NCT05318313

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 17, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

March 3, 2022

Last Update Submit

January 5, 2026

Conditions

Keywords

Temporomandibular DisordersTMDtelerehabilitationtelehealthphysical therapyPT

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

Other: Telerehabilitation

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

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

Interventions

The TR PT evaluation and follow-up visits will be performed via Zoom software

Hybrid 1Hybrid 2Telerehabilitation only

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Emily Kahnert

    University of Minnesota

    PRINCIPAL INVESTIGATOR

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

Locations