Dataset Information

The impact of pragmatic vs. prescriptive study designs on the outcomes of low back and neck pain when using mobilization or manipulation techniques: a systematic review and meta-analysis.

ABSTRACT:

Objective

The purpose of this systematic review and meta-analysis was to examine the impact of pragmatic versus prescriptive study designs on the outcomes of low back and neck pain when using mobilization or manipulation techniques.

Methods

This study design was a systematic review and meta-analysis, which was performed according to the PRISMA guidelines. A search of MEDLINE and CINAHL complete databases was performed. Article titles and abstracts were reviewed to identify studies comparing mobilization and manipulation in low back or neck pain that met eligibility criteria. Validity of studies was examined using the Cochrane Risk of Bias tool. Data analysis was performed using RevMan 5.3. Forest plots were constructed after data were analyzed to determine effect sizes.

Results

Thirteen studies with a total of 1313 participants were included in the systematic review, and 12 studies with 977 participants in the meta-analysis. For most time-points prescriptive studies found manipulation to be superior to mobilization for both pain and disability. At no time-point did pragmatic designs find a difference between mobilization and manipulation for either pain or disability.

Discussion

When a pragmatic design was used, representing actual clinical practice, patients improved with both techniques with no difference between mobilization and manipulation. When clinicians were prescribed techniques, not representing true clinical practice, manipulation showed better outcomes than mobilization for pain and disability.

Level of evidence

1a.

SUBMITTER: Roenz D

PROVIDER: S-EPMC6055961 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND CONTEXT:Mobilization and manipulation therapies are widely used to benefit patients with chronic low back pain. However, questions remain about their efficacy, dosing, safety, and how these approaches compare with other therapies. PURPOSE:The present study aims to determine the efficacy, effectiveness, and safety of various mobilization and manipulation therapies for treatment of chronic low back pain. STUDY DESIGN/SETTING:This is a systematic literature review and meta-analysis. OUTCOME MEASURES:The present study measures self-reported pain, function, health-related quality of life, and adverse events. METHODS:We identified studies by searching multiple electronic databases from January 2000 to March 2017, examining reference lists, and communicating with experts. We selected randomized controlled trials comparing manipulation or mobilization therapies with sham, no treatment, other active therapies, and multimodal therapeutic approaches. We assessed risk of bias using Scottish Intercollegiate Guidelines Network criteria. Where possible, we pooled data using random-effects meta-analysis. Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) was applied to determine the confidence in effect estimates. This project is funded by the National Center for Complementary and Integrative Health under Award Number U19AT007912. RESULTS:Fifty-one trials were included in the systematic review. Nine trials (1,176 patients) provided sufficient data and were judged similar enough to be pooled for meta-analysis. The standardized mean difference for a reduction of pain was SMD=-0.28, 95% confidence interval (CI) -0.47 to -0.09, p=.004; I2=57% after treatment; within seven trials (923 patients), the reduction in disability was SMD=-0.33, 95% CI -0.63 to -0.03, p=.03; I2=78% for manipulation or mobilization compared with other active therapies. Subgroup analyses showed that manipulation significantly reduced pain and disability, compared with other active comparators including exercise and physical therapy (SMD=-0.43, 95% CI -0.86 to 0.00; p=.05, I2=79%; SMD=-0.86, 95% CI -1.27 to -0.45; p<.0001, I2=46%). Mobilization interventions, compared with other active comparators including exercise regimens, significantly reduced pain (SMD=-0.20, 95% CI -0.35 to -0.04; p=.01; I2=0%) but not disability (SMD=-0.10, 95% CI -0.28 to 0.07; p=.25; I2=21%). Studies comparing manipulation or mobilization with sham or no treatment were too few or too heterogeneous to allow for pooling as were studies examining relationships between dose and outcomes. Few studies assessed health-related quality of life. Twenty-six of 51 trials were multimodal studies and narratively described. CONCLUSION:There is moderate-quality evidence that manipulation and mobilization are likely to reduce pain and improve function for patients with chronic low back pain; manipulation appears to produce a larger effect than mobilization. Both therapies appear safe. Multimodal programs may be a promising option.

