001) 2.5.[17]
Statistical Analysis
The SPSS 20 (Armonk, NY: IBM Corp) was used to analysis of data. For descriptive analysis mean, standard deviation (SD) used. For performing ANCOVA, the pretest scores were used as covariates.
Results
The mean age was 40.3, SD = 8.2. 45% of females were working and the rest were a house wife. 38% had two children, 55% one child and the rest did have children. All were married and from middle-income families. 9.8% of patients reported very low physical quality of life, and the rest were low (54.8%) and moderate (36.4%). This was 12.4%, 40% and 47.6% very low, low and medium levels of mental quality of life in patients participated in our study (n = 48). The mean and SD of patients in MBSR and control group showed a decrease in pain and increase in mental and physical quality of life [Table 2].
Table 2: Mean and SD of patients in pain, mental and physical quality of life in baseline, after intervention and 4 weeks after intervention.
Comparative Results
Pain. The results indicated that after adjusting for pretest scores, there was a significant effect of the between subject factor group (F [1, 45] =110.4, P < 0.001) and (F [1, 45] =115.8, P < 0.001). Adjusted post-test scores suggest that the intervention had an effect on increasing the pain scores of the NSCLBP patients who received the MBSR as compared to those who were in the control group and did not receive any mind-body therapy [Table 3].
Table 3: The result of comparison of pain and quality of life of MBSR and control group after intervention (time 1) and 4 weeks after intervention (time 2).
Quality of life. The results shows that after adjusting for pretest scores, there was a significant effect of the between subject factor group (F [1, 45] =16.45, P < 0.001) and (F [1, 45] =21.51, P < 0.001). Adjusted post-test scores suggest that the intervention had an effect on increasing the physical quality of life scores of the NSCLBP patients who received the MBSR as compared to those who were in the control group and did not receive any mind-body therapy [Table 3].
The results also showed that after adjusting for pretest scores, there was a significant effect of the between subject factor group (F [1, 45] =13.80, P < 0.001) and (F [1, 45] =25.07, P < 0.001). Adjusted post-test scores suggest that the intervention had an effect on increasing the mental quality of life scores of the NSCLBP patients who received the MBSR as compared to those who were in the control group and did not receive any psychological therapy [Table 3].
Dr. Alex Jimenez’s Insight
Mindfulness is the psychological process which involves�activating a brain relaxation pathway by intentionally ignoring mental “chatter”, bringing one’s attention to experiences occurring in the present moment and focusing on your breathing. Mindfulness can commonly be achieved through the practice of meditation and stress management methods and techniques. According to research studies, mindfulness is an effective treatment option which can help decrease chronic low back pain. Researchers have previously compared mindfulness-based stress reduction, or MBSR, with cognitive behavioral therapy to determine whether these mindfulness interventions could improve chronic low back pain. The following article was also conducted to determine if mindfulness meditation is an effective treatment option for chronic low back pain. The results of both research studies were promising, demonstrating that mindfulness can be more effective for chronic low back pain than traditional treatment options as well as the use of drugs and/or medication.
Discussion
The results showed that the experimental group who were subjected to the MBSR showed a significant improvement in their overall pain severity, physical and mental quality of life scores due to the training received as compared to the control group who received only usual medical care. The program reduced pain perception and enhanced both physical and mental quality of life and impacted on the experimental group clearly in comparison of the usual medical care. Baranoff et al., 2013,[18] Nykl�cek and Kuijpers, 2008,[19] and Morone (2) et al., 2008[20] reported the same results.
Kabat-Zinn et al. believed the process of pain reduction occurred by �uncoupling� the physical sensation, from the emotional and cognitive experience of pain, the patient is able to reduce the pain.[21] In the current study, the participants uncoupled the different components of the experience of pain. Breathing exercise distract their mind from pain to breathing and mindful living made them aware about maladaptive coping strategies.
In the first session, information given about the fundamentals of mindfulness, describing the mindfulness supporting attitudes included being nonjudgmental toward thought, emotions or sensations as they arise, patience, nonstriving, compassion, acceptance and curiosity gave them a wisdom and believe that they are suffering from painful thoughts more than the pain itself.
Furthermore, during body scan practice they learned to see their real body conditions, as it truly was, without trying to change the reality. Accepting their chronic illness condition helped them see the other possible abilities in their social and emotional roles. In fact the body scan practice helped them change the relationship with their body and pain. Through direct experience in body scan, one realizes the interconnection between the state of the mind and the body, and thereby increases patients� self-control over their life. Mindful living techniques also improved their quality of life by teaching them to pay more attention to their daily life necessities, which led to the experience of subtle positive emotions, like peace and joy, self-esteem and confidence. Furthermore, they appreciated positive things. Once they learned to see the persistent pain objectively and observe other sensations in their body, they applied the same principles through mindful living techniques in their everyday life. As a result, they learned how to manage their health and began to engage in their duties mindfully.
A number of research studies such as Plews-Ogan et al.,[22] Grossman et al.,[23] and Sephton et al., (2007)[24] showed effectiveness of mindfulness meditation program on quality of life of patients with chronic pain conditions.
Conclusion
All together the result of this study and previous studies highlighted the effectiveness of complementary and alternative treatment for patients with chronic LBP. Regarding the considerable role of quality of life in professional and personal life designing the effective psychotherapies especially for enhancement of quality of life of patients with chronic LBP strongly suggested by the authors.
This study involved with several limitations such as ununiformed usual care received by patients. The provided physiotherapy sessions or methods and medicine prescribed by different physicians in slightly different manner. Although some patients commonly dose not completed physiotherapy sessions. The sample size was small and it was only limited to three centers. This is suggested for future researchers to conduct study with considering physiologic variables such as MRI, NMR and neurologic signals to test the efficacy of MBSR to decrease pain sufferer.
In conclusion, more evidence-based larger scale researches with longer-term follow-up need to be done to increase the therapeutic weight and value of MBSR as a part of complementary alternative medicine being preventive and rehabilitation method among CLBP patients.
Acknowledgement
We are thankful from patients who were corporate with us. Dr. Afzalifard and staff of physiotherapy centers of Ardebil.
Footnotes
Source of support: Nil.
Conflict of interest: None declared.
In conclusion,�mindfulness�is the most prevalent treatment with the best supporting evidence towards improving and managing chronic low back pain. Mindfulness interventions, such as mindfulness-based stress reduction and cognitive behavioral therapy, have demonstrated to be effective for chronic low back pain. Furthermore, mindfulness meditation was also demonstrated to effectively help improve as well as manage chronic low back pain caused by stress. However, further research studies are still required to determine a solid outcome measure for mindfulness interventions and chronic pain. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .
Curated by Dr. Alex Jimenez
Additional Topics: Back Pain
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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15.�Adelmanesh F, Arvantaj A, Rashki H, Ketabchi S, Montazeri A, Raissi G. Results from the translation and adaptation of the Iranian Short-Form McGill Pain Questionnaire (I-SF-MPQ): Preliminary evidence of its reliability, construct validity and sensitivity in an Iranian pain population.�Sports Med Arthrosc Rehabil Ther Technol.�2011;3:27.�[PMC free article]�[PubMed]
16.�Ware JE, Jr, Kosinski M, Turner-Bowker DM, Gandek B. Lincoln, RI: Quality Metric Incorporated; 2002. How to Score Version 2 of the SF-12� Health Survey (With a Supplement Documenting Version 1)
17.�Montazeri A, Vahdaninia M, Mousavi SJ, Omidvari S. The Iranian version of 12-item short form health survey (SF-12): A population-based validation study from Tehran, Iran.�Health Qual Life Outcomes.�2011;9:12.�[PMC free article]�[PubMed]
18.�Baranoff J, Hanrahan SJ, Kapur D, Connor JP. Acceptance as a process variable in relation to catastrophizing in multidisciplinary pain treatment.�Eur J Pain.�2013;17:101�10.�[PubMed]
19.�Nykl�cek I, Kuijpers KF. Effects of mindfulness-based stress reduction intervention on psychological well-being and quality of life: Is increased mindfulness indeed the mechanism?�Ann Behav Med.�2008;35:331�40.�[PMC free article]�[PubMed]
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A herniated disc, also known as a slipped or ruptured disc, is a healthcare condition which occurs when a tear in the outer, fibrous ring of an intervertebral disc causes its soft, central portion to bulge out from the damaged, surrounding cartilage. Disc herniations are generally due to the degeneration of the outer ring of an intervertebral disc, known as the anulus fibrosus. Trauma, lifting injuries or straining may also cause a herniated disc. A tear in the intervertebral disc may result in the release of chemicals which may cause irritation and ultimately become the direct cause of severe back pain, even without nerve root compression.
Disc herniations also commonly develop following a previously existing disc protrusion, a healthcare condition in which the outermost layers of the anulus fibrosus remain intact, however, these can bulge if the disc is placed under pressure. Unlike a disc herniation, none of the gel-like section escapes the intervertebral disc. Herniated discs often heal on their own within several weeks. Severe disc herniations may require surgery, however, a variety of research studies have demonstrated that nonoperative treatment may help improve and manage the recovery process of a herniated disc without the need for surgical interventions.
Surgical vs Nonoperative Treatment for Lumbar Disk Herniation Using The Spine Patient Outcomes Research Trial (SPORT): A Randomized Trial
Abstract
Context: Lumbar diskectomy is the most common surgical procedure performed for back and leg symptoms in US patients, but the efficacy of the procedure relative to nonoperative care remains controversial.
Objective: To assess the efficacy of surgery for lumbar intervertebral disk herniation.
Design, Setting, and Patients: The Spine Patient Outcomes Research Trial, a randomized clinical trial enrolling patients between March 2000 and November 2004 from 13 multidisciplinary spine clinics in 11 US states. Patients were 501 surgical candidates (mean age, 42 years; 42% women) with imaging-confirmed lumbar intervertebral disk herniation and persistent signs and symptoms of radiculopathy for at least 6 weeks.
Interventions: Standard open diskectomy vs nonoperative treatment individualized to the patient.
