Using virtual reality at home to treat chronic temporomandibular joint disorders
| ISRCTN | ISRCTN12473220 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12473220 |
| Secondary identifying numbers | HP-00069094 |
- Submission date
- 30/06/2023
- Registration date
- 18/07/2023
- Last edited
- 08/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
The purpose of this research study is to better understand pain perception and how it can be influenced by using virtual reality tools in a home setting. In this study, we will investigate the effect of pain-specific virtual reality (VR) modules on the physical and psychological responses to pain, as compared to an audio intervention and no-intervention. This study can provide valuable information for a long-term study in the future.
Who can participate?
Adult participants with ongoing chronic orofacial pain primarily diagnosed with temporomandibular disorder (TMD).
What does the study involve?
This study will be completed over one month. During week one, the study team will educate the participants on how to daily record their pain via an online link. From week 2-4, we will assign them several different interventions: virtual reality, audio, or no-intervention. The participants will take part in the study in the comfort of their homes. Through the mail, they will receive a virtual reality headset and audio player. The participants will use the VR device continuously for 5 days with a 20 minutes session each day. In a randomized order, participants will also complete MP3/4 intervention for another 5 days.
What are the possible benefits and risks of participating?
Participants may or may not benefit from participating in this study. The risks of participating include loss of confidentiality, breaching of privacy, the risk associated with psychological questionnaires, the risk associated with immersive VR, and unknown risks.
Where is the study run from?
University of Maryland, Baltimore (USA)
When is the study starting and how long is it expected to run for?
July 2020 to May 2021
Who is funding the study?
MPowering the State grant (USA)
Who is the main contact?
Luana Colloca, MD, PhD, MS
colloca@umaryland.edu
Contact information
Principal Investigator
655 W Lombard Street
Baltimore City
21201
United States of America
 ORCID ID |
0000-0002-6503-4709 |
|---|---|
| Phone | +1 410-706-8244 |
| colloca@umaryland.edu |
Study information
| Study design | Randomized controlled cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Care home, Home, Internet/virtual |
| Study type | Treatment, Efficacy |
| Participant information sheet | 43876 PIS.pdf |
| Scientific title | At-home virtual reality as a therapeutic approach for individuals with chronic temporomandibular joint disorders |
| Study hypothesis | The purpose of this study is to investigate the effect of virtual reality educational modules on pain experiences at home, as compared to an audio intervention and no-intervention. |
| Ethics approval(s) |
Approved 10/07/2020, Institutional Review Board at the University of Maryland Baltimore (620 W Lexington Street, Baltimore City, 21201, United States of America; +1 410-706-5037; hrpo@umaryland.edu), ref: HP-00069094 |
| Condition | Treatment of chronic pain in patients with temporomandibular joint disorders |
| Intervention | All participants will receive a 5-day virtual reality treatment, and a 5-day audio treatment with identical contents. The sequence of receiving the treatment will be randomized according to a 1:1 ratio. These 5-day intervention periods will be preceded and followed by a 5-day run-in period to stabilize the medication and familiarize the daily monitoring method. There will also be a 5-day washout period with no intervention between the intervention periods. Virtual reality (VR) intervention: Participants will be mailed an AppliedVR headset and controller that can run pre-installed programs with immersive, calming environments and audio. They will complete daily 20-minute sessions for five days. Audio (MP3/4) intervention: Participants will be mailed an MP3/4 player with pre-installed programs to play soothing audio with identical content to VR (without immersion). They will complete daily 20-minute sessions for five days. No intervention: No experimental interventions will be introduced to the participants. Participants are allowed to keep their usual care regimen. |
| Intervention type | Behavioural |
| Primary outcome measure | Daily pain intensity levels will be measured using visual analogue scale (VAS) from 0=no pain at all to 100=maximum tolerable pain. |
| Secondary outcome measures | 1. Daily pain unpleasantness, anxiety, mood will be measured using VAS from 0=no pain unpleasantness/no anxiety at all/extremely bad to 100=maximum pain unpleasantness/maximum tolerable anxiety/extremely good. 2. Weekly pain behavior, pain interference, anxiety, and sleep disturbances will be measured using Patient Reported Outcome Measurement Information Systems (PROMIS) tools. |
| Overall study start date | 10/07/2020 |
| Overall study end date | 11/05/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 54 |
| Total final enrolment | 54 |
| Participant inclusion criteria | 1. Age (18-75 years old) 2. English speaker (written and spoken) 3. Temporal Mandibular Disorder (TMD) for at least 3 months 4. TMD Grade Chronic Pain Scale (GCPS) ≥1 5. TMD Screening from HP-00068315 2016 and after |
| Participant exclusion criteria | 1. Present or past degenerative neuromuscular disease 2. Cardiovascular, neurological diseases, pulmonary abnormalities, kidney disease, liver disease, history of cancer within past 3 years 3. Any personal (or family first degree) history of mania, schizophrenia, or other psychoses 4. Severe psychiatric condition (e.g. schizophrenia, bipolar disorders, autism) leading to hospitalization within the last 3 years. 5. Lifetime alcohol/drug dependence or alcohol/drug abuse in past 3 months 6. Pregnancy or breast feeding 7. Color-blindness 8. Impaired or uncorrected hearing 9. Any facial trauma that has occurred in the last 6 weeks 10. History of a severe facial trauma in the last 2-3 months 11. Conditions that would interfere with the VR mask placement (e.g. trauma, burn, infection) 12. Known history of severe motion sickness |
| Recruitment start date | 23/11/2020 |
| Recruitment end date | 30/04/2021 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Baltimore
21210
United States of America
Sponsor information
University/education
655 W Lombard Street
Baltimore
21201
United States of America
| Phone | +1 410-706-7452 |
|---|---|
| NRScommunications@umaryland.edu | |
| Website | http://www.umaryland.edu/ |
"ROR" |
https://ror.org/04rq5mt64 |
Funders
Funder type
Government
No information available
Government organisation / National government
- Alternative name(s)
- Office of Alternative Medicine, National Center for Complementary and Alternative Medicine, NCCIH, OAM, NCCAM
- Location
- United States of America
Results and Publications
| Intention to publish date | 30/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We plan to publish one paper. We will also disseminate the study findings in local, domestic, and international events and conferences. |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be available upon request from the principal investigator Dr. Luana Colloca at colloca@umaryland.edu. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 04/07/2023 | No | Yes | ||
| Results article | 07/04/2025 | 08/04/2025 | Yes | No |
Additional files
Editorial Notes
08/04/2025: Publication reference added.
04/07/2023: Trial's existence confirmed by Institutional Review Board at the University of Maryland Baltimore.
