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一项针对慢性肌肉骨骼疼痛的在线正念减压计划的可行性与可接受性:一项试点随机对照试验方案

The feasibility and acceptability of an online mindfulness-based stress reduction program for chronic musculoskeletal pain: protocol for a pilot randomised controlled trial.

作者信息

Amorim Anita B, Rebbeck Trudy, Van Dam Nicholas T, Johnstone Charlotte, Ashton-James Claire, Costa Nathalia, Barnet-Hepples Talia, Jennings Matthew, Refshauge Kathryn, Pappas Evangelos

机构信息

Discipline of Physiotherapy, School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.

John Walsh Centre for Rehabilitation Research (Kolling Institute), Northern Sydney Local Health District, St Leonards, New South Wales, Australia.

出版信息

Pilot Feasibility Stud. 2025 Mar 15;11(1):30. doi: 10.1186/s40814-025-01612-w.

DOI:10.1186/s40814-025-01612-w
PMID:40089768
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11909893/
Abstract

BACKGROUND

Chronic musculoskeletal pain conditions affect millions of people worldwide and place a significant burden on individuals and the healthcare systems. Managing chronic musculoskeletal pain requires a multidisciplinary approach that considers biological, psychological, and social factors. However, access to multidisciplinary pain care is challenging, and long wait times can lead to increased stress and health deterioration. Mindfulness-based stress reduction (MBSR) is a mind-body approach developed specifically to reduce the distress of living with chronic conditions, such as chronic musculoskeletal pain. This study proposed a novel approach by offering an online MBSR program to patients on waitlists to attend a multidisciplinary pain clinic in Australia's public healthcare system that could improve health outcomes. The study aims to assess the feasibility, acceptability, and potential efficacy of this approach using a pilot study design with a mixed-methods approach.

METHODS

This is a mixed-methods pilot randomised controlled trial with an embedded qualitative study. Participants will be recruited from waitlists at two multidisciplinary pain management centres within the Sydney Local Health District in New South Wales, Australia. This pilot trial will randomly assign 32 individuals with chronic musculoskeletal pain to either an online MBSR group or a usual care control group. Feasibility outcomes, patient-reported outcomes, adherence to mindfulness practice, and adverse events will be assessed using validated questionnaires. Semi-structured interviews will be conducted with participants in the MBSR group to explore their experiences and evaluate acceptability, and barriers and facilitators of engagement with the intervention.

DISCUSSION

This pilot study will evaluate a novel approach to integrating MBSR into the Australian public healthcare system as a mechanism for providing support to individuals with chronic musculoskeletal pain who are waitlisted for a multidisciplinary pain management program. Findings from this study will indicate the feasibility, acceptability, safety, and preliminary efficacy of this approach in terms of patient-reported outcomes to guide the design of future large-scale clinical trials.

TRIAL REGISTRATION

This trial was prospectively registered in the Australian New Zealand Clinical Trials Registry (ACTRN12622000822785).

摘要

背景

慢性肌肉骨骼疼痛疾病影响着全球数百万人,给个人和医疗保健系统带来了沉重负担。管理慢性肌肉骨骼疼痛需要一种多学科方法,该方法要考虑生物、心理和社会因素。然而,获得多学科疼痛护理具有挑战性,长时间等待可能导致压力增加和健康状况恶化。基于正念的减压疗法(MBSR)是一种身心疗法,专门为减轻患有慢性疾病(如慢性肌肉骨骼疼痛)的生活困扰而开发。本研究提出了一种新方法,即向等待进入澳大利亚公共医疗系统多学科疼痛诊所的患者提供在线MBSR项目,这可能会改善健康结果。该研究旨在采用混合方法的试点研究设计评估这种方法的可行性、可接受性和潜在疗效。

方法

这是一项带有嵌入式定性研究的混合方法试点随机对照试验。参与者将从澳大利亚新南威尔士州悉尼地方卫生区的两个多学科疼痛管理中心的等待名单中招募。这项试点试验将把32名患有慢性肌肉骨骼疼痛的个体随机分配到在线MBSR组或常规护理对照组。将使用经过验证的问卷评估可行性结果、患者报告的结果、对正念练习的依从性和不良事件。将对MBSR组的参与者进行半结构化访谈,以探索他们的经历并评估可接受性以及参与干预的障碍和促进因素。

讨论

这项试点研究将评估一种将MBSR整合到澳大利亚公共医疗系统中的新方法,作为为等待多学科疼痛管理项目的慢性肌肉骨骼疼痛患者提供支持的一种机制。本研究的结果将表明这种方法在患者报告结果方面的可行性、可接受性、安全性和初步疗效,以指导未来大规模临床试验的设计。

试验注册

该试验已在澳大利亚新西兰临床试验注册中心(ACTRN12622000822785)进行前瞻性注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c02f/11909893/9499be5e1493/40814_2025_1612_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c02f/11909893/517779fe77ad/40814_2025_1612_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c02f/11909893/9499be5e1493/40814_2025_1612_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c02f/11909893/517779fe77ad/40814_2025_1612_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c02f/11909893/9499be5e1493/40814_2025_1612_Fig2_HTML.jpg

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