Main Outcome Measures: Primary outcomes were changes from baseline for the Medical Outcomes Study 36-item Short-Form Health Survey bodily pain and physical function scales and the modified Oswestry Disability Index (American Academy of Orthopaedic Surgeons MODEMS version) at 6 weeks, 3 months, 6 months, and 1 and 2 years from enrollment. Secondary outcomes included sciatica severity as measured by the Sciatica Bothersomeness Index, satisfaction with symptoms, self-reported improvement, and employment status.
Results: Adherence to assigned treatment was limited: 50% of patients assigned to surgery received surgery within 3 months of enrollment, while 30% of those assigned to nonoperative treatment received surgery in the same period. Intent-to-treat analyses demonstrated substantial improvements for all primary and secondary outcomes in both treatment groups. Between-group differences in improvements were consistently in favor of surgery for all periods but were small and not statistically significant for the primary outcomes.
Conclusions: Patients in both the surgery and the nonoperative treatment groups improved substantially over a 2-year period. Because of the large numbers of patients who crossed over in both directions, conclusions about the superiority or equivalence of the treatments are not warranted based on the intent-to-treat analysis.
Lumbar diskectomy is the most common surgical procedure performed in the United States for patients having back and leg symptoms; the vast majority of the procedures are elective. However, lumbar disk herniation is often seen on imaging studies in the absence of symptoms[1,2] and can regress over time without surgery.[3] Up to 15-fold variation in regional diskectomy rates in the United States[4] and lower rates internationally raise questions regarding the appropriateness of some of these surgeries.[5,6]
Several studies have compared surgical and nonoperative treatment of patients with herniated disk, but baseline differences between treatment groups, small sample sizes, or lack of validated outcome measures in these studies limit evidence-based conclusions regarding optimal treatment.[7-12] The Spine Patient Outcomes Research Trial (SPORT) was initiated in March 2000 to compare the outcomes of surgical and nonoperative treatment for lumbar intervertebral disk herniation, spinal stenosis, or degenerative spondylolisthesis.[13] The trial included both a randomized cohort and an observational cohort who declined to be randomized in favor of designating their own treatment but otherwise met all the other criteria for inclusion and who agreed to undergo follow-up according to the same protocol. This article reports intent-to-treat results through 2 years for the randomized cohort.
Methods
Study Design
SPORT was conducted at 13 multidisciplinary spine practices in 11 US states (California, Georgia, Illinois, Maine, Michigan, Missouri, Nebraska, New York, New Hampshire, Ohio, Pennsylvania). The human subjects committee of each participating institution approved a standardized protocol. All patients provided written informed consent. An independent data and safety monitoring board monitored the study at 6-month intervals.[13]
Patient Population
Patients were considered for inclusion if they were 18 years and older and diagnosed by participating physicians during the study enrollment period as having intervertebral disk herniation and persistent symptoms despite some nonoperative treatment for at least 6 weeks. The content of preenrollment nonoperative care was not prespecified in the protocol but included education/counseling (71%), physical therapy (67%), epidural injections (42%), chiropractic therapy (32%), anti-inflammatory medications (61%), and opioid analgesics (40%).
Specific inclusion criteria at enrollment were radicular pain (below the knee for lower lumbar herniations, into the anterior thigh for upper lumbar herniations) and evidence of nerve-root irritation with a positive nerve-root tension sign (straight leg raise�positive between 30� and 70� or positive femoral tension sign) or a corresponding neurologic deficit (asymmetrical depressed reflex, decreased sensation in a dermatomal distribution, or weakness in a myotomal distribution). Additionally, all participants were surgical candidates who had undergone advanced vertebral imaging (97% magnetic resonance imaging, 3% computed tomography) showing disk herniation (protrusion, extrusion, or sequestered fragment)[14] at a level and side corresponding to the clinical symptoms. Patients with multiple herniations were included if only one of the herniations was considered symptomatic (ie, if only one was planned to be operated on).
Exclusion criteria included prior lumbar surgery, cauda equina syndrome, scoliosis greater than 15�, segmental instability (>10� angular motion or >4-mm translation), vertebral fractures, spine infection or tumor, inflammatory spondyloarthropathy, pregnancy, comorbid conditions contraindicating surgery, or inability/unwillingness to have surgery within 6 months.
Study Interventions
The surgery was a standard open diskectomy with examination of the involved nerve root.[15,16] The procedure agreed on by all participating centers was performed under general or local anesthesia, with patients in the prone or knee-chest position. Surgeons were encouraged to use loupe magnification or a microscope. Using a midline incision reflecting the paraspinous muscles, the interlaminar space was entered as described by Delamarter and McCullough.[15] In some cases the medial border of the superior facet was removed to provide a clear view of the involved nerve root. Using a small annular incision, the fragment of disk was removed as described by Spengler.[16] The canal was inspected and the foramen probed for residual disk or bony pathology. The nerve root was decompressed, leaving it freely mobile.
The nonoperative treatment group received �usual care,� with the study protocol recommending that the minimum nonsurgical treatment include at least active physical therapy, education/counseling with home exercise instruction, and nonsteroidal anti-inflammatory drugs, if tolerated. Other nonoperative treatments were listed, and physicians were encouraged to individualize treatment to the patient; all nonoperative treatments were tracked prospectively.[13,17]
Study Measures
The primary measures were the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) bodily pain and physical function scales[18-21] and the American Academy of Orthopaedic Surgeons MODEMS version of the Oswestry Disability Index (ODI).[22] As specified in the trial protocol, the primary outcomes were changes from baseline in these scales at 6 weeks, 3 months, 6 months, and 1 and 2 years from enrollment.
Secondary measures included patient self-reported improvement, work status, and satisfaction with current symptoms and with care.[23] Symptom severity was measured by the Sciatica Bothersomeness Index (range, 0-24; higher scores represent worse symptoms).[24,25]
Recruitment, Enrollment, and Randomization
A research nurse at each site identified potential participants and verified eligibility. For recruitment and informed consent, evidence-based videotapes described the surgical and non-operative treatments and the expected benefits, risks, and uncertainties.[26,27] Participants were offered enrollment in either the randomized trial or a concurrent observational cohort, the results of which are reported in a companion article.
Enrollment began in March 2000 and ended in November 2004. Baseline variables were collected prior to randomization. Patients self-reported race and ethnicity using National Institutes of Health categories.
Computer-generated random treatment assignment based on permuted blocks (randomly generated blocks of 6, 8, 10, and 12)[28] within sites occurred immediately after enrollment via an automated system at each site, ensuring proper allocation concealment. Study measures were collected at baseline and at regularly scheduled follow-up visits. Short-term follow-up visits occurred at 6 weeks and 3 months. If surgery was delayed beyond 6 weeks, additional follow-up data were obtained 6 weeks and 3 months postoperatively. Longer-term follow-up visits occurred at 6 months, 1 year from enrollment, and annually thereafter.
Statistical Analyses
We originally determined a sample size of 250 patients in each treatment group to be sufficient (with a 2-sided significance level of .05 and 85% power) to detect a 10-point difference in the SF-36 bodily pain and physical functioning scales or a similar effect size in the ODI. This difference corresponded to patients’ reports of being �a little better� in the Maine Lumbar Spine Study (MLSS).[29] The sample size calculation allowed for up to 20% missing data but did not account for any specific levels of nonadherence.
The analyses for the primary and secondary outcomes used all available data for each period on an intent-to-treat basis. Predetermined end points for the study included results at each of 6 weeks, 3 months, 6 months, 1 year, and 2 years. To adjust for the possible effect of missing data on the study results, the analysis of mean changes for continuous outcomes was performed using maximum likelihood estimation for longitudinal mixed-effects models under �missing at random� assumptions and including a term for treatment center. Comparative analyses were performed using the single imputation methods of baseline value carried forward and last value carried forward, as well as a longitudinal mixed model controlling for covariates associated with missed visits.[30]
For binary secondary outcomes, longitudinal logistic regression models were fitted using generalized estimating equations[31] as implemented in the PROC GENMOD program of SAS version 9.1 (SAS Institute Inc, Cary, NC). Treatment effects were estimated as differences in the estimated proportions in the 2 treatment groups.
P<.05 (2-sided) was used to establish statistical significance. For the primary outcomes, 95% confidence intervals (CIs) for mean treatment effects were calculated at each designated time point. Global tests of the joint hypothesis of no treatment effect at any of the designated periods were performed using Wald tests[32] as implemented in SAS. These tests account for the intraindividual correlation due to repeated measurements over time.[32]
Nonadherence to randomly assigned treatment may mean that the intention-to-treat analysis underestimates the real benefit of the treatment.[33,34] As a preplanned sensitivity analysis, we also estimated an �as-treated� longitudinal analysis based on comparisons of those actually treated surgically and nonoperatively. Repeated measures of outcomes were used as the dependent variables, and treatment received was included as a time-varying covariate. Adjustments were made for the time of surgery with respect to the original enrollment date to approximate the designated follow-up times. Baseline variables that were individually found to predict missing data or treatment received at 1 year were included to adjust for possible confounding.
Results
SPORT achieved full enrollment, with 501 (25%) of 1991 eligible patients enrolled in the randomized trial. A total of 472 participants (94%) completed at least 1 follow-up visit and were included in the analysis. Data were available for between 86% and 73% of patients at each of the designated follow-up times (Figure 1).
Figure 1: Flow Diagram of the SPORT Randomized Controlled Trial of Disk Herniation: Exclusion, Enrollment, Randomization, and Follow-up.
Patient Characteristics
Baseline patient characteristics are shown in Table 1. Overall, the study population had a mean age of 42 years, with majorities being male, white, employed, and having attended at least some college; 16% were receiving disability compensation. All patients had radicular leg pain, 97% in a classic dermatomal distribution. Most of the herniations were at L5-S1, posterolateral, and were extrusions by imaging criteria.[14] The 2 randomized groups were similar at baseline.
Nonoperative Treatments
A variety of nonoperative treatments were used during the study (Table 2). Most patients received education/counseling (93%) and anti-inflammatory medications (61%) (nonsteroidal anti-inflammatory drugs, cyclooxygenase 2 inhibitors, or oral steroids); 46% received opiates; more than 50% received injections (eg, epidural steroids); and 29% were prescribed activity restriction. Forty-four percent received active physical therapy during the trial; however, 67% had received it prior to enrollment.
