Gert Bronfort

A Randomized Clinical Trial of Exercise and Spinal Manipulation for Patients With Chronic Neck Pain

Study Design. A randomized, parallel-group, single-blinded clinical trial was performed. After a 1-week baseline period, patients were randomized to 11 weeks of therapy, with posttreatment follow-up assessment 3, 6, and 12 months later. Objectives. To compare the relative efficacy of rehabilitative neck exercise and spinal manipulation for the management of patients with chronic neck pain. Summary of Background Data. Mechanical neck pain is a common condition associated with substantial morbidity and cost. Relatively little is known about the efficacy of spinal manipulation and exercise for chronic neck pain. Also, the combination of both therapies has yet to be explored. Methods. Altogether, 191 patients with chronic mechanical neck pain were randomized to receive 20 sessions of spinal manipulation combined with rehabilitative neck exercise (spinal manipulation with exercise), MedX rehabilitative neck exercise, or spinal manipulation alone. The main outcome measures were patient-rated neck pain, neck disability, functional health status (as measured by Short Form-36 [SF-36]), global improvement, satisfaction with care, and medication use. Range of motion, muscle strength, and muscle endurance were assessed by examiners blinded to patients’ treatment assignment. Results. Clinical and demographic characteristics were similar among groups at baseline. A total of 93% of the patients completed the intervention phase. The response rate for the 12-month follow-up period was 84%. Except for patient satisfaction, where spinal manipulative therapy and exercise were superior to spinal manipulation with (P = 0.03), the group differences in patient-rated outcomes after 11 weeks of treatment were not statistically significant (P = 0.13). However, the spinal manipulative therapy and exercise group showed greater gains in all measures of strength, endurance, and range of motion than the spinal manipulation group (P < 0.05). The spinal manipulation with exercise group also demonstrated more improvement in flexion endurance and in flexion and rotation strength than the MedX group (P < 0.03). The MedX exercise group had larger gains in extension strength and flexion–extension range of motion than the spinal manipulation group (P < 0.05). During the follow-up year, a greater improvement in patient-rated outcomes were observed for spinal manipulation with exercise and for MedX exercise than for spinal manipulation alone (P = 0.01). Both exercise groups showed very similar levels of improvement in patient-rated outcomes, although the spinal manipulation and exercise group reported greater satisfaction with care (P < 0.01). Conclusions. For chronic neck pain, the use of strengthening exercise, whether in combination with spinal manipulation or in the form of a high-technology MedX program, appears to be more beneficial to patients with chronic neck pain than the use of spinal manipulation alone. The effect of low-technology exercise or spinal manipulative therapy alone, as compared with no treatment or placebo, and the optimal dose and relative cost effectiveness of these therapies, need to be evaluated in future studies.

Effectiveness of manual therapies: the UK evidence report.

BackgroundThe purpose of this report is to provide a succinct but comprehensive summary of the scientific evidence regarding the effectiveness of manual treatment for the management of a variety of musculoskeletal and non-musculoskeletal conditions.MethodsThe conclusions are based on the results of systematic reviews of randomized clinical trials (RCTs), widely accepted and primarily UK and United States evidence-based clinical guidelines, plus the results of all RCTs not yet included in the first three categories. The strength/quality of the evidence regarding effectiveness was based on an adapted version of the grading system developed by the US Preventive Services Task Force and a study risk of bias assessment tool for the recent RCTs.ResultsBy September 2009, 26 categories of conditions were located containing RCT evidence for the use of manual therapy: 13 musculoskeletal conditions, four types of chronic headache and nine non-musculoskeletal conditions. We identified 49 recent relevant systematic reviews and 16 evidence-based clinical guidelines plus an additional 46 RCTs not yet included in systematic reviews and guidelines.Additionally, brief references are made to other effective non-pharmacological, non-invasive physical treatments.ConclusionsSpinal manipulation/mobilization is effective in adults for: acute, subacute, and chronic low back pain; migraine and cervicogenic headache; cervicogenic dizziness; manipulation/mobilization is effective for several extremity joint conditions; and thoracic manipulation/mobilization is effective for acute/subacute neck pain. The evidence is inconclusive for cervical manipulation/mobilization alone for neck pain of any duration, and for manipulation/mobilization for mid back pain, sciatica, tension-type headache, coccydynia, temporomandibular joint disorders, fibromyalgia, premenstrual syndrome, and pneumonia in older adults. Spinal manipulation is not effective for asthma and dysmenorrhea when compared to sham manipulation, or for Stage 1 hypertension when added to an antihypertensive diet. In children, the evidence is inconclusive regarding the effectiveness for otitis media and enuresis, and it is not effective for infantile colic and asthma when compared to sham manipulation.Massage is effective in adults for chronic low back pain and chronic neck pain. The evidence is inconclusive for knee osteoarthritis, fibromyalgia, myofascial pain syndrome, migraine headache, and premenstrual syndrome. In children, the evidence is inconclusive for asthma and infantile colic.

