Last updated 52 days ago

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

50 patients around the world
Available in Chile
This is a randomized controlled trial designed to evaluate the effectiveness of a tele-rehabilitation program that combines artificial intelligence (AI) and computer vision with pain neuroscience education for patients with fibromyalgia. The study aims to assess the impact of this novel approach on improving chronic pain management, physical function, and quality of life in patients with fibromyalgia, a population that often faces significant challenges with conventional treatment approaches. Intervention: The intervention group will use a tele-rehabilitation platform that employs AI and computer vision to guide personalized exercise programs. The AI will monitor participants' performance in real-time, adjusting exercises to match individual capabilities and progress. In addition to the exercise component, participants will engage in weekly sessions of pain neuroscience education, aimed at enhancing their understanding of how pain is processed by the nervous system and how it can be better managed through cognitive and behavioral strategies. The control group will receive standard care for fibromyalgia, which typically includes pharmacological management (e.g., analgesics, antidepressants, anticonvulsants) and general advice on physical activity and self-care. By comparing these two groups, the study will provide insights into the potential benefits of integrating AI-guided tele-rehabilitation with educational interventions focused on the neuroscience of pain. Study Design: This study will recruit 50 participants who meet the American College of Rheumatology criteria for fibromyalgia. Participants will be randomly assigned to either the intervention or control group. The intervention will last 12 weeks, during which participants in the intervention group will complete three exercise sessions per week, along with one educational session each week. All sessions will be conducted remotely through a user-friendly platform accessible via smartphones or computers. Data collection for primary and secondary outcomes will occur at baseline, post-intervention, and at follow-up time points. Objectives: The primary objective is to evaluate the effectiveness of the AI-guided exercise and education program in reducing pain intensity and improving physical function in fibromyalgia patients. Secondary objectives include assessing changes in quality of life, psychological well-being, and treatment adherence. Data from this study will contribute to understanding whether technology-driven interventions can offer a viable, accessible alternative to standard care for managing fibromyalgia. Rationale: Traditional treatments for fibromyalgia, such as pharmacological interventions and standard physical therapy, often provide limited relief. Tele-rehabilitation offers a promising solution by making personalized, supervised exercise programs more accessible, especially for patients in remote areas. Additionally, combining exercise with pain neuroscience education may help reduce pain perception and improve patient outcomes by addressing both the physical and cognitive aspects of pain. This study aligns with public health policies that aim to improve care for chronic pain conditions like fibromyalgia, particularly in underserved or remote populations. The results could inform future guidelines for integrating telemedicine and AI-driven interventions into routine clinical practice for managing fibromyalgia and similar chronic pain conditions.
Marco Antonio Morales Osorio
1Research sites
50Patients around the world

This study is for people with

Fibromyalgia

Requirements for the patient

To 65 Years
All Gender

Medical requirements

Clinical diagnosis of fibromyalgia according to the American College of Rheumatology criteria.
Age between 18 and 65 years.
Access to an internet-connected device (smartphone or computer).
Ability to participate in a tele-rehabilitation program.
Participation in another clinical trial in the last 3 months.
Pregnancy or breastfeeding.
Uncontrolled severe medical conditions that could interfere with the intervention.
Physical or cognitive impairments that prevent following the exercise program.

Sites

UNIVERSIDAD SAN SEBASTIÁN, FACULTAD DE MEDICINA Y CIENCIA
Providencia, Región Metropolitana de Santiago 7500000
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