RECRUITING

The Effect of Manual Physical Therapy and Exercise in Addition to Routine Dental Care in Individuals with Temporomandibular Disorders

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this randomized clinical trial among US military active-duty service-members with temporomandibular disorders (TMD) is to determine whether standard care plus 6-weeks of tailored, individualized physical therapy (PT) treatment provides greater benefit than standard care alone in patient-reported outcomes, and maximal mouth opening. The aims of the study are to compare outcomes in individuals with TMD that receive standard care treatment versus standard care plus PT interventions at 0-, 6-, and 12-weeks. The investigators anticipate that subjects in the standard care plus PT group will exhibit improved patient-reported outcomes, and maximal mouth opening compared to those who received standard care alone. Additionally, the investigators will compare the amount and type of healthcare utilization between the two groups (Standard Care and Standard Care + PT) in the 12-month period following enrollment in the study. All participants will be managed by their primary dental provider and receive care as deemed appropriate by their provider. All participants will complete patient-reported outcome measures and have their jaw motion measured. Those randomized to the standard care plus PT group will also receive a tailored PT evaluation followed by an individualized plan of care two times per week for up to six weeks.

Official Title

The Effect of Manual Physical Therapy and Exercise in Addition to Routine Dental Care in Individuals with Temporomandibular Disorders: a Randomized Controlled Trial

Quick Facts

Study Start:2024-09-16
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06602375

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Active-Duty Service Members
  2. * Complaint of TMD symptoms
  3. * Must be able to be followed for twelve weeks after consent
  4. * TMD Screener score ≥ 3 45
  1. * Actively in a Trainee status
  2. * Utilized oral device in past 6 months
  3. * Facial injection therapy in the prior 6 months
  4. * Facial surgery in the preceding 6 months
  5. * Serious spinal pathology (acute fracture, active cancer, instability)
  6. * Diagnosed neurological or rheumatological disease
  7. * Currently under litigation related to temporomandibular or cervical spine pain(s)
  8. * Currently undergoing Medical Evaluation Board (MEB)
  9. * Retiring or separating from the military within a year

Contacts and Locations

Study Contact

Mason A Frank, DPT
CONTACT
301-606-8511
mason.a.frank.mil@health.mil
Benjamin R Hando, PhD, DPT
CONTACT
210-602-9024
benjamin.r.hando.civ@health.mil

Principal Investigator

Benjamin R Hando, PhD, DPT
STUDY_CHAIR
Army-Baylor Doctoral Fellowship in Orthopedic Manual Physical Therapy, Brooke Army Medical Center

Study Locations (Sites)

Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
United States

Collaborators and Investigators

Sponsor: Brooke Army Medical Center

  • Benjamin R Hando, PhD, DPT, STUDY_CHAIR, Army-Baylor Doctoral Fellowship in Orthopedic Manual Physical Therapy, Brooke Army Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-16
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2024-09-16
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • Temporomandibular Disorders
  • Physical Therapy
  • Manual Therapy
  • Exercise

Additional Relevant MeSH Terms

  • Temporomandibular Disorders (TMD)