A cochrane review of manipulation and mobilization for mechanical neck disorders

Study Design and Objectives. Our systematic review of randomized trials assessed whether manipulation and mobilization relieve pain or improve function/disability, patient satisfaction, and global perceived effect in adults with mechanical neck disorders. Summary of Background Data. Neck disorders are common, disabling, and costly. Methods. Computerized bibliographic databases were searched up to March 2002. Two independent reviewers conducted study selection, data abstraction, and methodologic quality assessment. Relative risk and standardized mean differences were calculated. In the absence of heterogeneity, pooled effect measures were calculated using a random effects model. Results. Of the 33 selected trials, 42% were high quality trials. Single or multiple (3–11) sessions of manipulation or mobilization showed no benefit in pain relief when assessed against placebo, control groups, or other treatments for acute/subacute/chronic mechanical neck disorders with or without headache. There was strong evidence of benefit favoring multimodal care (mobilization and/or manipulation plus exercise) over a waiting list control for pain reduction [pooled standardized mean differences −0.85 (95% CI: −1.20 to −0.50)], improvement in function [pooled SMD −0.57 (95% CI: −0.94 to −0.21)] and global perceived effect [standardized mean differences −2.73 (95% CI: −3.30 to −2.16)] for subacute/chronic mechanical neck disorders with or without headache. Conclusions. Mobilization and/or manipulation when used with exercise are beneficial for persistent mechanical neck disorders with or without headache. Done alone, manipulation and/or mobilization were not beneficial; when compared to one another, neither was superior. There was insufficient evidence available to draw conclusions for neck disorder with radicular findings. Factorial design would help determine the active agent(s) within a treatment mix.

Manipulation or mobilisation for neck pain: A Cochrane Review

Manipulation and mobilisation are often used, either alone or combined with other treatment approaches, to treat neck pain. This review assesses if manipulation or mobilisation improves pain, function/disability, patient satisfaction, quality of life (QoL), and global perceived effect (GPE) in adults experiencing neck pain with or without cervicogenic headache or radicular findings. A computerised search was performed in July 2009. Randomised trials investigating manipulation or mobilisation for neck pain were included. Two or more authors independently selected studies, abstracted data, and assessed methodological quality. Pooled relative risk (pRR) and standardised mean differences (pSMD) were calculated. 33% of 27 trials had a low risk of bias. Moderate quality evidence showed cervical manipulation and mobilisation produced similar effects on pain, function and patient satisfaction at intermediate-term follow-up. Low quality evidence suggested cervical manipulation may provide greater short-term pain relief than a control (pSMD -0.90 (95%CI: -1.78 to -0.02)). Low quality evidence also supported thoracic manipulation for pain reduction (NNT 7; 46.6% treatment advantage) and increased function (NNT 5; 40.6% treatment advantage) in acute pain and immediate pain reduction in chronic neck pain (NNT 5; 29% treatment advantage). Optimal technique and dose need to be determined.

