What side effects are associated with this type of intervention?

Common non-pharmacological treatments for pain management, such as acupuncture, neuromodulation (including transcranial magnetic stimulation and vagus nerve stimulation), and virtual reality, generally have mild side effects. Acupuncture may cause minor adverse effects like headache and scalp pain. Neuromodulation techniques can lead to mild device-associated events such as warm sensations, numbness, redness, itching, tingling, and muscle spasms. Virtual reality interventions are generally well-tolerated but may require more robust studies to confirm long-term safety and effectiveness.

What prior FDA approvals exist?

The FDA has approved several neuromodulation devices for pain management, such as transcranial magnetic stimulation (TMS) and noninvasive vagus nerve stimulation (nVNS). These treatments, like immersive virtual reality (VR), aim to reduce pain perception through non-pharmacological means. While VR itself is still being studied for its efficacy in pain management, its potential as a low-risk, non-invasive intervention is promising, similar to the approved neuromodulation techniques.

What other types of research exist?

Promising, novel alternatives to Immersive Virtual Reality for pain management include Remote Electrical Neuromodulation (REN), Transcranial Magnetic Stimulation (TMS), Noninvasive Vagus Nerve Stimulation (nVNS), and Cognitive Behavioral Therapy for Insomnia (CBT-I). These methods have shown efficacy in reducing pain perception and are considered low-risk interventions.

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Immersive Virtual Reality for Chronic Pain

Phase 1 & 2

Recruiting

Led By Luana Colloca, MD/PhD/MS

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

English speaker (written and spoken)

Age (18-88 years)

Must not have

Any facial trauma that has occurred in the last 6 weeks

Present or past degenerative neuromuscular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one session lasting from 2 to 3 hours

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include discomfort from wearing a VR headset such as eye strain or nausea due to motion sickness; Naloxone might cause withdrawal symptoms in individuals dependent on opioids.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can speak and write in English.

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I am between 18 and 88 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have or had a muscle-weakening disease.

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I have a history of fainting.

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I have had jaw or temple pain from a toothache or infection in the last 3 months.

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I have hearing problems that haven't been corrected.

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I have not been hospitalized for a severe psychiatric condition in the last 3 years.

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My neck pain is not due to TMD but another condition like stenosis.

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I have high blood pressure or symptoms of low blood pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one session lasting from 2 to 3 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one session lasting from 2 to 3 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and one session lasting from 2 to 3 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ischemic pain endurance

Secondary study objectives

Ischemic pain rating

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Natural HistoryExperimental Treatment4 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: NaloxoneActive Control4 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: SalinePlacebo Group4 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Active Virtual Reality

2015

N/A

~60

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Placebo treatments often work through psychological and neurobiological mechanisms such as patient expectations, conditioning, and the release of endogenous opioids. Immersive virtual reality (VR) leverages these mechanisms by engaging and distracting patients, which can reduce their perception of pain. This is important for placebo patients because it highlights the potential of non-pharmacological interventions like VR to manage pain effectively by harnessing the body's natural pain-relief processes.

Virtual Reality in the Management of Chronic Low Back Pain: A Scoping Review.Virtual reality relaxation for the general population: a systematic review.Virtual reality for stroke rehabilitation.