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.
Active-Duty Service Members
Complaint of TMD symptoms
Must be able to be followed for twelve weeks after consent
TMD Screener score ≥ 3 45
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
Parallel
Standard care
Other interventionThe 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 interventionParticipants 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.
Jaw Functional Limitation Scale - 8 item (JFLS-8)
This study's primary outcome variable is the Jaw Functional Limitation Scale - 8 Item version. This 8-item questionnaire is scored from 0 to 80 points, with higher scores indicating greater levels of functional limitation. The JFLS-8 is a reliable and valid tool to measure patient functional limitations related to the jaw. This questionnaire is supported by the dental and physical therapy communities to measure functional limitations of the jaw. Each item is scored from 0-10. The scores are summed and divided by the number of items answered. No more than two items can be missing for scoring to take place.
Numeric Pain Rating Scale (NPRS)
The Numeric Pain Rating Scale is an 11-point scale from 0-10 that measures pain intensity in adults, with higher scores indicating greater levels of pain. Subjects will select a value that is most in line with their current perceived pain intensity. The NPRS is a reliable and valid tool. The minimal clinically important difference has been widely established as two points.
Neck Disability Index (NDI)
The Neck Disability Index (NDI) contains 10-items scored from 0-5 on a Likert scale which assesses the construct of neck related disability. Scores range from 0 to 50 and are reported as percentages, with higher scores associated with greater levels of disability. The NDI is a valid, reliable, and responsive tool with a minimal clinically importance difference reported as 7.5 points, or 15%.
Central Sensitization Inventory (CSI)
The Central Sensitization Inventory (CSI) is a reliable and valid 25-item questionnaire with each item assessed on a scale ranging from "never" (0 points) to "always" (4 points) with a resultant score between 0 and 100. Scores higher than 40 points are suggestive of a central sensitization component to patient symptoms. This score will be dichotomized with scores of 40 or higher indicating central sensitization, and scores of 39 or less indicating no presence of central sensitization.
Global Rating of Change (GRoC)
The Global Rating of Change (GRoC) scale is a valid measure of a patient's overall perceived change in quality of life through an 11-point Likert scale. The scale ranges from "-5" to "+5" associated with "very much worse" to "completely recovered," respectively. The minimal clinically important difference is a change greater than or equal to two points. This score will be dichotomized with scores 3+ or greater indicating improvement, and scores 2 or less indicating no improvement.
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