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

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

Last updated 2026-01-02

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 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 AI and computer vision technology to guide personalized exercise sessions (three per week). Exercises are adjusted in real time by the AI system, and participants also attend weekly sessions of pain neuroscience education to develop improved pain management strategies. The program is delivered remotely via a digital platform that is visually identical for all participants. Supervising physiotherapists oversee progress and provide standardized support but remain blinded to group allocation.

OTHER

Usual Care for Fibromyalgia

Standard care includes pharmacological management (pain relievers, antidepressants, anticonvulsants) and general recommendations on physical activity and disease management. Drug: Pain Relievers - e.g., paracetamol, tramadol Drug: Antidepressants - e.g., amitriptyline, duloxetine Drug: Anticonvulsants - e.g., pregabalin, gabapentin Other: General Physical Activity and Disease Education - recommendations consistent with current clinical guidelines

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
2026-02-01
Primary Completion
2026-07-01
Completion
2026-08-01

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