Virtual Reality Treatment for Phantom Limb Pain

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

36 Participants Needed

Trial Summary

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 data supports the effectiveness of the 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 participants experienced a reduction in PLP after using a VR system, and a systematic review found that VR, augmented reality (AR), and mixed reality (MR) therapies improved pain-related outcomes in 78% of cases. ^{1 2 3 4 5}

Is virtual reality treatment for phantom limb pain safe for humans?

Virtual reality treatments for phantom limb pain have been tested in humans and are generally considered safe, as they are non-invasive and low-cost therapy options. In studies, participants have successfully used these treatments without significant safety concerns. ^{2 3 4 5 6}

How does the Virtual Reality Treatment for Phantom Limb Pain differ from other treatments?

The Virtual Reality Treatment for Phantom Limb Pain is unique because it uses immersive virtual environments to simulate limb movements, allowing patients to control virtual limbs through myoelectric and motion-tracking technology. This approach offers a non-invasive, interactive experience that can provide significant pain relief, especially for those who do not respond to traditional mirror therapy. ^{2 3 4 5 7}

What is the purpose of this trial?

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.

Research Team

Laurel Buxbaum, PsyD

Principal Investigator

Albert Einstein Healthcare Netork

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Use and efficacy of virtual, augmented, or mixed reality technology for chronic pain: a systematic review. [2023]

2. England pubmed.ncbi.nlm.nih.gov

A Virtual Reality Intervention for the Treatment of Phantom Limb Pain: Development and Feasibility Results. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Use of virtual reality for the management of phantom limb pain: a systematic review. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Virtual and Augmented Reality-based Treatments for Phantom Limb Pain: A Systematic Review. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Trial of the Virtual Integration Environment to Treat Phantom Limb Pain With Upper Extremity Amputation. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy of mirror therapy and virtual reality therapy in alleviating phantom limb pain: a meta-analysis and systematic review. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Immersive Virtual Reality Therapy with Myoelectric Control for Treatment-resistant Phantom Limb Pain: Case Report. [2022]