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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 enhanced 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
2026-02-10
Completion Date
2026-06-14
Last Updated
2026-08-19
Healthy Volunteers
No
Conditions
Interventions
AI-Guided Exercise and Pain Neuroscience Education
This intervention consists of a 12-week tele-rehabilitation program using artificial intelligence and computer vision to guide personalized therapeutic exercise sessions three times per week. The platform provides real-time feedback on movement execution and individualized exercise progression. Participants additionally complete one asynchronous online Pain Neuroscience Education module per week for 12 weeks. Supervising physiotherapists review adherence and safety alerts and are not involved in outcome assessment.
Enhanced Usual Care for Fibromyalgia
Enhanced usual care includes continuation of prescribed pharmacological management and general recommendations regarding physical activity, lifestyle, and fibromyalgia self-management. Participants also receive access to standard, non-specific digital educational materials and general activity guidance, without AI-guided real-time exercise feedback or structured Pain Neuroscience Education modules.
Locations (2)
Universidad San Sebastián
Concepción, Biobio, Chile
Universidad Santiago de Cali
Cali, Colombia