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COMPLETED
NCT06672419
NA

Effectiveness of AI-Guided Exercise and Pain Neuroscience Education for Fibromyalgia (FIBROIA)

Sponsor: Instituto Neurociencia Del Dolor

View on ClinicalTrials.gov

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

Interventions

OTHER

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.

OTHER

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