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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment for TMJ dysfunction?

Research shows that combining manual physical therapy and exercise can improve symptoms of temporomandibular joint dysfunction, with one study noting a 13.9% improvement in disability scores after two weeks of treatment. ^{1 2 3 4 5}

Is physical therapy safe for treating TMJ dysfunction?

The research does not specifically address safety concerns, but physical therapy is generally considered a safe treatment for temporomandibular disorders (TMD) and is often recommended as part of a standard treatment approach. ^{4 5 6 7 8}

How does physical therapy for TMJ dysfunction differ from other treatments?

Physical therapy for TMJ dysfunction is unique because it focuses on exercises and manual techniques to improve jaw function and reduce pain, unlike surgical options or medications. It can include specific exercises to maintain and improve jaw mobility, and may be combined with other techniques like strapping to enhance effectiveness. ^{4 9 10 11 12}

Research Team

Benjamin R Hando, PhD, DPT

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

References

1. Brazil 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The effectiveness of exercise therapy for temporomandibular dysfunction: a systematic review and meta-analysis. [2018]

3. United States 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. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Manual physical therapy interventions and exercise for patients with temporomandibular disorders. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Physical therapy for temporomandibular disorders and orofacial pain. [2008]

6. England 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. [2020]

7. Switzerland 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. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

A systematic review of the effectiveness of physical therapy interventions for temporomandibular disorders. [2022]

9. India pubmed.ncbi.nlm.nih.gov

Strapping for temporomandibular joint dysfunction. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Postoperative physical therapy in temporomandibular joint arthroplasty. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Postarthroscopy physical therapy management of a patient with temporomandibular joint dysfunction. [2005]

12. United States pubmed.ncbi.nlm.nih.gov

Manipulative and multimodal therapy for upper extremity and temporomandibular disorders: a systematic review. [2022]