Virtual Reality Gaming for Neuropathic Pain

(VRWalk Trial)

Recruiting at 2 trial locations

Overseen By Amanda Sainz-Higgins, M.E.d

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Texas A&M University

Disqualifiers: C1-C4 injury, Under 18, Blind, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if playing a virtual reality walking game can reduce neuropathic pain in people with chronic spinal cord injuries. Participants will play one of two different VR games, VR Game 1 or VR Game 2, twice daily for ten days. The trial seeks adults who have experienced persistent, daily pain for at least three months and have stable pain medication. Participants should not have severe motion sickness and must have mobile connectivity. This trial may suit those with a spinal injury at the lower neck or back, sustained for over a year. As an unphased trial, it offers a unique opportunity to explore innovative pain relief methods through virtual reality.

Will I have to stop taking my current medications?

The trial requires that you have been stable on your pain medication for at least one month, so you will not need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that using virtual reality (VR) games for nerve pain is generally safe. Studies have found that VR games, such as VR Game 1 and VR Game 2, can help manage pain in people with spinal cord injuries. Most participants handle the treatment well. Some studies noted that a few individuals might experience dizziness or nausea, similar to motion sickness, from the game. However, no major safety concerns have been reported. This indicates that the VR games are mostly well-tolerated by those who try them. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using virtual reality (VR) games for neuropathic pain because these treatments offer a non-invasive and drug-free alternative to traditional pain management methods like medications or physical therapy. Unlike standard treatments that may involve opioids or other drugs with potential side effects, VR games provide an innovative approach by engaging patients in immersive environments that can distract from pain and potentially retrain the brain's response to pain signals. Additionally, VR games can be customized and scaled for individual needs, offering a personalized experience that standard treatments may not provide. This approach not only aims to reduce pain effectively but also improves the overall patient experience by making treatment more engaging and enjoyable.

What evidence suggests that this trial's virtual reality games could be effective for neuropathic pain?

This trial will compare two virtual reality (VR) games for managing neuropathic pain. Studies have shown that VR Game 1 can significantly reduce nerve pain, with a 42-point drop on a 0–100 scale. Similarly, VR Game 2 has shown a positive and measurable impact, with an effect size of 0.31. Both VR games have demonstrated promise in helping manage pain for people with spinal cord injuries. ^{1 3 4 6 7}

Who Is on the Research Team?

Zina Trost, PhD

Principal Investigator

Texas A&M University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic spinal cord injury who have been experiencing significant neuropathic pain daily for at least three months. Participants should be stable on pain medication, able to move their elbows, and have a compatible mobile device. Those with motion sickness affecting daily life or blindness cannot join.

Inclusion Criteria

I have been cleared to participate in physical activities.

My spinal injury is classified as A, B, C, or D and is in the lumbar region or affects my arms and legs.

It has been over a year since my injury.

Exclusion Criteria

Prisoners

Your injury does not fit the specific type needed for the study.

Not meeting the necessary requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants play a virtual reality game twice a day for 10 days

2 weeks

Daily virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 18 months

What Are the Treatments Tested in This Trial?

Interventions

• VR Game 1
• VR Game 2

Trial Overview

The study is testing whether playing one of two virtual reality walking games can reduce neuropathic pain in individuals with spinal cord injuries. It's designed to compare the effectiveness of these VR games in managing pain symptoms.

How Is the Trial Designed?

Group I: Virtual reality (VR) game 1 Active Control 1 Intervention

Participants will be asked to play a virtual reality game twice a day for 10 days.

Group II: Virtual reality (VR) game 2 Active Control 1 Intervention

Participants will be asked to play a virtual reality game twice a day for 10 days.

Who Is Running the Clinical Trial?

Texas A&M University

Lead Sponsor

Trials

156

Recruited

28,900+

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

McGuire Veterans Hospital

Collaborator

Trials

1

Recruited

250+

Immersive Experience Labs

Collaborator

Trials

2

Recruited

300+

Richmond VA Medical Center

Collaborator

Trials

1

Recruited

250+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

Virtual reality (VR) was successfully used to treat severe chronic neuropathic pain in a healthy adolescent boy who had not responded to multiple medical and psychological treatments over 3 years.

