Clinical Trial

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

Study acronym: FibroIA
Not Yet Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated January 2, 2026 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-10-31; most recent amendment 2025-12-27.
Status change: Recruiting → Not Yet Recruiting 2025-12-27
Status change: Not Yet Recruiting → Recruiting 2025-08-27
Status change: Recruiting → Not Yet Recruiting 2025-06-12
Status change: Not Yet Recruiting → Recruiting 2025-05-11
Trial Details
NCT Number NCT06672419
Lead Sponsor Instituto Neurociencia Del Dolor
Collaborators: Universidad San Sebastián, Universidad Santiago de Cali
Conditions Fibromyalgia, Fibromyalgia Syndrome
Enrollment 50 participants
Start Date 2026-02-01
Primary Completion 2026-07-01 (estimated)
Study Completion 2026-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-02