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

NCT06672419 | Not Yet Recruiting

• 2 other identifiers: FibroIAID: USS_0003_11-07-2
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Fibromyalgia; Fibromyalgia Syndrome

Keywords

Fibromyalgia; Tele-rehabilitation; Artificial Intelligence; Computer Vision; Pain Neuroscience Education; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

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

  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.

  12 weeks

Secondary Outcomes (5)

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

  12 weeks

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

  12 weeks

• Change in Quality of Life Measured by EQ-5D

  12 weeks

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

  12 weeks

• Perceived Barriers to Treatment Adherence Measured by the Treatment Adherence Barriers Questionnaire

  12 weeks

Study Arms (2)

AI-Guided Tele-rehabilitation

EXPERIMENTAL

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).

Other: AI-Guided Exercise and Pain Neuroscience Education

Usual Care for Fibromyalgia

ACTIVE COMPARATOR

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)

Other: Usual Care for Fibromyalgia

Interventions

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.

AI-Guided Tele-rehabilitation

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

Usual Care for Fibromyalgia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Neurociencia Del Dolor: lead
• Universidad San Sebastián: collaborator
• Universidad Santiago de Cali: collaborator

Study Sites (2)

Universidad San Sebastián

Concepción, Región del Biobío, 4030000, Chile

Location

Universidad Santiago de Cali

Cali, Colombia

Location

Related Publications (1)

• Suero-Pineda A, Oliva-Pascual-Vaca A, Duran MR, Sanchez-Laulhe PR, Garcia-Frasquet MA, Blanquero J. Effectiveness of a Telerehabilitation Evidence-Based Tablet App for Rehabilitation in Traumatic Bone and Soft Tissue Injuries of the Hand, Wrist, and Fingers. Arch Phys Med Rehabil. 2023 Jun;104(6):932-941. doi: 10.1016/j.apmr.2023.01.016. Epub 2023 Feb 8.

  PMID: 36758713 RESULT

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Marco Morales-Osorio, PhD

  Universidad San Sebastian

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco A Morales-Osorio, PhD

CONTACT

+56932367359; marco.morales@uss.cl

Romualdo Ordoñez-Vega, MsC

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: November 4, 2024
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after publication of the primary results and for a period of 5 years thereafter.
• Access Criteria: vailable upon reasonable request from qualified researchers. A data use agreement will be required.

Locations

CO (1); CL (1)