Status:

COMPLETED

Efficacy and Mechanisms of Virtual Reality Treatment of Phantom Leg Pain

Lead Sponsor:

Albert Einstein Healthcare Network

Collaborating Sponsors:

University of Pennsylvania

University of Washington

Conditions:

Phantom Limb Pain

Eligibility:

All Genders

18-100 years

Phase:

NA

Brief Summary

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 experienc...

Detailed Description

Almost 2 million people in the US have had an amputation and up to 90% of people with limb amputation experience the persistent sensation of the missing extremity, a phenomenon known as a "phantom lim...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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

Key Trial Info

Start Date :

May 10 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 6 2025

Estimated Enrollment :

46 Patients enrolled

Trial Details

Trial ID

NCT05296265

Start Date

May 10 2022

End Date

April 6 2025

Last Update

October 3 2025

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Moss Rehabilitation Research Institute

Elkins Park, Pennsylvania, United States, 19027

2

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

3

University of Washington-Harborview Medical Center

Seattle, Washington, United States, 98104

Efficacy and Mechanisms of Virtual Reality Treatment of Phantom Leg Pain | DecenTrialz