Surgical Treatment and Complications
Table 3 gives the characteristics of surgical treatment and complications. The median surgical time was 75 minutes (interquartile range, 58-90), with a median blood loss of 49.5 mL (interquar-tile range, 25-75). Only 2% required transfusions. There were no perioperative deaths; 1 patient died from complications of childbirth 11 months after enrollment. The most common intraoperative complication was dural tear (4%). There were no postoperative complications in 95% of patients. Reoperation occurred in 4% of patients within 1 year of the initial surgery; more than 50% of the reoperations were for recurrent herniations at the same level.
Nonadherence
Nonadherence to treatment assignment affected both groups, ie, some patients in the surgery group chose to delay or decline surgery, and some in the nonoperative treatment group crossed over to receive surgery (Figure 1). The characteristics of crossover patients that were statistically different from patients who did not cross over are shown in Table 4. Those more likely to cross over to receive surgery tended to have lower incomes, worse baseline symptoms, more baseline disability on the ODI, and were more likely to rate their symptoms as getting worse at enrollment than the other patients receiving nonoperative treatment. Those more likely to cross over to receive nonoperative care were older, had higher incomes, were more likely to have an upper lumbar disk herniation, less likely to have a positive straight leg�raising test result, had less pain, better physical function, less disability on the ODI, and were more likely to rate their symptoms as getting better at enrollment than the other surgery patients.
Missing Data
The rates of missing data were equivalent between the groups at each time point, with no evidence of differential dropout according to assigned treatment. Characteristics of patients with missed visits were very similar to those of the rest of the cohort except that patients with missing data were less likely to be married, more likely to be receiving disability compensation, more likely to smoke, more likely to display baseline motor weakness, and had lower baseline mental component summary scores on the SF-36.
Intent-to-Treat Analyses
Table 5 shows estimated mean changes from baseline and the treatment effects (differences in changes from baseline between treatment groups) for 3 months, 1 year, and 2 years. For each measure and at each point, the treatment effect favors surgery. The treatment effects for the primary outcomes were small and not statistically significant at any of the points. As shown in Figure 2, both treatment groups showed strong improvements at each of the designated follow-up times, with small advantages for surgery. However, for each primary outcome the combined global test for any difference at any period was not statistically significant. This test accounts for intraindividual correlations as described in the �Methods� section.
Figure 2: Mean Scores Over Time for SF-36 Bodily Pain and Physical Function Scales and Oswestry Disability Index.
Table 5: Treatment Effects for Primary and Secondary Outcomes Based on Intent-to-Treat Analyses*
For the secondary outcome of sciatica bothersomeness, Table 5 and Figure 3 show that there were greater improvements in the Sciatica Bothersomeness Index in the surgery group at all designated follow-up times: 3 months (treatment effect, ?2.1; 95% CI, ?3.4 to ?0.9), 1 year (treatment effect, ?1.6; 95% CI, ?2.9 to ?0.4), and 2 years (treatment effect, ?1.6; 95% CI, ?2.9 to ?0.3), with results of the global hypothesis test being statistically significant (P=.003). Patient satisfaction with symptoms and treatment showed small effects in favor of surgery while employment status showed small effects in favor of nonoperative care, but none of these changes was statistically significant. Self-rated progress showed a small statistically significant advantage for surgery (P=.04).
Figure 3: Measures Over Time for Sciatica Bothersomeness Index, Employment Status, Satisfaction With Symptoms, Satisfaction With Care, and Self-rated Improvement.
As-treated analyses based on treatment received were performed with adjustments for the time of surgery and factors affecting treatment crossover and missing data. These yielded far different results than the intent-to-treat analysis, with strong, statistically significant advantages seen for surgery at all follow-up times through 2 years. For example, at 1 year the estimated treatment effects for the SF-36 bodily pain and physical function scales, the ODI, and the sciatica measures were 15.0 (95% CI, 10.9 to 19.2), 17.5 (95% CI, 13.6 to 21.5), ?15.0 (95% CI, ?18.3 to ?11.7), and ?3.2 (95% CI, ?4.3 to ?2.1), respectively.
Sensitivity analysis was performed for 4 different analytic methods of dealing with the missing data. One method was based on simple mean changes for all patients with data at a given time point with no special adjustment for missing data. Two methods used single imputation methods�baseline value carried forward and last value carried forward.[32] The latter method used the same mixed-models approach for estimating mean changes as given in Table 5 but also adjusted for factors affecting the likelihood of missing data. Treatment effect estimates at 1 year ranged from 1.6 to 2.9 for the SF-36 bodily pain scale, 0.74 to 1.4 for the physical function scale, ?2.2 to ?3.3 for the ODI, and ?1.1 to ?1.6 for the sciatica measures. Given these ranges, there appear to be no substantial differences between any of these methods.
Dr. Alex Jimenez’s Insight
Herniated disc symptoms vary on the location of the condition and on the surrounding soft tissues affected along the spine. Lumbar disc herniations, one of the most common area for herniated discs to occur, are characterized by the compression of the nerve roots along the lower back and can generally cause symptoms of sciatica. Surgery is commonly recommended to treat disc herniations, however, numerous treatment methods can help manage the condition without the need of surgical interventions. A research study conducted on sciatica caused by herniated discs determined that about 73 percent of participants experienced an improvement in symptoms with nonoperative treatment. The results of this article concluded that nonoperative treatment can be as effective as surgery in the treatment of herniated discs.
Comment
Both operated and nonoperated patients with intervertebral disk herniation improved substantially over a 2-year period. The intent-to-treat analysis in this trial showed no statistically significant treatment effects for the primary outcomes; the secondary measures of sciatica severity and self-reported progress did show statistically significant advantages for surgery. These results must be viewed in the context of the substantial rates of nonadherence to assigned treatment. The pattern of nonadherence is striking because, unlike many surgical studies, both the surgical and nonoperative treatment groups were affected.[35] The most comparable previous trial[8] had 26% crossover into surgery at 1 year, but only 2% crossover out of surgery. The mixing of treatments due to crossover can be expected to create a bias toward the null.[34] The large effects seen in the as-treated analysis and the characteristics of the crossover patients suggest that the intent-to-treat analysis underestimates the true effect of surgery.
SPORT findings are consistent with clinical experience in that relief of leg pain was the most striking and consistent improvement with surgery. Importantly, all patients in this trial had leg pain with physical examination and imaging findings that confirmed a disk herniation. There was little evidence of harm from either treatment. No patients in either group developed cauda equina syndrome; 95% of surgical patients had no intraoperative complications. The most common complication, dural tear, occurred in 4% of patients, similar to the 2% to 7% noted in the meta-analysis by Hoffman et al,7 2.2% seen in the MLSS,[29] and 4% in the recent series from Stanford.[36]
One limitation is the potential lack of representativeness of patients agreeing to be randomized to surgery or nonoperative care; however, the characteristics of patients agreeing to participate in SPORT were very similar to those in other studies.[29,36] The mean age of 42 years was similar to the mean ages in the MLSS,[29] the series of Spangfort,[37] and the randomized trial by Weber,[8] and only slightly older than those in the recent series from Stanford (37.5 years).[36] The proportion of patients receiving workers’ compensation in SPORT (16%) was similar to the proportion in the Stanford population (19%) but lower than that in the MLSS population (35%), which specifically oversampled patients receiving compensation. Baseline functional status was also similar, with a mean baseline ODI of 46.9 in SPORT vs 47.2 in the Stanford series, and a mean baseline SF-36 physical function score of 39 in SPORT vs 37 in the MLSS.
The strict eligibility criteria, however, may limit the generalizability of these results. Patients unable to tolerate symptoms for 6 weeks and demanding earlier surgical intervention were not included, nor were patients without clear signs and symptoms of radiculopathy with confirmatory imaging. We can draw no conclusions regarding the efficacy of surgery in these other groups. However, our entry criteria followed published guidelines for patient selection for elective diskectomy, and our results should apply to the majority of patients facing a surgical decision.[38,39]
To fully understand the treatment effect of surgery compared with nonoperative treatment, it is worth noting how each group fared. The improvements with surgery in SPORT were similar to those of prior series at 1 year: for the ODI, 31 points vs 34 points in the Stanford series; for the bodily pain scale, 40 points vs 44 in the MLSS; and for sciatica bothersomeness, 10 points vs 11 in the MLSS. Similarly, Weber[8] reported 66% �good� results in the surgery group, compared with the 76% reporting �major improvement� and 65% satisfied with their symptoms in SPORT.
The observed improvements with nonoperative treatment in SPORT were greater than those in the MLSS, resulting in the small estimated treatment effect. The nonoperative improvement of 37, 35, and 9 points in bodily pain, physical function, and sciatica bothersomeness, respectively, were much greater than the improvements of 20, 18, and 3 points reported in the MLSS. The greater improvement with nonoperative treatment in SPORT may be related to the large proportion of patients (43%) who underwent surgery in this group.
The major limitation of SPORT is the degree of nonadherence with randomized treatment. Given this degree of crossover, it is unlikely that the intent-to-treat analysis can form the basis of a valid estimate of the true treatment effect of surgery. The �as-treated� analysis with adjustments for possible confounders showed much larger effects in favor of surgical treatment. However, this approach does not have the strong protection against confounding that is afforded by randomization. We cannot exclude the possibility that baseline differences between the as-treated groups, or the selective choice of some but not other patients to cross over into surgery, may have affected these results, even after controlling for important covariates. Due to practical and ethical constraints, this study was not masked through the use of sham procedures. Therefore, any improvements seen with surgery may include some degree of �placebo effect.�
Another potential limitation is that the choice of nonoperative treatments was at the discretion of the treating physician and patient. However, given the limited evidence regarding efficacy for most nonoperative treatments for lumbar disk herniation and individual variability in response, creating a limited, fixed protocol for nonoperative treatment was neither clinically feasible nor generalizable. The nonoperative treatments used were consistent with published guidelines.[17,38,39] Compared with the MLSS, SPORT had lower use of activity restriction, spinal manipulation, transcutaneous electrical nerve stimulation, and braces and corsets, and higher rates of epidural steroid injections and use of narcotic analgesics. This flexible nonoperative protocol had the advantages of individualization that considered patient preferences in the choice of nonoperative treatment and of reflecting current practice among multidisciplinary spine practices. However, we cannot make any conclusion regarding the effect of surgery vs any specific nonoperative treatment. Similarly, we cannot adequately assess the relative efficacy of any differences in surgical technique.
