Telerehabilitation for TMD

Temporomandibular Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05318313
• Other study ID #: DENT-2022-30141
• Status: Recruiting
• Start date: January 3, 2017
• Est. completion date: July 1, 2024

Study information

• Verified date: April 2024
• Source: University of Minnesota
• Contact: Tom Keeler
• Phone: 218-208-7045
• Email: keele075[@]umn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 189
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Headache
• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Other:
• Telerehabilitation
The TR PT evaluation and follow-up visits will be performed via Zoom software

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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