Efficacy and Mechanisms of Virtual Reality Treatment of Phantom Leg Pain.Home-Based Treatment (PLP Home-Based)

Albert Einstein Healthcare Network

Status

Enrolling

Conditions

Amputation

Phantom Pain Following Amputation of Lower Limb

Treatments

Behavioral: Active Virtual Reality Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT07044323

5R01HD104158-03 (U.S. NIH Grant/Contract)

AEHN2022-775

Details and patient eligibility

About

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 study will explore the feasibility and efficacy of a home-based, active VR treatment for phantom limb pain (PLP).

Full 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 limb"Additionally, a significant proportion of individuals with a phantom limb - up to 85% in some studies - experience persistent and debilitating pain in the missing limb, a condition known as phantom limb pain (hereafter PLP). Although existing therapies provide pain relief in some cases, there is widespread agreement that current approaches fall short of bringing relief to most individuals with PLP

The investigators recently completed the in-person part of the study in which they compared the efficacy of Active VR treatment to Distractor VR treatment for PLP on measures of pain as well as psychological health and quality of life.

In the Active VR treatment, subjects played a variety of active games requiring leg movements while receiving high-quality visual feedback of the missing lower leg. Feedback about leg position was provided via the VR headset controller, and the program generated an image of the missing lower leg, visible as a first-person avatar. The "Distractor" treatment was the REAL i-Series® immersive VR experience: subjects navigated through a pleasant VR environment, without seeing any rendering of their body and making no movements with their legs. The results of the in-person study showed superior efficacy in reducing pain intensity of the Active Treatment as compared to the Distractor treatment.

The specific aim of the current study is to assess the feasibility and efficacy of a home-based, active VR treatment for PLP.

Enrollment

44 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18 -100
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 greater1.
Pain averaged over the preceding 1 month in the phantom limb rated as greater than 4 on a scale of 0-10.

Exclusion criteria

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
Substantial depression or anxiety affecting their ability to perform tasks necessary for the study.
Current abuse of alcohol or drugs, prescription or otherwise
Nursing a child, pregnant, or intent to become pregnant during the study