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

doi:10.2196/37823

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

^*Corresponding author for this work

Institute of Biomedical Research at the Faculty of Dental Medicine

Research output: Contribution to journal › Article › peer-review

1 Scopus citations

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.

Original language	American English
Article number	e37823
Journal	JMIR Research Protocols
Volume	11
Issue number	9
DOIs	https://doi.org/10.2196/37823
State	Published - 1 Sep 2022

Bibliographical note

Funding Information:
We thank Dr Maisa S Ziadni for providing comments on an earlier version of this manuscript and Sara Miller for assistance in creating Figure 2. This work was supported, in part, through funding from the NIH’s National Center for Complementary and Integrative Health (NCCIH; grants P01 AT006651 [SM], P01 AT006651-S1 [BD], R01 AT008561 [BD and SM], and K23 AT008477 [J-TK]), the National Institute on Drug Abuse (NIDA; grants K24 DA029262 [SM] and K24 DA053564 [BD]), the National Institute of Neurological Disorders and Stroke (grant K24 NS126781 [SM]), the NIDA (grant T32 DA035165 [SM]), and the Redlich Pain Endowment (SM). All statements in this report are solely those of the authors and do not necessarily represent the views of the National Institutes of Health (NIH).

Publisher Copyright:
© JMIR Publications Inc.. All rights reserved.

Keywords

chronic low back pain
mind-body therapies
neuroimaging
nonpharmacologic treatments

Access to Document

10.2196/37823

Cite this

Mackey, S., Gilam, G., Darnall, B., Goldin, P., Kong, J. T., Law, C., Heirich, M., Karayannis, N., Kao, M. C., Tian, L., Manber, R., & Gross, J. (2022). Mindfulness-Based Stress Reduction, Cognitive Behavioral Therapy, and Acupuncture in Chronic Low Back Pain: Protocol for Two Linked Randomized Controlled Trials. JMIR Research Protocols, 11(9), Article e37823. https://doi.org/10.2196/37823

@article{ada466a8ce4b4925b144e938446baad2,

title = "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-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.",

keywords = "chronic low back pain, mind-body therapies, neuroimaging, nonpharmacologic treatments",

author = "Sean Mackey and Gadi Gilam and Beth Darnall and Philippe Goldin and Kong, {Jiang Ti} and Christine Law and Marissa Heirich and Nicholas Karayannis and Kao, {Ming Chih} and Lu Tian and Rachel Manber and James Gross",

note = "Funding Information: We thank Dr Maisa S Ziadni for providing comments on an earlier version of this manuscript and Sara Miller for assistance in creating Figure 2. This work was supported, in part, through funding from the NIH{\textquoteright}s National Center for Complementary and Integrative Health (NCCIH; grants P01 AT006651 [SM], P01 AT006651-S1 [BD], R01 AT008561 [BD and SM], and K23 AT008477 [J-TK]), the National Institute on Drug Abuse (NIDA; grants K24 DA029262 [SM] and K24 DA053564 [BD]), the National Institute of Neurological Disorders and Stroke (grant K24 NS126781 [SM]), the NIDA (grant T32 DA035165 [SM]), and the Redlich Pain Endowment (SM). All statements in this report are solely those of the authors and do not necessarily represent the views of the National Institutes of Health (NIH). Publisher Copyright: {\textcopyright} JMIR Publications Inc.. All rights reserved.",

year = "2022",

month = sep,

day = "1",

doi = "10.2196/37823",

language = "American English",

volume = "11",

journal = "JMIR Research Protocols",

issn = "1929-0748",

publisher = "JMIR Publications Inc.",

number = "9",

}

Mackey, S, Gilam, G, Darnall, B, Goldin, P, Kong, JT, Law, C, Heirich, M, Karayannis, N, Kao, MC, Tian, L, Manber, R & Gross, J 2022, 'Mindfulness-Based Stress Reduction, Cognitive Behavioral Therapy, and Acupuncture in Chronic Low Back Pain: Protocol for Two Linked Randomized Controlled Trials', JMIR Research Protocols, vol. 11, no. 9, e37823. https://doi.org/10.2196/37823

TY - JOUR

T1 - Mindfulness-Based Stress Reduction, Cognitive Behavioral Therapy, and Acupuncture in Chronic Low Back Pain

T2 - Protocol for Two Linked Randomized Controlled Trials

AU - Mackey, Sean

AU - Gilam, Gadi

AU - Darnall, Beth

AU - Goldin, Philippe

AU - Kong, Jiang Ti

AU - Law, Christine

AU - Heirich, Marissa

AU - Karayannis, Nicholas

AU - Kao, Ming Chih

AU - Tian, Lu

AU - Manber, Rachel

AU - Gross, James

N1 - Funding Information: We thank Dr Maisa S Ziadni for providing comments on an earlier version of this manuscript and Sara Miller for assistance in creating Figure 2. This work was supported, in part, through funding from the NIH’s National Center for Complementary and Integrative Health (NCCIH; grants P01 AT006651 [SM], P01 AT006651-S1 [BD], R01 AT008561 [BD and SM], and K23 AT008477 [J-TK]), the National Institute on Drug Abuse (NIDA; grants K24 DA029262 [SM] and K24 DA053564 [BD]), the National Institute of Neurological Disorders and Stroke (grant K24 NS126781 [SM]), the NIDA (grant T32 DA035165 [SM]), and the Redlich Pain Endowment (SM). All statements in this report are solely those of the authors and do not necessarily represent the views of the National Institutes of Health (NIH). Publisher Copyright: © JMIR Publications Inc.. All rights reserved.

PY - 2022/9/1

Y1 - 2022/9/1

N2 - 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.

AB - 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.

KW - chronic low back pain

KW - mind-body therapies

KW - neuroimaging

KW - nonpharmacologic treatments

UR - http://www.scopus.com/inward/record.url?scp=85139722235&partnerID=8YFLogxK

U2 - 10.2196/37823

DO - 10.2196/37823

M3 - Article

C2 - 36166279

AN - SCOPUS:85139722235

SN - 1929-0748

VL - 11

JO - JMIR Research Protocols

JF - JMIR Research Protocols

IS - 9

M1 - e37823

ER -

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

Abstract

Bibliographical note

Keywords

Access to Document

Other files and links

Fingerprint

Cite this