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

Trial Summary

What is the purpose of this trial?

Phantom limb pain (PLP) is a significant and pervasive issue among upper limb amputees, severely impacting their quality of life. The literature delineating prevalence of upper versus lower limb amputations is limited, but the prevalence of total amputations in the United States is estimated to reach 3 million individuals by 2050, with approximately 185,000 new cases annually. PLP affects 60-68% of these patients, leading to heightened levels of anxiety, depression, and reduced overall well-being.

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 data supports the effectiveness of the treatment Virtual Reality Therapy for Phantom Limb Pain?

Research shows that virtual reality (VR) therapy can help reduce pain intensity in people with phantom limb pain and other chronic pain conditions. In one case, a patient with severe phantom limb pain experienced significant pain relief after using immersive VR therapy, with pain scores decreasing by up to 90%. ^{1 2 3 4 5}

Is virtual reality therapy safe for humans?

Research on virtual reality therapy for pain management, including phantom limb pain, suggests it is generally safe for humans, but there is limited information on adverse events (side effects). More studies are needed to fully understand its safety profile. ^{2 4 5 6 7}

How is Virtual Reality Therapy different from other treatments for phantom limb pain?

Virtual Reality Therapy is unique because it uses immersive environments and motion-tracking technology to create a virtual representation of the missing limb, allowing patients to interact with it as if it were real. This approach can provide significant pain relief, especially for those who do not respond to traditional treatments like mirror therapy. ^{2 3 5 8 9}

Research Team

Glenn Gaston, MD

Principal Investigator

Atrium Health Musculoskeletal Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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]

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 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 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]

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]

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

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

4. Switzerland 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. [2022]

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

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

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

The State of Science in the Use of Virtual Reality in the Treatment of Acute and Chronic Pain: A Systematic Scoping Review. [2023]

8. England pubmed.ncbi.nlm.nih.gov

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

9. Switzerland pubmed.ncbi.nlm.nih.gov

Immersive Low-Cost Virtual Reality Treatment for Phantom Limb Pain: Evidence from Two Cases. [2022]