Efficacy and Mechanisms of Virtual Reality Treatment of Phantom Leg Pain (NCT05296265) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Mechanisms of Virtual Reality Treatment of Phantom Leg Pain
United States46 participantsStarted 2022-05-10
Plain-language 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 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.
Who can participate
Age range18 Years – 100 Years
SexALL
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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 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 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
What they're measuring
1
Changes in pain intensity
Timeframe: pre each intervention (8 sessions); immediately after each intervention (8 session); baseline, pre-intervention; immediately after the end of the intervention; 1 week after the end of the intervention; 8 weeks after the end of the intervention
2
Changes in pain quality
Timeframe: baseline, pre-intervention; immediately after the end of the intervention; 1 week after the end of the intervention; 8 weeks after the end of the intervention