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

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 o...

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Autores principales: Mackey, Sean, Gilam, Gadi, Darnall, Beth, Goldin, Philippe, Kong, Jiang-Ti, Law, Christine, Heirich, Marissa, Karayannis, Nicholas, Kao, Ming-Chih, Tian, Lu, Manber, Rachel, Gross, James
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9555327/
https://www.ncbi.nlm.nih.gov/pubmed/36166279
http://dx.doi.org/10.2196/37823
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author Mackey, Sean
Gilam, Gadi
Darnall, Beth
Goldin, Philippe
Kong, Jiang-Ti
Law, Christine
Heirich, Marissa
Karayannis, Nicholas
Kao, Ming-Chih
Tian, Lu
Manber, Rachel
Gross, James
author_facet Mackey, Sean
Gilam, Gadi
Darnall, Beth
Goldin, Philippe
Kong, Jiang-Ti
Law, Christine
Heirich, Marissa
Karayannis, Nicholas
Kao, Ming-Chih
Tian, Lu
Manber, Rachel
Gross, James
author_sort Mackey, Sean
collection PubMed
description 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://clinicaltrials.gov/ct2/show/NCT02503475 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/37823
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spelling pubmed-95553272022-10-13 Mindfulness-Based Stress Reduction, Cognitive Behavioral Therapy, and Acupuncture in Chronic Low Back Pain: Protocol for Two Linked Randomized Controlled Trials Mackey, Sean Gilam, Gadi Darnall, Beth Goldin, Philippe Kong, Jiang-Ti Law, Christine Heirich, Marissa Karayannis, Nicholas Kao, Ming-Chih Tian, Lu Manber, Rachel Gross, James JMIR Res Protoc Protocol 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://clinicaltrials.gov/ct2/show/NCT02503475 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/37823 JMIR Publications 2022-09-27 /pmc/articles/PMC9555327/ /pubmed/36166279 http://dx.doi.org/10.2196/37823 Text en ©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. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Mackey, Sean
Gilam, Gadi
Darnall, Beth
Goldin, Philippe
Kong, Jiang-Ti
Law, Christine
Heirich, Marissa
Karayannis, Nicholas
Kao, Ming-Chih
Tian, Lu
Manber, Rachel
Gross, James
Mindfulness-Based Stress Reduction, Cognitive Behavioral Therapy, and Acupuncture in Chronic Low Back Pain: Protocol for Two Linked Randomized Controlled Trials
title Mindfulness-Based Stress Reduction, Cognitive Behavioral Therapy, and Acupuncture in Chronic Low Back Pain: Protocol for Two Linked Randomized Controlled Trials
title_full Mindfulness-Based Stress Reduction, Cognitive Behavioral Therapy, and Acupuncture in Chronic Low Back Pain: Protocol for Two Linked Randomized Controlled Trials
title_fullStr Mindfulness-Based Stress Reduction, Cognitive Behavioral Therapy, and Acupuncture in Chronic Low Back Pain: Protocol for Two Linked Randomized Controlled Trials
title_full_unstemmed Mindfulness-Based Stress Reduction, Cognitive Behavioral Therapy, and Acupuncture in Chronic Low Back Pain: Protocol for Two Linked Randomized Controlled Trials
title_short Mindfulness-Based Stress Reduction, Cognitive Behavioral Therapy, and Acupuncture in Chronic Low Back Pain: Protocol for Two Linked Randomized Controlled Trials
title_sort mindfulness-based stress reduction, cognitive behavioral therapy, and acupuncture in chronic low back pain: protocol for two linked randomized controlled trials
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9555327/
https://www.ncbi.nlm.nih.gov/pubmed/36166279
http://dx.doi.org/10.2196/37823
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