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

NCT06672419 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-19

No results posted yet for this study

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.

Conditions

  • Fibromyalgia
  • Fibromyalgia Syndrome

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.

Sponsors & Collaborators

  • Universidad San Sebastián

    collaborator OTHER

  • Universidad Santiago de Cali

    collaborator OTHER

  • Instituto Neurociencia Del Dolor

    lead OTHER

Principal Investigators

  • Marco Morales-Osorio, PhD · Universidad San Sebastian

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-10
Primary Completion
2026-06-14
Completion
2026-06-14

Countries

  • Chile
  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06672419 on ClinicalTrials.gov