VR + Nerve Ablation for Chronic Knee Pain

Overseen By Paul Fitzgerald, RN,BSN,MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Opioids, Anticoagulants

Disqualifiers: Substance abuse, Seizure disorder, others

Stay on Your Current Meds You can continue your current medications while participating

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: 2

Duration: 1 day

62 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on chronic opioid use or anticoagulation therapy that cannot be stopped, you may not be eligible to participate.

What data supports the effectiveness of this treatment for chronic knee pain?

Research shows that virtual reality (VR) therapy can help reduce pain and improve movement in people with chronic musculoskeletal disorders, which includes conditions like chronic knee pain. In studies, VR therapy was effective in relieving pain and increasing joint mobility for many patients. ^{1 2 3 4 5}

Is virtual reality therapy safe for treating chronic pain?

Research on virtual reality (VR) therapy for pain management, including chronic pain, suggests it is generally safe for humans. However, few studies have specifically examined adverse events (side effects), indicating a need for more research on safety. ^{1 2 4 6 7}

How does the VR + Nerve Ablation treatment for chronic knee pain differ from other treatments?

This treatment is unique because it combines virtual reality (VR) technology, which has been shown to improve pain outcomes, with nerve ablation, a procedure that targets and destroys specific nerves to reduce pain. This combination offers a novel approach by using VR to potentially enhance the pain relief effects of nerve ablation. ^{1 2 4 5 8}

What is the purpose of this trial?

This study will examine the impact of virtual reality used in conjunction with sedation compared to sedation alone in patients undergoing watervcooled genicular nerve ablations for chronic knee pain. The goals of the study is to determine the relative efficacy of virtual reality as a distraction modality when used as an adjuvant to procedural sedation compared to sedation alone for procedure related pain. To assess procedural satisfaction, and 1-month pain and functional outcomes.To explore whether virtual reality and lower procedure-related pain scores affect 1-month outcomes. And finally to determine whether demographic and clinical characteristics are associated with outcome measures.

Research Team

Jason Ross, MD

Principal Investigator

Northwestern Univesity

Eligibility Criteria

This trial is for individuals experiencing chronic knee pain who are undergoing a specific nerve ablation procedure. Participants should be suitable for sedation and the study will explore if adding virtual reality to their treatment can help with pain.

Inclusion Criteria

My knee X-ray shows signs of osteoarthritis.

I am scheduled for or have had a genicular RFA procedure.

My knee pain averages more than 4 out of 10.

Exclusion Criteria

Secondary gain expected to influence treatment outcomes

Nursing

Individuals without evidence of osteoarthritis on X-ray

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo water-cooled genicular nerve ablation with or without virtual reality as a distraction modality

1 day

1 visit (in-person)

Immediate Post-procedure

Participants are assessed for procedural pain, anxiety, and satisfaction

10 minutes after procedure

Follow-up

Participants are monitored for pain and functional outcomes 1 month after the procedure

4 weeks

1 visit (virtual or in-person)

Treatment Details

Interventions

• Virtual Reality

Trial Overview The study is testing the effectiveness of using a virtual reality headset during genicular nerve ablations versus just sedation alone. It aims to see if VR can better manage pain, improve satisfaction, and enhance function and pain outcomes after one month.

Participant Groups

Group I: Group #1: Virtual Reality Headset Experimental Treatment 1 Intervention

Group 1 will be assigned to the Virtual Realtity Headset. Participants will wear the headset for at least 10 minutes prior to the planned procedure. Subjects will receive standard procedure. The VR Headset will be removed 10 minutes after the planned procedure.

Group II: Group 2 No Virtual Reality Headset Active Control 1 Intervention

Group 2 will receive standard care without the use of the Virtuality Reality Headset.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Findings from Research

Virtual reality (VR) therapies have shown promise in effectively distracting patients from both acute and chronic pain, suggesting a new approach to pain management beyond traditional methods like opioids and physical therapy.

Clinical studies indicate that VR can be beneficial for various pain conditions, including fibromyalgia and phantom limb pain, by immersing patients in interactive environments that reduce their perception of pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality as a Clinical Tool for Pain Management. Pourmand, A., Davis, S., Marchak, A., et al.[2018]

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]

A scoping review of 14 randomized controlled trials found that virtual reality (VR) significantly alleviates pain and improves functional capacity in patients with chronic musculoskeletal disorders compared to standard care.

VR treatment also showed notable effectiveness in providing pain relief for burn patients with acute pain, but it was less effective for non-chronic pain conditions like total knee replacements or ankle sprains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Scoping Review of The Efficacy of Virtual Reality and Exergaming on Patients of Musculoskeletal System Disorder. Lin, HT., Li, YI., Hu, WP., et al.[2020]

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]

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]

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]

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

Virtual Reality as a Clinical Tool for Pain Management. [2018]

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

Use and efficacy of virtual, augmented, or mixed reality technology for chronic pain: a systematic review. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

A Scoping Review of The Efficacy of Virtual Reality and Exergaming on Patients of Musculoskeletal System Disorder. [2020]

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

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

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

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

6. 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]

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

The Impact of Virtual Reality on Chronic Pain. [2022]

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

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