Project description:A model for integrative medicine (IM) adapted to Swedish primary care was previously developed. The aim of this study was to explore the feasibility of a pragmatic randomised clinical trial to investigate the effectiveness of the IM model versus conventional primary care in the management of patients with non-specific back/neck pain. Specific objectives included the exploration of recruitment and retention rates, patient and care characteristics, clinical differences and effect sizes between groups, selected outcome measures and power calculations to inform the basis of a full-scale trial.Eighty patients with back/neck pain of at least two weeks duration were randomised to the two types of care. Outcome measures were standardised health related quality of life (the eight domains of SF-36) complemented by a set of exploratory "IM tailored" outcomes targeting self-rated disability, stress and well-being (0-10 scales); days in pain (0-14); and the use of analgesics and health care over the last two weeks (yes/no). Data on clinical management were derived from medical records. Outcome changes from baseline to follow-up after 16 weeks were used to explore the differences between the groups.Seventy-five percent (80/107) of screened patients in general practice were eligible and feasible to enroll into the trial. Eighty-two percent (36/44) of the integrative and 75% (27/36) of the conventional care group completed follow-up after 16 weeks. Most patients had back/neck pain of at least three months duration. Conventional care typically comprised advice and prescription of analgesics, occasionally complemented with sick leave or a written referral to physiotherapy. IM care generally integrated seven treatment sessions from two different types of complementary therapies with conventional care over ten weeks. The study was underpowered to detect any statistically significant differences between the groups. One SF-36 domain showed a clinically relevant difference between groups that was also supported by a small distribution based effect size, i.e. vitality (-7.3 points, Cohen's d -0.34) which was in favour of IM. There was a clinical trend between groups showing that IM contributed to less use of prescription and non-prescription analgesics (-11.7 and - 9.7 percent units respectively) compared to conventional care. Exploring clinically relevant differences and the SF-36 as the basis for a main outcome measure showed that the sample sizes needed per arm to adequately power a full-scale trial depended on the target domain, i.e. ranging from 60 (vitality) to 339 (role emotion).This pilot study investigated the implementation of IM in the primary care management of non-specific back and neck pain. Recruiting patients and implementing IM in routine clinical practice was feasible. The results warrant further exploration into different perspectives and relevant combinations of outcome measures including the use of health resources, drugs and cost-effectiveness to help understand the relevance of IM in primary care. Future research should prioritize larger scale studies considering variability, pain duration and small to moderate treatment effects.Clinical trials NCT00565942.

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Project description:Study Design Systematic review. Study Rationale Neck pain is a prevalent condition. Spinal manipulation and mobilization procedures are becoming an accepted treatment for neck pain. However, data on the effectiveness of these treatments have not been summarized. Objective To compare manipulation or mobilization of the cervical spine to physical therapy or exercise for symptom improvement in patients with neck pain. Methods A systematic review of the literature was performed using PubMed, the National Guideline Clearinghouse Database, and bibliographies of key articles, which compared spinal manipulation or mobilization therapy with physical therapy or exercise in patients with neck pain. Articles were included based on predetermined criteria and were appraised using a predefined quality rating scheme. Results From 197 citations, 7 articles met all inclusion and exclusion criteria. There were no differences in pain improvement when comparing spinal manipulation to exercise, and there were inconsistent reports of pain improvement in subjects who underwent mobilization therapy versus physical therapy. No disability improvement was reported between treatment groups in studies of acute or chronic neck pain patients. No functional improvement was found with manipulation therapy compared with exercise treatment or mobilization therapy compared with physical therapy groups in patients with acute pain. In chronic neck pain subjects who underwent spinal manipulation therapy compared to exercise treatment, results for short-term functional improvement were inconsistent. Conclusion The data available suggest that there are minimal short- and long-term treatment differences in pain, disability, patient-rated treatment improvement, treatment satisfaction, health status, or functional improvement when comparing manipulation or mobilization therapy to physical therapy or exercise in patients with neck pain. This systematic review is limited by the variability of treatment interventions and lack of standardized outcomes to assess treatment benefit.

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