Clinical trial NCT05318313: Telerehabilitation for TMD
Official title: Telerehabilitation Effectiveness for Individuals With Temporomandibular Disorders (TMD): A Non-Inferiority Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temporomandibular Disorder
TMJ Disc Displacement With Reduction
TMJ Disc Displacement Without Reduction
Masticatory Myofascial Pain
TMJ Arthralgia
TMD Headache
Keywords: Temporomandibular Disorders
TMD
telerehabilitation
telehealth
physical therapy
PT
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.


Eligibility 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

Primary outcomes:
measure: Specialist diagnosis
timeFrame: Measured directly after the PT evaluation (Day 1)
measure: Diagnostic agreement
timeFrame: Measured directly after the PT evaluation (Day 1)
measure: The Oral Health Impact Profile for TMD summary score
timeFrame: 6 weeks after intervention onset
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Emily Kahnert
role: PRINCIPAL_INVESTIGATOR
References: