Mindfulness-Based Stress Reduction, Cognitive Behavioral Therapy, and Acupuncture in Chronic Low Back Pain: Protocol for Two Linked Randomized Controlled Trials

Sean Mackey, Gadi Gilam, Beth Darnall, Philippe Goldin, Jiang-Ti Kong, Christine Law, Marissa Heirich, Nicholas Karayannis, Ming-Chih Kao, Lu Tian, Rachel Manber, James Gross, Sean Mackey, Gadi Gilam, Beth Darnall, Philippe Goldin, Jiang-Ti Kong, Christine Law, Marissa Heirich, Nicholas Karayannis, Ming-Chih Kao, Lu Tian, Rachel Manber, James Gross

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-a collaborative, National Institutes of Health P01-funded, multidisciplinary research center-was established to investigate the common and distinct biobehavioral mechanisms of three mind-body therapies for chronic low back pain: cognitive behavioral therapy (CBT) that is used to treat pain, mindfulness-based stress reduction (MBSR), and electroacupuncture. 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 is running 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 across different treatment arms within each project. The first project will examine pain-CBT compared with MBSR and a wait-list control group. The second project will examine real versus sham electroacupuncture. We will use behavioral, psychophysical, physical measure, 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 uses 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.

Trial registration: ClinicalTrials.gov NCT02503475; https://ichgcp.net/clinical-trials-registry/NCT02503475.

International registered report identifier (irrid): PRR1-10.2196/37823.

Keywords: chronic low back pain; mind-body therapies; neuroimaging; nonpharmacologic treatments.

Conflict of interest statement

Conflicts of Interest: BD is Chief Science Advisor at AppliedVR, and her consulting role with this company (personal fees) is unrelated to the current work. BD receives royalties for four pain treatment books she has authored or coauthored. She is the principal investigator for pain research awards from the Patient-Centered Research Outcomes Research Institute and the National Institutes of Health (NIH) that investigate cognitive behavioral therapy (CBT) for chronic pain. BD serves on the Board of Directors for the American Academy of Pain Medicine and is on the Board of Directors for the Institute for Brain Potential. BD is a scientific member of the NIH Interagency Pain Research Coordinating Committee, a former member of the Centers for Disease Control and Prevention Opioid Workgroup (2020-2021), a former scientific advisory board member of the National Pain Advocacy Center (2021-2022), a current member of the Pain Advisory Group of the American Psychological Association, and serves on the Medical Advisory Board for the Facial Pain Association.

©Sean Mackey, Gadi Gilam, Beth Darnall, Philippe Goldin, Jiang-Ti Kong, Christine Law, Marissa Heirich, Nicholas Karayannis, Ming-Chih Kao, Lu Tian, Rachel Manber, James Gross. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 27.09.2022.

Figures

Figure 1
Figure 1
Schematic depiction of brain regions commonly involved in cognitive regulation reappraisal, mindful-attention regulation, and targets for pain and emotion regulation. ACC: anterior cingulate cortex; Amyg: amygdala; dm/dl-PFC: dorso medial and dorso lateral prefrontal cortex; NAcc: nucleus accumbens; PAG: periaqueductal gray; PCC: posterior cingulate cortex; PL: parietal lobe; SSMC: somatosensory motor cortex; Thlms: thalamus; TP: temporal pole; vl-PFC: ventro lateral prefrontal cortex.
Figure 2
Figure 2
Flowchart overview of participant process in the Stanford Center for Low Back Pain project. btw: between; CBT: cognitive behavioral therapy; MBSR: mindfulness-based stress reduction; mo.: month; QST: quantitative sensory testing; wks: weeks; WL: wait-list.

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