Effectiveness of AI-Guided Exercise and Pain Neuroscience Education for Fibromyalgia (FIBROIA)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorInstituto Neurociencia Del Dolor
About this trial
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.
Eligibility criteria
Qualifiers
Clinical diagnosis of fibromyalgia according to the American College of Rheumatology criteria (2016).
Age between 18 and 65 years.
Access to an internet-connected device (smartphone or computer).
Ability to participate in a tele-rehabilitation program.
Disqualifiers
Participation in another clinical trial in the last 3 months.
Pregnancy or breastfeeding.
Uncontrolled severe medical conditions that could interfere with the intervention (e.g., cardiac or pulmonary diseases).
Physical or cognitive impairments that prevent following the exercise program.
Trial design
Treatments tested in this trial
- AI-Guided Exercise and Pain Neuroscience Education
- Usual Care for Fibromyalgia
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Instituto Neurociencia Del Dolor
Lead sponsor
Universidad San Sebastián
Collaborator
Universidad Santiago de Cali
Collaborator
Source ClinicalTrials.gov