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

Официальное название

Effectiveness of an Immersive Virtual Reality-based Therapeutic Exercise Program With Altered Visual Feedback in Patients With Fibromyalgia: A Randomized Controlled Trial

Обзор

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 extension range of motion, somatosensory function, body perception distortion, muscle strength of the handgrip and quadriceps, functional mobility, lower limb strength, behavioral regulation concerning exercise adherence, and patient-reported experiences regarding IVR use. This trial seeks to elucidate whether incorporating IVR into therapeutic exercise protocols reduces the impact of fibromyalgia on patients' daily lives and improves physiological, psychological, and physical outcomes compared to traditional exercise approaches without IVR.

Подробное описание

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 and increasing healthcare costs. Although therapeutic exercise is a first-line, evidence-based treatment, its implementation is often hindered by low adherence, kinesiophobia, and maladaptive pain beliefs. Immersive virtual reality (IVR) has gained attention as a novel approach to enhance exercise efficacy through sensory immersion, cognitive distraction, and embodiment. Visual feedback manipulation in IVR-such as creating the illusion of reduced movement-has been shown to increase range of motion and engagement without intensifying perceived pain or effort. While non-immersive VR systems have shown benefits in symptom management and adherence, IVR appears to offer superior outcomes via real-time multisensory integration. However, no studies have yet investigated the clinical effects of integrating IVR with altered visual input during therapeutic exercise in FM. This will be a randomized controlled trial evaluating a 6-week IVR-based exercise program that modulates visual input to create the perception of reduced movement in FM patients. The experimental group will be compared to a control group following the same exercise program without IVR. Outcome measures include pain intensity, fatigue, sleep quality, kinesiophobia, functional capacity, symptom severity, and user experience. This study seeks to fill a critical gap in FM rehabilitation by testing whether IVR-enhanced exercise with visual modulation reduces the impact of fibromyalgia on patients' daily lives and improves physiological, psychological, and physical outcomes compared to traditional exercise approaches without IVR.

Вмешательства

• Другое Immersive Virtual Reality
  Participants will wear an HTC Vive Pro head-mounted display with waist, hand and foot trackers during 60-min sessions, 2 times/week for 6 weeks (12 sessions). A gender- and skin-tone-matched first-person avatar will be calibrated to the user's anthropometrics and will mirror all real-time movements. Standardised audio instructions will be played through the headset; a virtual mirror will provide visual feedback. To facilitate lumbar mobility, two sensorimotor illusions will be applied: (1) Flex
• Другое Physical Activity
  Participants will undertake a 6-week therapeutic exercise program, consisting of two sessions per week (12 sessions total), with a primary objective of reducing fibromyalgia's impact on daily life. Each session will involve ten exercises performed in one or two sets each, depending on the week of the protocol. Exercise repetitions and intensity will be individualized using the Borg Rating of Perceived Exertion (RPE) scale (6-20), maintaining an intensity range of RPE 13-17. Specifically, intensi

Первичные конечные точки

• Fibromyalgia Impact [Срок оценки: At six weeks]

Вторичные конечные точки (12)

• Fatigue [Срок оценки: At six weeks]
• Sleep quality [Срок оценки: At six weeks]
• Pain distribution [Срок оценки: At six weeks]
• Symptom severity [Срок оценки: At six weeks]
• Change in Fibromyalgia Survey Diagnostic Criteria (FSDC) total score [Срок оценки: At six weeks]
• Health-related quality of life [Срок оценки: At six weeks]
• Anxiety and depression [Срок оценки: At six weeks]
• Pain catastrophizing [Срок оценки: At six weeks]
• Fear-avoidance beliefs [Срок оценки: At six weeks]
• Kinesiophobia [Срок оценки: At six weeks]
• Central sensitization [Срок оценки: At six weeks]
• Pressure Pain Threshold [Срок оценки: At six weeks]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Juan Fco. Lisón — Valencia

Публикации

• Salvador-Huerta C, Jordan-Lopez J, Azanon-Nogueira P, Garcia-Lucas C, Amer-Cuenca JJ, Lison JF. Effectiveness of a fully immersive virtual reality-based therapeutic exercise programme with altered visual feedback in patients with fibromyalgia: A study protocol for a randomised controlled trial. PLoS One. 2026 Jun 4;21(6):e0348346. doi: 10.1371/journal.pone.0348346. eCollection 2026. PMID 42241401

Идентификаторы

NCT: NCT06948500 · UNIVERSITY CARDENAL HERRERA-80 · CEEI25/643

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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