Virtual Reality Treatment for Phantom Limb Pain

No longer 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)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two virtual reality (VR) treatments for individuals experiencing phantom limb pain after leg amputation. The goal is to evaluate how effectively each VR approach reduces pain. One treatment provides a relaxing VR experience, while the other involves interactive games requiring virtual leg movements. Individuals who had a leg amputated at least three months ago and continue to experience significant phantom pain may be suitable for this study. As an unphased trial, this study offers a unique opportunity to explore innovative VR treatments for pain relief.

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 trial coordinators or your doctor.

What prior data suggests that these virtual reality treatments are safe for managing phantom limb pain?

Research has shown that virtual reality (VR) treatments are generally safe for people. They are non-invasive, meaning they don't involve entering the body, and are considered affordable. Studies have demonstrated that VR can significantly reduce phantom limb pain, with 88% of participants in one study reporting relief.

The Active VR treatment involves playing VR games using a virtual version of both legs. This method has proven effective and is linked to a noticeable decrease in pain and phantom sensations. The Distractor VR treatment, which immerses participants in enjoyable VR environments, has also reduced pain.

Both treatments have been tested on people and are well-tolerated, with no serious side effects reported. This makes them promising options for those experiencing phantom limb pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for phantom limb pain, which often include medications like painkillers or antidepressants, the VR treatments being studied offer a unique, non-invasive approach. The Active VR treatment is particularly innovative because it immerses users in a virtual environment where they can engage in games and activities that require movement of their amputated limb, potentially retraining the brain's perception of the missing limb. Meanwhile, the Distractor VR treatment provides a soothing virtual experience without focusing on limb movement, aiming to reduce pain through relaxation. Researchers are excited about these treatments because they could offer a drug-free, engaging alternative that directly addresses the brain's role in phantom limb pain.

What evidence suggests that this trial's virtual reality treatments could be effective for phantom limb pain?

Research has shown that virtual reality (VR) can significantly reduce phantom limb pain, the pain felt where a limb used to be. In this trial, participants will receive one of two VR treatments. Studies have found that the Active VR treatment, which involves playing games with a virtual limb, lessens pain and alters perceptions of the missing limb. The Distractor VR treatment, which places users in a calming VR setting, has also shown promise in reducing pain, even without focusing on limb movement. Both treatments aim to engage the brain and change its experience of the missing limb, offering hope for those facing this challenging condition. ^{1 3 4 6 7}

Who Is on the Research Team?

Laurel Buxbaum, PsyD

Principal Investigator

Albert Einstein Healthcare Netork

Are You a Good Fit for This Trial?

This trial is for adults aged 18-100 who've had an arm or leg amputated above or below the knee at least 3 months ago, experience significant phantom limb pain (pain in the missing part), and can think clearly enough to consent. It's not for those with major medical issues like stroke, severe brain injuries, uncontrolled mental health conditions, substance abuse problems, or women who are nursing or pregnant.

Inclusion Criteria

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

You must score 18 or higher on a test that measures your memory and thinking skills.

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

Exclusion Criteria

Nursing a child, pregnant, or intent to become pregnant during the study

I have had a serious brain condition, like a severe head injury or stroke.

You are currently experiencing major feelings of sadness or worry, as determined by a specific scale.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either Distractor VR treatment or Active VR treatment for phantom limb pain, involving immersive VR experiences and interactive games.

8 weeks

8 sessions

Follow-up

Participants are monitored for changes in pain intensity, quality, and psychological health after the treatment.

8 weeks

1 week and 8 weeks after treatment

What Are the Treatments Tested in This Trial?

Interventions

• VR treatment for phantom limb pain

Trial Overview

The study tests two virtual reality treatments for phantom limb pain. One distracts patients with immersive VR that doesn't involve moving their legs. The other ('Active VR') has them play games that simulate using both legs. The goal is to see which treatment better eases the pain of a missing limb.

How Is the Trial Designed?

Group I: Distractor VR treatment Experimental Treatment 1 Intervention

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

Group II: Active VR treatment Experimental Treatment 1 Intervention

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

VR treatment for phantom limb pain is already approved in United States, European Union for the following indications:

Approved in United States as Virtual Reality Treatment for Phantom Limb Pain for:

• Phantom limb pain management

Approved in European Union as Virtual Reality Treatment for Phantom Limb Pain for:

• Phantom limb pain management

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+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Published Research Related to This Trial

A systematic review of 46 studies involving 1456 participants found that virtual, augmented, or mixed reality (VR/AR/MR) technology improved pain-related outcomes in 78% of randomized controlled trials (RCTs) for individuals with chronic pain.