Conclusion
Patients in both the surgery and nonoperative treatment groups improved substantially over the first 2 years. Between-group differences in improvements were consistently in favor of surgery for all outcomes and at all time periods but were small and not statistically significant except for the secondary measures of sciatica severity and self-rated improvement. Because of the high numbers of patients who crossed over in both directions, conclusions about the superiority or equivalence of the treatments are not warranted based on the intent-to-treat analysis alone.
Manipulation or Microdiskectomy for Sciatica? A Prospective Randomized Clinical Study
Abstract
Objective: The purpose of this study was to compare the clinical efficacy of spinal manipulation against microdiskectomy in patients with sciatica secondary to lumbar disk herniation (LDH).
Methods: One hundred twenty patients presenting through elective referral by primary care physicians to neurosurgical spine surgeons were consecutively screened for symptoms of unilateral lumbar radiculopathy secondary to LDH at L3-4, L4-5, or L5-S1. Forty consecutive consenting patients who met inclusion criteria (patients must have failed at least 3 months of nonoperative management including treatment with analgesics, lifestyle modification, physiotherapy, massage therapy, and/or acupuncture) were randomized to either surgical microdiskectomy or standardized chiropractic spinal manipulation. Crossover to the alternate treatment was allowed after 3 months.
Results: Significant improvement in both treatment groups compared to baseline scores over time was observed in all outcome measures. After 1 year, follow-up intent-to-treat analysis did not reveal a difference in outcome based on the original treatment received. However, 3 patients crossed over from surgery to spinal manipulation and failed to gain further improvement. Eight patients crossed from spinal manipulation to surgery and improved to the same degree as their primary surgical counterparts.
Conclusions: Sixty percent of patients with sciatica who had failed other medical management benefited from spinal manipulation to the same degree as if they underwent surgical intervention. Of 40% left unsatisfied, subsequent surgical intervention confers excellent outcome. Patients with symptomatic LDH failing medical management should consider spinal manipulation followed by surgery if warranted.
In conclusion, a herniated disc causes the soft, central portion of an intervertebral disc to bulge out a tear in its outer, fibrous ring as a result of degeneration, trauma, lifting injuries or straining. Most disc herniations can heal on their own but those considered to be severe may require surgical interventions to treat them. Research studies, such as the one above, have demonstrated that nonoperative treatment may help the recovery of a herniated disc without the need for surgery. 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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Herniated discs are a debilitating condition characterized by pain, numbness and weakness in one or more limbs. While some people may experience no pain at all, those that do may often wish for fast pain relief to avoid long periods of sick leave from their jobs. Many healthcare professionals recommend surgery for patients with persistent and/or worsening herniated disc symptoms but other non-operative treatment options can help treat disc herniations. The purpose of the following article is to demonstrate how a�structured physiotherapy treatment model can provide rapid relief to patients who qualify for lumbar disc surgery.
A Structured Physiotherapy Treatment Model Can Provide Rapid Relief to Patients Who Qualify for Lumbar Disc Surgery: A Prospective Cohort Study
Abstract
Objective: To evaluate a structured physiotherapy treatment model in patients who qualify for lumbar disc surgery.
Design: A prospective cohort study.
Patients: Forty-one patients with lumbar disc herniation, diagnosed by clinical assessments and magnetic resonance imaging.
Methods: Patients followed a structured physiotherapy treatment model, including Mechanical Diagnosis and Therapy (MDT), together with graded trunk stabilization training. Study outcome measures were the Oswestry Disability Index, a visual analogue scale for leg and back pain, the Tampa Scale for Kinesiophobia, the European Quality of Life in 5 Dimensions Questionnaires, the Zung Self-Rating Depression Scale, the Self-Efficacy Scale, work status, and patient satisfaction with treatment. Questionnaires were distributed before treatment and at 3-, 12- and 24-month follow-ups.
Results: The patients had already improved significantly (p<0.001) 3 months after the structured physiotherapy treatment model in all assessments: disability, leg and back pain, kinesiophobia, health-related quality of life, depression and self-efficacy. The improvement could still be seen at the 2-year follow-up.
Conclusion: This study recommends adopting the structured physiotherapy treatment model before considering surgery for patients with symptoms such as pain and disability due to lumbar disc herniation.
Symptoms of lumbar disc herniation are relatively common in the general population, although the prevalence rates vary widely between different studies (1). Symptom severity also varies and, in many patients, pain and loss of function may lead to disability and long periods of sick leave (2). Spontaneous resolution of symptoms after a lumbar disc herniation is regarded as common, which makes it difficult to evaluate the effects of treatment. Furthermore, in studies evaluating spontaneous healing, different physiotherapy treatments are often included, together with pain medication (3�5), which makes it difficult to determine the extent of natural healing. On the other hand, in patients with sciatica, but without confirmed disc herniation on magnetic resonance imaging (MRI), approximately one-third of subjects recover 2 weeks after the onset of sciatica and approximately three-quarters recover after 3 months (6).
In contrast to evaluating spontaneous healing, surgery for lumbar disc herniation has been investigated in numerous studies. Surgery has been compared with a variety of treatments, such as education, chiropractic, unspecified physiotherapy, acupuncture, injections and medication (7�10). The non-surgical treatments have, however, been described only in vague terms, and variations in treatments have been used. Previous studies have reported favourable short-term (after 1 year) outcomes for surgery, but no major differences between surgical and other treatments have been demonstrated in the long term (over 2 years) (7, 10, 11). The conclusions that are drawn from the comparison between surgery and non-systematic non-surgical treatments may thus be misleading. This has been confirmed in a systematic review, which concluded that there is conflicting evidence as to whether surgery is more beneficial than nonsurgical care for both short- and long-term follow-up (12).
Kinesiophobia has been evaluated in patients after lumbar disc surgery, and almost 50% of patients were classified as having kinesiophobia (13). To our knowledge kinesiophobia has not been evaluated in patients with lumbar disc herniation treated with a structured physiotherapy treatment.
There are many different non-surgical treatment methods for patients with low-back pain and sciatica. One common management method is Mechanical Diagnosis and Therapy (MDT), also known as the McKenzie method, which aims to eliminate or minimize pain (14). A systematic review from 2004 of the efficacy of MDT showed that patients with low-back pain treated�with MDT reported a greater, more rapid reduction in pain and disability compared with non-steroidal anti-inflammatory drugs (NSAIDs), educational booklets, back massage and back care advice, strength training, spinal mobilization and general exercises (15). In a randomized controlled trial with a 1-year follow-up from 2008, Paatelma and co-workers (16) found that the McKenzie method was only marginally more effective compared with only giving advice to patients with low-back pain. For patients with low-back pain, sciatica and a verified lumbar disc herniation, it has, however, been shown that a selected group of patients who responded to MDT after 5 days of treatment also reported that they were satisfied after 55 weeks (17). The patients started treatment just 12 days after the onset of symptoms and the effects of spontaneous healing cannot therefore be excluded. Taken together, the treatment effects of MDT for patients with a verified lumbar disc herniation appear to require further evaluation.
Trunk stabilization exercises, which aim to restore deep trunk muscle control, have been used for the prevention and rehabilitation of low-back pain (18). A randomized controlled trial revealed a reduction in the recurrence of low-back pain episodes after specific trunk stabilization exercises compared with a control group receiving advice and the use of medication (19). Dynamic lumbar stabilization exercises have been found to relieve pain and improve function in patients who have undergone microdiscectomy (20). The effects of trunk stabilization exercises combined with MDT have, however, not been studied in patients with non-operated lumbar disc herniation. MDT is seldom recommended for patients with MRI verified lumbar disc herniation with a broken outer annulus. At our hospital, however, we have several years of good clinical experience of a combination of MDT and trunk stabilization exercises for this category of patients. To our knowledge, no previous study has investigated whether patients with a lumbar disc herniation verified by MRI, symptoms for at least 6 weeks (minimizing effects of spontaneous healing) and who qualified for disc surgery could improve with a structured physiotherapy treatment model including MDT and gradually progressive trunk stabilization exercises. The aim of this study was therefore to�evaluate a structured physiotherapy treatment model in patients who qualified for lumbar disc surgery.
Material and Methods
During the study inclusion period, 150 patients, who were referred to the orthopaedic clinic at Sahlgrenska University Hospital, Gothenburg, from November 2003 to January 2008, were identified as potential participants since disc herniation was confirmed with MRI. Inclusion criteria were: 18�65 years of age; MRI confirming disc herniation explaining the clinical findings; symptoms for at least 6 weeks (minimizing the effects of spontaneous healing) and pain distribution with concomitant neurological disturbances correlated to the affected nerve root. Exclusion criteria were: cauda equina syndrome, previous spinal surgery, other spinal diseases, such as spinal stenosis and spondylolisthesis, and inadequate command of Swedish. However, 70 patients were excluded because of spontaneous resolution of pain and symptoms. The remaining 80 patients met the inclusion criteria and qualified for surgery. Orthopaedic surgeons determined whether the patients qualified for lumbar disc surgery after MRI and physical examination according to the recommendations of the American Academy of Orthopaedic Surgeons for patients with lumbar disc herniation (21).
Initially, the study was planned as a randomized controlled trial (RCT) between a structured physiotherapy treatment model and surgery, but the number of patients was not sufficient to obtain acceptable power. Eighteen of the 80 patients were initially randomized to physiotherapy, 17 patients were randomized to surgery and 45 patients did not agree to undergo randomization. Twenty-seven of the 45 patients who did not agree to randomization agreed to take part in the structured physiotherapy treatment and 18 patients agreed to undergo surgery. A decision was therefore made solely to present a cohort of 45 patients treated according to the structured physiotherapytreatment protocol (Fig. 1). Patients were given verbal and written information and informed consent was obtained. The study was approved by the Regional Ethical Review Board.
