Recruiting

Manual Physical Therapy

Sponsor:

Brooke Army Medical Center

Code:

NCT06602375

Conditions

Temporomandibular Disorders (TMD)

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Standard care

Physical Therapy (PT)

Study Details

Brief summary:

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.

Conditions

Temporomandibular Disorders (TMD)

Study ID

NCT06602375

Start date

Sep 16, 2024

Status verified date

Sep, 2024

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Active-Duty Service Members
  • Complaint of TMD symptoms
  • Must be able to be followed for twelve weeks after consent
  • TMD Screener score ≥ 3 45

Exclusion Criteria:

  • Actively in a Trainee status
  • Utilized oral device in past 6 months
  • Facial injection therapy in the prior 6 months
  • Facial surgery in the preceding 6 months
  • Serious spinal pathology (acute fracture, active cancer, instability)
  • Diagnosed neurological or rheumatological disease
  • Currently under litigation related to temporomandibular or cervical spine pain(s)
  • Currently undergoing Medical Evaluation Board (MEB)
  • Retiring or separating from the military within a year

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Standard care plus physical therapy

Participants randomized to this group will receive standard care from their treating dental provider. In addition, they will receive routine physical therapy interventions over a 6-week (+/- 2 week) period. Study participants will receive treatments based on their clinical examination. Subjects will attend up to 12 sessions over 6-weeks (+/- 2 weeks). The initial physical therapy visit will be 60-minutes long with all subsequent appointments being 30-minutes, to include any booster sessions. The interventions will be pragmatic in nature, with provided treatment being specific to the subject's specific complaints, goals, and examination identified impairments.

active comparator: Standard Care

Those randomized to the standard care (control) group will follow the plan of care determined by their treating dental provider. This group will receive standard (routine) care from the dental provider for the treatment of TMD. These decisions will be based on the clinical judgment of the dental provider, as is customary with routine care for TMD.

Interventions

Standard care

The standard care (control) group will follow the plan of care determined by their treating dental provider. These decisions will be based on the clinical judgment of the dental provider and subject desires. Intervention may include, but is not limited to typical patient education, pharmacotherapy, oral splinting or occlusal device, cryo/thermotherapy recommendations, and exercise handouts.

Physical Therapy (PT)

Participants randomized to this group will receive individualized, tailored courses of physical therapy care. Interventions may be directed at the temporomandibular, cervical, and/or scapulothoracic regions based on subject clinical presentation and impairments. Manual therapy joint and soft tissue mobilizations may be used to address pain, mobility, and motor control. Motor control exercises may be used to promote relaxation, improve range of motion, and appropriate postures. Strengthening exercise, primarily directed to the cervical and scapulothoracic regions, may be implemented as appropriate. Stretching exercise may be used to address pain and mobility deficits. The interventions are intentionally pragmatic; study participants will receive treatment as they are comfortable and as recommended by the treating therapist.

Primary outcome measure

  • Jaw Functional Limitation Scale - 8 item (JFLS-8) [ Time Frame: From enrollment to 12 weeks post enrollment (primary), will also be assed at 6-weeks ]

Central Contacts and Locations

Central contacts

Mason A Frank, DPT

301-606-8511mason.a.frank.mil@health.mil

Benjamin R Hando, PhD, DPT

210-602-9024benjamin.r.hando.civ@health.mil

Locations

Brooke Army Medical Center

Recruiting

Fort Sam Houston, Texas, United States, 78234

Contacts

Mason A Frank, Primary Investigator, DPT

301-606-8511mason.a.frank.mil@health.mil

Benjamin R Hando, PhD, DPT

210-602-9024benjamin.r.hando.civ@health.mil

Principal Investigator:

Mason A Frank, DPT

More Information

Sponsor

Brooke Army Medical Center

Last update posted

Feb 5, 2025

Last verified

Sep, 2024

Keywords

  • Temporomandibular Disorders
  • Physical Therapy
  • Manual Therapy
  • Exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brooke Army Medical Center on 2025-02-05.