Efficacy of Spinal Manipulation for Chronic Headache: A Systematic Review

BACKGROUND Chronic headache is a prevalent condition with substantial socioeconomic impact. Complementary or alternative therapies are increasingly being used by patients to treat headache pain, and spinal manipulative therapy (SMT) is among the most common of these. OBJECTIVE To assess the efficacy/effectiveness of SMT for chronic headache through a systematic review of randomized clinical trials. STUDY SELECTION Randomized clinical trials on chronic headache (tension, migraine and cervicogenic) were included in the review if they compared SMT with other interventions or placebo. The trials had to have at least 1 patient-rated outcome measure such as pain severity, frequency, duration, improvement, use of analgesics, disability, or quality of life. Studies were identified through a comprehensive search of MEDLINE (1966-1998) and EMBASE (1974-1998). Additionally, all available data from the Cumulative Index of Nursing and Allied Health Literature, the Chiropractic Research Archives Collection, and the Manual, Alternative, and Natural Therapies Information System were used, as well as material gathered through the citation tracking, and hand searching of non-indexed chiropractic, osteopathic, and manual medicine journals. DATA EXTRACTION Information about outcome measures, interventions and effect sizes was used to evaluate treatment efficacy. Levels of evidence were determined by a classification system incorporating study validity and statistical significance of study results. Two authors independently extracted data and performed methodological scoring of selected trials. DATA SYNTHESIS Nine trials involving 683 patients with chronic headache were included. The methodological quality (validity) scores ranged from 21 to 87 (100-point scale). The trials were too heterogeneous in terms of patient clinical characteristic, control groups, and outcome measures to warrant statistical pooling. Based on predefined criteria, there is moderate evidence that SMT has short-term efficacy similar to amitriptyline in the prophylactic treatment of chronic tension-type headache and migraine. SMT does not appear to improve outcomes when added to soft-tissue massage for episodic tension-type headache. There is moderate evidence that SMT is more efficacious than massage for cervicogenic headache. Sensitivity analyses showed that the results and the overall study conclusions remained the same even when substantial changes in the prespecified assumptions/rules regarding the evidence determination were applied. CONCLUSIONS SMT appears to have a better effect than massage for cervicogenic headache. It also appears that SMT has an effect comparable to commonly used first-line prophylactic prescription medications for tension-type headache and migraine headache. This conclusion rests upon a few trials of adequate methodological quality. Before any firm conclusions can be drawn, further testing should be done in rigorously designed, executed, and analyzed trials with follow-up periods of sufficient length.

Two-Year Follow-up of a Randomized Clinical Trial of Spinal Manipulation and Two Types of Exercise for Patients with Chronic Neck Pain

Study Design. Randomized clinical trial. Objectives. To compare the effects of spinal manipulation combined with low-tech rehabilitative exercise, MedX rehabilitative exercise, or spinal manipulation alone in patient self-reported outcomes over a two-year follow-up period. Summary of Background Data. There have been few randomized clinical trials of spinal manipulation and rehabilitative exercise for patients with neck pain, and most have only reported short-term outcomes. Methods. One hundred ninety-one patients with chronic neck pain were randomized to 11 weeks of one of the three treatments. Patient self-report questionnaires measuring pain, disability, general health status, improvement, satisfaction, and OTC medication use were collected after 5 and 11 weeks of treatment and 3, 6, 12, and 24 months after treatment. Data were analyzed taking into account all time points using repeated measures analyses. Results. Ninety-three percent (178) of randomized patients completed the 11-week intervention phase, and 76% (145) provided data at all evaluation time points over the two-year follow-up period. A difference in patient-rated pain with no group-time interaction was observed in favor of the two exercise groups [F(2141) = 3.2;P = 0.04]. There was also a group difference in satisfaction with care [F(2143) = 7.7;P = 0.001], with spinal manipulation combined with low-tech rehabilitative exercise superior to MedX rehabilitative exercise (P = 0.02) and spinal manipulation alone (P < 0.001). No significant group differences were found for neck disability, general health status, improvement, and OTC medication use, although the trend over time was in favor of the two exercise groups. Conclusion. The results of this study demonstrate an advantage of spinal manipulation combined with low-tech rehabilitative exercise and MedX rehabilitative exercise versus spinal manipulation alone over two years and are similar in magnitude to those observed after one-year follow-up. These results suggest that treatments including supervised rehabilitative exercise should be considered for chronic neck pain sufferers. Further studies are needed to examine the cost effectiveness of these therapies and how spinal manipulation compares to no treatment or minimal intervention.

