Immersive Healing: The Therapeutic Potential of Virtual Reality

NCT06077227 | Recruiting DMC FDA Device

• 1 other identifier: IRB00100006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Phantom Limb Pain (PLP)

Keywords

amputee; pain management; virtual reality (VR) therapy

Outcome Measures

Primary Outcomes (5)

• 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 6

Secondary Outcomes (7)

• Change in Brief Pain Inventory (BPI) scores

  Hour 24

• Change in Short-Form McGill Pain Questionnaire (SF-MPQ) scores

  Week 6

• Phantom Limb Experience Survey score

  Baseline

• Change in Virtual Reality (VR) Therapy Survey scores

  Week 6

• System Usability Scale

  Week 6

Study Arms (2)

Virtual Reality (VR) Intervention

EXPERIMENTAL

Individuals undergoing virtual reality therapy intervention

Device: virtual reality therapy

Matched Control

SHAM COMPARATOR

The matched controls will receive standard care without the VR intervention

Other: matched control group

Interventions

virtual reality therapy DEVICE

6 2 times weekly sessions of 30-minute VR therapy in the office with pre- and post-intervention surveys

Also known as: VR Intervention

Virtual Reality (VR) Intervention

matched control group OTHER

taking the same surveys as the VR intervention group on a weekly basis for 6 weeks

Also known as: control group

Matched Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of major limb amputation
• Age \> 18 years old
• Presence of phantom limb pain or negative phantom sensation(s)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

OrthoCarolina Hand Center

Charlotte, North Carolina, 28207, United States

RECRUITING

MeSH Terms

Conditions

Phantom Limb; Agnosia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Glenn Gaston, MD

  Atrium Health Musculoskeletal Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Steinke

CONTACT

704-942-4351; joshua.steinke@orthocarolina.com

Ben Connell

CONTACT

ben.connell@orthocarolina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 11, 2023
• Study Start: December 21, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 31, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal

Locations

US (1)