RESTORE-Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain: study protocol for a randomised controlled trial.

INTRODUCTION: Low back pain (LBP) is the leading cause of disability globally and its costs exceed those of cancer and diabetes combined. Recent evidence suggests that individualised cognitive and movement rehabilitation combined with lifestyle advice (cognitive functional therapy (CFT)) may produce larger and more sustained effects than traditional approaches, and movement sensor biofeedback may enhance outcomes. Therefore, this three-arm randomised controlled trial (RCT) aims to compare the clinical effectiveness and economic efficiency of individualised CFT delivered with or without movement sensor biofeedback, with usual care for patients with chronic, disabling LBP. METHODS AND ANALYSIS: Pragmatic, three-arm, randomised, parallel group, superiority RCT comparing usual care (n=164) with CFT (n=164) and CFT-plus-movement-sensor-biofeedback (n=164). Inclusion criteria include: adults with a current episode of LBP >3 months; sought primary care ≥6 weeks ago for this episode of LBP; average LBP intensity of ≥4 (0-10 scale); at least moderate pain-related interference with work or daily activities. The CFT-only and CFT-plus-movement-sensor-biofeedback participants will receive seven treatment sessions over 12 weeks plus a 'booster' session at 26 weeks. All participants will be assessed at baseline, 3, 6, 13, 26, 40 and 52 weeks. The primary outcome is pain-related physical activity limitation (Roland Morris Disability Questionnaire). Linear mixed models will be used to assess the effect of treatment on physical activity limitation across all time points, with the primary comparison being a formal test of adjusted mean differences between groups at 13 weeks. For the economic (cost-utility) analysis, the primary outcome of clinical effect will be quality-adjusted life years measured across the 12-month follow-up using the EuroQol EQ-5D-5L . ETHICS AND DISSEMINATION: Approved by Curtin University Human Research Ethics Committee (HRE2018-0062, 6 Feb 2018). Study findings will be disseminated through publication in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12618001396213).

Efficacy of classification-based cognitive functional therapy in patients with non-specific chronic low back pain: a randomized controlled trial.

BACKGROUND: Non-specific chronic low back pain disorders have been proven resistant to change, and there is still a lack of clear evidence for one specific treatment intervention being superior to another. METHODS: This randomized controlled trial aimed to investigate the efficacy of a behavioural approach to management, classification-based cognitive functional therapy, compared with traditional manual therapy and exercise. Linear mixed models were used to estimate the group differences in treatment effects. Primary outcomes at 12-month follow-up were Oswestry Disability Index and pain intensity, measured with numeric rating scale. Inclusion criteria were as follows: age between 18 and 65 years, diagnosed with non-specific chronic low back pain for >3 months, localized pain from T12 to gluteal folds, provoked with postures, movement and activities. Oswestry Disability Index had to be >14% and pain intensity last 14 days >2/10. A total of 121 patients were randomized to either classification-based cognitive functional therapy group n = 62) or manual therapy and exercise group (n > = 59). RESULTS: The classification-based cognitive functional therapy group displayed significantly superior outcomes to the manual therapy and exercise group, both statistically (p < 0.001) and clinically. For Oswestry Disability Index, the classification-based cognitive functional therapy group improved by 13.7 points, and the manual therapy and exercise group by 5.5 points. For pain intensity, the classification-based cognitive functional therapy improved by 3.2 points, and the manual therapy and exercise group by 1.5 points. CONCLUSIONS: The classification-based cognitive functional therapy produced superior outcomes for non-specific chronic low back pain compared with traditional manual therapy and exercise.

Integration of subclassification strategies in randomised controlled clinical trials evaluating manual therapy treatment and exercise therapy for non-specific chronic low back pain: a systematic review.

