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Pre-print of statistical analysis plan for the RESOLVE trial for people with chronic low back pain

Sensitivity analysis of recent meta-analyses of pharmacological interventions for pain in people with low back pain

A randomised clinical trial for chronic low back pain

Refereed/Peer-reviewed Importance: The effects of altered neural processing, defined as altering neural networks responsible for perceptions of pain and function, on chronic pain remains unclear. Objective: To estimate the effect of a graded sensorimotor retraining intervention (RESOLVE) on pain intensity in people with chronic low back pain. Design, Setting, and Participants: This parallel, 2-group, randomized clinical trial recruited participants with chronic (>3 months) nonspecific low back pain from primary care and community settings. A total of 276 adults were randomized (in a 1:1 ratio) to the intervention or sham procedure and attention control groups delivered by clinicians at a medical research institute in Sydney, Australia. The first participant was randomized on December 10, 2015, and the last was randomized on July 25, 2019. Follow-up was completed on February 3, 2020. Interventions: Participants randomized to the intervention group (n = 138) were asked to participate in 12 weekly clinical sessions and home training designed to educate them about and assist them with movement and physical activity while experiencing lower back pain. Participants randomized to the control group (n = 138) were asked to participate in 12 weekly clinical sessions and home training that required similar time as the intervention but did not focus on education, movement, and physical activity. The control group included sham laser and shortwave diathermy applied to the back and sham noninvasive brain stimulation. Main Outcomes and Measures: The primary outcome was pain intensity at 18 weeks, measured on an 11-point numerical rating scale (range, 0 [no pain] to 10 [worst pain imaginable]) for which the between-group minimum clinically important difference is 1.0 point. Results: Among 276 randomized patients (mean [SD] age, 46 [14.3] years; 138 [50%] women), 261 (95%) completed follow-up at 18 weeks. The mean pain intensity was 5.6 at baseline and 3.1 at 18 weeks in the intervention group and 5.8 at baseline and 4.0 at 18 weeks in the control group, with an estimated between-group mean difference at 18 weeks of -1.0 point ([95% CI, -1.5 to -0.4]; P =.001), favoring the intervention group. Conclusions and Relevance: In this randomized clinical trial conducted at a single center among patients with chronic low back pain, graded sensorimotor retraining, compared with a sham procedure and attention control, significantly improved pain intensity at 18 weeks. The improvements in pain intensity were small, and further research is needed to understand the generalizability of the findings. Trial Registration: ANZCTR Identifier: ACTRN12615000610538.

Refereed/Peer-reviewed Introduction: Chronic low back pain (CLBP) is pain that has persisted for greater than three months. It is common and burdensome and represents a significant proportion of primary health presentations. For the majority of people with CLBP, a specific nociceptive contributor cannot be reliably identified, and the pain is categorised as 'non-specific'. Exercise therapy is recommended by international clinical guidelines as a first-line treatment for non-specific CLBP. Aim: This comprehensive review aims to synthesise and appraise the current research to provide practical, evidence-based guidance concerning exercise prescription for non-specific CLBP. We discuss detailed initial assessment and being informed by patient preferences, values, expectations, competencies and goals. Methods: We searched the Cochrane Database of Systematic Reviews, PubMed and the Physiotherapy Evidence Database (PEDro) using broad search terms from January 2000 to March 2021, to identify the most recent clinical practice guidelines, systematic reviews and randomised controlled trials on exercise for CLBP. Results/Discussion: Systematic reviews show exercise is effective for small, short-term reductions in pain and disability, when compared with placebo, usual care, or waiting list control, and serious adverse events are rare. A range of individualised or group-based exercise modalities have been demonstrated as effective in reducing pain and disability. Despite this consensus, controversies and significant challenges remain. Conclusion: To promote recovery, sustainable outcomes and self-management, exercise can be coupled with education strategies, as well as interventions that enhance adherence, motivation and patient self-efficacy. Clinicians might benefit from intentionally considering their own knowledge and competencies, potential harms of exercise and costs to the patient. This comprehensive review provides evidence-based practical guidance to health professionals who prescribe exercise for people with non-specific CLBP.