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Effectiveness of an IVR-based Therapeutic Exercise Program With Altered Visual Feedback in Fibromyalgia Patients

RecruitingNAAges 18 Years - 80 YearsAllCardenal Herrera University
NCT06948500 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 proprioceptive input during exercise, for patients diagnosed with fibromyalgia (FM). Participants will be randomly allocated into two groups: an experimental group performing therapeutic exercises integrated with IVR featuring modified visual feedback, and a control group executing identical exercises without IVR integration. The primary outcome will assess the impact of fibromyalgia on daily activities, while secondary outcomes will comprehensively evaluate fatigue, sleep quality, severity of fibromyalgia symptoms, health-related quality of life, anxiety and depressive symptoms, fear-avoidance beliefs, pain catastrophizing, kinesiophobia, indicators of central sensitization, lumbar spine flexion and

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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.
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What it tests

  • Immersive Virtual Reality
  • Physical Activity
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Where

1 site
Juan Fco. Lisón
Valencia, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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