Evidence-informed management of chronic low back pain with spinal manipulation and mobilization

The management of chronic low back pain (CLBP) has proven very challenging in North America, as evidenced by its mounting socioeconomic burden. Choosing among available nonsurgical therapies can be overwhelming for many stakeholders, including patients, health providers, policy makers, and third-party payers. Although all parties share a common goal and wish to use limited health-care resources to support interventions most likely to result in clinically meaningful improvements, there is often uncertainty about the most appropriate intervention for a particular patient. To help understand and evaluate the various commonly used nonsurgical approaches to CLBP, the North American Spine Society has sponsored this special focus issue of The Spine Journal, titled Evidence Informed Management of Chronic Low Back Pain Without Surgery. Articles in this special focus issue were contributed by leading spine practitioners and researchers, who were invited to summarize the best available evidence for a particular intervention and encouraged to make this information accessible to nonexperts. Each of the articles contains five sections (description, theory, evidence of efficacy, harms, and summary) with common subheadings to facilitate comparison across the 24 different interventions profiled in this special focus issue, blending narrative and systematic review methodology as deemed appropriate by the authors. It is hoped that articles in this special focus issue will be informative and aid in decision making for the many stakeholders evaluating nonsurgical interventions for CLBP.

Spinal Manipulation, Medication, or Home Exercise With Advice for Acute and Subacute Neck Pain: A Randomized Trial

BACKGROUND Mechanical neck pain is a common condition that affects an estimated 70% of persons at some point in their lives. Little research exists to guide the choice of therapy for acute and subacute neck pain. OBJECTIVE To determine the relative efficacy of spinal manipulation therapy (SMT), medication, and home exercise with advice (HEA) for acute and subacute neck pain in both the short and long term. DESIGN Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00029770) SETTING 1 university research center and 1 pain management clinic in Minnesota. PARTICIPANTS 272 persons aged 18 to 65 years who had nonspecific neck pain for 2 to 12 weeks. INTERVENTION 12 weeks of SMT, medication, or HEA. MEASUREMENTS The primary outcome was participant-rated pain, measured at 2, 4, 8, 12, 26, and 52 weeks after randomization. Secondary measures were self-reported disability, global improvement, medication use, satisfaction, general health status (Short Form-36 Health Survey physical and mental health scales), and adverse events. Blinded evaluation of neck motion was performed at 4 and 12 weeks. RESULTS For pain, SMT had a statistically significant advantage over medication after 8, 12, 26, and 52 weeks (P ≤ 0.010), and HEA was superior to medication at 26 weeks (P = 0.02). No important differences in pain were found between SMT and HEA at any time point. Results for most of the secondary outcomes were similar to those of the primary outcome. LIMITATIONS Participants and providers could not be blinded. No specific criteria for defining clinically important group differences were prespecified or available from the literature. CONCLUSION For participants with acute and subacute neck pain, SMT was more effective than medication in both the short and long term. However, a few instructional sessions of HEA resulted in similar outcomes at most time points. PRIMARY FUNDING SOURCE National Center for Complementary and Alternative Medicine, National Institutes of Health.

SPINAL MANIPULATION: Current State of Research and Its Indications

Based on the most recent and comprehensive systematic reviews, there is moderate evidence of short-term efficacy for spinal manipulation in the treatment of both acute and chronic low back pain. There is insufficient data available to draw conclusions regarding the efficacy for lumbar radiculopathy. The evidence is also not conclusive for the long-term efficacy of spinal manipulation for any type of low back pain.

2015 Updated Method Guideline for Systematic Reviews in the Cochrane Back and Neck Group

Study Design. Method guideline for systematic reviews of trials of interventions for neck and back pain, and related spinal disorders. Objective. To help authors design, conduct, and report systematic reviews of trials in this field. Summary of Background Data. In 1997, the Cochrane Back Review Group editorial board published the Method Guideline for Systematic Reviews, which was updated in 2003 and in 2009. Since then, new methodological evidence has emerged and standards have changed, therefore it was clear that revisions were needed to the 2009 guideline. In May 2015 the group changed its name to Cochrane Back and Neck. Methods. The editorial board met in September 2014 to review the relevant new methodological evidence and determine how it should be incorporated. Members of the advisory board were consulted. Based on the feedback received, an updated method guideline was prepared and approved by the editorial board. Results. We have updated recommendations in 7 categories: objectives, literature search, selection criteria, risk of bias assessment, data extraction, data analysis, and reporting of results and conclusions. Each category is classified into minimum criteria (mandatory) and further guidance (optional). This update also includes some new guidance for preparation of summary of finding tables and for conducting nonintervention reviews. Conclusion. Citations of previous versions of the method guideline in published scientific articles (1193 in total) suggest that others may find this guideline useful to plan, conduct, or evaluate systematic reviews in the field of back and neck pain, and spinal disorders. Level of Evidence: N/A