Efficacy and Mechanisms of Virtual Reality Treatment of Phantom Leg Pain
Completed · Not applicable
Conditions studied: Phantom Limb Pain
In brief
After amputation of an arm or leg, up to 90% of subjects experience a "phantom limb", a phenomenon characterized by persistent feelings of the missing limb. Many subjects with a phantom limb experience intense pain in the missing extremity that is often poorly responsive to medications or other interventions. The proposed work will contrast the efficacy of two virtual reality treatments for phantom limb pain: a 'Distractor' and an Active VR treatment. In the Distractor treatment, participants are engaged in a visually immersive virtual reality experience that does not require leg movements (REAL i-Series® immersive VR experience). In the Active VR treatment, subjects play a series of VR games using the virtual rendering of both legs.
Key facts
- Study ID
- NCT05296265
- Run by
- Albert Einstein Healthcare Network
- People needed
- 46
- Starts
- 2022-05-10
- Expected to finish
- 2025-04-06
- Last updated by the study team
- 2025-10-03
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 - 100 years
- Capacity to provide Informed Consent
- Unilateral above or below knee amputation more than 3 months prior to enrollment
- Absence of cognitive impairment, operationally defined as a Montreal Cognitive Assessment score of 18 or greater
- Pain averaged over the preceding 1 month in the phantom limb rated as greater than 4 on a scale of 0-10.
You may not qualify if…
- History of significant medical or neurological disorder such as stroke or moderate to severe traumatic brain injury (operationally defined as loss of consciousness for more than 30 minutes)
- History of significant or poorly controlled psychiatric disorders
- Current significant depression or anxiety as judged by the Hospital Anxiety and Depression Scale (HADS) (Zigmond \& Snaith, 1983).
- Current abuse of alcohol or drugs, prescription or otherwise
- Nursing a child, pregnant, or intent to become pregnant during the study
Where it is running
- Moss Rehabilitation Research Institute — Elkins Park, Pennsylvania, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- University of Washington-Harborview Medical Center — Seattle, Washington, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.