Before structured physiotherapy treatment began, 4 patients recovered to the extent that they could no longer be accepted as surgical candidates and they were therefore excluded from the study. The remaining 41 patients treated according to the structured physiotherapy model are presented in this paper.
A Structured Physiotherapy Treatment Model
Six physiotherapists with credentialed examinations in MDT, which is an examination within the MDT concept after completing 4 courses of 4 days each for evaluating and treating patients with spinal problems. Following completion of these courses, an extensive literature study and practice in evaluating and treating patients is required before the examination can be completed. The physiotherapists involved in the study had 5�20 years of clinical experience of treating patients with back problems and herniated lumbar disc. The inter-examiner reliability of the MDT assessment has been shown to be good if the examiner is trained in the MDT method (22). The physiotherapists examined and treated the patients during a 9-week period (Table I). For the first 2 weeks of treatment, an MDT protocol was followed, based on clinical examinations of individual mechanical and symptomatic responses to positions and movements, with the aim of minimizing pain and with the emphasis on self-management (14). During the third week of treatment, graded trunk stabilization exercises were added to the MDT protocol. The purpose of graded trunk stabilization exercises was to improve muscle control (23). The low-load muscular endurance exercises were gradually increased in intensity on an individual�basis with respect to the patients� reported leg pain and the observed movement control and quality. During treatment, the patients were encouraged to continue exercising on their own at a gym, or to perform some other type of physical training of their own choice after the structured physiotherapy treatment was concluded. Four weeks after the completion of the 9-week physiotherapy treatment period, the patients attended a follow-up visit with the physiotherapist who had treated them. The aim of this visit was to encourage a high level of compliance with respect to continued trunk stabilization exercises and MDT practice (Table I).
Study Outcome Measures
The patients were given a battery of questionnaires to complete. Independent examiners, who were not involved in the treatment, distributed the questionnaires before treatment (baseline) and at the 3-, 12- and 24-month follow-ups.
The primary outcome measures were pain intensity in the leg, rated using a visual analogue scale (VAS) 0�100 mm (24) and the Oswestry Disability Index (ODI) 0�100 % (25). A score of 0�10 mm on the VAS was defined as no pain according to �berg et al. (26). An ODI score of 0�20% was defined as minimal or no disability, and a score of over 40% was defined as severe disability (25). These primary outcome measures are commonly used in evaluations after surgery for lowback pain and for assessing patients with lumbar disc herniation (27).
Secondary outcome measures included pain intensity in the back rated using a VAS and the degree of kinesiophobia using the Tampa Scale for Kinesiophobia (TSK). The TSK score varies between 17 and 68 and a cut-off more than 37 was defined as a high degree of kinesiophobia (28). Health-Related Quality of Life (HRQoL) in the European Quality of Life in 5 Dimensions Questionnaires (EQ-5D) was used. The EQ-5D includes 2 parts, EQ-5Dindex ranges from 0 to 1.0, where 1.0 is optimal health and EQ-5DVAS is a vertical visual analogue scale ranging from 0 (worst possible health state) to 100 (best possible health state) (29). The Zung Self-Rating Depression Scale (ZDS) ranges from 20�80 and the more depressed the patient is, the higher score (30). The Self-Efficacy Scale (SES) ranges from 8 to 64, with higher scores indicating more positive beliefs (31) was also used. Work status was measured using a 3-grade Likert scale: working full time, full-time sick leave and part-time sick leave. Likewise, patient�satisfaction with treatment was measured on a 3-grade Likert scale; satisfied, less satisfied and dissatisfied (32). These secondary outcome measures evaluate bio-psychosocial factors described as important in connection with lumbar disc surgery (33).
Statistical Analyses
The results are presented as median values and interquartile range (IQR), except for age, which is presented as the mean and standard deviation (SD). Changes over time within the group were analysed with the Wilcoxon signed-rank test. Statistical significance was set at an alpha level of 0.05.
Results
The baseline characteristics are shown in Table II. No patient had undergone surgery at the 3-month follow-up. At the 12-month follow-up, 3 patients had undergone surgery and, at the 24-month follow-up, 1 additional patient had been operated on. After surgery, these 4 patients were excluded from further follow-ups (Fig. 1).
Change Over Time in Primary Outcome Measures
Disability. The patients showed significant improvements (p < 0.001) in ODI at the 3-month follow-up compared with baseline. The median (IQR) score decreased from 42 (27�53) to 14 (8�33). This improvement could still be seen at 12 and 24 months (Table III and Fig. 2). At baseline, 22 patients reported�severe disability (54%) and 3 patients reported no disability. The degree of disability decreased at the 3-month follow-up, as only 9 patients (22%) reported severe disability and 26 (64%) reported no disability. At 12- and 24-month follow-ups only 2 patients (5%) reported severe disability. At 12-month followup 26 patients still reported no disability, and at 24-month follow-up 27 patients reported no disability.
Leg pain. A significant reduction in patients� leg pain was found at the 3-month follow-up (p < 0.001) on the VAS compared with baseline. The median (IQR) on the VAS decreased from 60 (40�75) to 9 (2�27). This improvement could still be seen at the 12- and 24-month follow-ups (Table III and Fig. 2). Before treatment, all patients reported leg pain. Three months after treatment, the median on the VAS was 9 mm, i.e. classified as no leg pain (26). Twenty-three patients (56%) reported no leg pain at the 3-month follow-up. At the 12-month follow-up 22 patients reported no leg pain, and after 24 months 24 patients reported no leg pain.
Change in Secondary Outcome Measures Over Time
Back pain. A significant improvement in back pain was found at the 3-month follow-up (p < 0.001) on the VAS compared with baseline. This improvement could still be seen at 12 and 24 months (Table III). At baseline, 6 patients (15%) reported no back pain. Three months after treatment began, 20 patients (49%) reported no back pain.
Kinesiophobia. The degree of kinesiophobia showed a significant improvement at the 3-month follow-up (p < 0.001) and the improvement could be seen throughout the follow-up period (Table III). Before treatment, 25 patients (61%) were classified as having kinesiophobia and 15 patients (37%) had no kinesiophobia, while data for 1 patient was missing. After 3 months, 15 patients (37%) had kinesiophobia and 26 (63%) had no kinesiophobia. At the 12-month follow-up, the number of patients with kinesiophobia had reduced to 4 (11%) (Fig. 3).
Health-related quality of life, depression and self-efficacy. All 4 assessments (EQ-5Dindex, EQ-5DVAS, ZDS and SES) showed significant improvements at the 3-month follow-up (p < 0.001). This improvement could still be seen at 12 and 24 months (Table III).
Sick leave. At baseline, 22 patients (54%) were on full-time sick leave (Table IV), compared with 9 (22%) patients at�the 3-month follow-up. At baseline, 14 patients (34%) were working full time, compared with 22 (54%) at the 3-month follow-up.
Satisfaction with Treatment
At the 3-month follow-up, 32 (78%) of 41 patients were satisfied with the structured physiotherapy treatment. Seven patients were less satisfied and 2 patients were dissatisfied. Both of the dissatisfied patients were later operated. At the 2-year follow-up, the number of satisfied patients was 29 (80%) of 36. Seven patients were less satisfied, but none dissatisfied after structured physiotherapy treatment.
Dr. Alex Jimenez’s Insight
A disc herniation in the lumbar spine can cause pain, numbness and weakness in the lower back. Because of the severity of the symptoms, many patients seeking fast pain relief consider surgery. However, many non-operative treatment options can help improve as well as manage lumbar herniated disc symptoms.�A structured physiotherapy treatment model can provide rapid pain relief to patients who would otherwise qualify for lumbar disc surgery, according to the following article. Patients looking to avoid taking long periods of sick leave from work due to their symptoms may benefit from a structured physiotherapy treatment model. As with any type of injury and/or condition, the use of other treatment options should be properly considered before turning to surgical interventions for fast pain relief.
Discussion
The principal finding of this study was that patients who qualified for lumbar disc surgery improved to a statistically significant and clinically substantial degree just 3 months after the start of the structured physiotherapy treatment in all assessments: disability, leg and back pain, kinesiophobia, health-related quality of life, depression and self-efficacy. The improvements could still be seen at the 2-year follow-up.
The natural course of healing must be considered carefully, especially when evaluating treatment effects in patients with disc herniation. The symptoms often vary over time and many discs heal spontaneously and the symptoms cease. Approximately 75% of patients with sciatica, without an MRI-verified disc herniation, recover within 3 months, and approximately one-third of patients recover within 2 weeks after the onset of sciatica (6). The natural course of sciatica was evaluated in a randomized controlled trial (34), which compared NSAIDs with placebo. The patients were, however, examined within 14 days after the onset of radiating leg pain. After 3 months, 60% of the patients had recovered and, after 12 months, 70% had recovered. In order to minimize the influence of spontaneous healing in the present study, the patients were therefore included only if they had had persistent pain and disability for more than 6 weeks. In fact, the majority of the patients had had pain and disability for more than 3 months. It is therefore most likely that the effects of treatment seen in the present study are, in the majority of patients, an effect of the structured physiotherapy treatment model and not a result of spontaneous healing.
In the study by Weber et al. (34), the VAS leg pain mean score was reduced from 54 mm at baseline to 19 mm within 4 weeks for all 183 patients, regardless of treatment. After 1 year, the VAS leg pain mean score was 17 mm. The patients in the present study who were a little worse at baseline (60 mm) reported 9 mm on the VAS leg pain just 3 months after treatment. Consequently, in the present study, the median VAS level had already been reduced to under the no-pain score, defined as 0�10 on the VAS (26), at the 3-month follow-up and this was maintained to the 12- and 24-month follow-ups.
Physiotherapy treatment for patients with lumbar disc herniation can lead to improvements. Br�tz et al. (17) included a selected group of patients who responded with the centralization of pain after the first 5 daily sessions of treatment according to the MDT method. Centralization of pain is defined as a clinically induced change in the location of pain referred from the spine, that moves from the most distal position toward the lumbar midline (35). However, the patients� medium duration of symptoms before treatment was only 12 days and the possibility that patients recovered naturally cannot therefore be excluded (17).
