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远程医疗支持的结构化运动计划对慢性腰痛患者的影响:一项随机对照试验的研究方案

Effect of Telemedicine-Supported Structured Exercise Program in Patients with Chronic Low Back Pain: Study Protocol for a Randomized Controlled Trial.

作者信息

Feng Yuan, Jia Chengsen, Liu Huizhen, Bao Tianjie, Wang Chongyang, Wang Zezhang, Huang Jielei, Jiang Yiwen, Wang Xiaoyi, Zhang Ruishi, Zhang Yujia, Zhang Shaojun, Zhu Siyi, He Chengqi

机构信息

Rehabilitation Medicine Center and Institute of Rehabilitation Medicine, West China Hospital, Sichuan University, Chengdu, People's Republic of China.

Key Laboratory of Rehabilitation Medicine in Sichuan Province, West China Hospital, Sichuan University, Chengdu, People's Republic of China.

出版信息

J Pain Res. 2025 Jun 7;18:2809-2822. doi: 10.2147/JPR.S518072. eCollection 2025.

Abstract

PURPOSE

Telemedicine-based structured exercise programs have the potential to benefit patients with chronic low back pain (CLBP). However, evidence-practice gaps persist, including low exercise adherence and insufficient focus on mental health. Consequently, further research is warranted to clarify the impact of telemedicine-supported structured exercise programs on patients with CLBP.

PATIENTS AND METHODS

This randomized controlled trial will include patients with CLBP who have not received exercise therapy in the past three months. Participants in the trial group will receive patient education, health coaching, and home-based exercise therapy via mobile health (mHealth) applications loaded with wearable device integration. Those in the control group will receive conventional treatment, comprising patient education and written instructions for home exercises. Disability including pain intensity will be assessed as primary outcomes using the Roland-Morris Disability Questionnaire (RMDQ) and the Numerical Rating Scale (NRS) at baseline, 4 weeks, and 8 weeks. Statistical analyses will depend on assumptions such as homogeneity of variance and sphericity: if met, a two-factor, three-level repeated measures analysis of variance will be used; otherwise, a linear mixed-effects model will be employed.

摘要

目的

基于远程医疗的结构化运动计划有可能使慢性下腰痛(CLBP)患者受益。然而,证据与实践之间的差距依然存在,包括运动依从性低以及对心理健康关注不足。因此,有必要进行进一步研究,以阐明远程医疗支持的结构化运动计划对CLBP患者的影响。

患者与方法

这项随机对照试验将纳入过去三个月未接受过运动治疗的CLBP患者。试验组参与者将通过加载了可穿戴设备集成功能的移动健康(mHealth)应用程序接受患者教育、健康指导和家庭运动治疗。对照组参与者将接受常规治疗,包括患者教育和家庭锻炼的书面指导。将使用罗兰·莫里斯残疾问卷(RMDQ)和数字评分量表(NRS)在基线、4周和8周时评估包括疼痛强度在内的残疾情况作为主要结局。统计分析将取决于方差齐性和球对称性等假设:若满足条件,将使用双因素、三级重复测量方差分析;否则,将采用线性混合效应模型。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4be0/12153955/578a81bd3870/JPR-18-2809-g0001.jpg

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