Virtual Reality Treatment for Phantom Limb Pain

(PLP Home-Based Trial)

Recruiting at 2 trial locations

Overseen By Laurel Buxbaum

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Albert Einstein Healthcare Network

Disqualifiers: Stroke, Brain injury, Psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 8 weeks

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether virtual reality (VR) can reduce phantom limb pain for individuals who have lost an arm or leg. Phantom limb pain is the sensation of pain in a limb that no longer exists, and many standard treatments prove ineffective. Participants will use a VR system at home to determine if it eases their pain. Individuals who underwent amputation more than three months ago and experience significant daily phantom limb pain might be suitable candidates. As an unphased trial, this study offers a unique opportunity to explore innovative pain relief methods that could enhance daily life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this virtual reality treatment is safe for phantom limb pain?

Research has shown that virtual reality treatments for phantom limb pain are generally safe. These treatments are non-invasive, meaning they don't involve surgery or entering the body. Studies have found that they not only help reduce pain but are also well-tolerated by most people. No major reports of negative effects have emerged from using virtual reality for pain management, making it a promising option for those with phantom limb pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the virtual reality treatment for phantom limb pain because it offers a unique, non-invasive approach compared to traditional methods like medication or physical therapy. Unlike other treatments that primarily aim to manage symptoms through drugs or physical rehabilitation, this virtual reality treatment works by immersing patients in a digital environment that can trick the brain into perceiving the presence and movement of the missing limb, potentially reducing pain. Additionally, it is self-administered and home-based, providing patients with the convenience and flexibility to manage their pain more independently. This innovative technology could transform how we approach phantom limb pain by directly engaging the brain's perception processes.

What evidence suggests that this virtual reality treatment is effective for phantom limb pain?

Research has shown that virtual reality (VR) therapy can help treat phantom limb pain (PLP). In a review of studies, 14 out of 15 reported reduced pain in people using VR. Another study found that VR treatments significantly lowered pain levels, with an average decrease of 2.30 points on the pain scale. Additionally, a feasibility study discovered that a new VR treatment not only reduced pain intensity but also decreased phantom sensations. This trial will evaluate a home-based, self-administered Active Virtual Reality treatment, suggesting that VR could be a promising option for people dealing with PLP. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who have had an arm or leg amputated and are experiencing phantom limb pain, which is a sensation of pain in the missing limb. Participants should be able to use virtual reality equipment at home.

Inclusion Criteria

Absence of cognitive impairment, operationally defined as a Montreal Cognitive Assessment score of 18 or greater

I understand and can agree to the study's procedures and risks.

I had a leg amputation above or below the knee over 3 months ago.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo home-based, self-administered Active Virtual Reality treatment for phantom limb pain

8 weeks

8 sessions (self-administered at home)

Follow-up

Participants are monitored for changes in pain intensity, quality of life, and other outcomes after the treatment

8 weeks

Follow-up assessments at 1 week and 8 weeks post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Active Virtual Reality Treatment

Trial Overview The study tests a home-based active Virtual Reality (VR) treatment designed to alleviate phantom limb pain, which many amputees suffer from despite traditional treatments.

How Is the Trial Designed?

Group I: Home-based treatment Experimental Treatment 1 Intervention

Self-administered Active Virtual Reality treatment

Who Is Running the Clinical Trial?

Albert Einstein Healthcare Network

Lead Sponsor

Trials

65

Recruited

869,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12179911/

Innovative exploration of phantom limb pain treatment based ... We explore the potential of virtual reality, augmented reality, and mixed reality in alleviating pain and improving psychological status and quality of life of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07044323

NCT07044323 | Efficacy and Mechanisms of Virtual Reality ... The study will explore the feasibility and efficacy of a home-based, active VR treatment for phantom limb pain (PLP).

3. academic.oup.com academic.oup.com/painmedicine/article/20/10/2051/5511535

Virtual Reality Intervention for the Treatment of Phantom Limb ... This feasibility study of a novel VR intervention for PLP was practical and was associated with significant reductions in PLP intensity and phantom sensations.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666138123000130

X-reality for phantom limb management for amputees Overall, the X-reality interventions reduced the pain level of the amputees (mean difference: -2.30, 95% CI, -3.38 to -1.22), especially the virtual reality ...

5. withpower.com withpower.com/trial/phase-phantom-limb-pain-plp-3-2022-75926

Virtual Reality Treatment for Phantom Limb Pain Virtual reality (VR) therapy shows promise as an effective treatment for phantom limb pain (PLP), with 14 out of 15 studies reporting reductions in pain scores ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03338842

Virtual Reality Treatment for Phantom Limb Pain A decrease (i.e. reduction in the scores) in pain severity and in the pain interference in daily activity is expected as consequence of the virtual reality ...

7. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2023.1203670/full

Virtual reality for pain management: an umbrella review VR might be effective in reducing phantom limb pain (PLP). VR therapy provided advantages over mirror therapy, including greater freedom to ...