Many clinical trials on chiropractic management of low back pain have neglected to include specific forms of care. This study compared two well-defined treatment protocols. The objective was to compare the outcome of flexion-distraction (FD) procedures performed by chiropractors with an active trunk exercise protocol (ATEP) performed by physical therapists. A randomized clinical trial study design was used. Subjects, 18 years of age and older, with a primary complaint of low back pain (>3 months) were recruited. A 100 mm visual analogue scale (VAS) for perceived pain, the Roland Morris (RM) Questionnaire for low back function, and the SF-36 for overall health status served as primary outcome measures. Subjects were randomly allocated to receive either FD or ATEP. The FD intervention consisted of the application of flexion and traction applied to specific regions in the low back, with the aid of a specially designed manipulation table. The ATEP intervention included stabilizing and flexibility exercises, the use of modalities, and cardiovascular training. A total of 235 subjects met the inclusion/exclusion criteria and signed the informed consent. Of these, 123 were randomly allocated to FD and 112 to the ATEP. Study patients perceived significantly less pain and better function after intervention, regardless of which group they were allocated to (P<0.01). Subjects randomly allocated to the flexion-distraction group had significantly greater relief from pain than those allocated to the exercise program (P=0.01). Subgroup analysis indicated that subjects categorized as chronic, with moderate to severe symptoms, improved most with the flexion-distraction protocol. Subjects categorized with recurrent pain and moderate to severe symptoms improved most with the exercise program. Patients with radiculopathy did significantly better with FD. There were no significant differences between groups on the Roland Morris and SF-36 outcome measures. Overall, flexion-distraction provided more pain relief than active exercise; however, these results varied based on stratification of patients with and without radiculopathy and with and without recurrent symptoms. The subgroup analysis provides a possible explanation for contrasting results among randomized clinical trials of chronic low back pain treatments and these results also provide guidance for future work in the treatment of chronic low back pain.

BackgroundLow back pain is one of the leading causes of disability worldwide. Exercise therapy is widely recommended to treat persistent non-specific low back pain. While evidence suggests exercise is, on average, moderately effective, there remains uncertainty about which individuals might benefit the most from exercise.MethodsIn parallel with a Cochrane review update, we requested individual participant data (IPD) from high-quality randomised clinical trials of adults with our two primary outcomes of interest, pain and functional limitations, and calculated global recovery. We compiled a master data set including baseline participant characteristics, exercise and comparison characteristics, and outcomes at short-term, moderate-term and long-term follow-up. We conducted descriptive analyses and one-stage IPD meta-analysis using multilevel mixed-effects regression of the overall treatment effect and prespecified potential treatment effect modifiers.ResultsWe received IPD for 27 trials (3514 participants). For studies included in this analysis, compared with no treatment/usual care, exercise therapy on average reduced pain (mean effect/100 (95% CI) −10.7 (−14.1 to –7.4)), a result compatible with a clinically important 20% smallest worthwhile effect. Exercise therapy reduced functional limitations with a clinically important 23% improvement (mean effect/100 (95% CI) −10.2 (−13.2 to –7.3)) at short-term follow-up. Not having heavy physical demands at work and medication use for low back pain were potential treatment effect modifiers—these were associated with superior exercise outcomes relative to non-exercise comparisons. Lower body mass index was also associated with better outcomes in exercise compared with no treatment/usual care. This study was limited by inconsistent availability and measurement of participant characteristics.ConclusionsThis study provides potentially useful information to help treat patients and design future studies of exercise interventions that are better matched to specific subgroups.Protocol publicationhttps://doi.org/10.1186/2046-4053-1-64

Study Design A three-arm controlled trial with adaptive allocation. Objectives The aim of this study was to compare short-term effects of a side-lying, thrust spinal manipulation (SM) procedure and a non-thrust, flexion-distraction SM procedure in adults with subacute or chronic low back pain (LBP) over 2 weeks. Summary of Background Data SM has been recommended in recently published clinical guidelines for LBP management. Previous studies suggest that thrust and non-thrust SM procedures, though distinctly different in joint loading characteristics, have similar effects on patients with LBP. Methods Participants were eligible if they were 21-54 years old, had LBP for at least 4 weeks, scored 6 or above on the Roland-Morris disability questionnaire, and met the diagnostic classification of 1, 2, or 3 according to the Quebec Task Force Classification for Spinal Disorders. Participants were allocated in a 3:3:2 ratio to 4 sessions of thrust or non-thrust SM procedures directed at the lower lumbar and pelvic regions, or to a 2-week wait list control. The primary outcome was LBP-related disability using Roland-Morris disability questionnaire and the secondary outcomes were LBP intensity using visual analog scale, Fear-Avoidance Beliefs Questionnaire, and the 36-Item Short Form Health Survey. The study was conducted at the Palmer Center for Chiropractic Research with care provided by experienced doctors of chiropractic. Clinicians and patients were not blinded to treatment group. Results Of 192 participants enrolled, the mean age was 40 years and 54% were male. Improvement in disability, LBP intensity, Fear-Avoidance Beliefs Questionnaire – work subscale, and 36-Item Short Form Health Survey – physical health summary measure for the two SM groups were significantly greater than the control group. No difference in any outcomes was observed between the two SM groups. Conclusions Thrust and non-thrust SM procedures with distinctly different joint loading characteristics demonstrated similar effects in short-term LBP improvement and both were superior to a wait list control.

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