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

Conditions

• Temporomandibular Disorders (TMD)

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Not accepted

Interventions

• Standard care — OTHER
  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) — OTHER
  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.

Study Details

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.

Key Dates

Start date

Sep 16, 2024

Status verified

Sep 2024

Primary completion

Jun 30, 2025

Completion

Jun 30, 2026

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

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

• Mason A Frank, DPT
  301-606-8511
  [email protected]
• Benjamin R Hando, PhD, DPT
  210-602-9024
  [email protected]

Locations (1)

Find similar trials in Fort Sam Houston, TX

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