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

Official title

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

Overview

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.

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 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.

Interventions

• Other 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
• Other 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

Primary outcome measures

• Fibromyalgia Impact [Time frame: At six weeks]

Secondary outcome measures (12)

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Juan Fco. Lisón — Valencia

Publications

• 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

Identifiers

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

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