Effectiveness of tele-rehabilitation using AI-guided exercise and pain neuroscience education for fibromyalgia (FIBROIA): Protocol for a randomized controlled trial
Abstract
Introduction: Fibromyalgia (FM) is a chronic condition characterized by widespread pain and cognitive dysfunction, with pharmacological treatments offering limited efficacy. Although Pain Neuroscience Education (PNE) and therapeutic exercise are evidence-based interventions, accessibility and adherence remain major challenges particularly in underserved regions such as Latin America. This trial investigates the effectiveness of a 12-week tele-rehabilitation program (FIBROIA) that integrates Artificial Intelligence (AI)-guided exercise with PNE to enhance access to comprehensive multimodal care.
Methods and analysis: This multicentre, randomized, assessor-blinded, parallel-group controlled trial will enroll fifty adults meeting the 2016 ACR criteria for FM. Participants will be randomly assigned (1:1) to either the intervention group or enhanced usual care. The intervention consists of three personalized exercise sessions per week delivered through the Rehbody AI platform, which provides real-time biomechanical feedback, along with a weekly PNE module designed to reconceptualize pain. The primary outcome is the change in pain intensity, measured using the Visual Analogue Scale (VAS), at week 13 (±7 days), immediately following completion of the 12-week program. Secondary outcomes include the Fibromyalgia Impact Questionnaire-Revised (FIQ-R), lower-limb strength assessed by the 30-Second Sit-to-Stand test, and health-related quality of life measured with the EQ-5D-3L.…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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