Immersive Virtual Reality for Chronic Pain

Overseen By Rachel Massalee, MS

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Maryland, Baltimore

Must not be taking: Antidepressants, ADHD meds, Narcotics, others

Disqualifiers: Cardiovascular, Neurological, Psychiatric, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 session lasting 2 to 3 hours

259 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how immersive virtual reality might help manage chronic pain in individuals with Temporal Mandibular Disorder (TMD), a jaw condition persisting for at least three months. Researchers compare the effects of active virtual reality experiences with placebo effects (inactive treatments). Treatment groups include those receiving immersive virtual reality, a nasal spray called naloxone, and a saline solution for comparison. Individuals with TMD for over three months who can speak and understand English might be suitable participants. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications, such as antidepressants, ADHD medication, non-over-the-counter painkillers, methadone, benzodiazepines, barbiturates, and narcotics, if you have used them in the past 3 months.

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

Research has shown that virtual reality (VR) offers a promising and safe method for managing long-term pain. Studies have found that VR effectively reduces pain levels in individuals with ongoing muscle and joint pain. This non-drug approach is generally well-tolerated, with most individuals experiencing no major side effects. In fact, VR has improved pain, mood, and overall quality of life.

Importantly, studies have reported no serious adverse reactions when using VR for pain relief, making it a low-risk option for those seeking new, non-medication-based pain management strategies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using immersive virtual reality (VR) for chronic pain management because it offers a non-drug alternative that could revolutionize how we treat pain. Unlike traditional pain treatments like opioids, which can have serious side effects and risk of addiction, VR aims to reduce pain perception through immersive distraction and engagement. The study is also exploring how opioid tone might affect VR's pain-relieving effects, using naloxone and saline as comparators. This could pave the way for personalized, non-invasive pain management techniques that are free of the downsides of current medication-based therapies.

What evidence suggests that immersive virtual reality is effective for chronic pain?

Research has shown that immersive virtual reality (VR), a treatment under study in this trial, can help reduce chronic pain. Studies have found that VR lowers pain levels and anxiety in people with various pain conditions. For instance, one study found that VR use led to significant pain relief for those with long-term muscle and joint pain. Another study showed that the pain relief lasted even 12 months after treatment. Overall, immersive VR is a promising non-drug option for managing chronic pain. Participants in this trial may receive either immersive VR or sham VR to evaluate their effectiveness in managing chronic pain. ^{3 6 7 8 9}

Who Is on the Research Team?

Luana Colloca, MD/PhD/MS

Principal Investigator

University of Maryland Baltimore School of Nursing

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 18-88 with Temporomandibular Disorder (TMD) for at least 3 months. Excluded are those with certain psychiatric conditions, recent substance abuse, pregnancy, color-blindness, severe facial trauma or motion sickness, and those on specific medications like antidepressants.

Inclusion Criteria

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

I can speak and write in English.

Exclusion Criteria

I have not had any facial injuries in the last 6 weeks.

You have had very bad motion sickness in the past.

You have tested positive for illegal drugs like opiates, cocaine, methamphetamines, amphetamines, and THC.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo VR sessions and receive either naloxone or saline to assess VR-induced hypoalgesia

1 session lasting 2 to 3 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Active Virtual Reality
• sham Virtual Reality

Trial Overview

The study explores how immersive virtual reality can manage chronic pain compared to placebo effects. It involves active VR treatment, sham VR (placebo), no intervention control groups, and the administration of Naloxone or Saline to understand pain mechanisms.

How Is the Trial Designed?

Group I: Natural History Experimental Treatment 4 Interventions

Natural history group, where participants will not be given any drugs. Participants will be stratified for sex and then randomized to the Natural History group.

Group II: Naloxone Active Control 4 Interventions

NARCAN® Naloxone Nasal Spray will be used to determine how the opioid tone shapes VR-induced hypoalgesia. Participants will be stratified for sex and then randomized to naloxone (The dose of naloxone will be 4 mg, so 0.1 mL of 40 mg/ml naloxone solution given intranasally) or saline (0.1 mL 0.9% sodium chloride intranasally), respectively. Investigators, staff, and participants will be blinded to the treatment options.

Group III: Saline Placebo Group 4 Interventions

Saline group, where participants will be given saline solution (4mg) via an identical spray device. Participants will be stratified for sex and then randomized to saline arm (The dose of saline will be (0.1 mL 0.9% sodium chloride intranasally), respectively. Investigators, staff, and participants will be blinded to the treatment options.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Published Research Related to This Trial

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 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) 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]

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]

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]

Virtual reality (VR) has been shown to effectively reduce pain intensity in patients suffering from various types of chronic pain, including phantom limb pain and chronic headaches, based on a systematic review of 17 peer-reviewed articles.

While VR shows promise in improving pain outcomes, there is insufficient evidence to determine its effects on anxiety, depression, and mood, indicating a need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Virtual Reality-Based Interventions for Managing Chronic Pain on Pain Reduction, Anxiety, Depression and Mood: A Systematic Review. Wong, KP., Tse, MMY., Qin, J.[2022]

In a case series involving 10 chronic pain patients, 5 reported reduced pain during virtual reality (VR) therapy sessions, suggesting potential short-term benefits of VR for pain management.

While VR therapy did not show significant overall changes in pain scores after treatment, it was safe with no serious adverse events, although 60% of participants experienced some cybersickness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality as an Adjunct Home Therapy in Chronic Pain Management: An Exploratory Study. Garrett, B., Taverner, T., McDade, P.[2020]

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]

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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39965778/

Virtual Reality Interventions and Chronic Pain: Scoping ...

Virtual reality (VR) interventions have demonstrated efficacy for more than a decade for mood and anxiety disorders and emerging evidence suggests they can ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39159449/

Immersive and Nonimmersive Virtual Reality-Assisted ...

Our study findings suggest that VR is effective in alleviating chronic musculoskeletal pain. Trial registration: PROSPERO CRD42022302912 ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0272735825000327

A synthesis of meta-analyses of immersive virtual reality ...

Immersive VR shows strong efficacy for improving pain intensity and anxiety in procedural pain populations of all ages. · Immersive VR is most efficacious in ...

4.

nature.com

nature.com/articles/s41746-025-01553-x

Telehealth virtual reality intervention reduces chronic pain ...

The study found significant long-term reductions in pain intensity and pain interference at 12 months post-treatment, demonstrating the ...

5.

bmcmedicine.biomedcentral.com

bmcmedicine.biomedcentral.com/articles/10.1186/s12916-024-03266-6

Efficacy of virtual reality for pain relief in medical procedures

Immersive VR technology offers effective pain control across various medical procedures, albeit statistical heterogeneity.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11369537/

Immersive and Nonimmersive Virtual Reality–Assisted ...

Virtual reality (VR) in different immersive conditions has been increasingly used as a nonpharmacological method for managing chronic musculoskeletal pain.

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S1297319X24000800

Virtual reality as a treatment for chronic musculoskeletal ...

There is growing evidence that VR is an efficient and safe option for treating chronic musculoskeletal pain, suggesting it could become part of multimodal ...

8.

mdpi.com

mdpi.com/2076-3417/15/11/5956

Immersive Virtual Reality-Based Exercise for Pain ...

Immersive virtual reality-based exercise (iVRE) represents a novel therapeutic approach for chronic pain management, combining the well-established clinical ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9131143/

Virtual Reality Applications in Chronic Pain Management

Evidence has been found for the effects of VR on pain, functioning, mobility, functional capacity, psychological outcomes, quality of life, neuropsychological ...