Most positive effects were observed immediately or up to one month after treatment, highlighting the need for further RCTs to evaluate long-term benefits and accessibility for those facing pain management disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use and efficacy of virtual, augmented, or mixed reality technology for chronic pain: a systematic review. Matthie, NS., Giordano, NA., Jenerette, CM., et al.[2023]

In a feasibility study involving 14 veterans, a virtual reality (VR) treatment modeled after mirror therapy significantly reduced phantom limb pain (PLP) intensity, with only 28.6% of participants reporting PLP after treatment compared to 57.1% before.

Participants rated the VR treatment highly in terms of helpfulness, realism, and satisfaction, with no adverse experiences reported, indicating that VR could be a safe and effective option for managing PLP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Virtual Reality Intervention for the Treatment of Phantom Limb Pain: Development and Feasibility Results. Rutledge, T., Velez, D., Depp, C., et al.[2020]

A meta-analysis of 15 studies involving 300 participants found that both mirror therapy and virtual reality (VR) significantly reduced phantom limb pain (PLP), with mirror therapy showing a mean reduction in pain of 2.54 on the visual analogue scale (VAS) and VR showing a reduction of 2.24, both statistically significant (p<0.001).

There was no significant difference in pain relief between mirror therapy and VR (p=0.69), indicating that both treatments are equally effective for alleviating PLP, although the small sample size limited the exploration of other influencing factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of mirror therapy and virtual reality therapy in alleviating phantom limb pain: a meta-analysis and systematic review. Rajendram, C., Ken-Dror, G., Han, T., et al.[2023]

A patient with severe phantom limb pain experienced significant pain relief after five sessions of immersive virtual reality mirror therapy, with pain scores decreasing by 55% to 90% across different measures.

The therapy not only provided immediate pain relief but also resulted in continued improvement six weeks after treatment, suggesting that virtual reality could be an effective option for those who do not respond to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersive Virtual Reality Therapy with Myoelectric Control for Treatment-resistant Phantom Limb Pain: Case Report. Chau, B., Phelan, I., Ta, P., et al.[2022]

In a study involving 14 male military personnel with upper extremity amputations, the Virtual Integration Environment (VIE) virtual reality simulator significantly reduced phantom limb pain (PLP) in 88% of participants after an average of 18 sessions.

The VIE system also effectively reduced residual limb pain (RLP) in 80% of those who reported it, demonstrating its potential as a non-invasive and cost-effective therapy for managing pain associated with limb loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Trial of the Virtual Integration Environment to Treat Phantom Limb Pain With Upper Extremity Amputation. Perry, BN., Armiger, RS., Wolde, M., et al.[2020]

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 after VR sessions.

Combining VR therapy with tactile stimulation enhances its effectiveness, leading to greater reductions in PLP compared to VR therapy alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of virtual reality for the management of phantom limb pain: a systematic review. Hali, K., Manzo, MA., Koucheki, R., et al.[2023]

A systematic review of 20 studies on virtual reality (VR) and augmented reality (AR) treatments for phantom limb pain (PLP) found that the majority of studies (12 out of 20) reported decreased PLP, with 8 showing significant reductions, indicating promising efficacy for these technologies.

Despite the encouraging results, most studies were case series rather than randomized controlled trials, suggesting that while AR/VR treatments for PLP are effective, further high-quality research is needed to confirm these findings and optimize treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual and Augmented Reality-based Treatments for Phantom Limb Pain: A Systematic Review. Vassantachart, AY., Yeo, E., Chau, B.[2023]

Citations

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This feasibility study of a novel VR intervention for PLP was practical and was associated with significant reductions in PLP intensity and phantom sensations.

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X-reality can significantly relieve phantom pain despite heterogeneity in studies. Themes included motor control, skills training, and stimulus-sensing.

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NCT02784548 | Virtual Reality for Phantom Limb Pain

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Virtual Reality Treatment for Phantom Limb Pain

Research shows that virtual reality (VR) treatments can significantly reduce phantom limb pain (PLP) in individuals with amputations. In one study, 88% of ...