BACKGROUND: There is lack of evidence for specific treatment interventions for patients with non-specific chronic low back pain (NSCLBP) despite the substantial amount of randomised controlled clinical trials evaluating treatment outcome for this disorder. HYPOTHESIS: It has been hypothesised that this vacuum of evidence is caused by the lack of subclassification of the heterogeneous population of patients with chronic low back pain for outcome research. STUDY DESIGN: A systematic review. METHODS: A systematic review with a meta-analysis was undertaken to determine the integration of subclassification strategies with matched interventions in randomised controlled clinical trials evaluating manual therapy treatment and exercise therapy for NSCLBP. A structured search for relevant studies in Embase, Cinahl, Medline, PEDro and the Cochrane Trials Register database, followed by hand searching all relevant studies in English up to December 2008. RESULTS: Only 5 of 68 studies (7.4%) subclassified patients beyond applying general inclusion and exclusion criteria. In the few studies where classification and matched interventions have been used, our meta-analysis showed a statistical difference in favour of the classification-based intervention for reductions in pain (p=0.004) and disability (p=0.0005), both for short-term and long-term reduction in pain (p=0.001). Effect sizes ranged from moderate (0.43) for short term to minimal (0.14) for long term. CONCLUSION: A better integration of subclassification strategies in NSCLBP outcome research is needed. We propose the development of explicit recommendations for the use of subclassification strategies and evaluation of targeted interventions in future research evaluating NSCLBP.

The inter-examiner reliability of a classification method for non-specific chronic low back pain patients with motor control impairment.

The importance of classifying chronic low back pain (LBP) patients into homogeneous sub-groups has recently been emphasized. This paper reports on two studies examining clinicians ability to agree independently on patients' chronic LBP classification, using a novel classification system (CS) proposed by O'Sullivan. In the first study, a sub-group of 35 patients with non-specific chronic LBP were independently classified by two 'expert' clinicians. Almost perfect agreement (kappa-coefficient 0.96; %-of-agreement 97%) was demonstrated. In the second study, 13 clinicians from Australia and Norway were given 25 cases (patients' subjective information and videotaped functional tests) to classify. Kappa-coefficients (mean 0.61, range 0.47-0.80) and %-of-agreement (mean 70%, range 60-84%) indicated substantial reliability. Increased familiarity with the CS improved reliability. These studies demonstrate the reliability of this multi-dimensional mechanism-based CS and provide essential evidence in a multi-step validation process. A fully validated CS will have significant research and clinical application.

Does peppermint oil relieve spasm during barium enema?

The effectiveness of topical peppermint oil added to barium sulphate suspension in relieving colonic muscle spasm during double contrast barium enema examination was assessed in a double blind study. 141 patients were randomized either to a control group (71 patients) examined with standard barium suspension or to the treatment group which received peppermint oil mixed with the barium preparation. No residual spasm was evident in a significant proportion of patients in the treated group (60%) compared with the control group (35%) (p < 0.001). The patients' acceptability of the procedure was good and there were no adverse effects on the overall quality of the examination. In conclusion, the addition of peppermint oil to the barium suspension seems to reduce the incidence of colonic spasm during the examination. The technique is simple, safe, cheap and it may lessen the need for intravenous administration of spasmolytic agents.

Alumni perspectives comparing a general internal medicine program and a traditional medicine program.

OBJECTIVE: To evaluate a primary care internal medicine curriculum, the authors surveyed four years (1983-1986) of graduates of the primary care and traditional internal medicine residency programs at their institution concerning the graduates' preparation. DESIGN: Mailed survey of alumni of a residency training program. SETTING: Teaching hospital alumni. SUBJECTS/METHODS: Of 91 alumni of an internal medicine training program for whom addresses had been found, 82 (90%) of the residents (20 primary care and 62 traditional) rated on a five-point Likert scale 82 items for both adequacy of preparation for practice and importance of training. These items were divided into five groups: traditional medical disciplines (e.g., cardiology), allied disciplines (e.g., orthopedics), areas related to medical practice (e.g., patient education), basic skills and knowledge (e.g., history and physical), and technical procedures. MAIN RESULTS: Primary care residents were more likely to see themselves as primary care physicians versus subspecialists (84% versus 45%). The primary care graduates felt significantly better prepared in the allied disciplines and in areas related to medical practice (p less than 0.01). There was no significant difference overall in perceptions of preparation in the traditional medical disciplines, basic skills and knowledge, and procedures. The same results were obtained when the authors looked only at graduates from the two programs who spent more than 50% of their time as primary care physicians versus subspecialists. There was no significant difference between the two groups in the perceived importance of these areas to current practice. CONCLUSIONS: These results suggest that the primary care curriculum has prepared residents in areas particularly relevant to primary care practice. Additionally, these individuals feel as well prepared as do their colleagues in the traditional medical disciplines, basic skills and knowledge, and procedural skills.