Efficacy and Mechanisms of Virtual Reality Treatment of Phantom Leg Pain
Phantom Limb Pain
About this trial
This is an interventional treatment trial for Phantom Limb Pain
Eligibility Criteria
Inclusion Criteria:
- 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 24 or greater
- Pain averaged over the preceding 1 month in the phantom limb rated as greater than 40 on the visual analog scale of the McGill Pain Questionnaire (Melzack, 1987)
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
- 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
Sites / Locations
- Moss Rehabilitation Research InstituteRecruiting
- University of PennsylvaniaRecruiting
- University of Washington-Harborview Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Active VR treatment
Distractor VR treatment
Subjects assigned to the Active VR treatment will begin by selecting an avatar, with features such as gender and skin color that can be chosen according to preference. During treatment, they will participate in a variety of games and activities developed and used by our teams including Kick, Dog Food, Quest for Fire, Chess, Checkers, Sudoku, and surfing the internet. Subjects will have substantial flexibility to select games according to their interests but will be required to spend at least 30 minutes in each session in games that require forceful, large amplitude, movements of the amputated lower limb (e.g., Quest for Fire, Kick). Time spent and level of engagement as measured by movements of the avatar or, in the case of chess, checkers, solitaire, Sudoku, and internet surfing, the number of clicks produced with each leg will be recorded for each activity using custom software
Subjects assigned to the Distractor VR treatment will participate in REAL i-Series immersive VR experience (REAL system), which has been demonstrated to reduce pain in several studies but lacks the hypothesized "active ingredients" of our Active VR treatment (visual and auditory feedback of movement of an extrapolated amputated limb). Subjects will navigate through pleasant and relaxing VR environments; they will not see any rendering of their body and make no movements with their legs