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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2026-08-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Fibromyalgia Fibromyalgia Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Due to the nature of the intervention (exercise), complete participant blinding is not feasible. However, to minimize performance and expectation bias, the control group utilizes a visually identical digital platform interface ('sham' digital experience). Outcomes Assessors and the Principal Investigator will remain strictly blinded to group allocation until database lock. Treating physiotherapists (Care Providers) managing the platform alerts may be unblinded to ensure safety, but they are not involved in outcome assessments.

Study Groups

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AI-Guided Tele-rehabilitation

Participants in this arm will receive a 12-week tele-rehabilitation program guided by artificial intelligence (AI) and computer vision technology. The program consists of three personalized exercise sessions per week, delivered remotely and adapted in real time to participants' capabilities and progress. In addition, participants will attend weekly educational sessions focused on pain neuroscience to improve their understanding of chronic pain mechanisms and enhance self-management strategies.

The intervention is delivered through a visually identical digital platform used by all participants. Supervising physiotherapists monitor progress and provide standardized support but remain blinded to treatment allocation, as only the intervention group receives the active content (AI-guided exercise and PNE).

Group Type EXPERIMENTAL

AI-Guided Exercise and Pain Neuroscience Education

Intervention Type 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

Participants in this arm will receive standard care for fibromyalgia, which typically includes pharmacological management such as pain relievers (e.g., paracetamol, tramadol), antidepressants (e.g., amitriptyline, duloxetine), and anticonvulsants (e.g., pregabalin, gabapentin). They will also be provided with general recommendations on physical activity and disease self-management, in line with current clinical guidelines. In addition, participants will use the same digital platform with a visually identical interface, receiving standard, non-specific educational materials and general activity guidance (without AI-guided exercise feedback or pain neuroscience education modules)

Group Type ACTIVE_COMPARATOR

Usual Care for Fibromyalgia

Intervention Type 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

Interventions

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AI-Guided Exercise and Pain Neuroscience Education

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.

Intervention Type OTHER

Usual Care for Fibromyalgia

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No