Immersive Healing: The Therapeutic Potential of Virtual Reality

Study Overview
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Brief Summary
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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
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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.

Official Title
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Immersive Healing: The Therapeutic Potential of Virtual Reality in Phantom Limb Experience

Conditions
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Phantom Limb Pain (PLP)

Intervention / Treatment
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* Behavioral: virtual reality therapy
* Other: matched control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pre- and post-intervention surveys will be used to assess the effects of virtual reality (VR) therapy on the phantom limb experience in the intervention group. Matched controls from the registry will be surveyed on their phantom limb symptoms at matching time intervals to the intervention group for comparison.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality (VR) Intervention<br>Individuals undergoing virtual reality therapy intervention | Behavioral: virtual reality therapy<br>* 4 weekly sessions of 30-minute VR therapy in the office with pre- and post-intervention surveys<br>* Other names: VR Intervention;|
| Sham Comparator: Matched Control<br>The matched controls will receive standard care without the VR intervention | Other: matched control group<br>* taking the same surveys as the VR intervention group on a weekly basis for 4 weeks<br>* Other names: control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ) | 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. | Baseline | 
| Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ) | 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. | Week 1 | 
| Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ) | 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. | Week 2 | 
| Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ) | 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. | Week 3 | 
| Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ) | 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. | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Brief Pain Inventory (BPI) interference scale scores | Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain - Scores range from 0 to 10 with higher scores indicating greater pain interference. | Week 4 | 
| Change in Short-Form McGill Pain Questionnaire (SF-MPQ) scores | A short form of the McGill Pain Questionnaire (SF-MPQ) has been developed. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Consists of 22 different descriptors of pain and each item is rated based on a 0-10 scale with 0 equal to no pain and 10 equal to the worst pain ever during the past week. The total score is calculated by summing 22 individual scores. | Week 4 | 
| Phantom Limb Experience Survey score | This is only being administered once at the beginning of study - it is qualitative and there is no good or bad, this is just to define the population and better characterize phantom limb experience. | Baseline | 
| Change in Virtual Reality (VR) Therapy Survey scores | There are several questions within this survey to assess attitude towards VR, which activities are favored and then the effect VR had on them. There is a mix of qualitative questions and quantitative. Quantitative questions are on Likert Scale 1-5. An interval change of +1 on Likert scale would be good for question on posture, control over limb. For how long the therapy effect lasts after session is over, it will vary from hours to days to weeks (which is why all descriptors are in there). Even if it lasted 1 hour this would be considered good. | Week 4 | 
| Change in Patient Health Questionnaire-9 (PHQ-9) scores | Scores less than 5 almost always signified the absence of a depressive disorder; scores of 5 to 9 predominantly represented patients with either no depression or subthreshold (i.e., other) depression; scores of 10 to 14 represented a spectrum of patients; and scores of 15 or greater usually indicated major depression. | Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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amputee, pain management, virtual reality (VR) therapy