Osteopathic Treatment for TMJ Dysfunction

Overseen By Daniel Cawley, DC, MSHS, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edward Via Virginia College of Osteopathic Medicine

Must not be taking: Muscle relaxers

Disqualifiers: Spinal surgery, Cancer, Diabetes, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to measure the effects of osteopathic manipulative treatment (OMT) on tissues of the craniocervico-mandibular unit (CCMU) in individuals with neck pain and headaches. The main questions to answer are: 1. How does OMT affect CCMU muscle stiffness 2. How does OMT affect jaw motion 3. How does OMT affect autonomic function 4. Is pain pressure threshold affected by OMT of the CCMU Participants will undergo the following interventions: 1. Photos taken to measure head and neck angles 2. Ultrasound 3. Smooth Pursuit Neck Torsion Test 4. Motion Capture 5. Autonomic Protocol 6. Algometry 7. Surveys

Will I have to stop taking my current medications?

The trial requires that you stop taking muscle relaxers to participate.

What data supports the effectiveness of the treatment Osteopathic Manipulative Treatment (OMT) for TMJ Dysfunction?

Research suggests that Osteopathic Manipulative Treatment (OMT) might help reduce symptoms in people with temporomandibular disorders (TMD), which are conditions affecting the jaw. Although the evidence is not definitive, some studies indicate that OMT can improve jaw movement and alleviate pain. ^{1 2 3 4 5}

Is osteopathic treatment generally safe for humans?

Research on osteopathic manipulative treatment (OMT) suggests that while adverse events (unwanted effects) can occur, they are not well-defined in terms of how often they happen or how severe they are. Overall, there is no clear benchmark for safety, but it is a popular treatment approach for various conditions. ^{2 6 7 8 9}

How is osteopathic treatment for TMJ dysfunction different from other treatments?

Osteopathic Manipulative Treatment (OMT) for TMJ dysfunction is unique because it involves hands-on techniques to improve jaw function and posture, rather than relying on medication or surgery. It focuses on manipulating the body's structure to alleviate symptoms, which may also influence overall posture and pressure distribution in the body. ^{1 2 3 10 11}

Eligibility Criteria

This trial is for individuals experiencing jaw pain and dysfunction, commonly known as TMJ Dysfunction, along with headaches and neck pain. Participants should be able to undergo various non-invasive tests like photos, ultrasound, motion capture, and surveys.

Inclusion Criteria

I am between 19 and 65 years old.

I have had neck pain or headaches for more than a month.

Exclusion Criteria

I have a diagnosed jaw condition.

I have been diagnosed with a connective tissue or muscle disorder.

I am currently taking medication to relax my muscles.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive osteopathic manipulative treatment (OMT) to assess its effects on craniocervico-mandibular unit (CCMU) dysfunction, including interventions such as photos, ultrasound, motion capture, and various tests.

4 weeks

Follow-up

Participants are monitored for changes in neck pain, headaches, and other symptoms after treatment, using surveys and tests like the Neck Disability Index and Headache Impact Test.

5 weeks

Treatment Details

Interventions

• Osteopathic Manipulative Treatment

Trial Overview The study is testing the effectiveness of Osteopathic Manipulative Treatment (OMT) on muscle stiffness in the head-neck-jaw area, jaw movement quality, nerve system function related to automatic body processes, and sensitivity to pressure-related pain.

Participant Groups

Group I: Osteopathic Manipulative Treatment Group Experimental Treatment 1 Intervention

Osteopathic Manipulative Treatment is already approved in United States, European Union for the following indications:

Approved in United States as OMT for:

• Positional plagiocephaly
• Deformational plagiocephaly

Approved in European Union as OMT for:

• Positional plagiocephaly
• Deformational plagiocephaly

Who Is Running the Clinical Trial?

Edward Via Virginia College of Osteopathic Medicine

Lead Sponsor

Trials

24

Recruited

2,700+

Findings from Research

In a randomized controlled trial involving 50 adult patients with temporomandibular disorders (TMD), osteopathic manual therapy (OMT) was found to be a valid treatment option, showing similar clinical results to conventional conservative therapy (CCT) after six months.

Patients receiving OMT required significantly less medication, such as non-steroidal anti-inflammatory drugs and muscle relaxants, indicating a potential benefit in reducing medication use while managing TMD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteopathic manual therapy versus conventional conservative therapy in the treatment of temporomandibular disorders: a randomized controlled trial. Cuccia, AM., Caradonna, C., Annunziata, V., et al.[2010]

Cranial osteopathic manipulative medicine (OMM) shows potential benefits in reducing pain, improving sleep patterns, and enhancing autonomic nervous system function based on a review of 8 studies, including 7 randomized controlled trials.

However, the evidence is heterogeneous and of moderate quality, indicating that more rigorous research is necessary to establish definitive conclusions about the efficacy of cranial OMM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic effects of cranial osteopathic manipulative medicine: a systematic review. Jäkel, A., von Hauenschild, P.[2022]

Osteopathic Manipulative Treatment (OMT) significantly improved maximal mouth opening and opening velocity in 28 children with temporomandibular disorders (TMD) after 2 months, indicating its efficacy in enhancing mandibular kinematics.

