Clinical trial NCT06672419: Effectiveness of AI-Guided Exercise and Pain Neuroscience Education for Fibromyalgia (FIBROIA)
Official title: Effectiveness of Tele-Rehabilitation for Fibromyalgia Using AI-Guided Exercise and Computer Vision Combined With Pain Neuroscience Education (FIBRO IA): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fibromyalgia
Fibromyalgia Syndrome
Keywords: Fibromyalgia
Tele-rehabilitation
Artificial Intelligence
Computer Vision
Pain Neuroscience Education
Randomized Controlled Trial
Lead sponsor: Instituto Neurociencia Del Dolor
Sponsor class: OTHER
Collaborators: name: Universidad San Sebastián
First posted: 2024-11-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study employs a parallel-group randomized controlled trial (RCT) design. Participants will be randomly assigned to one of two groups: the intervention group, which will receive AI-guided exercise and pain neuroscience education through a tele-rehabilitation platform, or the control group, which will receive standard care for fibromyalgia, including pharmacological treatment and general physical activity recommendations. The study will use a 1:1 randomization ratio and will be conducted remotely. Randomization will be performed using a computer-generated allocation sequence to ensure unbiased group assignment.
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effectiveness of a tele-rehabilitation program for patients with fibromyalgia. The program combines AI-guided exercises and computer vision technology with pain neuroscience education to improve physical function and reduce pain. Participants will be randomized into two groups: one receiving the AI-guided rehabilitation and the other receiving standard care. The intervention group will complete personalized exercise sessions and educational modules remotely over 12 weeks. The primary goal is to assess pain reduction and physical function improvement using validated tools such as the Visual Analog Scale (VAS) and the Revised Fibromyalgia Impact Questionnaire (FIQ-R). Secondary outcomes include quality of life and psychological well-being.

Participants must have a confirmed diagnosis of fibromyalgia, be between 18-65 years old, and have access to a smartphone or computer. The study will take place entirely online, making it accessible to a broad population, especially those in remote areas. Results from this study could help develop more effective and accessible treatments for fibromyalgia.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

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.

Primary outcomes:
measure: Change in Pain Intensity Measured by Visual Analog Scale (VAS)
timeFrame: 12 weeks
measure: Change in the Impact of Fibromyalgia on Daily Life Measured by the Revised Fibromyalgia Impact Questionnaire (FIQ-R)
timeFrame: 12 weeks
measure: Lower Limb Strength and Endurance Measured by the 30-Second Sit-to-Stand Test
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Quality of Life Measured by EQ-5D
timeFrame: 12 weeks
measure: Change in Psychological Well-being Measured by the Numeric Rating Scale for Anxiety (NRS-A)
timeFrame: 12 weeks
measure: Perceived Barriers to Treatment Adherence Measured by the Treatment Adherence Barriers Questionnaire
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Concepción
country: Chile
facility: Universidad San Sebastián
state: Biobio
Study officials:
affiliation: Universidad San Sebastian
name: Marco Morales-Osorio, PhD
role: PRINCIPAL_INVESTIGATOR
References: