Pain, Virtual Reality, Placebo, Temporomandibular Disorder
Conditions
Keywords
Naloxone, Observation, TMD volunteers, VR
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.
Interventions
BEHAVIORALActive Virtual Reality
Participants will be assigned to an immersive VR environment.
BEHAVIORALsham Virtual Reality
Participants will be assigned to a sham VR environment without the immersive experience.
OTHERNo Intervention
Participants will experience tonic pain tolerance tests without exposure to any environments.
DRUGNaloxone
4mg of Naloxone will be administered (0.1 mL of 40 mg/ml naloxone solution given intranasally). A random allocation sequence will be independently generated by the UM Pharmacy. The Principal investigator will call for each experiment.
OTHERSaline
Intranasal Normal Saline (0.1 mL 0.9% sodium chloride) will be administered shortly before beginning the fMRI experiment. A random allocation sequence will be independently generated by the UM Pharmacy. The Principal investigator will call for each experiment.
OTHERNatural history
Participants will not be provided Naloxone or Saline.
Sponsors
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The UM Pharmacy will assign de-identified study IDs to participants and provide the study drug (Naloxone or Saline) so that participants, the person conducting the experiment, and the investigator will be blind to the participant's group.
Intervention model description
AIM 1: This is a double-blinded, randomized, between- and within-subjects design (3 X 3) with TMD participants randomly assigned to one of three groups. The three groups are 1. Naloxone group 2. Saline group 3. Natural history group, in which participants will not be given any drugs. Within-subjects factor: All three groups will go through the following 3 conditions:1. Active VR (theBlu); 2. Sham VR; 3. No-VR.
Eligibility
Sex/Gender
ALL
Age
18 Years to 88 Years
Healthy volunteers
No
Inclusion criteria
* Age (18-88 years) * English speaker (written and spoken) * Temporal Mandibular Disorder (TMD) for at least 3 months
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLuana Colloca, MD/PhD/MS
University of Maryland Baltimore School of Nursing
Outcome results
None listed