Telerehabilitation for TMD

Sponsor

University of Minnesota (Other)

Overall Status

Recruiting

CT.gov ID

NCT05318313

Collaborator

(none)

189

Enrollment

Location

23.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Temporomandibular Disorder TMJ Disc Displacement With Reduction TMJ Disc Displacement Without Reduction Masticatory Myofascial Pain TMJ Arthralgia TMD Headache	Other: Telerehabilitation

Study Design

Study Type:

Observational

Anticipated Enrollment :

189 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 15, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Telerehabilitation only Participants choose to have all of their physical therapy provided virtually throughout the length of the study	Other: Telerehabilitation The TR PT evaluation and follow-up visits will be performed via Zoom software
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	Other: Telerehabilitation The TR PT evaluation and follow-up visits will be performed via Zoom software
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	Other: Telerehabilitation The TR PT evaluation and follow-up visits will be performed via Zoom software

Outcome Measures

Primary Outcome Measures

Specialist diagnosis [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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