Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 25, 2020
Date Accepted: May 13, 2021
Investigating the mechanisms of graded sensorimotor precision training in adults with chronic non-specific low back pain: Protocol for causal mediation analysis of the RESOLVE trial
ABSTRACT
Background:
Chronic low back pain (CLBP) is a global health problem associated with an increasing burden on individuals, healthcare systems and society. Common treatments for people with CLBP produce, on average, small short-term improvements in pain and function compared to minimal care. The RESOLVE trial randomly allocated 276 people with CLBP to a new complex treatment strategy, pain education integrated with graded sensorimotor precision training (RESOLVE), or a sham-control. The RESOLVE treatment was developed within a theoretical framework to target possible treatment mechanisms associated with CLBP development and persistence.
Objective:
This protocol describes the planned mechanism evaluation of these proposed treatment mechanisms. Improved understanding of the mechanisms underpinning the RESOLVE treatment may guide its refinement and implementation.
Methods:
We will use causal mediation analysis to evaluate the proposed treatment mechanisms including, pain self-efficacy, back beliefs, pain catastrophising, kinesiophobia, back perception, tactile acuity, and movement coordination. The primary outcomes are pain intensity and function at 18-weeks post-allocation. Data were collected blind to allocation and hypotheses at baseline (mediators, outcomes, confounders), end of treatment (mediators) and at 18-weeks post-allocation (outcomes). We will test the robustness of our findings by conducting planned sensitivity analyses.
Results:
Ethical approval was granted by the University of New South Wales Human Research Ethics Committee (HC15357). A total of 276 participants have been recruited from primary care practices and the community in Sydney, Australia.
Conclusions:
The RESOLVE treatment constitutes a new paradigm for CLBP management with potentially wide-reaching implications. This mechanism evaluation will provide evidence for the hypothesised treatment mechanisms and help explain why the treatment strategy did or did not have an effect on patient reported outcomes. These results will help guide the treatment refinement and implementation. Clinical Trial: Australian and New Zealand Clinical Trials Registry (ACTRN12615000610538).
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