Telerehabilitation for TMD
Telerehabilitation Effectiveness for Individuals With Temporomandibular Disorders (TMD): A Non-Inferiority Study
1 other identifier
observational
207
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2022
CompletedFirst Posted
Study publicly available on registry
April 8, 2022
CompletedStudy Start
First participant enrolled
June 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedJanuary 6, 2026
January 1, 2026
2 years
March 3, 2022
January 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 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 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.
6 weeks after intervention onset
Study Arms (4)
Telerehabilitation only
Participants 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
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
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
Interventions
The TR PT evaluation and follow-up visits will be performed via Zoom software
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emily Kahnert
University of Minnesota
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2022
First Posted
April 8, 2022
Study Start
June 17, 2022
Primary Completion
July 1, 2024
Study Completion
July 1, 2024
Last Updated
January 6, 2026
Record last verified: 2026-01