Accepted for/Published in: JMIR Research Protocols
Date Submitted: Mar 10, 2022
Open Peer Review Period: Mar 8, 2022 - Mar 17, 2022
Date Accepted: Jun 6, 2022
(closed for review but you can still tweet)
Mindfulness-Based Stress Reduction, Cognitive-Behavioral Therapy, and Acupuncture in Chronic Low Back Pain: Protocol for Two Linked Randomized Controlled Trials
ABSTRACT
Background:
Nonpharmacologic mind-body therapies have demonstrated efficacy in low back pain. However, the mechanisms underlying these therapies remain to be fully elucidated.
Objective:
In response to these knowledge gaps, the Stanford Center for Low Back Pain is a collaborative, National Institutes of Health P01-funded, multidisciplinary research center was established to investigate the common and distinct bio-behavioral mechanisms of three mind-body therapies for chronic low back pain: pain cognitive-behavioral therapy, mindfulness-based stress reduction, and electro-acupuncture. Here, we describe the design and implementation of the center structure and the associated randomized controlled trials for characterizing the mechanisms of chronic low back pain treatments.
Methods:
The multidisciplinary center includes two randomized controlled trials that share common resources for recruitment, enrollment, study execution, and data acquisition. We expect to recruit over 300 chronic low back pain participants across two projects and different treatment arms within each project. The first project will examine pain-cognitive-behavioral therapy compared with mindfulness-based stress reduction and a waitlist control group. The second will examine real versus sham electro-acupuncture. We will use behavioral, psychophysical, physical measures, and neuroimaging techniques to characterize the central pain modulatory and emotion regulatory systems in chronic low back pain at baseline and longitudinally. We will characterize how these interventions impact these systems, characterize the longitudinal treatment effects, and identify predictors of treatment efficacy.
Results:
Participant recruitment began on March 17, 2015 and will end in March 2023. Recruitment was halted in March 2020 due to COVID-19 and resumed in December 2021.
Conclusions:
This center utilizes a comprehensive approach to study chronic low back pain. Findings are expected to significantly advance our understanding in (1) the baseline and longitudinal mechanisms of chronic low back pain; (2) the common and distinctive mechanisms of three mind-body therapies, and (3) predictors of treatment response, thereby informing future delivery of nonpharmacologic chronic low back pain treatments. Clinical Trial: ClinicalTrials.gov NCT02503475; https://clinicaltrials.gov/ct2/show/NCT02503475
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