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NCT Number: NCT06672419

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

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 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.

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Key information

Conditions

Fibromyalgia Fibromyalgia Syndrome Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad San Sebastián, Concepción, Biobio, Chile

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About this study

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 the statistician will also remain blinded until database 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AI-Guided Exercise and Pain Neuroscience Education

Other

This intervention consists of a 12-week tele-rehabilitation program using AI and computer vision technology to guide personalized exercise sessions (three per week). Exercises are adjusted in real time by the AI system, and participants also attend weekly sessions of pain neuroscience education to develop improved pain management strategies. The program is delivered remotely via a digital platform that is visually identical for all participants. Supervising physiotherapists oversee progress and provide standardized support but remain blinded to group allocation.

Usual Care for Fibromyalgia

Other

Standard care includes pharmacological management (pain relievers, antidepressants, anticonvulsants) and general recommendations on physical activity and disease management.

Drug: Pain Relievers - e.g., paracetamol, tramadol

Drug: Antidepressants - e.g., amitriptyline, duloxetine

Drug: Anticonvulsants - e.g., pregabalin, gabapentin

Other: General Physical Activity and Disease Education - recommendations consistent with current clinical guidelines

Primary outcomes

  1. Change in Pain Intensity Measured by Visual Analog Scale (VAS)

    Time frame: 12 weeks

    Pain intensity will be measured using the Visual Analog Scale (VAS), which ranges from 0 (no pain) to 10 (worst pain imaginable). Participants will rate their pain at baseline and after 12 weeks of intervention. Higher scores indicate a worse outcome (greater pain intensity). The primary outcome focuses on changes in pain intensity from baseline to the end of the 12-week period.

Secondary outcomes

  1. Change in the Impact of Fibromyalgia on Daily Life Measured by the Revised Fibromyalgia Impact Questionnaire (FIQ-R)

    Time frame: 12 weeks

    The impact of fibromyalgia on daily life will be assessed using the Revised Fibromyalgia Impact Questionnaire (FIQ-R), a tool that measures the overall burden of fibromyalgia on patients through three key domains: overall impact on daily life, severity of specific symptoms, and functional ability in daily tasks. The FIQ-R provides a comprehensive score ranging from 0 to 100, where higher scores reflect a worse outcome (indicating a greater negative impact of fibromyalgia on daily life). This secondary outcome measure will evaluate changes in the total FIQ-R score from baseline to the end of a 12-week intervention period.

  2. Lower Limb Strength and Endurance Measured by the 30-Second Sit-to-Stand Test

    Time frame: 12 weeks

    The 30-second sit-to-stand test measures lower limb strength and endurance by counting the number of times a participant can stand up from a seated position and sit back down within 30 seconds. Higher scores indicate a better outcome (greater strength and endurance). This test serves as a reliable indicator of overall physical function and has been validated for remote use (Bowman et al., 2023). The test will be conducted at baseline and after 12 weeks of intervention.

  3. Change in Quality of Life Measured by EQ-5D

    Time frame: 12 weeks

    Quality of life will be assessed using the EQ-5D (EuroQol-5 Dimension), a standardized measure to evaluate health-related quality of life. The EQ-5D examines five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores range from -0.59 to 1, where higher scores indicate a better quality of life. Scores will be compared from baseline to the end of the 12-week intervention.

  4. Change in Psychological Well-being Measured by the Numeric Rating Scale for Anxiety (NRS-A)

    Time frame: 12 weeks

    The NRS-A is a simple, validated tool that allows patients to rate their level of anxiety on a scale of 0 to 10, where 0 indicates 'no anxiety' and 10 represents 'the worst imaginable anxiety.' Anxiety levels will be measured at baseline and after 12 weeks of intervention.

  5. Perceived Barriers to Treatment Adherence Measured by the Treatment Adherence Barriers Questionnaire

    Time frame: 12 weeks

    The Treatment Adherence Barriers Questionnaire identifies perceived barriers that patients face in adhering to treatment recommendations. This measure provides valuable insights into factors affecting adherence and will be evaluated at baseline and after 12 weeks.

Study contacts

Contact information is provided by the study sponsor or research team.

Marco A Morales-Osorio, PhD

CONTACT

[email protected]

+56932367359

Romualdo Ordoñez-Vega, MsC

CONTACT

Sponsors and collaborators

Lead sponsor

Instituto Neurociencia Del Dolor

Other

Collaborators

  • Universidad San Sebastián
  • Universidad Santiago de Cali

Registry information

Official study 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

Acronym: FibroIA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 4, 2024
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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