Temporomandibular DisorderNCT05318313
Telerehabilitation for TMD
An observational study of Temporomandibular Disorder and TMJ Disc Displacement With Reduction, run by University of Minnesota at 1 site in United States.
Trial summary
This study will compare after physical therapy for Temporomandibular Disorders (TMD) performed either in-person or virtually using telerehabilitation. Comparing diagnostic reliability and quality-of-life outcomes in each group will determine (based on a 10% margin) whether delivering physical therapy via… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Temporomandibular Disorder, TMJ Disc Displacement With Reduction, TMJ Disc Displacement Without Reduction
- What is being tested?
- Telerehabilitation
- How many people
- 207 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2022to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals diagnosed with at least one subtype of temporomandibular disorders by a TMD specialist at the University of Minnesota TMD, Orofacial Pain and Dental Sleep Medicine Clinic and referred for physical therapy at the same clinic.
Who may be able to join
- 18-70 years old
- Referred to PT with ≥1 TMD subtype diagnosis
- PI has no previous knowledge of the participant's diagnosis
- Email access
- Possession of any device that can be positioned for hands-free TR visits (TR group only)
- Willingness and ability to comply with all study requirements and PT program
- Able to provide informed consent
Who cannot join
- Non-English speakers
- Permanent residence outside of the state of Minnesota (TR group only)
- Women in the last trimester of pregnancy
- Referred for post-surgical rehabilitation
- Severe chronic pain as identified by level 4 classification on the GCPS
- Current diagnosis or existence of the following conditions that can limit response to PT and participation in study activities:
Show all 13Show fewer
- Neuropathic pain
- Fibromyalgia and/or generalized widespread pain on both sides of the body in ≥3 areas above and below the waist
- Rheumatoid arthritis or juvenile idiopathic arthritis
- Dystonia or other movement disorder
- Fractures and/or recent jaw or facial trauma
- Malignancies
- Current substance abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Telerehabilitation Effectiveness for Individuals With Temporomandibular Disorders (TMD): A Non-Inferiority Study
This study will compare after physical therapy for Temporomandibular Disorders (TMD) performed either in-person or virtually using telerehabilitation. Comparing diagnostic reliability and quality-of-life outcomes in each group will determine (based on a 10% margin) whether delivering physical therapy via telerehabilitation is as good as standard in-person care for these individuals. Long term outcomes including patient satisfaction, cost-effectiveness analysis, and functional status will describe the feasibility of telerehabilitation as a management intervention for this population.
- Conditions
- Temporomandibular Disorder, TMJ Disc Displacement With Reduction, TMJ Disc Displacement Without Reduction, Masticatory Myofascial Pain, TMJ Arthralgia, TMD Headache
- Being tested
- Telerehabilitation
- Keywords
- Temporomandibular Disorders, TMD, telerehabilitation, telehealth, physical therapy, PT
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationOther
The TR PT evaluation and follow-up visits will be performed via Zoom software
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation only | Participants choose to have all of their physical therapy provided virtually throughout the length of the study Receives: Other: Telerehabilitation | |
| In-person only | Participants choose to have all of their physical therapy provided in-person throughout the length of the study | |
| Hybrid 1 | The TR PT evaluation and follow-up visits in the initial 6 weeks will be performed via Zoom software and subsequent follow-up visits will switch to in person after 6 weeks Receives: Other: Telerehabilitation | |
| Hybrid 2 | The PT evaluation and follow-up visits in the initial 6 weeks will be performed in person and will switch to TR via Zoom software after 6 weeks Receives: Other: Telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specialist diagnosis
Diagnosis will be determined by putting clinical assessment results into the Brief Diagnostic Criteria for TMD (Brief DC/TMD) algorithm and getting one or more of 7 possible diagnoses: TMJ arthralgia (joint), Masticatory myofascial pain (muscle), TMJ disc displacement with reduction (joint), TMJ disc displacement without reduction (joint), TMJ arthritis (joint), TMD headache (muscle), other (neither). The diagnosis will be measured as one of four options: 1. joint; 2. muscle; 3. both; or 4. neither.
Measured: Measured directly after the PT evaluation (Day 1)
Diagnostic agreement
Agreement data for each subject will be collected comparing two specialist diagnoses: dentist and physical therapist. Agreement about the diagnostic category will be recorded as a binary "yes/no" measure.
