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Virtual Reality Treatment for Phantom Leg Pain

This study is exploring a new way to treat phantom leg pain (pain felt in a missing limb after amputation) using Virtual Reality (VR). Many people who have had a leg amputated experience this type of pain, and current treatments don't always work well. This study will test a home-based VR treatment called "Active Virtual Reality Treatment." You would play VR games that involve leg movements, and the VR system would show you a visual image of your missing leg. Researchers want to see if this VR treatment can reduce pain intensity and improve the quality of your pain. To join, you need to be between 18 and 100 years old, have had a leg amputation more than three months ago, and experience phantom limb pain rated as 4 or higher on a 0-10 scale. The study plans to enroll 44 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 44 participants.
What's involved
You would participate in 8 twice-weekly sessions of Active Virtual Reality Treatment, each lasting about 1 hour. Pain will be measured before and after each session, and at several points up to 8 weeks after the treatment ends.
Compensation
Not stated in the trial record.
Follow-up
Your pain will be monitored for 8 weeks after the end of the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07044323

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

Recruiting
NAAges 18+InterventionalTreatment
Albert Einstein Healthcare Network
~44 participants
Updated 2025-08-08 on ClinicalTrials.gov
What's tested:Active Virtual Reality Treatment

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in pain intensity
Measured over 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.
+1 more outcome measured

Conditions

Phantom Pain Following Amputation of Lower Limb
Amputation

Explore related trials

Phantom Limb Pain

NCT07044323

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Jefferson Moss Rehabilitation Research Institute

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

  • University of Washington

    Seattle, Washingtonstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Laurel Buxbaum
[email protected]
215-663-6321
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Changes in pain intensitypre 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.

    the change in phantom limb pain score pre and post each VR intervention, at baseline, after the VR intervention and in the follow-up sessions as assessed using an 11-point numerical rating pain scale (0 - minimum score/no pain; 10 maximum score/pain as bad as you can imagine) assessing the current PLP level.

  • Changes in pain quality of the McGill Short Form Questionnairebaseline, 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

    The change in the phantom limb pain quality between baseline, post-intervention, and follow-up sessions using McGill Short Form Questionnaire that measures the characteristics of pain (e.g., throbbing, etc.) using a 4-point rating pain scale (0 - minimum score - none: better outcome /4 maximum score - severe: worse outcome).