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

48 Participants Needed

Trial Summary

What is the purpose of this trial?

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 setting and for at-home use by individuals with upper and lower extremity amputation. We hypothesize that the system will improve PLP for individuals with upper or lower extremity amputation, as measured through with various outcome measures and questionnaires.

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 data supports the effectiveness of the treatment Coapt Phantom Limb Pain Management System for phantom limb pain?

Research shows that virtual reality (VR) therapy can help reduce phantom limb pain by creating a virtual environment where patients can see and control a virtual limb, which may help ease the pain. Studies have found that VR treatments, similar to the Coapt system, have been effective in managing phantom limb pain by using motion capture technology to simulate limb movement. ^{1 2 3 4 5}

Is VR therapy safe for treating phantom limb pain?

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. ^{1 2 4 6 7}

How does the Coapt Phantom Limb Pain Management System treatment differ from other treatments for phantom limb pain?

The Coapt Phantom Limb Pain Management System is unique because it uses virtual reality (VR) and myoelectric pattern recognition to create a virtual limb that responds directly to muscle signals from the stump, allowing patients to control the virtual limb and experience pain relief. This approach differs from traditional mirror therapy by not relying on the opposite limb and instead focuses on the patient's own muscle activity to facilitate phantom limb movements. ^{1 2 5 8 9}

Research Team

Levi Hargrove, PhD

Principal Investigator

Shirley Ryan AbilityLab

Eligibility Criteria

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

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

You have trouble understanding or following instructions due to issues with thinking or vision.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

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

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

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

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

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

4. England pubmed.ncbi.nlm.nih.gov

Recent advances in understanding and managing phantom limb pain. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Exploratory findings with virtual reality for phantom limb pain; from stump motion to agency and analgesia. [2022]

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

A randomized controlled study to evaluate the efficacy of noninvasive limb cover for chronic phantom limb pain among veteran amputees. [2021]

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

Self-reported treatments used for lower-limb phantom pain: descriptive findings. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Treatment of phantom limb pain (PLP) based on augmented reality and gaming controlled by myoelectric pattern recognition: a case study of a chronic PLP patient. [2022]

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

Robotic therapy for phantom limb pain in upper limb amputees. [2018]