Virtual Walking Therapy for Neuropathic Pain

Overseen By Ami Lisenbee

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Texas A&M University

Disqualifiers: C1-C4 injury, Under 18, Recent injury, Non-English, Prison, Blind, Severe motion sickness

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a virtual reality walking game can ease neuropathic pain in adults with incomplete spinal cord injuries. Participants will play one of two VR games twice daily for 10 days. The trial is ideal for individuals who primarily use a wheelchair, experience consistent daily pain, and have had their injury for over a year and a half. As an unphased trial, it offers a unique opportunity to explore innovative pain management techniques.

Will I have to stop taking my current medications?

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

What prior data suggests that Virtual Walking Therapy is safe for neuropathic pain?

Research has shown that virtual walking therapy can safely help manage nerve pain. Studies have found that virtual walking not only eases pain but also improves daily activities without causing any disruption. Importantly, these studies reported no serious side effects.

Specifically, four studies found that virtual walking reduced pain levels in people with spinal cord injuries, indicating that the therapy is well-tolerated. Although this trial phase is labeled "Not Applicable," existing research supports its safety for pain management. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for neuropathic pain rely on medications like anticonvulsants or antidepressants, which can have various side effects and take time to work. Unlike these standard options, Virtual Walking Therapy uses virtual reality (VR) games to provide a non-invasive and interactive approach. Researchers are excited because this method can engage patients in an immersive environment that may reduce pain perception through distraction and brain engagement. Additionally, this therapy has the potential to show effectiveness quickly, with participants engaging in VR sessions just twice a day for 10 days. This innovative approach provides an alternative that could be effective without the side effects associated with traditional medications.

What evidence suggests that this trial's treatments could be effective for neuropathic pain?

Research has shown that virtual walking therapy can reduce nerve pain in people with spinal cord injuries. In one study, all four investigations into virtual walking for nerve pain found it lowered pain levels. Another review noted that eight out of nine studies reported significant pain reduction. This trial will compare two different virtual reality walking games to assess their effectiveness in managing pain in adults with partial spinal cord injuries. These findings suggest that playing a virtual reality walking game might help manage pain, making virtual walking therapy a promising way to ease pain without medication. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with incomplete spinal cord injuries who are experiencing neuropathic pain. Specific eligibility criteria have not been provided, but typically participants must meet certain health conditions and may be excluded based on factors that could interfere with the study or their safety.

Inclusion Criteria

I have been on a stable pain medication regimen for at least a month.

Must endorse more than 2 items on a 7-item Spinal Cord Injury Pain Instrument, SCIPI

It has been over 18 months since my injury.

Exclusion Criteria

Individuals who are in prison

I am under 18 years old.

Individuals who experience severe motion sickness

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 changes in pain intensity, quality of life, mood, and neurological changes

up to 18 months

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Walking Therapy

Trial Overview The study is testing whether two different virtual reality walking games can help alleviate neuropathic pain in individuals who have suffered from an incomplete spinal cord injury. The effectiveness of each game will likely be compared to see if one is superior.

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+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Immersive Experience Labs

Collaborator

Trials

2

Recruited

300+

Published Research Related to This Trial

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]

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]

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]

In a study involving five paraplegic patients, a visual illusion technique called 'virtual walking' significantly reduced neuropathic pain by an average of 42 mm on a 100 mm pain scale, which is about a 65% decrease.

When four patients continued virtual walking therapy for three weeks, they experienced a sustained pain reduction of 53 mm immediately after training and 43 mm at a three-month follow-up, suggesting that this method could be a promising treatment for pain following spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using visual illusion to reduce at-level neuropathic pain in paraplegia. Moseley, LG.[2022]

Chronic neuropathic pain can lead to altered bodily perceptions due to changes in the somatosensory cortex, making it challenging to treat and manage.

Using virtual reality to create body illusions may help manipulate these altered perceptions, offering a promising approach for relieving neuropathic pain, as suggested by various experimental and clinical studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Altered bodily perceptions in chronic neuropathic pain conditions and implications for treatment using immersive virtual reality. Donegan, T., Ryan, BE., Sanchez-Vives, MV., et al.[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]

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]

Virtual walking treatment for spinal cord injury-related neuropathic pain (SCI-NP) showed positive outcomes regardless of pain location, with a notable trend indicating greater pain reduction in patients experiencing at-level pain.

The study suggests that certain sensory profiles, such as cold and pressure hypersensitivity at the injury level, may limit the effectiveness of virtual walking for below-level pain, highlighting the need for personalized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Virtual Walking Treatment on Spinal Cord Injury-Related Neuropathic Pain: Pilot Results and Trends Related to Location of Pain and at-level Neuronal Hypersensitivity. Jordan, M., Richardson, EJ.[2016]

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]

Neuropathic pain (NP) is a challenging condition often following spinal cord injuries, significantly impacting quality of life, and current treatments are largely ineffective, highlighting the need for new approaches.

Virtual reality (VR) shows promise as a therapeutic tool for managing NP by creating immersive experiences that may help modulate pain perception and improve outcomes, particularly in patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Therapeutic Matrix: Virtual Reality as a Clinical Tool for Spinal Cord Injury-Induced Neuropathic Pain. Leemhuis, E., Giuffrida, V., Giannini, AM., et al.[2021]

Citations

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2. nature.com nature.com/articles/s41394-024-00667-w

Virtual walking therapy in neuropathic spinal cord injury pain The primary outcome measured was satisfaction with acceptance of and adherence to virtual walking therapy, alongside suggestions for therapy ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07165353

Virtual Walking to Reduce Chronic Neuropathic Pain in ... The aim of the present study is to evaluate (1) the efficiency of the standardised VW-setting with regard to pain reduction in subjects with complete and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1877065718314532

Virtual reality for spinal cord injury-associated neuropathic ... All 4 studies investigating virtual walking for treating neuropathic pain in SCI patients found that it reduced pain intensity, which suggests that virtual ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7919871/

Virtual reality for the treatment of neuropathic pain in people ... Outcomes included pain sensitivity, motor function and body ownership. Eight of the nine studies reported significant reductions in neuropathic pain intensity.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12019490/

A scoping review on the role of virtual walking intervention in ... This scoping review highlights that virtual walking can serve as a promising non-pharmacological therapy for improving pain, physical mobility, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12502972/

Virtual Reality Interventions for Spinal Cord Injury-Related ... Trost et al demonstrated that interactive virtual walking interventions significantly reduced pain's overall interference with daily activities.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05005026

Virtual Walking Intervention for Neuropathic Pain in Spinal ... The purpose of this study is to determine if playing a virtual reality walking game can help improve neuropathic pain in adults with chronic ...