Clinical trial NCT06077227: Immersive Healing: The Therapeutic Potential of Virtual Reality
Official title: Immersive Healing: The Therapeutic Potential of Virtual Reality in Phantom Limb Experience
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Phantom Limb Pain (PLP)
Keywords: amputee
pain management
virtual reality (VR) therapy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
timeFrame: Baseline
measure: Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
timeFrame: Week 1
measure: Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
timeFrame: Week 2
measure: Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
timeFrame: Week 3
measure: Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
timeFrame: Week 6
Secondary outcomes:
measure: Change in Brief Pain Inventory (BPI) scores
timeFrame: Hour 24
measure: Change in Short-Form McGill Pain Questionnaire (SF-MPQ) scores
timeFrame: Week 6
measure: Phantom Limb Experience Survey score
timeFrame: Baseline
measure: Change in Virtual Reality (VR) Therapy Survey scores
timeFrame: Week 6
measure: System Usability Scale
timeFrame: Week 6
measure: Simulator Sickness Questionnaire
timeFrame: Week 6
measure: Change in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) scores
timeFrame: Week 6
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: OrthoCarolina Hand Center
state: North Carolina
Study officials:
affiliation: Atrium Health Musculoskeletal Institute
name: Glenn Gaston, MD
role: PRINCIPAL_INVESTIGATOR
References: