Physical Therapy for TMJ Dysfunction

Overseen By Benjamin R Hando, PhD, DPT

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Brooke Army Medical Center

Disqualifiers: Trainee status, Oral device, Facial injection, Facial surgery, Spinal pathology, Neurological disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

Duration: 6 weeks (+/- 2 weeks)

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding personalized physical therapy (PT) to the usual treatment for temporomandibular disorders (TMD) can improve outcomes, such as jaw movement and overall comfort, more than standard care alone. Participants will receive either standard care from their dental provider or standard care plus tailored PT sessions over six weeks. Researchers aim to assess healthcare usage in each group during the year following trial enrollment. The trial seeks active-duty service members with TMD symptoms who can be followed for twelve weeks after joining. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance treatment options for TMD.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It seems that participants will continue to receive care as deemed appropriate by their primary dental provider.

What prior data suggests that this physical therapy treatment is safe for individuals with TMD?

A previous study showed that manual physical therapy and exercise helped people with temporomandibular disorders (TMD) experience less pain and improved jaw mobility. Patients could open their mouths wider and felt less discomfort. Another study found that manual therapy reduced pain and enhanced jaw movement.

Regarding safety, physical therapy is generally safe for most people. It includes exercises and movements that aid the body's healing and function. Studies have not reported any serious side effects from this treatment. However, like any physical activity, mild soreness or discomfort might occur, but these usually resolve quickly. Overall, these findings suggest that physical therapy for TMD is safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using physical therapy for TMJ dysfunction because it offers a hands-on approach tailored to each patient's unique needs. Unlike standard dental care, which typically involves medication and splints, this treatment combines manual physical therapy with targeted exercises to address specific impairments identified during clinical exams. This personalized intervention aims to improve jaw function and reduce pain by directly targeting the muscles and joints involved, potentially offering more comprehensive relief and functionality than traditional methods.

What evidence suggests that this trial's treatments could be effective for TMJ dysfunction?

Research has shown that hands-on physical therapy and exercise can help treat jaw joint disorders, known as temporomandibular disorders (TMD). In this trial, participants in the "Standard care plus physical therapy" arm will receive these therapies in addition to standard care. Studies have found that this type of therapy can temporarily improve jaw function and reduce pain, though the benefits might lessen over time. Combining exercises with hands-on therapy has also proven effective for adults with TMD. These treatments aim to ease jaw movement and reduce discomfort, helping individuals with TMD function better in daily life. ^{2 3 4 6 7}

Who Is on the Research Team?

Benjamin R Hando, PhD, DPT

Principal Investigator

Army-Baylor Doctoral Fellowship in Orthopedic Manual Physical Therapy, Brooke Army Medical Center

Are You a Good Fit for This Trial?

This trial is for active-duty US military service-members with temporomandibular disorders (TMD). Participants must be receiving routine dental care. Those with additional conditions that might interfere with the study or who cannot commit to the full duration of treatment are likely excluded.

Inclusion Criteria

Must be able to be followed for twelve weeks after consent

Active-Duty Service Members

TMD Screener score ≥ 3 45

Exclusion Criteria

Retiring or separating from the military within a year

Currently under litigation related to temporomandibular or cervical spine pain(s)

Currently undergoing Medical Evaluation Board (MEB)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 hour

1 visit (in-person)

Treatment

Participants receive standard care plus physical therapy interventions over a 6-week period, attending up to 12 sessions.

6 weeks (+/- 2 weeks)

Up to 12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with outcomes collected at 6 and 12 weeks.

6 weeks

2 visits (in-person)

Long-term Follow-up

Healthcare utilization data is collected to determine medical utilization related to TMD in the 12-month period following enrollment.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Manual Physical Therapy and Exercise

Trial Overview

The study is testing if adding a tailored, individualized physical therapy program twice a week for six weeks to standard dental care improves outcomes in TMD patients more than standard dental care alone. Outcomes measured include patient-reported improvements and jaw movement.

How Is the Trial Designed?

Group I: Standard care plus physical therapy Experimental Treatment 2 Interventions

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.

Group II: Standard Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Brooke Army Medical Center

Lead Sponsor

Trials

134

Recruited

28,100+

Published Research Related to This Trial

Active exercises and manual mobilizations are recommended as effective physical therapy interventions for temporomandibular disorder, based on a systematic review of 30 studies.

Mid-laser therapy has shown greater effectiveness compared to other electrotherapy modalities, and combining various techniques like relaxation and biofeedback may enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the effectiveness of exercise, manual therapy, electrotherapy, relaxation training, and biofeedback in the management of temporomandibular disorder. Medlicott, MS., Harris, SR.[2018]

Physical therapy is essential in managing temporomandibular joint dysfunction (TMJD), particularly for treating stiffness following trauma.

Combining TMJ strapping with conventional physical therapy can effectively reduce clicking sounds, alleviate pain, and enhance jaw function in patients with TMJD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strapping for temporomandibular joint dysfunction. Babu, AS., John, SM., Unni, A.[2019]

A rehabilitation program involving cervical mobilization and exercise significantly improved jaw function and reduced self-reported pain in 12 women with temporomandibular disorder (TMD), as evidenced by a 7-point improvement on the Mandibular Functional Impairment Questionnaire and a reduction in pain levels.

