Effectiveness of an Immersive Virtual Reality-based Therapeutic Exercise Program With Altered Visual Feedback in Patients With Fibromyalgia: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Fibromyalgia Impact
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Immersive Virtual Reality + Physical Activity
A set of ten therapeutic exercises using IVR will be implemented. These exercises are designed to enhance strength, stability, mobility, and flexibility in the abdomino-lumbo-pelvic region and lower limbs. During each exercise, participants will wear IVR goggles that modify visual proprioceptive feedback by altering the perceived range of movement. Specifically, the visual input provided by the IVR system will create a discrepancy between actual physical movement and perceived motion, allowing participants to visually experience movements differently from reality.
Intervention: Immersive Virtual Reality (Other)
Immersive Virtual Reality + Physical Activity
A set of ten therapeutic exercises using IVR will be implemented. These exercises are designed to enhance strength, stability, mobility, and flexibility in the abdomino-lumbo-pelvic region and lower limbs. During each exercise, participants will wear IVR goggles that modify visual proprioceptive feedback by altering the perceived range of movement. Specifically, the visual input provided by the IVR system will create a discrepancy between actual physical movement and perceived motion, allowing participants to visually experience movements differently from reality.
Intervention: Physical Activity (Other)
Physical Activity
Control-group participants will perform the same 6-week therapeutic-exercise program as the experimental group; the only difference will be the absence of the IVR. Training methodology, load progression, assessment procedures, and physiotherapist supervision will remain identical, ensuring comparability between groups.
Intervention: Physical Activity (Other)
Outcomes
Primary Outcomes
Fibromyalgia Impact
Time Frame: At six weeks
Measured with Spanish version of the Revised Fibromyalgia Impact Questionnaire (FIQR). This 21-item instrument evaluates physical function (0-30), overall impact (0-20), and symptom severity (0-50), yielding a total score from 0 to 100, with higher scores indicating greater impairment.
Secondary Outcomes
- Fatigue(At six weeks)
- Sleep quality(At six weeks)
- Pain distribution(At six weeks)
- Symptom severity(At six weeks)
- Change in Fibromyalgia Survey Diagnostic Criteria (FSDC) total score(At six weeks)
- Health-related quality of life(At six weeks)
- Anxiety and depression(At six weeks)
- Pain catastrophizing(At six weeks)
- Fear-avoidance beliefs(At six weeks)
- Kinesiophobia(At six weeks)
- Central sensitization(At six weeks)
- Pressure Pain Threshold(At six weeks)
- Temporal summation of pain(At six weeks)
- Conditioned pain modulation(At six weeks)
- Lower limb strength and endurance(At six weeks)
- Functional mobility(At six weeks)
- Isometric quadriceps strength(At six weeks)
- Handgrip strength(At six weeks)
- Behavioral regulations in exercise(At six weeks)
- Dizziness provoked by immersive virtual-reality(At six weeks)
- Change in total physical activity (MET-minutes/week)(At six weeks)
- Fatigue(At six weeks)
- Sleep quality(At six weeks)
- Change in Fibromyalgia Survey Diagnostic Criteria (FSDC) total score(At six weeks)
- Pain distribution(At six weeks)
- Health-related quality of life(At six weeks)
- Symptom severity(At six weeks)
- Anxiety and depression(At six weeks)
- Pain catastrophizing(At six weeks)
- Kinesiophobia(At six weeks)
- Central sensitization(At six weeks)
- Pressure Pain Threshold(At six weeks)
- Temporal summation of pain(At six weeks)
- Conditioned pain modulation(At six weeks)
- Fear-avoidance beliefs(At six weeks)
- Lower limb strength and endurance(At six weeks)
- Functional mobility(At six weeks)
- Isometric quadriceps strength(At six weeks)
- Handgrip strength(At six weeks)
- Behavioral regulations in exercise(At six weeks)
- Dizziness provoked by immersive virtual-reality(At six weeks)
- Change in pain intensity from pre- to post-exercise session (11-point Numeric Rating Scale, 0-10)(Immediately before and after each exercise session over the 6-week intervention period (two sessions per week).)
- Change in total physical activity (MET-minutes/week)(At six weeks)
Investigators
Juan F. Lisón Párraga, Dr
Chair Professor
Cardenal Herrera University