Status:
RECRUITING
Effectiveness of an IVR-based Therapeutic Exercise Program With Altered Visual Feedback in Fibromyalgia Patients
Lead Sponsor:
Cardenal Herrera University
Conditions:
Fibromyalgia
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The primary aim of this randomized controlled trial is to determine the efficacy of a 6-week immersive virtual reality (IVR)-based therapeutic exercise intervention, which manipulates visual proprioce...
Detailed Description
Fibromyalgia is a chronic and multifactorial condition marked by widespread pain, fatigue, sleep disturbances, and various neurocognitive and psychosomatic symptoms, severely impacting quality of life...
Eligibility Criteria
Inclusion
- Adults diagnosed with fibromyalgia according to any of the classification criteria established by the American College of Rheumatology (ACR), including those from 1990, 2010, 2011, or 2016;
- Ability to communicate effectively with the research staff;
- A self-reported pain intensity score of ≥3 on a 11-point Numerical Pain Rating Scale (NRS-11).
Exclusion
- Presence of comorbidities and/or symptoms that constitute a contraindication for immersive virtual reality or exercise-based interventions;
- Presence of medical conditions that may interfere with study outcomes, such as visual, auditory, perceptual, or sensory disorders;
- Use of medications that could potentially affect study results;
- Engagement in another therapeutic physical activity program during the intervention period, or any modifications to existing therapies (including medication or physical therapy) throughout the study.
Key Trial Info
Start Date :
May 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 10 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06948500
Start Date
May 5 2025
End Date
February 10 2027
Last Update
November 18 2025
Active Locations (1)
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1
Juan Fco. Lisón
Valencia, Valencia-valència, Spain, 46006