Virtual Reality for Chronic Pain

(VR TMD EEG Trial)

Recruiting at 1 trial location

Overseen By Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Must not be taking: Antipsychotics

Disqualifiers: Neuromuscular, Cardiovascular, Neurological, others

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

Compensation: Varies

Number of Visits: 12

78 Participants Needed

Trial Summary

What is the purpose of this trial?

This project examines, in chronic pain, the mechanisms of immersive virtual reality compared to the mechanisms of placebo hypoalgesia. The potential of developing new non-pharmacological premises for low-risk interventions for pain management is high.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using antipsychotics.

What data supports the effectiveness of the treatment Virtual Reality for Chronic Pain?

Research shows that virtual reality (VR) can effectively reduce pain intensity and improve quality of life for people with chronic pain. Studies found that VR treatments led to significant and lasting pain relief, better physical function, and reduced pain-related stress and interference in daily activities. ^{1 2 3 4 5}

Is virtual reality generally safe for treating chronic pain?

Few studies have looked at the safety of virtual reality for pain treatment, but the available research suggests it is generally safe for humans. Some studies have reported side effects, but they are not common. ^{3 4 6 7 8}

How does the treatment RelieVRx differ from other treatments for chronic pain?

RelieVRx is unique because it uses virtual reality (VR) to provide immersive pain relief skills training at home, which has shown to be more effective than a non-interactive sham VR experience. This approach targets the brain's cognitive and emotional processes involved in chronic pain, offering a non-drug, innovative method for managing pain with lasting benefits. ^{1 2 3 6 8}

Eligibility Criteria

This trial is for individuals experiencing chronic pain, specifically in the jaw joint (TMJ Dysfunction). Participants should be interested in trying non-drug treatments. Details on specific inclusion and exclusion criteria are not provided.

Inclusion Criteria

I can speak and write in English.

I have had jaw pain or dysfunction for at least 3 months.

I experience some level of chronic pain.

Exclusion Criteria

Color-blindness

Pregnancy or breast feeding

I don't have any injuries or infections that would prevent wearing a VR mask.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Active VR

Participants undergo active virtual reality intervention to assess changes in cortical excitability and clinical benefit

3 weeks

4 visits (in-person)

Sham VR

Participants undergo sham virtual reality intervention to compare with active VR effects

3 weeks

4 visits (in-person)

NH Phase

Participants undergo a non-intervention phase to assess baseline measurements

3 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• No-VR
• RelieVRx
• Sham-VR

Trial Overview The study is testing an immersive virtual reality system called RelieVRx against a fake VR treatment (Sham-VR) and no VR at all to understand how they affect chronic pain relief.

Participant Groups

Group I: Low impact TMD Experimental Treatment 3 Interventions

Other: TMD Phenotype TMD participants will be clinically phenotyped into two between-subject groups based on their score on the Graded Chronic Pain Scale (GCPS). This group will have a GCPS grade 0, 1, and 2a

Group II: High impact TMD Experimental Treatment 3 Interventions

Other: TMD Phenotype TMD participants will be clinically phenotyped into two between-subject groups based on their score on the Graded Chronic Pain Scale (GCPS). This group will have a GCPS grade 2b, 3, and 4.

RelieVRx is already approved in United States for the following indications:

Approved in United States as RelieVRx for:

• Chronic lower back pain

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

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 novel virtual reality neuroscience-based therapy (VRNT) significantly reduced pain intensity and interference in 31 participants with chronic back pain compared to usual care, with effects lasting for at least two weeks after treatment.

VRNT not only improved pain-related outcomes but also enhanced overall functioning by potentially altering brain networks associated with pain, as indicated by MRI findings showing changes in connectivity and white matter integrity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Virtual Reality Neuroscience-based Therapy on Clinical and Neuroimaging Outcomes in Patients with Chronic Back Pain: A Randomized Clinical Trial. Čeko, M., Baeuerle, T., Webster, L., et al.[2023]

An 8-week home-based therapeutic virtual reality (VR) program significantly reduced pain intensity and improved various pain-related factors (like activity and stress) compared to a Sham VR program, with effects lasting up to 3 months after treatment in adults with chronic low back pain.

The therapeutic VR program demonstrated sustained benefits and maintained superiority over Sham VR for most outcomes, indicating its potential as an effective long-term pain management strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-Month Follow-Up Results of a Double-Blind, Randomized Placebo-Controlled Trial of 8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality (VR) for Chronic Low Back Pain. Garcia, LM., Birckhead, BJ., Krishnamurthy, P., 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]

Virtual Reality (VR) shows promise as a noninvasive therapy for both acute and chronic pain, potentially offering an alternative to traditional analgesics that often have side effects or are insufficient for chronic pain management.

Mechanisms of pain relief through VR include distraction and cognitive behavioral changes, with immersive experiences enhancing effectiveness, making it a viable option for conditions like complex regional pain syndrome and phantom limb pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of Virtual Reality as a Component of Acute and Chronic Pain Treatment]. Lindner, S., Latoschik, ME., Rittner, H.[2020]

The 8-week home-based virtual reality (VR) program, EaseVRx, significantly reduced pain intensity and pain-related interference with activities, stress, and sleep for up to 6 months after treatment in adults with chronic low back pain, based on a study of 188 participants.

No adverse events were reported during the study, indicating that the VR program is a safe intervention for managing chronic pain without causing nausea or motion sickness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Durability of the Treatment Effects of an 8-Week Self-administered Home-Based Virtual Reality Program for Chronic Low Back Pain: 6-Month Follow-up Study of a Randomized Clinical Trial. Garcia, L., Birckhead, B., Krishnamurthy, P., et al.[2022]

This study is evaluating the effectiveness of guided relaxation-based virtual reality (VR-GR) compared to distraction-based VR (VR-D) and a passive control (360 video) in managing pain for 90 children and adolescents undergoing surgery, with a focus on pain intensity and related psychological factors.

The trial aims to determine if VR-GR can provide more lasting pain relief than traditional distraction methods, potentially reducing the need for opioid and benzodiazepine medications post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided relaxation-based virtual reality versus distraction-based virtual reality or passive control for postoperative pain management in children and adolescents undergoing Nuss repair of pectus excavatum: protocol for a prospective, randomised, controlled trial (FOREVR Peds trial). Olbrecht, VA., Williams, SE., O'Conor, KT., et al.[2021]

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]

References

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

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

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

The Effects of Virtual Reality Neuroscience-based Therapy on Clinical and Neuroimaging Outcomes in Patients with Chronic Back Pain: A Randomized Clinical Trial. [2023]

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

Three-Month Follow-Up Results of a Double-Blind, Randomized Placebo-Controlled Trial of 8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality (VR) for Chronic Low Back Pain. [2022]

4. 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]

5. Germany pubmed.ncbi.nlm.nih.gov

[Use of Virtual Reality as a Component of Acute and Chronic Pain Treatment]. [2020]

6. Canada pubmed.ncbi.nlm.nih.gov

Durability of the Treatment Effects of an 8-Week Self-administered Home-Based Virtual Reality Program for Chronic Low Back Pain: 6-Month Follow-up Study of a Randomized Clinical Trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Guided relaxation-based virtual reality versus distraction-based virtual reality or passive control for postoperative pain management in children and adolescents undergoing Nuss repair of pectus excavatum: protocol for a prospective, randomised, controlled trial (FOREVR Peds trial). [2021]

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

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