The VR gaming intervention resulted in significant pain relief and improved functionality, demonstrating its potential as an effective alternative therapy for medically refractory pain syndromes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Treatment of Severe Neuropathic Pain in an Adolescent Child: A Case Report. Sørensen, JCH., Vlachou, M., Milidou, I., et al.[2023]

A new virtual reality pain therapy program designed for cancer patients with neuropathic pain was found to be feasible and acceptable, with 39 out of 87 eligible patients participating in the study.

Patients using the virtual reality therapy reported less cybersickness and showed trends towards reduced opioid consumption and pain severity compared to the control group, suggesting potential benefits for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of virtual reality-delivered pain psychology therapy for cancer-related neuropathic pain: a pilot randomised controlled trial. Chuan, A., Hatty, M., Shelley, M., et al.[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]

Virtual reality (VR) gaming technologies show promise in enhancing chronic pain interventions, particularly in treating conditions like chronic low back pain by addressing pain-related fear and disability.

The review suggests that while VR can optimize existing therapies, there are limitations with traditional VR interfaces that need to be addressed for effective chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The promise and challenge of virtual gaming technologies for chronic pain: the case of graded exposure for low back pain. Trost, Z., Zielke, M., Guck, A., et al.[2015]

In a study involving 30 participants with chronic pain, a virtual reality application called Cool! significantly reduced pain levels, with a 33% decrease from pre-session to post-session and a remarkable 60% reduction during the session.

All participants experienced some level of pain relief during the VR session, and 33% reported complete pain relief, suggesting that VR could be a promising non-opioid treatment option for chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Virtual Reality on Chronic Pain. Jones, T., Moore, T., Choo, J.[2022]

This pilot study aims to explore the use of virtual reality (VR) as a nonpharmacological intervention to help Veterans with chronic pain overcome their fear of movement, potentially improving their overall functioning.

The study will involve up to 20 Veterans and will assess the feasibility of VR applications for gradual exposure to feared movements, with the goal of informing a larger randomized controlled trial on the effectiveness of VR in pain rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A virtual reality intervention for fear of movement for Veterans with chronic pain: protocol for a feasibility study. Fowler, CA., Ballistrea, LM., Mazzone, KE., et al.[2023]

Virtual reality (VR) has been beneficial in managing acute pain in adults for over 20 years, showing promise in pain relief through various mechanisms, although results for chronic pain and pediatric populations are mixed.

Many studies on VR's effectiveness have limitations, such as small sample sizes and lack of control over variables, highlighting the need for larger, randomized controlled trials to clarify its most effective applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality and the Mediation of Acute and Chronic Pain in Adult and Pediatric Populations: Research Developments. Hadjiat, Y., Marchand, S.[2022]

Interactive virtual reality (VR) has shown potential in reducing pain for specific conditions like ankylosing spondylitis and post-mastectomy pain, based on findings from controlled trials involving patients with chronic pain.

Uncontrolled studies suggest that interactive VR may also help alleviate neuropathic and phantom limb pain, although its effectiveness for nonspecific chronic back pain remains unclear, highlighting the need for more rigorous research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of interactive virtual reality on pain perception: a systematic review of clinical studies. Wittkopf, PG., Lloyd, DM., Coe, O., et al.[2021]

A pilot study involving 27 individuals with complete paraplegia showed that an interactive virtual reality walking intervention significantly reduced chronic neuropathic pain intensity and related activity interference over a 2-week period.

Participants using the interactive virtual reality reported notable improvements in mood and affect, suggesting that this novel therapy could be a promising approach for managing neuropathic pain in spinal cord injury patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersive interactive virtual walking reduces neuropathic pain in spinal cord injury: findings from a preliminary investigation of feasibility and clinical efficacy. Trost, Z., Anam, M., Seward, J., et al.[2023]

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The VRWalk trial investigates a novel virtual reality walking treatment to decrease neuropathic pain after spinal cord injury.

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Virtual Reality Gaming for Neuropathic Pain (VRWalk Trial)

Virtual reality treatments for neuropathic pain have been generally safe, with some studies noting a risk of cybersickness (nausea or dizziness) in certain ...