In a retrospective study, 95 patients were treated with a functional restoration programme (36). The patients achieved significant improvements after a mean treatment period of 8.7 months. The evaluation was performed at discharge only. With a treatment period of this length, it is, however, difficult to differentiate between the effects of treatment and the natural healing process. In the present study, a shorter treatment period was adopted, and large and significant improvements were found after just 3 months and were still present at the 24-month follow-up. It is therefore not likely that the natural healing process was responsible for the positive results in the present study.
In a prospective study of 82 consecutive patients with acute severe sciatica, included for conservative management, only a minority of the patients had made a full recovery after 12 months (37). Twenty-five percent of the patients underwent surgery within 4 months and one-third had surgery within 1 year. In spite of the fact that the inclusion criteria in the present study followed the recommendations for surgery (21, 38), no patient required surgery at the 3-month follow-up and, after 12 months, only 3 patients (7%) had undergone surgery. The interpretation of the divergence could be that the structured physiotherapy treatment model used in the present study appeared to influence patients with lumbar disc herniation in a very positive direction. One recommendation is therefore to follow the structured physiotherapy treatment model before considering surgery.
In this study, MRI verification of disc herniation was an inclusion criterion. In clinical practice, MRI verification is not mandatory, as it is in surgical treatment, before introducing structured physiotherapy treatment to patients with symptoms from a disc herniation. Consequently, treatment according to the structured physiotherapy treatment model can start early after the commencement of symptoms, as it is not necessary to wait for an MRI. It is possible to speculate that, if treatment with a structured physiotherapy model starts earlier than in the present study, the improvements would be even better, further reducing the risk of persistent pain and accompanying problems. Moreover, the need for MRI is likely to diminish; this, however, should be further evaluated in future studies.
One explanation for the good results of this study could be that the patients followed a structured physiotherapy treatment model, comprising MDT and trunk stabilization exercises, allowing for an individual design and progression of the treatment. Similar results were described in a retrospective cohort study (39) using several treatment methods for pain control as well as for exercise training for patients with lumbar disc herniation. The evaluation was not carried out until approximately 31 months after treatment. The results of Saal et al. (39) and of the present study are in agreement, in that structured physiotherapy treatment can reduce symptoms, but symptoms were relieved much more rapidly in the present study.
In a multicentre study comprising 501 patients, randomized to surgery or non-operative care, 18% of the patients assigned to non-operative treatment underwent surgery within 6 weeks and 30% had surgery at approximately 3 months (7). The nonoperative treatment group received non-specified �usual care�, which could include a variety of different treatment methods. In contrast, the patients in the present study were offered a structured physiotherapy treatment model that included both bio-psychological and social components, as described in the International Classification of Functioning, Disability and Health (40).
There are many possible explanations for the positive effects seen in this present study, and 5 of these will now be discussed. Firstly, the patients were well informed about the design of the structured physiotherapy treatment model, including the timetable for different phases of the treatment and when the treatment was planned to end. This information enhanced the patients� opportunity for self-management and gave them an active role in treatment decision-making.
Secondly, the patients acquired strategies to deal with their pain by using the different activities and movements in order to reduce pain according to the MDT method (14). The MDT method aims to enhance the patients� ability to cope with the symptoms, motivate the patient to comply with the treatment and empower them to achieve independence. Leijon et al. (41) have shown that low levels of motivation plus pain are important factors that enhance non-adherence to physical activity. It therefore appears important to reduce pain and increase motivation as early as possible. It is reasonable to believe that, when the patients participated in the evaluation of different activities and exercises, this augmented their opportunity to discover the connection between activities and the following reduction or increase in symptoms. This could have led to the increased self-efficacy and empowerment of the patients. The use of empowerment in physiotherapy has been recommended in a review by Perrault (42), who argues that empowerment improves the intervention.
Thirdly, the intensity of exercises was gradually increased on an individual basis with respect to the patients� reported pain. The objective was to strengthen the patients� self-efficacy, which also improved significantly in the present study. Fourthly, the trunk stabilization exercises were conducted with the aim of increasing deep trunk muscle control (23). It can be speculated that the physiological effects of training may also have led to reduced pain through increased blood circulation, muscle relaxation and the release of pain-reducing substances, such as endorphins.
Finally, one reason for the improvements could be that the physiotherapists were experienced and well educated in the MDT method. Subsequently, the physiotherapists were able to guide the patients during the rehabilitation process. It is, however, not possible to determine whether and how much each of the reasons discussed above contributed to the improvements. It seems reasonable to assume that all 5 factors were operating.
In this study, the majority of patients experienced kinesiophobia before treatment started. As early as 3 months after the structured physiotherapy treatment started, the number of patients with kinesiophobia fell dramatically and the majority of patients no longer experienced kinesiophobia. These results are in agreement with those of a study of patients with chronic pain and high kinesiophobia who increased their physical activity level after a pain management programme designed to enable the patients to regain overall function (43).
There are some limitations to this study. It is not possible to exclude the possibility that some patients may have improved spontaneously without treatment. Measures were taken to limit this risk by using symptoms for at least 6 weeks as an inclusion criterion. Again, the majority of patients had symptoms for more than 3 months. Another limitation might relate to whether the patients were selected accurately for the study. Clinically experienced orthopaedic surgeons evaluated the clinical findings and the MRI scans and classified the patients as surgical candidates based on recommendations from the American Academy of Orthopaedic Surgeons for intervention for disc herniation published in 1993 (21). The patients included in the present study also fulfilled the recommendations as presented by Bono and co-workers in 2006 (38). The patients can therefore be regarded as serving as their own controls, and comparisons can be made with baseline symptoms and with patients from other studies. An RCT would have been the best way to explore different treatment options; however, we did not reach the number of patients required for an RCT. As the treatment model used in the present study has not been evaluated previously in a group of patients with long-standing pain, with the majority of the patients having pain for more than 3 months due to disc herniation, and, as the results are clinically interesting, it was decided to present the results as a cohort study.
In conclusion, this study shows that patients eligible for lumbar disc surgery improved significantly after treatment with the structured physiotherapy model, as early as 3 months after treatment, and the results could still be seen at the 24-month follow-up. Consequently, these patients did not qualify for lumbar disc surgery 3 months after the physiotherapy treatment started. Moreover, the majority of patients had symptoms for more than 3 months at the start of treatment and, for this reason, most of the spontaneous healing ought to have occurred before this study started. This study therefore recommends adoption of the structured physiotherapy treatment model before considering surgery when patients report symptoms such as pain and disability due to lumbar disc herniation.
Acknowledgements
The authors would like to thank physiotherapists Patrik Drevander, Christina Grund�n, Sofia Frid�n and Eva Fahlgren for treating the patients and Valter Sundh for statistical support. This study was supported by grants from the Health & Medical Care Committee of the V�stra G�taland Region, Ren�e Eander�s Foundation and Wilhelm & Martina Lundgren�s Foundation of Science.
Herniated discs can cause pain, numbness and weakness, a variety of symptoms which may often become so severe, that surgery might seem like the only option for fast relief. However, a�structured physiotherapy treatment model can provide rapid relief to patients who qualify for lumbar disc surgery, according to the results of the research study. 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: Neck Pain
Neck pain is a common complaint which can result due to a variety of injuries and/or conditions. According to statistics, automobile accident injuries and whiplash injuries are some of the most prevalent causes for neck pain among the general population. During an auto accident, the sudden impact from the incident can cause the head and neck to jolt abruptly back-and-forth in any direction, damaging the complex structures surrounding the cervical spine. Trauma to the tendons and ligaments, as well as that of other tissues in the neck, can cause neck pain and radiating symptoms throughout the human body.
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A herniated disc is typically a very painful condition, especially if the inner gel-like substance of the intervertebral disc, known as the nucleus pulposus, pushes through the thick, outer ring of cartilage and puts pressure on the sensitive nerves of the spine. Discs are soft, rubbery pads found between each vertebrae of the spine that act as shock-absorbers, allowing the spine to bend and/or flex. An intervertebral disc may begin to rupture as a result of wear-and-tear or due to a sudden injury. Fortunately, most individuals who’ve suffered a herniated disc can find relief from a variety of non-operative treatments before considering surgery. The following article highlights the impact of early treatment for herniated discs in the lumbar spine, or low back.
The Impact of Early Recovery on Long-Term Outcomes in a Cohort of Patients Undergoing Prolonged Non-Operative Treatment for Lumbar Disc Herniation: Clinical Article
Abstract
Object
The authors comprehensively studied the recovery of individual patients undergoing treatment for lumbar disc herniation. The primary goal was to gain insight into the variability of individual patient utility scores within a treatment cohort. The secondary goal was to determine how the rates and variability of patient recovery over time, represented by improvement in utility scores, affected long-term patient outcomes.
Methods
EuroQol Group�5 Dimension (EQ-5D) scores were obtained at baseline and at 2, 4, 8, 12, 26, 38, and 52 weeks for 93 patients treated under a prolonged conservative care protocol for lumbar disc herniation. Gaussian kernel densities were used to estimate the distribution of utility scores at each time point. Logistic regression and multistate Markov models were used to characterize individual patient improvement over time. Fisher exact tests were used to compare the distribution of EQ-5D domain scores.
Results
The distribution of utility scores was bimodal at 1 year and effectively sorted patients into a �higher� utility group (EQ-5D = 1; 43% of cohort) and a �lower� utility group (EQ-5D ? 0.86; 57% of cohort). Fisher exact tests revealed that pain/discomfort, mobility, and usual activities significantly differed between the 2 utility groups (p ? 0.001). The utility groups emerged at 8 weeks and were stable for the remainder of the treatment period. Using utility scores from 8 weeks, regression models predicted 1-year outcomes with 62% accuracy.
Conclusions
This study is the first to comprehensively consider the utility recovery of individual patients within a treatment cohort for lumbar disc herniation. The results suggest that most utility is recovered during the early treatment period. Moreover, the findings suggest that initial improvement is critical to a patient’s long-term outcome: patients who do not experience significant initial recovery appear unlikely to do so at a later time under the same treatment protocol.
