Effectiveness of AI-Guided Exercise and Pain Neuroscience Education for Fibromyalgia (FIBROIA)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorInstituto Neurociencia Del Dolor
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
AI-Guided Exercise and Pain Neuroscience Education
Other interventionThis 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 interventionStandard 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
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: AI-Guided Tele-rehabilitationExperimental treatment 1 intervention
Group B: Usual Care for FibromyalgiaActive comparator 1 intervention
Trial outcomes
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.
Time frame
12 weeksSecondary outcomes
1
Change in the Impact of Fibromyalgia on Daily Life Measured by the Revised Fibromyalgia Impact Questionnaire (FIQ-R)
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.
Time frame
12 weeks2
Lower Limb Strength and Endurance Measured by the 30-Second Sit-to-Stand Test
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.
Time frame
12 weeks3
Change in Quality of Life Measured by EQ-5D
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.
Time frame
12 weeks4
Change in Psychological Well-being Measured by the Numeric Rating Scale for Anxiety (NRS-A)
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.
Time frame
12 weeksSponsors and contacts
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Instituto Neurociencia Del Dolor
Lead sponsor
Universidad San Sebastián
Collaborator
Universidad Santiago de Cali
Collaborator
Source ClinicalTrials.gov
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