Clinical Trial Finder

Telerehabilitation for TMD

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05318313
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Minnesota
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Emily Kahnert
Principal Investigator Affiliation University of Minnesota
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Temporomandibular Disorder, TMJ Disc Displacement With Reduction, TMJ Disc Displacement Without Reduction, Masticatory Myofascial Pain, TMJ Arthralgia, TMD Headache
Arms & Interventions

Arms

: Telerehabilitation only

Participants choose to have all of their physical therapy provided virtually throughout the length of the study

: 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

: 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

Interventions

Other: - Telerehabilitation

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Minnesota, Minneapolis, Minnesota

Status

Recruiting

Address

University of Minnesota

Minneapolis, Minnesota, 55455

Site Contact

Tom Keeler

[email protected]

218-208-7045

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