Clinical trial NCT06948500: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Immersive Virtual reality
Exercise
Pain
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 the Visual Analogue Scale (VAS).

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.

Primary outcomes:
measure: Fibromyalgia Impact
timeFrame: At six weeks
Secondary outcomes:
measure: Fatigue
timeFrame: At six weeks
measure: Sleep quality
timeFrame: At six weeks
measure: Pain distribution
timeFrame: At six weeks
measure: Symptom severity
timeFrame: At six weeks
measure: Change in Fibromyalgia Survey Diagnostic Criteria (FSDC) total score
timeFrame: At six weeks
measure: Health-related quality of life
timeFrame: At six weeks
measure: Anxiety and depression
timeFrame: At six weeks
measure: Pain catastrophizing
timeFrame: At six weeks
measure: Fear-avoidance beliefs
timeFrame: At six weeks
measure: Kinesiophobia
timeFrame: At six weeks
measure: Central sensitization
timeFrame: At six weeks
measure: Pressure Pain Threshold
timeFrame: At six weeks
measure: Temporal summation of pain
timeFrame: At six weeks
measure: Conditioned pain modulation
timeFrame: At six weeks
measure: Lower limb strength and endurance
timeFrame: At six weeks
measure: Functional mobility
timeFrame: At six weeks
measure: Isometric quadriceps strength
timeFrame: At six weeks
measure: Handgrip strength
timeFrame: At six weeks
measure: Behavioral regulations in exercise
timeFrame: At six weeks
measure: Dizziness provoked by immersive virtual-reality
timeFrame: At six weeks
measure: Change in pain intensity from pre- to post-exercise session (VAS 0-10)
timeFrame: At six weeks
measure: Change in total physical activity (MET-minutes/week)
timeFrame: At six weeks
Other outcomes:
Locations:
city: València
country: Spain
facility: Juan Fco. Lisón
state: Valencia-valència
Study officials:
affiliation: Cardenal Herrera University
name: Juan F Lisón, PhD
role: PRINCIPAL_INVESTIGATOR
References: