Effectiveness of AI-Guided Exercise and Pain Neuroscience Education for Fibromyalgia (FIBROIA) (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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AI-Guided Tele-rehabilitation
Participants in this arm receive a 12-week home-based tele-rehabilitation program combining AI- and computer vision-guided therapeutic exercise with Pain Neuroscience Education.
Participants complete three personalized exercise sessions per week.
The platform analyzes movement performance in real time, provides audiovisual corrective feedback, and adapts exercise difficulty according to individual performance and adherence data.
Participants also complete one asynchronous online PNE module per week for 12 weeks.
Supervising physiotherapists review adherence and safety alerts but are not involved in outcome assessment; complete blinding of treating physiotherapists is not feasible.
|
This intervention consists of a 12-week tele-rehabilitation program using artificial intelligence and computer vision to guide personalized therapeutic exercise sessions three times per week.
The platform provides real-time feedback on movement execution and individualized exercise progression.
Participants additionally complete one asynchronous online Pain Neuroscience Education module per week for 12 weeks.
Supervising physiotherapists review adherence and safety alerts and are not involved in outcome assessment.
|
|
Active Comparator: Enhanced Usual Care for Fibromyalgia
Participants in this arm 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.
|
Enhanced usual care includes continuation of prescribed pharmacological management and general recommendations regarding physical activity, lifestyle, and fibromyalgia self-management.
Participants also receive access to standard, non-specific digital educational materials and general activity guidance, without AI-guided real-time exercise feedback or structured Pain Neuroscience Education modules.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Time Frame: Baseline to Week 13 (±7 days)
|
Pain intensity is measured using a 10-cm Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).
The primary endpoint is the change in VAS pain intensity between baseline (Week 0) and the post-intervention assessment at Week 13 (±7 days), immediately following completion of the 12-week intervention.
Higher scores indicate greater pain intensity.
|
Baseline to Week 13 (±7 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the Impact of Fibromyalgia on Daily Life Measured by the Revised Fibromyalgia Impact Questionnaire (FIQ-R)
Time Frame: Baseline to Week 13 (±7 days)
|
The impact of fibromyalgia is assessed using the Revised Fibromyalgia Impact Questionnaire (FIQ-R), with a total score ranging from 0 to 100, where higher scores indicate greater disease impact.
Change in the total FIQ-R score is assessed between baseline (Week 0) and post-intervention at Week 13 (±7 days), immediately following completion of the 12-week intervention.
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Baseline to Week 13 (±7 days)
|
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Change in Lower Limb Strength and Endurance Measured by the 30-Second Sit-to-Stand Test
Time Frame: Baseline to Week 13 (±7 days)
|
Lower limb strength and endurance are assessed using the 30-Second Sit-to-Stand Test, recorded as the number of complete repetitions performed within 30 seconds.
Higher values indicate better physical performance.
Change is assessed between baseline (Week 0) and post-intervention at Week 13 (±7 days), immediately following completion of the 12-week intervention.
|
Baseline to Week 13 (±7 days)
|
|
Change in Health-Related Quality of Life Measured by the EQ-5D-3L
Time Frame: Baseline to Week 13 (±7 days)
|
Health-related quality of life is assessed using the EQ-5D-3L.
The utility index ranges from negative values to 1, with higher scores indicating better health-related quality of life.
Change in the EQ-5D-3L index is assessed between baseline (Week 0) and post-intervention at Week 13 (±7 days), immediately following completion of the 12-week intervention.
|
Baseline to Week 13 (±7 days)
|
|
Change in Psychological Well-being Measured by the Numeric Rating Scale for Anxiety (NRS-A)
Time Frame: Baseline to Week 13 (±7 days)
|
Anxiety is assessed using the Numeric Rating Scale for Anxiety (NRS-A), ranging from 0 (no anxiety) to 10 (worst imaginable anxiety), with higher scores indicating greater anxiety.
Change is assessed between baseline (Week 0) and post-intervention at Week 13 (±7 days), immediately following completion of the 12-week intervention.
|
Baseline to Week 13 (±7 days)
|
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Perceived Barriers to Treatment Adherence Measured by the Treatment Adherence Barriers Questionnaire
Time Frame: Baseline to Week 13 (±7 days)
|
Perceived barriers to treatment adherence are assessed using the Treatment Adherence Barriers Questionnaire adapted for tele-rehabilitation.
The measure evaluates logistical, motivational, contextual, and other perceived barriers to adherence.
Assessments are performed at baseline (Week 0) and post-intervention at Week 13 (±7 days).
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Baseline to Week 13 (±7 days)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marco Morales-Osorio, PhD, Universidad San Sebastián
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FibroIA
- ID: USS_0003_11-07-2 (Other Identifier: Universidad San Sebastián)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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