Immersive Healing: The Therapeutic Potential of Virtual Reality in Phantom Limb Experience
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
Study Overview
Brief Summary
Phantom limb pain (PLP) is a significant and pervasive issue among upper limb amputees, severely impacting their quality of life. The literature delineating prevalence of upper versus lower limb amputations is limited, but the prevalence of total amputations in the United States is estimated to reach 3 million individuals by 2050, with approximately 185,000 new cases annually. PLP affects 60-68% of these patients, leading to heightened levels of anxiety, depression, and reduced overall well-being.
Detailed Description
Although studies exploring the efficacy of VR therapy for PLP have reported positive outcomes, several limitations, such as small sample sizes, lack of randomization, and inconsistent treatment protocols, have impeded widespread adoption of these innovative approaches. Additionally, the literature does not sufficiently delineate which aspects of the phantom limb experience may be addressed with VR therapy. To overcome these limitations and optimize treatment efficacy, it is crucial to gain a comprehensive understanding of the phantom limb experience, including both somatosensory and kinesthesia-related symptoms. Additionally, this study will address these limitations by employing a larger sample size, rigorous methodology, and a standardized treatment protocol.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •History of major limb amputation
- •Age > 18 years old
- •Presence of phantom limb pain or negative phantom sensation(s)
Exclusion Criteria
- •Active mental illness, neurological disease, or cognitive impairment that would interfere with survey completion
- •Those without phantom limb pain or negative phantom limb sensations
- •Non-English speaking
Arms & Interventions
Virtual Reality (VR) Intervention
Individuals undergoing virtual reality therapy intervention
Intervention: virtual reality therapy (Device)
Matched Control
The matched controls will receive standard care without the VR intervention
Intervention: matched control group (Other)
Outcomes
Primary Outcomes
Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
Time Frame: Week 6
Short-form McGill Pain Questionnaire - The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain. A person with a high score, nearer to the highest score of 78, more than likely deals with chronic pain daily.
Secondary Outcomes
- Change in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) scores(Week 6)
- Change in Brief Pain Inventory (BPI) scores(Hour 24)
- System Usability Scale(Week 6)
- Phantom Limb Experience Survey score(Baseline)
- Change in Virtual Reality (VR) Therapy Survey scores(Week 6)
- Simulator Sickness Questionnaire(Week 6)
- Change in Short-Form McGill Pain Questionnaire (SF-MPQ) scores(Week 6)