Participants also experienced a significant increase in pain-free maximum mouth opening and pressure pain thresholds in the jaw muscles, indicating enhanced mandibular function, although the clinical relevance of these improvements remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of cervical mobilization and exercise on pain, movement and function in subjects with temporomandibular disorders: a single group pre-post test. Calixtre, LB., Grüninger, BL., Haik, MN., et al.[2022]

Patients with temporomandibular disorder (TMD) showed significant improvement in disability after a 2-week rehabilitation program that included manual physical therapy and exercise, with a mean improvement of 13.9% in TMD Disability Index scores.

The study involved consecutive patients who completed self-report measures, and the results indicate that this multimodal treatment approach can lead to clinically meaningful improvements in TMD symptoms in a short time frame.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manual physical therapy interventions and exercise for patients with temporomandibular disorders. Furto, ES., Cleland, JA., Whitman, JM., et al.[2015]

Arthroscopy of the temporomandibular joint (TMJ) is a minimally invasive procedure that effectively treats TMJ dysfunction, as demonstrated in a case where a patient with bilateral capsular impingement and adhesions showed significant improvement.

The four-stage rehabilitation protocol used post-surgery led to the patient achieving full range of motion and reduced pain within a month, with sustained results at a one-year follow-up, indicating the efficacy of this combined surgical and rehabilitation approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postarthroscopy physical therapy management of a patient with temporomandibular joint dysfunction. Wilk, BR., Stenback, JT., McCain, JP.[2005]

A scoping review of 23 high-quality clinical trials on physical therapy for temporomandibular disorders (TMDs) found that none included irritable bowel syndrome (IBS) as an eligibility criterion, despite the known comorbidity between the two conditions.

This suggests a gap in research, as the exclusion of IBS may overlook important factors that could influence treatment outcomes for patients with TMDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is Irritable Bowel Syndrome Considered in Clinical Trials on Physical Therapy Applied to Patients with Temporo-Mandibular Disorders? A Scoping Review. Rodrigues-de-Souza, DP., Paz-Vega, J., Fernández-de-Las-Peñas, C., et al.[2021]

Physical therapy interventions, including therapeutic exercises and acupuncture, show potential effectiveness in managing temporomandibular disorders, with specific techniques like postural exercises and manual therapy demonstrating pain reduction and improved oral function.

Despite some positive findings, the overall methodological quality of the studies was low, indicating that the results should be interpreted cautiously and more rigorous research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the effectiveness of physical therapy interventions for temporomandibular disorders. McNeely, ML., Armijo Olivo, S., Magee, DJ.[2022]

Physical therapy is gaining recognition as a standard treatment for temporomandibular disorders and orofacial pain, emphasizing its role in a multidisciplinary approach.

Most existing evidence for the efficacy of physical therapy in these conditions comes from clinical reports rather than well-controlled studies, indicating a need for more rigorous research to support its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapy for temporomandibular disorders and orofacial pain. Sturdivant, J., Fricton, JR.[2008]

The article presents a revised physical therapy approach for rehabilitating the temporomandibular joint (TMJ) after surgical intervention, specifically for chronic cases where previous treatments have failed.

Surgical options discussed include various techniques such as diskectomy and total joint replacement, indicating that surgery is considered only when symptoms significantly impair daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative physical therapy in temporomandibular joint arthroplasty. Bertolucci, LE.[2019]

The systematic review analyzed 129 studies related to manual and manipulative therapy (MMT) for upper extremity pain, concluding that there is a Fair (B) level of evidence supporting MMT combined with exercise or multimodal therapy for conditions like lateral epicondylopathy, carpal tunnel syndrome, and temporomandibular joint disorders in the short term.

Out of 81 randomized controlled trials, 35 were included, indicating a substantial body of research that can help practitioners effectively treat various upper extremity complaints using MMT techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manipulative and multimodal therapy for upper extremity and temporomandibular disorders: a systematic review. Brantingham, JW., Cassa, TK., Bonnefin, D., et al.[2022]

A pilot study involving 247 physical therapists in Florida revealed that nearly 70% felt they did not receive adequate education on treating temporomandibular disorders (TMD).

About 50% of the therapists reported a lack of confidence in their ability to treat TMD, highlighting the need for improved training in this area during their initial education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapists' self-perceived adequacy of entry-level education and their current confidence levels with respect to temporomandibular disorders: A pilot study. Gadotti, IC., Lakow, A., Cheung, J., et al.[2020]

Exercise therapy is effective in providing moderate short-term relief from pain and improving range of motion in patients with temporomandibular joint dysfunction, based on a systematic review of six studies involving 419 participants.

Mobility and mixed exercise approaches are the most commonly used methods, but while they help reduce pain and increase range of motion, they do not significantly improve overall function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of exercise therapy for temporomandibular dysfunction: a systematic review and meta-analysis. Dickerson, SM., Weaver, JM., Boyson, AN., et al.[2018]

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