Measured: Measured directly after the PT evaluation (Day 1)
The Oral Health Impact Profile for TMD summary score
The OHIP-TMD is a condition-specific quality-of-life scale with 22 items and a 0-4 scoring option for each item. A higher score means lower quality-of life. The summary score after 6 weeks will be compared to the baseline summary score, and a score decrease ≥6.9 units will be considered evidence of therapy success. The proportion of therapy success in each group will be used for non-inferiority comparison.
Measured: 6 weeks after intervention onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start17 Jun 2022
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily Kahnert, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318313
- Sponsor's protocol ID
- DENT-2022-30141
- Status last verified
- Jan 2026
- First submitted
- 3 Mar 2022
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation Effectiveness for Individuals With Temporomandibular Disorders (TMD): A Non-Inferiority Study
- ClinicalTrials.gov ID
- NCT05318313
- Acronym / sponsor ID
- DENT-2022-30141
- Conditions
- Temporomandibular Disorder, TMJ Disc Displacement With Reduction, TMJ Disc Displacement Without Reduction, Masticatory Myofascial Pain, TMJ Arthralgia, TMD Headache
- Keywords
- Temporomandibular Disorders, TMD, telerehabilitation, telehealth, physical therapy, PT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare after physical therapy for Temporomandibular Disorders (TMD) performed either in-person or virtually using telerehabilitation. Comparing diagnostic reliability and quality-of-life outcomes in each group will determine (based on a 10% margin) whether delivering physical therapy via telerehabilitation is as good as standard in-person care for these individuals. Long term outcomes including patient satisfaction, cost-effectiveness analysis, and functional status will describe the feasibility of telerehabilitation as a management intervention for this population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation only | – | Other: TelerehabilitationParticipants choose to have all of their physical therapy provided virtually throughout the length of the study |
| In-person only | – | –Participants choose to have all of their physical therapy provided in-person throughout the length of the study |
| Hybrid 1 | – | Other: TelerehabilitationThe TR PT evaluation and follow-up visits in the initial 6 weeks will be performed via Zoom software and subsequent follow-up visits will switch to in person after 6 weeks |
| Hybrid 2 | – | Other: TelerehabilitationThe PT evaluation and follow-up visits in the initial 6 weeks will be performed in person and will switch to TR via Zoom software after 6 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals diagnosed with at least one subtype of temporomandibular disorders by a TMD specialist at the University of Minnesota TMD, Orofacial Pain and Dental Sleep Medicine Clinic and referred for physical therapy at the same clinic.
Key inclusion criteria (7 listed)
- 18-70 years old
- Referred to PT with ≥1 TMD subtype diagnosis
- PI has no previous knowledge of the participant's diagnosis
- Email access
- Possession of any device that can be positioned for hands-free TR visits (TR group only)
Key exclusion criteria (13 listed)
- Non-English speakers
- Permanent residence outside of the state of Minnesota (TR group only)
- Women in the last trimester of pregnancy
- Referred for post-surgical rehabilitation
- Severe chronic pain as identified by level 4 classification on the GCPS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelerehabilitationThe TR PT evaluation and follow-up visits will be performed via Zoom software | Other | Hybrid 1, Hybrid 2, Telerehabilitation only |
Primary outcome
Specialist diagnosis
Time frame: Measured directly after the PT evaluation (Day 1)
Diagnosis will be determined by putting clinical assessment results into the Brief Diagnostic Criteria for TMD (Brief DC/TMD) algorithm and getting one or more of 7 possible diagnoses: TMJ arthralgia (joint), Masticatory myofascial pain (muscle), TMJ disc displacement with reduction (joint), TMJ disc displacement without reduction (joint), TMJ arthritis (joint), TMD headache (muscle), other (neither). The diagnosis will be measured as one of four options: 1. joint; 2. muscle; 3. both; or 4. neither.
Diagnostic agreement
Time frame: Measured directly after the PT evaluation (Day 1)
Agreement data for each subject will be collected comparing two specialist diagnoses: dentist and physical therapist. Agreement about the diagnostic category will be recorded as a binary "yes/no" measure.
The Oral Health Impact Profile for TMD summary score
Time frame: 6 weeks after intervention onset
The OHIP-TMD is a condition-specific quality-of-life scale with 22 items and a 0-4 scoring option for each item. A higher score means lower quality-of life. The summary score after 6 weeks will be compared to the baseline summary score, and a score decrease ≥6.9 units will be considered evidence of therapy success. The proportion of therapy success in each group will be used for non-inferiority comparison.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Kahnert principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Disorder and TMJ Disc Displacement With Reduction, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specialist diagnosis (time frame: Measured directly after the PT evaluation (Day 1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.