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

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

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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.

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