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Effectiveness of AI-Guided Exercise and Pain Neuroscience Education for Fibromyalgia (FIBROIA)
Sponsor: Instituto Neurociencia Del Dolor
Summary
This randomized controlled trial will evaluate the effectiveness of a 12-week, home-based telerehabilitation program for adults with fibromyalgia (FM) combining AI-guided exercise with Pain Neuroscience Education (PNE). Fifty participants will be randomized (1:1) to the digital intervention or usual care. The primary outcome is change in pain intensity from baseline to post-intervention (week 13 ± 7 days), with secondary outcomes including physical function and health-related quality of life. Outcome assessors, the principal investigator, and the study statistician will be blinded to group allocation until database lock.
Official title: Effectiveness of Tele-Rehabilitation for Fibromyalgia Using AI-Guided Exercise and Computer Vision Combined With Pain Neuroscience Education (FIBRO IA): A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-02-01
Completion Date
2026-08-01
Last Updated
2026-01-02
Healthy Volunteers
No
Conditions
Interventions
AI-Guided Exercise and Pain Neuroscience Education
This intervention consists of a 12-week tele-rehabilitation program using AI and computer vision technology to guide personalized exercise sessions (three per week). Exercises are adjusted in real time by the AI system, and participants also attend weekly sessions of pain neuroscience education to develop improved pain management strategies. The program is delivered remotely via a digital platform that is visually identical for all participants. Supervising physiotherapists oversee progress and provide standardized support but remain blinded to group allocation.
Usual Care for Fibromyalgia
Standard care includes pharmacological management (pain relievers, antidepressants, anticonvulsants) and general recommendations on physical activity and disease management. Drug: Pain Relievers - e.g., paracetamol, tramadol Drug: Antidepressants - e.g., amitriptyline, duloxetine Drug: Anticonvulsants - e.g., pregabalin, gabapentin Other: General Physical Activity and Disease Education - recommendations consistent with current clinical guidelines
Locations (2)
Universidad San Sebastián
Concepción, Región del Biobío, Chile
Universidad Santiago de Cali
Cali, Colombia