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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.
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.
In this study, based on our PAF study and modulation of autonomic measurements via VR, we will determine the role of acute and 3-week VR intervention to help restore PAF oscillations to normal. PAF and autonomic measurements will be collected in TMD participants characterized by low/high-impact pain. All participants will go through Active VR, Sham VR and NH phases (3-week each) where participants will be monitored for changes in cortical excitability via PAF oscillations and clinical benefit via EMA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High impact TMD | Other | Other: TMD Phenotype TMD participants will be clinically phenotyped into two between-subject groups based on their score on the Graded Chronic Pain Scale (GCPS). This group will have a GCPS grade 2b, 3, and 4. |
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| Low impact TMD | Other | Other: TMD Phenotype TMD participants will be clinically phenotyped into two between-subject groups based on their score on the Graded Chronic Pain Scale (GCPS). This group will have a GCPS grade 0, 1, and 2a |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RelieVRx | Device | Participants will use RelieVRx daily for 20min/day for 3 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Peak alpha frequency (PAF) | EEG response PAF when participants are undergoing the in-person VR | We will acquire 2-10 min of baseline EEG with open eyes and 2-10 min of EEG with closed eyes. This measurement will occur at each of the four in-person visit approximately every 3 weeks. |
| Objective incremental Celsius changes in heat-pain tolerance | Heat pain tolerance to incremental change in temperature will be obtained using a timer (minutes of tolerance) | The heat incremental changes range from 30 sec to 2 min tolerance. This measurement will occur at each of the four in-person visit approximately every 3 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective VAS (Visual Analog Scale) scores for mood, situational anxiety, and pain intensity/unpleasantness | Participants will take Ecological Momentary Assessment questionnaires. Minimum Value: 0 Maximum Value: 100 Score interpretation: 0=not at all, 100=most/strongest For example, anxiety on a scale of 0-100, 0=no anxiety, 100=the most anxious | Daily during the 3-week condition timeframe |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Research Coordinator | Contact | 410-706-5975 | NRSCollocaLab@umaryland.edu | |
| Katia Matychak, MS | Contact | 410-706-5975 | katiamatychak@umaryland.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luana Colloca | Recruiting | Baltimore | Maryland | 21201-1512 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30817437 | Background | Honzel E, Murthi S, Brawn-Cinani B, Colloca G, Kier C, Varshney A, Colloca L. Virtual reality, music, and pain: developing the premise for an interdisciplinary approach to pain management. Pain. 2019 Sep;160(9):1909-1919. doi: 10.1097/j.pain.0000000000001539. No abstract available. | |
| 32345915 | Background | Colloca L, Raghuraman N, Wang Y, Akintola T, Brawn-Cinani B, Colloca G, Kier C, Varshney A, Murthi S. Virtual reality: physiological and behavioral mechanisms to increase individual pain tolerance limits. Pain. 2020 Sep 1;161(9):2010-2021. doi: 10.1097/j.pain.0000000000001900. |
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At this time, there is neither intent nor plan to share IPD.
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| ID | Term |
|---|---|
| D010146 | Pain |
| D013705 | Temporomandibular Joint Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017271 | Craniomandibular Disorders |
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This is a 2 (high- vs. low-impact pain) by 3 (3-week Active VR vs. 3-week Sham VR vs. 3-week NH) conditions mixed experimental design. TMD participants will be clinically phenotype into high-impact or low-impact pain groups according to Graded Chronic Pain Scale (GCPS). All participants will go through Active VR, Sham VR and NH phases (3-week each).
There will be 4 in-person visits where participants will be monitored for changes in cortical excitability via PAF oscillations and clinical benefit via Ecological Momentary Assessments (EMA) during the 3-week conditions.
Crossover Study Model was chosen because each participant will receive VR, Sham-VR, and No-VR in random order
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Participants will be blinded to the VR and Sham-VR conditions
| Sham-VR | Device | Participants will use Sham-VR, consisting of video, images, and sound in a head-mounted display but lack the "sense of presence" and immersive features of Active-VR (for example, scene changes with head movement). Participants will use the Sham-VR daily for 20min/day for 3 weeks |
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| No-VR (natural history control) | Other | Participants will continue regular/usual care without any VR devices (goggles or audiovisual input) |
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| University of Maryland | Recruiting | Baltimore | Maryland | 21201-1512 | United States |
|
| 9870976 | Background | Amanzio M, Benedetti F. Neuropharmacological dissection of placebo analgesia: expectation-activated opioid systems versus conditioning-activated specific subsystems. J Neurosci. 1999 Jan 1;19(1):484-94. doi: 10.1523/JNEUROSCI.19-01-00484.1999. |
| 30216744 | Background | Colloca L. The Placebo Effect in Pain Therapies. Annu Rev Pharmacol Toxicol. 2019 Jan 6;59:191-211. doi: 10.1146/annurev-pharmtox-010818-021542. Epub 2018 Sep 14. |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |