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 to individual capacities and
progress. In parallel, participants will attend weekly sessions of pain neuroscience
education, designed to improve their understanding of pain processing within the nervous
system and to promote more effective self-management through cognitive and behavioral
strategies.
The control group will receive standard care for fibromyalgia, which typically includes
pharmacological management (e.g., analgesics, antidepressants, anticonvulsants) alongside
general recommendations for physical activity and self-care. Comparison between the
groups will allow assessment of the added value of combining AI-guided
tele-rehabilitation with PNE.
Study Design Participants will be randomly assigned (1:1) to intervention or control
group. The intervention will last 12 weeks, during which participants in the intervention
group will complete three exercise sessions per week and one educational session weekly.
All sessions will be conducted remotely through a user-friendly platform accessible via
smartphones or computers. Outcome assessments will be conducted at baseline and
immediately after completion of the 12-week program.
Masking: Participants and investigators will remain blinded to group allocation. Outcome
assessors and statisticians will also remain blinded until data lock.
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.
