基于正念减压疗法、认知行为疗法和针灸治疗慢性下腰痛：两项关联随机对照试验方案

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

作者信息

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

机构信息

Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Palo Alto, CA, United States.

The Institute of Biomedical and Oral Research, Faculty of Dental Medicine, Hebrew University of Jerusalem, Jerusalem, Israel.

出版信息

JMIR Res Protoc. 2022 Sep 27;11(9):e37823. doi: 10.2196/37823.

DOI:10.2196/37823

PMID:36166279

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9555327/

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://clinicaltrials.gov/ct2/show/NCT02503475.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/37823.

摘要

背景

非药物身心疗法已被证明对腰痛有效。然而，这些疗法背后的机制仍有待充分阐明。

目的

为填补这些知识空白，成立了斯坦福腰痛中心——一个由美国国立卫生研究院P01资助的合作性多学科研究中心——以研究三种针对慢性腰痛的身心疗法的共同和独特生物行为机制：用于治疗疼痛的认知行为疗法（CBT）、基于正念的减压疗法（MBSR）和电针疗法。在此，我们描述该中心结构的设计与实施以及相关随机对照试验，以阐明慢性腰痛治疗的机制。

方法

该多学科中心正在开展两项随机对照试验，这两项试验在招募、入组、研究执行和数据采集方面共享共同资源。我们预计在两个项目以及每个项目内的不同治疗组中招募300多名慢性腰痛参与者。第一个项目将比较疼痛-CBT与MBSR以及一个等待名单对照组。第二个项目将比较真电针与假电针。我们将使用行为、心理物理、身体测量和神经成像技术，在基线和纵向层面表征慢性腰痛患者的中枢疼痛调节和情绪调节系统。我们将描述这些干预措施如何影响这些系统，表征纵向治疗效果，并确定治疗效果的预测因素。