Not Yet RecruitingNot Applicable

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

Chile, Colombia50 participantsStarted 2026-02-01

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion Criteria: * 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. Exclusion Criteria: * 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.

What they're measuring

Change in Pain Intensity Measured by Visual Analog Scale (VAS)

Timeframe: 12 weeks

Trial details

NCT IDNCT06672419

SponsorInstituto Neurociencia Del Dolor

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-01

Contact for this trial

Marco A Morales-Osorio, PhD

+56932367359 marco.morales@uss.cl