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基于证据的数字支持在跨学科疼痛康复计划后 1 年期间为慢性肌肉骨骼疼痛患者提供,以促进可持续返回工作:一项基于登记的多中心随机对照试验研究方案。

Evidence-based digital support during 1 year after an Interdisciplinary Pain Rehabilitation Programme for persons with chronic musculoskeletal pain to facilitate a sustainable return to work: a study protocol for a registry-based multicentre randomised controlled trial.

机构信息

Department of Health Medicine and Caring Sciences, Linkoping University, Linkoping, Sweden

Department of Health Medicine and Caring Sciences, Linkoping University, Linkoping, Sweden.

出版信息

BMJ Open. 2022 Apr 25;12(4):e060452. doi: 10.1136/bmjopen-2021-060452.

Abstract

INTRODUCTION

Chronic musculoskeletal pain (CMSP) severely affects the individual's quality of life, functioning and ability to work, and comes with significant societal costs for sick leave and productivity loss. After rehabilitation, patients with CMSP often experience lack of support when responsibility for the return-to-work process is taken over by the employer. Therefore, we aim to evaluate the effectiveness of a digital support (Sustainable WorkEr digital support for Persons with chronic Pain and their Employers (SWEPPE)) for promoting a sustainable return-to-work for persons with CMSP and to facilitate the employers' supportive role and responsibilities in the process.

METHODS AND ANALYSIS

In this registry-based multicentre randomised controlled trial, 360 patients with CMSP will be randomised to either receive the smartphone application SWEPPE (n=180) or to a control group (n=180). The intervention group will use SWEPPE for 1 year and the control group will not receive any intervention for return to work (RTW). Participants will be recruited from approximately 10 specialist and primary care level units connected to the Swedish National Quality Registry for Pain Rehabilitation providing Interdisciplinary Pain Rehabilitation Programmes (IPRP) for CMSP. Eligibility criteria are age 18-65 years and a need for support in RTW or continued support at work for creating a sustainable work situation. Baseline data will be collected when the participants have completed the IPRP. Final assessment will be performed after 12 months. The primary outcome will be a number of days with sickness cash benefit. Secondary outcomes and explanatory variables including important domains affected by CMSP such as health-related quality of life, functioning and work ability will be collected.

ETHICS AND DISSEMINATION

The Swedish Ethics Review Board approved the study (Dnr 2020-01593, Dnr 2021-01854). The study findings will be disseminated through publication, national and international conferences, and meetings to be available for patients, healthcare providers or stakeholders.

TRIAL REGISTRATION NUMBER

NCT05058547.

摘要

简介

慢性肌肉骨骼疼痛(CMSP)严重影响个体的生活质量、功能和工作能力,并导致病假和生产力损失带来巨大的社会成本。在康复后,CMSP 患者在将重返工作的责任移交给雇主时,往往会感到缺乏支持。因此,我们旨在评估数字支持(Sustainable WorkEr 数字支持患有慢性疼痛的患者及其雇主(SWEPPE))对促进 CMSP 患者可持续重返工作岗位的有效性,并促进雇主在该过程中的支持作用和责任。

方法和分析

在这项基于登记的多中心随机对照试验中,将 360 名 CMSP 患者随机分为接受智能手机应用程序 SWEPPE(n=180)或对照组(n=180)。干预组将使用 SWEPPE 进行 1 年,对照组将不接受任何重返工作(RTW)干预。参与者将从大约 10 个连接到瑞典国家疼痛康复质量登记处的专科和初级保健级单位招募,为 CMSP 提供跨学科疼痛康复计划(IPRP)。纳入标准为年龄 18-65 岁,需要支持重返工作岗位或继续在工作中提供支持以创造可持续的工作环境。当参与者完成 IPRP 时将收集基线数据。最终评估将在 12 个月后进行。主要结局指标是因病领取现金津贴的天数。次要结局和解释性变量包括 CMSP 影响的重要领域,如健康相关生活质量、功能和工作能力。

伦理和传播

瑞典伦理审查委员会批准了该研究(编号 2020-01593,编号 2021-01854)。研究结果将通过发表、国家和国际会议以及会议传播,供患者、医疗保健提供者或利益相关者使用。

试验注册编号

NCT05058547。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ce0c/9039404/9e799cf4b015/bmjopen-2021-060452f01.jpg

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