Neural Mechanisms of Immersive Virtual Reality in Chronic Pain
- Conditions
- Virtual RealityPainPlaceboTemporomandibular Disorder
- Interventions
- Behavioral: Active Virtual RealityBehavioral: sham Virtual RealityOther: No InterventionOther: Natural historyOther: Saline
- Registration Number
- NCT04851301
- Lead Sponsor
- University of Maryland, Baltimore
- Brief Summary
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.
- Detailed Description
Virtual reality (VR) has been seen as an intervention for alleviating clinical chronic (and acute) pain. An approach to pain management utilizing VR presents opportunities for reducing pain and suffering by using immersive, aesthetic, and multisensory stimulation. Investigator will analyze the behavioral and neural mechanisms of active VR against sham VR as two methods that investigate descending pain modulation. Thus, the central hypothesis is that those who respond to placebos will likely respond to active VR. If VR-induced analgesia depends upon the release of endogenous opioids.
In this project, the investigators will determine the effects of VR at the neural and clinical levels directly for TMD participants, inviting participants from an existing Colloca Lab-based cohort phenotyped for diagnosis, grade, and low/high impact pain profiles and prospective TMD participants in collaboration with Johns Hopkins University. These participants have agreed to be recontacted for further research. Investigator will determine the role of the opioid tone (AIM1). In Aim 1, the investigators will determine the role of the endogenous opioid tone for VR-induced hypoalgesia in TMD participants using VR, tonic painful stimuli, and naloxone given intranasally with established mu-opioid receptor occupancy to determine how the opioid tone shapes VR-induced hypoalgesia.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 259
- Age (18-88 years)
- English speaker (written and spoken)
- Temporal Mandibular Disorder (TMD) for at least 3 months
- Present or past degenerative neuromuscular disease
- Cardiovascular, neurological diseases, pulmonary abnormalities, kidney disease, liver disease, history of cancer within past 3 years
- Cervical pain other than TMD related (e.g. stenosis, radiculopathy)
- Any personal (or family first degree) history of mania, schizophrenia, or other psychoses
- Severe psychiatric condition (e.g., schizophrenia, bipolar disorders, autism) leading to hospitalization within the last 3 years.
- Use of antidepressants, ADHD medication, non-over-the-counter painkillers, methadone, benzodiazepines, barbiturates, and/or narcotics during the past 3 months
- Lifetime alcohol/drug dependence or alcohol/drug abuse in the past 3 months
- Pregnancy or breastfeeding
- Color-blindness
- Pain in jaw or temple in last 3 months due to toothache or infection
- Any facial trauma that has occurred in the last 6 weeks
- History of severe facial trauma in the last 3 months
- Impaired or uncorrected hearing
- Conditions that would interfere with the VR mask placement (e.g. trauma, burn, infection)
- Known history of severe motion sickness
- High blood pressure or symptomatic low blood pressure
- History of fainting
- History of angioedema
- Failed drug test (testing for opiates, cocaine, methamphetamines, amphetamines, and THC)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Saline No Intervention 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. Saline sham Virtual Reality 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. Naloxone sham Virtual Reality 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. Naloxone Active Virtual Reality 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. Naloxone No Intervention 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. Natural History Natural history 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. Saline Saline 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. Natural History Active Virtual Reality 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. Natural History No Intervention 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. Saline Active Virtual Reality 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. Natural History sham Virtual Reality 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. Naloxone Naloxone 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.
- Primary Outcome Measures
Name Time Method Ischemic pain endurance one session lasting from 2 to 3 hours Increments in experimental ischemic pain endurance will be assessed using a timer (minutes of tolerance)
- Secondary Outcome Measures
Name Time Method Ischemic pain rating one session lasting from 2 to 3 hours Increments in experimental ischemic pain endurance will be assessed using Visual Analogue Scale (VAS) (self-reported numbers) anchored from 0=no pain to 100=maximum tolerable pain. The VAS will be used every 10 seconds during the ischemic pain endurance task
Trial Locations
- Locations (1)
Luana Colloca
🇺🇸Baltimore, Maryland, United States