Immersive Healing: The Therapeutic Potential of Virtual Reality

Wake Forest University (WFU)

Status: Enrolling

Conditions: Phantom Limb Pain (PLP)

Treatments: Device: virtual reality therapy; Other: matched control group

Study type: Interventional

Funder types: Other

Identifiers

NCT06077227

IRB00100006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Virtual Reality (VR) Intervention

Experimental group

Description:

Individuals undergoing virtual reality therapy intervention

Treatment:

Device: virtual reality therapy

Matched Control

Sham Comparator group

Description:

The matched controls will receive standard care without the VR intervention

Treatment:

Other: matched control group