VR Therapy for Phantom Limb Pain

Overseen By Suzanne Finucane

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: Cognitive deficits, Visual impairment, others

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

Compensation: Varies

Number of Visits: 7

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a virtual reality therapy system designed to manage Phantom Limb Pain (PLP), a common issue for individuals who have lost a limb. The researchers aim to determine if the Coapt Phantom Limb Pain Management System can reduce pain and improve quality of life, both in clinical settings and at home. Participants will use the system at home for eight weeks and attend follow-up sessions to track progress. Suitable candidates are English-speaking adults with an upper or lower limb amputation who have experienced chronic phantom pain for at least six months. As an unphased trial, this study offers a unique opportunity to explore innovative therapy and contribute to advancements in pain management.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it requires that your pain medication use has been stable for more than one month.

What prior data suggests that this virtual rehabilitation system is safe for treating Phantom Limb Pain?

Research has shown that VR therapy for phantom limb pain is generally safe. Studies have not reported any major safety concerns. This therapy uses virtual reality to help manage pain for those who have lost a limb. Designed for ease of use, it can be applied both in research settings and at home. Although no major safety issues have been identified, discussing participation with a healthcare provider is important to ensure suitability. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for phantom limb pain that often rely on medications or invasive procedures, the Coapt Phantom Limb Pain Management System utilizes a non-invasive approach with virtual reality and electrode cuff technology. This system is designed to engage users in a unique at-home therapy that focuses on muscle contractions and visual feedback, aiming to retrain the brain's perception of the missing limb. Researchers are excited about this trial because it could offer a more accessible and less invasive alternative to managing phantom limb pain, potentially improving quality of life without the side effects associated with medications.

What evidence suggests that the Coapt Phantom Limb Pain Management System is effective for treating Phantom Limb Pain?

Research has shown that virtual reality (VR) therapy can help manage phantom limb pain (PLP), the pain felt in an amputated limb. Studies have found that VR rehabilitation can effectively reduce this type of pain. This trial will evaluate the Coapt Phantom Limb Pain Management System, which uses a special device and muscle movements to relieve pain. Early results suggest that regular use of this VR system at home can lead to better outcomes. The Coapt Phantom Limb Pain Management System is designed to provide relief and improve the quality of life for those with PLP. ^{1 2 6 7 8}

Who Is on the Research Team?

Levi Hargrove, PhD

Principal Investigator

Shirley Ryan AbilityLab

Are You a Good Fit for This Trial?

This trial is for adults over 18 with upper or lower limb amputations who have chronic phantom limb pain (PLP) of moderate intensity and frequency. Participants must speak English, have stable medication use, and can't have skin issues on the residual limb, significant cognitive deficits, visual impairments that affect consent or participation, or be non-English speaking.

Inclusion Criteria

I have had phantom limb pain for at least 6 months.

I have had an amputation of a limb or limbs.

My pain level is below 5 on a scale of 0-10.

Exclusion Criteria

Non-English speaking

I have no skin issues on my residual limb that would stop me from using an electrode cuff.

You cannot handle having a liner or cuff on your remaining limb.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Usability and Functionality Testing

Complete in-lab or virtual iterative usability and functionality testing of hardware and software components of The Coapt Phantom Limb Pain Management System to ensure readiness for at-home use

Treatment

Participants use the Phantom Limb Pain Management System at home for 8 weeks, 1.5 hours per week

8 weeks

4-5 sessions per week, 20-40 minutes each

Follow-up

Participants are monitored for safety and effectiveness after treatment through phone or Zoom calls at weeks 16, 24, and 32 to repeat questionnaires

24 weeks

3 virtual visits

What Are the Treatments Tested in This Trial?

Interventions

• Coapt Phantom Limb Pain Management System

Trial Overview

The study tests a virtual rehabilitation system called Coapt Phantom Limb Pain Management System to treat PLP in individuals with various types of limb amputations. The effectiveness will be measured using outcome measures and questionnaires.

How Is the Trial Designed?

Group I: Phantom Limb Pain Management System during at-home use. Experimental Treatment 1 Intervention

Participants attend either in person at Shirley Ryan AbilityLab or virtually via Zoom * Educational documents provided on pain and phantom limb pain. * Participants are measured for an electrode cuff either in person or virtually * Complete several questionnaires. * Provided training on the Phantom Limb Pain Program with use of the electrode cuff and muscular contractions of their limb * Participate in a 8 week home trial (1.5 hours per week of use, 20-40 minutes, 4-5x each week) * Once home trial is complete - participants will be asked to participate in a phone or Zoom call at weeks 16,24 and 32 to repeat questionnaires.

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Coapt, LLC

Industry Sponsor

Trials

3

Recruited

70+

Published Research Related to This Trial

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]

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 novel virtual reality (VR) method using motion capture from the stump of amputees showed promise in reducing phantom limb pain, with 5 out of 7 subjects in both arm and leg groups reporting sensations of movement and pain relief beyond mere distraction.

This technique demonstrated similar effectiveness to traditional mirror box therapy and is advantageous due to its cost-effectiveness and portability, making it suitable for further home-based trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploratory findings with virtual reality for phantom limb pain; from stump motion to agency and analgesia. Cole, J., Crowle, S., Austwick, G., et al.[2022]

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]

Citations

1.

coaptengineering.com

coaptengineering.com/research-studies

Research Studies – Coapt, LLC

Intuitively Controlled Virtual Reality to Treat Phantom Limb Pain. GOAL: To develop a commercially viable VR rehabilitation system for the treatment of phantom ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05915065

NCT05915065 | VR to Evaluate Phantom Limb Pain

The objective of this study is to develop a virtual rehabilitation system that can be used to effectively treat Phantom Limb Pain (PLP) within the research ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6652103/

Recent advances in understanding and managing phantom ...

This narrative review focuses on recent advances in the treatment of PLP and reviews evidence of mechanism-based treatments from randomized controlled trials.

4.

conferences.lib.unb.ca

conferences.lib.unb.ca/index.php/mec/article/view/2476/1802

View of Preliminary Results of a Portable Take Home ...

Phantom limb pain (PLP) is a common complaint in individuals with limb absence. PLP can persist chronically, necessitating effective management strategies ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S1524904224002212

Integrating Complementary Therapies for Phantom Limb Pain

Three months later, the phantom limb pain was resolved, and she reported that her psychological state improved; and used Morphine about once weekly as needed ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9618240/

An Algorithm Approach to Phantom Limb Pain - PMC

Below we summarize the current state of knowledge in the field, as well as propose an algorithm for the approach to the treatment of PLP.

7.

withpower.com

withpower.com/trial/vr-therapy-for-phantom-limb-pain-1de78

VR Therapy for Phantom Limb Pain · Info for Participants

Research on VR therapy for phantom limb pain suggests it is generally safe for use in humans, as no significant safety concerns have been reported in studies.

8.

conferences.lib.unb.ca

conferences.lib.unb.ca/mec/article/download/2509/1835

a portable myoelectric pattern recognition-driven virtual

This paper describes the design of a portable myoelectric, pattern recognition-driven virtual training system, referred to as the Phantom Limb Pain Management ...