Abbreviations used in this paper: AUC = area under a receiver-operating curve; EQ-5D = EuroQol Group�5 Dimension. Address correspondence to: Matthew C. Cowperthwaite, Ph.D., The University of Texas at Austin, Texas Advanced Computing Center, J.J. Pickle Research Campus, ROC 1.101, 10100 Burnet Rd., Austin, TX 78758. email: mattccowp@mac.com.
Plublished online June 28, 2013; DOI: 10.3171/2013.5.SPINE12992.
Introduction
Lumbar disc herniation is one of the most common causes of low-back pain and radiculopathy.[4] Treatment for patients with a herniated lumbar disc usually begins with conservative care such as analgesics, epidural steroid injections, and physical therapy,[1,5] with surgery reserved for patients with severe nerve root or cauda equina dysfunction or if conservative therapy is unsuccessful in controlling the symptoms.
Several recent studies have compared the effectiveness of conservative care and surgical treatment protocols for treating herniated lumbar discs, and have arrived at varying conclusions.[2,3,9,10,15�18] However, these studies have generally considered outcomes over a period of years, which is a significant length of time for patients who are waiting for their quality of life to improve. In clinical practice, this often leads to the following dilemma: most patients, particularly those with moderate symptoms, would prefer to avoid surgery, but are unwilling to wait an indefinite period of time for their symptoms to resolve. Unsurprisingly, lumbar discectomy is the most frequently performed surgical procedure in the US.[17,18]
Moreover, the above-mentioned studies have typically compared the average difference between treatment groups, without regard for individual recovery within the cohort. Additionally, this approach assumes that recovery in the protocols being compared proceeded similarly between observation intervals. To better understand the treatment responses of individual patients and the time frames of their responses, we comprehensively analyzed a cohort of patients undergoing a prolonged conservative care treatment protocol to gain insight into the dynamics of individual patient recovery over time, and whether these recovery dynamics influence long-term outcomes.
Methods
Study Data Set
The data set contained 142 patients randomized to a protocol of prolonged conservative care as part of the Leiden�The Hague Spine Intervention Prognostic Study.[10,15] The Sciatica Trial was reviewed and approved by the Medical Ethics Committee of Leiden University Medical Center.[11] Patients were enrolled into the Sciatica Trial entirely in the Netherlands.
In the Sciatica Trial, all patients aged 18 to 65 years, with persistent radicular pain in the L-4, L-5, or S-1 dermatome (with or without mild neurological deficit), severe disabling leg pain (lumbosacral radicular syndrome) lasting 6�12 weeks, and radiologically (MRI) confirmed disc herniation were considered eligible to enroll in the trial. Cauda equina syndrome or severe paresis, prior complaints of lumbosacral radicular syndrome in the previous 12 months, history of same-level unilateral disc surgery, spinal canal stenosis, and degenerative or lytic spondylolisthesis were all exclusion criteria. Cohort demographics and baseline characteristics were previously described; all patients reported both back and leg pain, but leg pain was generally more severe (mean leg pain 67.2 � 27.7 vs back pain 33.8 � 29.6, measured on a 100-point, horizontal visual analog scale).[15]
The Sciatica Trial used a pragmatic study design: conservative-care management was influenced as little as possible and was supervised by each patient’s general practitioner. Use of analgesics and physical therapy was determined by the treating physician. In this cohort, 46 patients (32%) elected to have surgery before the end of the 1st year; the mean timing of surgery was 12.6 weeks after the start of treatment. The surgical patients and 3 additional subjects with more than 2 missing utility measures were removed from the sample, resulting in a cohort of 93 patients considered in the present study; the crossover patients will be discussed in a separate study (manuscript in preparation). Our results were qualitatively unchanged when the excluded patients were retained in the analyses (data not shown).
In the Leiden�The Hague Spine Intervention Prognostic Study the EQ-5D instrument was used to measure patient utility at baseline and at 2, 4, 8, 12, 26, 38, and 52 weeks after enrollment into the study. The average duration of sciatica prior to enrollment was 9.5 weeks.[10,15] Utility is a valuation of a patient’s quality of life on a scale between 0 (as bad as dead) and 1 (perfect health). To estimate utility, the EQ-5D assesses a patient’s functional impairment in 5 domains: mobility, self-care, usual activities, pain, and anxiety.[6] For each domain, patients self-report the scores of 1 (no problems), 2 (some problems), or 3 (extreme problems). Utility scores were computed using the US valuation model,[12] which clearly distinguishes patients reporting no health problems (EQ-5D = 1) from those reporting at least some health problems (EQ-5D ? 0.86). Our results are independent of the particular valuation model (not shown). Completeness of the EQ-5D measures during follow-up ranged from 98% at 2 weeks to 90% at 38 weeks.
Statistical Analysis
All statistical analyses were conducted using the R statistical environment (version 2.9.2; www.rproject.org/) with the additional �msm,�[8] �ROCR,�[14] and �rms�[7] packages (all freely available from cran.rproject.org). Continuous variables are presented as means (� SEM) and were compared using 2-tailed Student t-tests. Significance was assessed at an ? ? 0.05 significance level, unless otherwise indicated. Missing EQ-5D measures were imputed using the mean of the measures at adjacent time points; our results are qualitatively similar under forward or backward imputation schemes (not shown).
Gaussian kernel density estimates were computed to estimate the distribution of utility scores. The kernel density estimates were estimated using a Silverman’s �rule-of-thumb� bandwidth and a Gaussian smoothing kernel.[13] The left- and right-most points were set to the theoretical minimum and maximum EQ-5D values, respectively, so that the area under the density curve summed to 1.
To determine whether specific EQ-5D domains differed between utility groups, Fisher-exact tests were conducted on contingency tables of the number of patients in each utility group that reported scores of 1, 2, or 3. Significance was assessed using a Bonferroni-corrected p value of 0.01.
Two-state, continuous-time Markov models were used to study the patterns and probabilities of patients transitioning between a �lower� utility (EQ-5D ? 0.86) and a �higher� utility group (EQ-5D = 1). The threshold utility value defining the groups remained fixed over time and was used to assign each patient to a utility group at each observation time. The models were fitted using the �msm� package[14] with piecewise-constant transition intensity matrices (Qt) estimated for each time interval between the points t = 0, 4, 8, 12, 26, 38, 52 (t = 2 was omitted because there were insufficient transitions to yield a robust model). Transition intensities were permitted to change between subsequent observation intervals, but remained homogeneous within each observation interval. The starting transition intensities were based on the observed frequencies of transitions in the data set and were calculated using the formula
in which nij is the observed number of transitions from Group i to Group j over the duration of the study period (T), and nj is the initial number of patients in Group j. The fitted models were robust to the choice of starting transition intensities and yielded qualitatively similar parameter estimates over a range of starting parameters (not shown). The likelihood function was maximized using a Nelder-Mead algorithm, and convergence was visually verified and typically occurred well short of the maximum number of iterations.
Logistic regression models were used to test whether utility measurements from earlier time points could predict long-term outcomes. These models only included utility values up to a particular time point as predictors, with the response variable being the patient’s 1-year outcome (higher or lower utility group) modeled as a dichotomous variable; no additional clinical or demographic covariates were included in the models. The models were fitted using the �rms� package[7] and the fit was assessed using chi-square tests (? ? 0.05). Separate regression models were created for all utility measurements up to and including those for 2, 4, 8, 12, and 26 weeks; for example, the 8-week model would include utility measurements at 0, 2, 4, and 8 weeks. The AUC statistic was used to assess the performance of the models and was calculated using the ROCR package.[14]
Results
Delineation of Higher and Lower Utility Groups
The distributions of patient utility scores markedly changed over the course of 1 year of conservative care (Fig. 1). At baseline, the majority of patients reported a relatively poor quality of life; the mean EQ-5D score was 0.55 (median 0.60). Two distinct utility groups were found to be present at baseline: a �lower� utility group (EQ-5D ? 0.86) and a �higher� utility group (EQ-5D = 1). At 6 months, the lower utility group (n = 62, 67%) was larger than the higher utility group (n = 31, 33%); at 1 year, the lower utility group (n = 53, 57%) had declined, but remained larger than the higher utility group (n = 40, 43%).
Figure 1: Distribution of EQ-5D patient utilities at baseline, 6 months, and 1 year. The solid lines depict Gaussian kernel density estimates (right axis) of each distribution. The gray lines outline the histogram with the height of each bar representing the frequency of patients (left axis) in the equal-width bins (0.05) with utility greater than the lower bound and less than or equal to the upper bound. The bounds of both distributions are set to the theoretical minimum and maximum of the EQ-5D utility instrument.
EQ-5D Domain Scores Between Groups
The average scores in each domain of the EQ-5D (Table 1) suggested that the pain/discomfort (low score = 1.9, high score = 1.0), mobility (low score = 1.4, high score = 1.0), and usual activities (low score = 1.5, high score = 1.0) domains differed most significantly between the high and low utility groups (p ? 0.001). The anxiety (low score = 1.2, high score = 1.0) and self-care (low score = 1.1, high score = 1.0) domains differed much less between the 2 utility groups, although they were also significant (p < 0.01).
Trajectory of Patient Utility Over Time
The series of patient utility scores measured over the study period are referred to as utility �trajectories,� which were studied to understand how patients recovered over the study period. In the study cohort, all patients experienced improvement during at least 1 observation period; only 19.3% (n = 18) never experienced a decline during their recovery. Recovery was variable: 49.5% of the patients (n = 46) experienced at least 2 reversals, which were defined as improvements (declines) immediately followed by declines (improvements) at the next observation. Furthermore, only 29% of patients (n = 27) had stable trajectories with no reversals. Overall, increases in utility were 4 times more common than decreases in utility.
The utility of the entire cohort increased by 0.296 (51.8% above baseline; p ? 0.001, Wilcoxon Mann-Whitney test) over the year (Fig. 2), but was markedly faster during the first 2 months (0.022/week) than the final 3 months (0.005/week). Over the same time frames, utility scores improved by 0.178 (35.2% above the baseline average) over the first 2 months and by 0.063 (1.3% above the 9-month average) during the final 3 months. The mean utility scores significantly differed between the 2 final utility groups at 8 weeks and remained significant for the rest of the year (p < 0.01, Student t-test; Fig. 2).
