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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how virtual reality (VR) can help manage chronic pain. It compares an immersive VR experience, RelieVRx, to a placebo version, Sham-VR, to evaluate their effectiveness in reducing pain without medication. The goal is to discover new, low-risk methods to assist individuals with persistent pain, particularly those with Temporal Mandibular Disorder (TMD), a condition affecting the jaw. Individuals who have experienced TMD for at least three months and frequently suffer from jaw pain may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to investigate innovative pain management solutions without the constraints of traditional phases.

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 prior data suggests that virtual reality is safe for chronic pain management?

Research shows that RelieVRx is designed for home use to ease chronic lower back pain. In earlier studies, participants used the device about 38 times on average, and no serious safety issues emerged, indicating the treatment is generally safe and easy to handle.

For Sham-VR, studies found that it uses 2D nature scenes with calming music, which is also safe. These studies did not identify any major side effects, suggesting it is well-tolerated.

Both treatments do not involve drugs, which usually means they carry fewer risks than medications. While detailed data on side effects from these studies is lacking, available information suggests both options are safe for users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about RelieVRx because it uses virtual reality to address chronic pain, a novel approach compared to traditional treatments like medication or physical therapy. While most treatments for temporomandibular disorders (TMD) focus on managing symptoms through drugs or dental appliances, RelieVRx offers an immersive experience that may help rewire pain pathways in the brain. This innovative method has the potential to provide pain relief without the side effects often associated with medication, making it a promising option for those suffering from high and low impact TMD.

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

Research has shown that RelieVRx, a treatment in this trial, effectively reduces chronic pain. Studies have found it significantly decreases pain levels and the impact of pain on daily life, while also improving mood and sleep. Follow-up research confirmed that these benefits can last for at least six months after treatment.

Sham-VR, another treatment option in this trial used for comparison, has also shown some effectiveness. However, therapeutic VR treatments like RelieVRx consistently outperform in reducing pain and its effects. These findings suggest that immersive virtual reality could be a promising non-drug option for managing chronic pain. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

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

Failed drug test (testing for opiates, cocaine, methamphetamines, and amphetamines)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11976909/

Telehealth virtual reality intervention reduces chronic pain ... VR significantly reduced pain intensity, anxiety, and pain interference while improving mood and sleep quality.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35612905/

6-Month Follow-up Study of a Randomized Clinical Trial Primary outcomes were pain intensity and pain-related interference with activity, mood, stress, and sleep at 6 months posttreatment.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2949761223000834

In-Home Virtual Reality Program for Chronic Lower Back ... Average pain reductions for RelieVRx were clinically meaningful and similar to our previous efficacy trial (pain intensity reduction ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05263037

EaseVRx-8w+ for the Treatment of Chronic Lower Back Pain The aim of this randomized controlled trial (RCT) is to assess outcomes for virtual reality therapy (including pain intensity, pain interference, anxiety, ...

5. journals.lww.com journals.lww.com/painrpts/fulltext/2024/10000/twelve_month_results_for_a_randomized.6.aspx

Twelve-month results for a randomized sham-controlled... Clinically meaningful reductions in pain intensity (2.0 ± 1.9) and pain interference (2.3 ± 2.0) were observed at the end of treatment for Skills-Based VR that ...

6. relievrx.com relievrx.com/documents/clinical-resources.pdf

Clinical Resource Library The device is intended for in-home use for the reduction of pain and pain interference associated with chronic lower back pain. Contraindications. There are ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/K243417.pdf

K243417 - Michael Chibbaro - accessdata.fda.gov The device is intended for in-home use for the reduction of pain and pain interference associated with chronic lower back pain. EaseVRx is a ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04139564

EaseVRx for the Reduction of Chronic Pain and Opioid Use The investigators will conduct a proof-of-concept randomized study to assess the feasibility and efficacy of using EaseVRx as a 56-day, VR-based, at-home ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN210014.pdf

DEN210014 Decision Summary - accessdata.fda.gov The device is intended for in-home use for the reduction ofpain and pain interference associated with chronic lower back pain. LIMITATIONS. Page ...