Effectiveness of Tele-Rehabilitation for Fibromyalgia Using AI-Guided Exercise and Computer Vision Combined With Pain Neuroscience Education (FIBRO IA): A Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This randomized controlled trial will investigate a 12-week tele-rehabilitation program for individuals with fibromyalgia (FM), combining AI-guided exercise with pain neuroscience education. Fifty participants will be randomized to either the intervention program or standard care. The primary outcome is reduction in pain intensity, with secondary outcomes including physical function and quality of life. Participants and investigators will remain blinded to group allocation, and outcome assessors and statisticians will remain blinded until data lock.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Clinical diagnosis of fibromyalgia according to the American College of Rheumatology criteria.
• Age between 18 and 65 years.
• Access to an internet-connected device (smartphone or computer).
• Ability to participate in a tele-rehabilitation program.
Locations
Other Locations
Chile
Universidad San Sebastián
RECRUITING
Concepción
Contact Information
Primary
Marco A Morales-Osorio, PhD
marco.morales@uss.cl
+56932367359
Backup
Romualdo Ordoñez-Vega, MsC
Time Frame
Start Date:2025-12-01
Estimated Completion Date:2026-07-01
Participants
Target number of participants:50
Treatments
Experimental: AI-Guided Tele-rehabilitation
Participants in this arm will receive a 12-week tele-rehabilitation program guided by artificial intelligence (AI) and computer vision technology. The program consists of three personalized exercise sessions per week, delivered remotely and adapted in real time to participants' capabilities and progress. In addition, participants will attend weekly educational sessions focused on pain neuroscience to improve their understanding of chronic pain mechanisms and enhance self-management strategies.~The intervention is delivered through a visually identical digital platform used by all participants. Supervising physiotherapists monitor progress and provide standardized support but remain blinded to treatment allocation, as only the intervention group receives the active content (AI-guided exercise and PNE).
Active_comparator: Usual Care for Fibromyalgia
Participants in this arm will receive standard care for fibromyalgia, which typically includes pharmacological management such as pain relievers (e.g., paracetamol, tramadol), antidepressants (e.g., amitriptyline, duloxetine), and anticonvulsants (e.g., pregabalin, gabapentin). They will also be provided with general recommendations on physical activity and disease self-management, in line with current clinical guidelines.