Figure 2: Graph of mean patient utilities at each measurement time point. Error bars represent 95% CIs about the mean. High and low utility group refers to the final group in which the patient belongs at the 1-year time point.
Modeling Patient Recovery
Given that 2 utility groups were present over the study period, Markov models were used to study the robustness of these groups by estimating the likelihood of patients switching between the groups. The models suggested that the average probability of a patient remaining within their utility group was 97.9% and 97.6% for patients currently in the low and high utility groups, respectively (Fig. 3). The probability of a patient transitioning from the low to the high utility group was 2.1%; the corresponding probability for transitions from the high to the low utility group was 2.3%.
Figure 3: Graphs of the Markov transition probabilities (per week) for transitions within (lower) and between (upper) utility groups. Each point is centered at the middle of each time interval and represents the maximum-likelihood estimate of the per-week transition probability during the entire interval. Error bars (mean width of the 95% CI was 1.8) were omitted for clarity because the differences were not significant.
The models also suggested that the likelihood of a patient transitioning to another utility group declined over the study period. During the first 8 weeks, 2.8% and 3.5% of patients experienced low-to-high and high-to-low transitions, respectively; over the last 3 months, 1.6% and 1.3% of patients experienced low-to-high and high-to-low group transitions, respectively.
Predicting Individual Patient Outcome
At 8 weeks, logistic regression models could predict a patient’s outcome (final utility group) with modest accuracy (AUC = 0.62, or 62%). The accuracy of the models steadily increased as data from later time points were included; the 26-week model performance was good with an AUC of 0.78 (Fig. 4). The amount of improvement in utility scores from baseline to 8 weeks was also investigated as a predictor of good outcome (higher utility group). Patients with EQ-5D scores that improved by at least 0.30 during the first 8 weeks of treatment were 60% more likely to have a good outcome.
Figure 4: Graph showing the accuracy of classifiers based on patient utilities. The horizontal line is drawn at 0.50, above which models would perform better than randomly assigning patients to utility groups.
Dr. Alex Jimenez’s Insight
Herniated disc commonly develop in the lumbar spine, or lower back. Also referred to as a slipped disc or a ruptured disc, a herniated disc occurs when the soft, gel-like center of an intervertebral disc pushes through a tear in its surrounding outer ring, known as the annulus fibrosus. The symptoms of a herniated disc are generally specific to the exact level of the spine where the disc herniation occurs and whether or not the nerve tissue has been irritated by the intervertebral disc material leaking out of the inside of the disc. The most common symptoms of a disc herniation include pain, numbness, weakness and tingling sensations as well as causing radiating symptoms along the upper or lower extremities. Depending on the severity of the symptoms, herniated disc treatment can include, drugs and/or medications, epidural injections, physical therapy, chiropractic, and surgery, among others. According to the following article, early treatment can help promote and manage a faster herniated disc recovery from prolonged non-operative treatment methods.
Discussion
Several studies have sought to compare the relative effectiveness of surgery and conservative care for treatment of a lumbar disc herniation.[4�9,11] Generally, these studies have compared �average� differences between the study cohorts, while the individual trajectories by which patient utility changes over time have received less attention. To our knowledge, this study provides the first comprehensive statistical analysis of individual patient-level utility data from a large cohort of patients randomized to a prolonged conservative-care treatment protocol for lumbar disc herniation.[9]
The decision to proceed with surgery is straightforward in patients with severe, disabling symptoms or neurological deficits. Likewise, the decision to continue conservative care is simple for patients with mild symptoms or those who are content to live with their symptoms indefinitely. However, patients with moderate symptoms often present a greater challenge because most patients would prefer to avoid surgery if possible, but are also not content to wait indefinitely for their pain to resolve. These patients often ask for more than just the overall probability they will improve eventually; they usually want to know when they will recover. Moreover, they are usually interested in whether their current symptoms and progress affect the probability and extent of their future improvement.
For patients with moderate symptoms, the following observations from our study may be useful. First, the utility scores for individual patients diverged sharply at 8 weeks and were thereafter easily classified as either those reporting no health problems (higher utility, EQ-5D = 1) or those reporting at least some health problems (lower utility, EQ-5D ? 0.86). Among the lower utility group, the �pain/discomfort,� �mobility,� and �usual activities� domains of the EQ-5D differed most significantly from the higher utility group, which could potentially represent incompletely treated radiculopathy. Second, most improvement occurred early: almost one-third of the overall improvement in utility came in the first 2 months, while only 1% occurred in the last 3 months. Third, recovery is variable, with most patients (80%) experiencing at least 1 interval of deterioration and only 19% continuously improving without any setbacks. This may provide some reassurance to patients with generally good recovery to �stay the course� without resorting to more invasive measures such as surgery simply because of what may be a brief transient decrease in quality of life. Lastly, the probability of moving into another group was quite low (2%), which may be considered when counseling a patient who is not improving with his or her current treatment regimen.
We note the following limitations inherent in this cohort study. First, this is an observational study, and therefore we cannot infer causality for the emergence of the 2 utility groups, and because the individual treatment plans were unknown to us, we cannot comment on any specific type of conservative therapy. However, even if one considers the patients in the low utility group as nonresponders to conservative therapy (which is likely at least partly incorrect), the study does not imply that surgery would necessarily be beneficial in these patients. Second, the EQ-5D scores a patient’s overall health, and therefore unknown comorbid conditions likely account for at least some of the patients residing in the lower utility group and for part of the utility fluctuations. However, in the clinical setting, it should be obvious as to whether a patient’s symptoms are resulting from unresolved radiculopathy or from preexisting comorbidities. Lastly, we excluded crossover patients from our analysis. Crossover patients are likely those with the most severe symptoms and thus our results may be limited to patients with mild to moderate symptoms. However, we believe this exclusion is appropriate because, as mentioned above, the decision to operate is fairly straightforward when a patient has severe symptoms. From a clinical standpoint, patients with moderate symptoms and without neurological deficits after 8 weeks need the most information about the potential time course and extent of their nonoperative recovery to make an informed treatment decision.
The focus of the present study is individual utility recovery within a patient cohort rather than comparing average response to different treatment protocols. The goal was to gain insight into the dynamics of utility recovery among individual patients treated conservatively, but our approach could be applied to almost any treatment protocol. Studies of the changes (improvements or declines) in individual utility over time are useful because they may provide insights into a patient’s perception of their current treatment protocol (for example, patients in the low utility group would likely report a poor response to treatment), and also to identify a point at which continuing the same treatment is unlikely to improve a patient’s quality of life. Patients entering a conservative-care treatment protocol are likely to experience an initial period of rapid recovery, followed by a longer phase of more modest recovery. Our results suggest that, once the long-term recovery phase begins, patients are unlikely to spontaneously change their recovery for better or worse under the same treatment protocol. Lastly, patient utility scores early in the treatment process were reasonable predictors of long-term outcomes. This study is a comprehensive characterization of individual patients’ recovery of health utility from a lumbar disc herniation, and provides a unique picture for clinicians taking care of these patients. Our findings suggest that most recovery occurs early during treatment, and this early recovery period is important to long-term outcomes.
Conclusions
In a cohort of patients undergoing prolonged conservative care for treatment of lumbar disc herniation, 57% of the patients had lingering health problems at 1 year. Utility was recovered most rapidly early in the treatment process, and the majority of utility was also recovered in the initial treatment period. After the initial recovery period, we could identify with reasonable accuracy those patients who would fully recover and those who would not. Over the course of the year, recovery was observed to be highly variable, although most fluctuations were relatively small and only transient. These findings suggest that patients not initially responding to their treatment protocol should consider other options because they are unlikely to respond at a later time. However, patients and clinicians should also be mindful of transient decreases in quality of life, and carefully consider any changes in their treatment plan.
Disclosure
This work was partially supported by a charitable grant from the St. David’s Foundation Impact Fund to Dr. Cowperthwaite, and does not necessarily represent the views of the Impact Fund or the St. David’s Foundation.
Author contributions to the study and manuscript preparation include the following. Conception and design: all authors. Acquisition of data: Cowperthwaite, van den Hout. Analysis and interpretation of data: all authors. Drafting the article: Cowperthwaite. Critically revising the article: all authors. Reviewed submitted version of manuscript: all authors. Approved the final version of the manuscript on behalf of all authors: Cowperthwaite. Statistical analysis: Cowperthwaite, van den Hout. Administrative/technical/material support: Cowperthwaite. Study supervision: Cowperthwaite.
In conclusion, early non-operative treatment of lumbar herniated disc can effectively improve as well as manage recovery outcomes in patients with the condition. It’s important for patients with disc herniations in the lumbar spine to comprehend the source of their issue before receiving appropriate treatment for their symptoms. Furthermore, non-operative treatment is effective in most patients, surgical interventions may be considered according to the individual’s recovery outcome. 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: Neck Pain
Neck pain is a common complaint which can result due to a variety of injuries and/or conditions. According to statistics, automobile accident injuries and whiplash injuries are some of the most prevalent causes for neck pain among the general population. During an auto accident, the sudden impact from the incident can cause the head and neck to jolt abruptly back-and-forth in any direction, damaging the complex structures surrounding the cervical spine. Trauma to the tendons and ligaments, as well as that of other tissues in the neck, can cause neck pain and radiating symptoms throughout the human body.
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Cited By
1. Anurekha Ramakrishnan, MS, K. Michael Webb, MD, and Matthew C. Cowperthwaite, PhD. (2017) One-year outcomes of early-crossover patients in a cohort receiving nonoperative care for lumbar disc herniation. Journal of Neurosurgery: Spine 27:4, 391-396. . Online publication date: 1-Oct-2017. Abstract | Full Text | PDF (2037 KB)
2. Kimberly A Plomp, Una Strand Vi�arsd�ttir, Darlene A Weston, Keith Dobney, Mark Collard. (2015) The ancestral shape hypothesis: an evolutionary explanation for the occurrence of intervertebral disc herniation in humans. BMC Evolutionary Biology 15:1. . Online publication date: 1-Dec-2015. [Crossref]
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