Telerehabilitation for TMD

Recruiting

• Conditions: TMJ Disc Displacement With Reduction; TMJ Arthralgia; TMD Headache; Masticatory Myofascial Pain; Temporomandibular Disorder; TMJ Disc Displacement Without Reduction
• Interventions: Other: Telerehabilitation

• Registration Number: NCT05318313
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-03
• Study First Submitted: 2022-03-03
• Study First Submitted QC: 2022-03-31
• Study First Posted: 2022-04-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-11
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 189

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:

  1. Neuropathic pain
  2. Fibromyalgia and/or generalized widespread pain on both sides of the body in ≥3 areas above and below the waist
  3. Rheumatoid arthritis or juvenile idiopathic arthritis
  4. Dystonia or other movement disorder
  5. Fractures and/or recent jaw or facial trauma
  6. Malignancies
  7. Current substance abuse

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hybrid 1	Telerehabilitation	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
Telerehabilitation only	Telerehabilitation	Participants choose to have all of their physical therapy provided virtually throughout the length of the study
Hybrid 2	Telerehabilitation	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

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States