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

Effectiveness of Tele-Rehabilitation for Fibromyalgia Using AI-Guided Exercise and Computer Vision Combined With Pain Neuroscience Education (FIBRO IA): A Randomized Controlled Trial

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.

This randomized controlled trial aims to evaluate the effectiveness of a 12-week tele-rehabilitation program that integrates artificial intelligence (AI)-guided exercise, computer vision, and pain neuroscience education (PNE) for individuals with fibromyalgia (FM). The study seeks to determine whether this technology-driven approach can reduce pain intensity, improve physical function, and enhance quality of life in a population that frequently experiences limited benefit from conventional treatment strategies.

Intervention Participants in the intervention group will use a tele-rehabilitation platform that applies AI and computer vision to deliver personalized exercise programs. The AI system monitors performance in real time and adapts exercises according to individual capacity, performance, and progress. In parallel, participants will complete one asynchronous online Pain Neuroscience Education (PNE) module per week for 12 weeks, designed to promote pain reconceptualization and support active self-management..

Control group Participants in the control group receive enhanced usual care for fibromyalgia according to clinical guidelines, including continuation of prescribed pharmacological management and general lifestyle, physical activity, and self-management advice. In addition, participants use the same digital platform with a visually identical interface and receive standard, non-specific educational materials on fibromyalgia self-management and general physical activity guidance, without AI-guided exercise feedback or structured Pain Neuroscience Education modules.

Study Design This study employs a parallel-group randomized controlled trial (RCT) design. Participants are randomly assigned in a 1:1 ratio to either the intervention group, which receives AI-guided exercise and Pain Neuroscience Education through a tele-rehabilitation platform, or the control group, which receives enhanced usual care for fibromyalgia, including usual pharmacological management, general physical activity and self-management guidance, and access to non-specific digital educational materials without AI-guided exercise feedback or structured PNE modules. The study is conducted remotely. Randomization is performed using a computer-generated allocation sequence.

Masking: Because of the nature of the non-pharmacological digital exercise intervention, complete blinding of participants and treating physiotherapists was not feasible. Outcome assessors, the principal investigator, and the study statistician remained blinded to group allocation until database lock. Treating physiotherapists were not involved in outcome assessment.

Objectives

The primary objective is to determine whether the AI-guided exercise and PNE program reduces pain intensity and improves physical function compared with standard care. Secondary objectives include evaluating changes in quality of life, psychological well-being, and treatment adherence. Findings will provide evidence on whether technology-enabled rehabilitation can serve as an accessible, effective alternative for fibromyalgia management.

Rationale

Conventional therapies for fibromyalgia, such as pharmacological treatment and standard physical therapy, often provide suboptimal relief. Tele-rehabilitation represents a promising strategy to deliver personalized, supervised exercise at scale, particularly for patients in underserved or remote areas. When combined with pain neuroscience education, this approach addresses both physical and cognitive aspects of pain, with the potential to improve outcomes beyond current standards of care.

This study aligns with broader public health goals to improve access to effective interventions for chronic pain. Its results may inform future clinical guidelines and support the integration of AI-driven tele-rehabilitation into routine practice for fibromyalgia and related chronic pain conditions.

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.