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

Trial Summary

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

Research shows that virtual reality (VR) can help reduce chronic pain, with studies indicating improvements in pain-related outcomes for conditions like chronic back pain and phantom limb pain. VR therapy has been associated with significant pain reduction and improved overall functioning, suggesting it can be an effective non-drug treatment for managing chronic pain. ^{1 2 3 4 5}

Is immersive virtual reality safe for treating chronic pain?

Research on virtual reality for pain treatment shows it is generally safe, with few studies reporting side effects. However, more research is needed to fully understand any potential risks. ^{1 2 6 7 8}

How does the immersive virtual reality treatment for chronic pain differ from other treatments?

Immersive virtual reality (VR) is unique because it offers a non-drug approach to managing chronic pain by using technology to create an engaging and interactive environment that can distract patients from their pain. Unlike traditional treatments, VR can provide immediate pain relief during and shortly after sessions, and it has shown promise in reducing pain intensity across various chronic pain conditions. ^{1 2 4 5 9}

What is the purpose of this trial?

This trial investigates using virtual reality to help people with chronic pain from Temporomandibular Disorders (TMD). The VR experience aims to distract the brain from pain and may also trigger the release of natural pain-relieving chemicals. Researchers will compare the effects of real VR to see how effective it is. Virtual reality (VR) has been increasingly studied and used as a tool for pain management in various conditions, including chronic pain, procedural pain, and specific syndromes like complex regional pain syndrome and phantom limb pain.

Research Team

Luana Colloca, MD/PhD/MS

Principal Investigator

University of Maryland Baltimore School of Nursing

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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) 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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

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

3. 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]

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

The effect of interactive virtual reality on pain perception: a systematic review of clinical studies. [2021]

5. Switzerland 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. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

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

7. 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]

8. Canada pubmed.ncbi.nlm.nih.gov

Virtual Reality as an Adjunct Home Therapy in Chronic Pain Management: An Exploratory Study. [2020]

9. England 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. [2015]