Virtual Reality Therapy for Phantom Limb Pain

Overseen By Ben Connell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Active mental illness, Neurological disease, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests virtual reality therapy to help individuals experiencing phantom limb pain after an upper limb amputation. Phantom limb pain often leads to anxiety and depression, complicating daily life. Researchers aim to determine if virtual reality can reduce this pain and enhance overall well-being. Individuals who have undergone a major limb amputation and currently suffer from phantom limb pain may be suitable for this trial. Participants will either undergo virtual reality therapy or receive standard care for comparison. As an unphased trial, this study provides a unique opportunity to explore innovative therapy that could improve quality of life.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

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

Research has shown that virtual reality (VR) therapy is generally safe. Studies have found that VR is easy to use and can help with pain, including phantom limb pain (PLP). Most people do not experience serious side effects from VR; some might feel mild dizziness or nausea, but these feelings usually pass quickly.

In trials using VR for pain relief, participants often benefited without major side effects. This suggests VR therapy is a low-risk option for those dealing with PLP. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Virtual Reality Therapy for phantom limb pain because it offers a non-invasive, drug-free approach that can potentially rewire the brain's perception of the missing limb. Unlike conventional treatments such as pain medications or mirror therapy, VR creates an immersive environment that tricks the brain into experiencing the presence of the limb, which may help reduce or eliminate the sensation of pain. This innovative use of technology not only targets the root of phantom pain but also provides a customizable and engaging experience for patients, which could enhance adherence and outcomes.

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

Research shows that virtual reality (VR) therapy, which participants in this trial may receive, can help manage phantom limb pain (PLP). Studies have found that VR can greatly reduce the intensity of PLP and its associated sensations. One study discovered that a new VR method was practical and led to significant pain relief. Another study examined various VR and augmented reality treatments and suggested they can effectively manage PLP. Overall, current research supports VR therapy as a promising option for those experiencing phantom limb pain. ^{1 6 7 8 9}

Who Is on the Research Team?

Glenn Gaston, MD

Principal Investigator

Atrium Health Musculoskeletal Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have had a major limb amputated and are experiencing phantom limb pain or sensations. It's not suitable for individuals with active mental illness, neurological diseases, cognitive impairments that affect survey participation, those without phantom limb issues, or non-English speakers.

Inclusion Criteria

I am older than 18 years.

I experience pain or odd sensations where my limb used to be.

I have had a major limb amputated.

Exclusion Criteria

I do not experience phantom limb pain or sensations.

I do not have any mental, neurological, or cognitive conditions that would prevent me from completing a survey.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo virtual reality therapy intervention for phantom limb pain

6 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality Therapy

Trial Overview The study explores the effectiveness of virtual reality therapy in alleviating phantom limb pain compared to a matched control group. Participants will be randomly assigned to receive either VR therapy or no intervention to assess differences in their experiences of pain.

How Is the Trial Designed?

Group I: Virtual Reality (VR) Intervention Experimental Treatment 1 Intervention

Individuals undergoing virtual reality therapy intervention

Group II: Matched Control Placebo Group 1 Intervention

The matched controls will receive standard care without the VR intervention

Virtual Reality Therapy is already approved in United States for the following indications:

Approved in United States as Virtual Reality Therapy for:

• Pain management for vaso-occlusive crisis in sickle cell disease

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

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 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]

Virtual reality (VR) has been shown to effectively reduce pain intensity in patients suffering from various types of chronic pain, including phantom limb pain and chronic headaches, based on a systematic review of 17 peer-reviewed articles.

While VR shows promise in improving pain outcomes, there is insufficient evidence to determine its effects on anxiety, depression, and mood, indicating a need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Virtual Reality-Based Interventions for Managing Chronic Pain on Pain Reduction, Anxiety, Depression and Mood: A Systematic Review. Wong, KP., Tse, MMY., Qin, J.[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]

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]

This study suggests that low-cost immersive virtual reality (VR) training can significantly reduce phantom limb pain (PLP) in lower-limb amputees, with immediate pain relief observed after each session.

Two participants with unilateral transtibial amputation showed a notable decrease in their pain levels over multiple VR sessions, indicating that VR could be a promising treatment option for PLP where standard treatments often fail.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersive Low-Cost Virtual Reality Treatment for Phantom Limb Pain: Evidence from Two Cases. Ambron, E., Miller, A., Kuchenbecker, KJ., et al.[2022]

Virtual reality (VR) has been found to be an effective method for reducing both acute and chronic pain, with significant improvements in pain intensity (72.1%) and quality (75.0%) observed across 70 studies involving 4105 participants.

The primary mechanism of pain relief through VR is distraction, especially for acute pain, while embodiment is more commonly associated with chronic pain, indicating that different types of pain may benefit from tailored VR approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The State of Science in the Use of Virtual Reality in the Treatment of Acute and Chronic Pain: A Systematic Scoping Review. Baker, NA., Polhemus, AH., Haan Ospina, E., 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36724203/

Use of virtual reality for the management of phantom limb ... Conclusions: Based on the current literature, VR therapy has the potential to be an effective treatment modality for the management of PLP.

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). Detailed Description. Almost 2 million ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9776775/

Virtual and Augmented Reality-based Treatments for ... Objective. To evaluate the literature on the effectiveness of virtual reality (VR)- and augmented reality (AR)-based treatments for phantom limb pain (PLP) ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02784548

NCT02784548 | Virtual Reality for Phantom Limb Pain This study will develop a virtual reality-based treatment for phantom limb pain among Veterans and test it against the most established behavioral therapy for ...

5. 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.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04529083

Mixed Reality Based System to Manage Phantom Pain ... MAPP framework is using RGB-D camera to capture the movement of patients intact limb and mirror it to create the illusion of the phantom limb, the illusion ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1297319X24000800

Virtual reality as a treatment for chronic musculoskeletal ... Current research suggests VR mainly has short-term effects on pain, but there is also evidence suggesting potential long-term benefits and effects on other ...

8. 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 ...

9. researchprotocols.org researchprotocols.org/2025/1/e68008

Treating Lower Phantom Limb Pain in the Postoperative ... This protocol aims to outline the development and feasibility of the VR-GMI prototype for treating people with LLAs in the postoperative acute care setting.