Investigating the Mechanisms of Graded Sensorimotor Precision Training in Adults With Chronic Nonspecific Low Back Pain: Protocol for a Causal Mediation Analysis of the RESOLVE Trial.

Aidan G Cashin,Tasha R Stanton,Benedict M Wand,Matthew K Bagg,James H Mcauley,Hopin Lee,G Lorimer Moseley,Edel O'Hagan,Rodrigo R N Rizzo

doi:10.2196/26053

Abstract

BackgroundChronic low back pain (CLBP) is a global health problem associated with an increasing burden on individuals, health care systems, and society. Common treatments for people with CLBP produce, on average, small short-term improvements in pain and function compared with 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.ObjectiveThis protocol describes the planned evaluation of these proposed treatment mechanisms. Improved understanding of the mechanisms underpinning the RESOLVE treatment may guide its refinement and implementation.MethodsWe will use causal mediation analysis to evaluate the proposed treatment mechanisms, including pain self-efficacy, back beliefs, pain catastrophizing, kinesiophobia, back perception, tactile acuity, and movement coordination. The primary outcomes are pain intensity and function at 18 weeks following allocation. Data were collected blind to allocation and hypotheses at baseline (mediators, outcomes, confounders), end of treatment (mediators), and at 18 weeks following allocation (outcomes). We will test the robustness of our findings by conducting planned sensitivity analyses.ResultsEthical 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.ConclusionsThe RESOLVE treatment constitutes a new paradigm for CLBP management with potentially wide-reaching implications. This mechanistic evaluation will provide evidence for the hypothesized 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.Trial RegistrationAustralian and New Zealand Clinical Trials Registry ACTRN12615000610538; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368619&isReview=trueInternational Registered Report Identifier (IRRID)DERR1-10.2196/26053

Highlights

Low back pain (LBP) is a global health problem [1,2]
The RESOLVE treatment constitutes a new paradigm for Chronic low back pain (CLBP) management with potentially wide-reaching implications
The RESOLVE trial is a randomized controlled trial (RCT) evaluating a new complex treatment strategy partly informed by evidence of central nervous system dysfunction against a sham control

Summary

Methods

We will use causal mediation analysis to evaluate the proposed treatment mechanisms, including pain self-efficacy, back beliefs, pain catastrophizing, kinesiophobia, back perception, tactile acuity, and movement coordination. The primary outcomes are pain intensity and function at 18 weeks following allocation. Data were collected blind to allocation and hypotheses at baseline (mediators, outcomes, confounders), end of treatment (mediators), and at 18 weeks following allocation (outcomes). We will test the robustness of our findings by conducting planned sensitivity analyses

Conclusions

Introduction

Design

Participants

Discussion