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

Sponsor
Instituto Neurociencia Del Dolor
Study ID
NCT06672419
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Fibromyalgia
  • Fibromyalgia Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • AI-Guided Exercise and Pain Neuroscience Education — OTHER
    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.
  • Usual Care for Fibromyalgia — OTHER
    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

Study Details

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.

Key Dates

First listed
Nov 4, 2024
Start date
Feb 1, 2026
Status verified
Dec 2025
Primary completion
Jul 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AI-Guided Tele-rehabilitation
    Participants in this arm will receive a 12-week tele-rehabilitation program guided by artificial intelligence (AI) and computer vision technology. The program consists of three personalized exercise sessions per week, delivered remotely and adapted in real time to participants' capabilities and progress. In addition, participants will attend weekly educational sessions focused on pain neuroscience to improve their understanding of chronic pain mechanisms and enhance self-management strategies. The intervention is delivered through a visually identical digital platform used by all participants. Supervising physiotherapists monitor progress and provide standardized support but remain blinded to treatment allocation, as only the intervention group receives the active content (AI-guided exercise and PNE).
  • Active Comparator: Usual Care for Fibromyalgia
    Participants in this arm will receive standard care for fibromyalgia, which typically includes pharmacological management such as pain relievers (e.g., paracetamol, tramadol), antidepressants (e.g., amitriptyline, duloxetine), and anticonvulsants (e.g., pregabalin, gabapentin). They will also be provided with general recommendations on physical activity and disease self-management, in line with current clinical guidelines. In addition, participants will use the same digital platform with a visually identical interface, receiving standard, non-specific educational materials and general activity guidance (without AI-guided exercise feedback or pain neuroscience education modules)

Primary Outcome Measure

Change in Pain Intensity Measured by Visual Analog Scale (VAS) [ Time Frame: 12 weeks ]

Central Contacts

Related Studies