Recruiting

Virtual Reality

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06077227

Conditions

Phantom Limb Pain (PLP)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

virtual reality therapy

matched control group

Study Details

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)

Study ID

NCT06077227

Start date

Dec 21, 2023

Status verified date

Jul, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Virtual Reality (VR) Intervention

Individuals undergoing virtual reality therapy intervention

sham comparator: Matched Control

The matched controls will receive standard care without the VR intervention

Interventions

virtual reality therapy

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

matched control group

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

Primary outcome measure

  • Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: Baseline ]
  • Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: Week 1 ]
  • Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: Week 2 ]
  • Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: Week 3 ]
  • Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: Week 6 ]

Central Contacts and Locations

Central contacts

Joshua Steinke

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

Ben Connell

ben.connell@orthocarolina.com

Locations

OrthoCarolina Hand Center

Recruiting

Charlotte, North Carolina, United States, 28207

Contacts

Joshua Steinke

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

ben Connell

ben.connell@orthocarolina.com

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Keywords

  • amputee
  • pain management
  • virtual reality (VR) therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-31.