Telerehabilitation for TMD

Study Overview
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Brief Summary
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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.

Official Title
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Telerehabilitation Effectiveness for Individuals With Temporomandibular Disorders (TMD): A Non-Inferiority Study

Conditions
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Temporomandibular Disorder, TMJ Disc Displacement With Reduction, TMJ Disc Displacement Without Reduction, Masticatory Myofascial Pain, TMJ Arthralgia, TMD Headache

Intervention / Treatment
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* Other: Telerehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Telerehabilitation only<br>Participants choose to have all of their physical therapy provided virtually throughout the length of the study | Other: Telerehabilitation<br>* The TR PT evaluation and follow-up visits will be performed via Zoom software<br>|
| In-person only<br>Participants choose to have all of their physical therapy provided in-person throughout the length of the study | |
| Hybrid 1<br>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 | Other: Telerehabilitation<br>* The TR PT evaluation and follow-up visits will be performed via Zoom software<br>|
| Hybrid 2<br>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 | Other: Telerehabilitation<br>* The TR PT evaluation and follow-up visits will be performed via Zoom software<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TMD, Temporomandibular Disorders, telerehabilitation, telehealth, physical therapy, PT