In contrast, the control group showed no significant changes in mouth movement over a 6-month period, highlighting the potential benefits of OMT for TMD patients compared to no intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteopathic manipulative treatment (OMT) effects on mandibular kinetics: kinesiographic study. Monaco, A., Cozzolino, V., Cattaneo, R., et al.[2019]

In a pilot study involving 40 female patients with long-term temporomandibular disorders, both osteopathic manipulative treatment and osteopathy in the cranial field significantly reduced pain and improved quality of life after five weekly treatments.

Both treatment modalities showed similar effectiveness in alleviating symptoms, suggesting they are viable options for managing temporomandibular disorders, and highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of osteopathic manipulative treatment versus osteopathy in the cranial field in temporomandibular disorders - a pilot study. Gesslbauer, C., Vavti, N., Keilani, M., et al.[2018]

A 74-year-old man with cervicogenic headaches from a whiplash injury experienced immediate pain relief and improved cervical motion after receiving osteopathic cranial manipulation.

The treatment targeted somatic dysfunction in the head and cervical region, demonstrating the potential effectiveness of osteopathic manipulative treatment for whiplash-associated disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteopathic Cranial Manipulation for a Patient With Whiplash-Associated Disorder: A Case Report. Parravicini, G., Ghiringhelli, M.[2022]

In a study involving 884 patients, the incidence of adverse events immediately after osteopathic manipulative treatment (OMT) was found to be low at 2.5%, with pain or discomfort being the most common complaint.

Women reported experiencing adverse events more frequently than men, suggesting a potential demographic factor in the response to OMT, but overall, the rate of adverse events was lower than those reported in other manual therapy practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Adverse Events Reported Immediately After Osteopathic Manipulative Treatment. Degenhardt, BF., Johnson, JC., Brooks, WJ., et al.[2022]

Osteopathic manipulative treatment (OMT) shows promising effectiveness in reducing pain and improving function for conditions like acute and chronic non-specific low back pain, chronic non-specific neck pain, and chronic non-cancer pain, based on a review of nine systematic reviews and meta-analyses involving 3740 participants.

There is limited and inconclusive evidence regarding the efficacy of OMT for pediatric conditions, primary headaches, and irritable bowel syndrome, and no adverse events were reported in most studies, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of osteopathic manipulative treatment: an overview of systematic reviews. Bagagiolo, D., Rosa, D., Borrelli, F.[2022]

A systematic review of 23 studies found that the majority of adverse events (AEs) following osteopathic manipulative treatment (OMT) were mild, accounting for 98% of reported AEs, indicating a generally safe profile for this treatment.

The study established a patient safety benchmark for post-OMT AEs at 1.0 AEs per 100 post-OMT interval-days, providing a reference point for future research and comparisons in patient safety within osteopathic manipulative medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining the landscape of patient harm after osteopathic manipulative treatment: synthesis of an adverse event model. Unger, MD., Barr, JN., Brower, JA., et al.[2023]

A systematic review of 12 studies involving 367 participants found moderate-quality evidence that osteopathic manipulative treatment (OMT) significantly reduces disability, severity, and frequency of dizziness associated with neuro-otologic disorders.

Despite the positive findings, the evidence should be interpreted cautiously due to high risk of bias and small sample sizes in the studies reviewed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of osteopathic manipulative techniques on the management of dizziness caused by neuro-otologic disorders: systematic review and meta-analysis. Rehman, Y., Kirsch, J., Wang, MY., et al.[2023]

Osteopathic manipulative treatment (OMT) of the temporomandibular joint (TMJ) showed a moderate effect on muscle tension in the trapezius and TMJ areas, indicating potential benefits for individuals with temporomandibular disorder (TMD).

The study found a significant correlation between TMJ function and orthostatic posture, suggesting that OMT may positively influence posture, which could be relevant for managing TMD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between osteopathic manipulative treatment of the temporomandibular joint, molar shim and the orthostatic position: A randomized, controlled and double blinded study. Detoni, R., Hartz, CS., Fusatto, EL., et al.[2022]

A study involving 668 patients across 11 clinics showed that osteopathic manual treatment (OMT) is frequently used for musculoskeletal issues, with techniques like cranial and myofascial release being the most common.

The research highlights that patient demographics, such as age and sex, influence the likelihood of receiving specific OMT techniques, indicating a tailored approach in osteopathic care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Somatic dysfunction and use of osteopathic manual treatment techniques during ambulatory medical care visits: a CONCORD-PBRN study. Licciardone, JC., Kearns, CM., King, HH., et al.[2014]

References

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

Osteopathic manual therapy versus conventional conservative therapy in the treatment of temporomandibular disorders: a randomized controlled trial. [2010]

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

Therapeutic effects of cranial osteopathic manipulative medicine: a systematic review. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Osteopathic manipulative treatment (OMT) effects on mandibular kinetics: kinesiographic study. [2019]

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

Effectiveness of osteopathic manipulative treatment versus osteopathy in the cranial field in temporomandibular disorders - a pilot study. [2018]

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

Osteopathic Cranial Manipulation for a Patient With Whiplash-Associated Disorder: A Case Report. [2022]

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

Characterizing Adverse Events Reported Immediately After Osteopathic Manipulative Treatment. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of osteopathic manipulative treatment: an overview of systematic reviews. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Defining the landscape of patient harm after osteopathic manipulative treatment: synthesis of an adverse event model. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

Impact of osteopathic manipulative techniques on the management of dizziness caused by neuro-otologic disorders: systematic review and meta-analysis. [2023]

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

Relationship between osteopathic manipulative treatment of the temporomandibular joint, molar shim and the orthostatic position: A randomized, controlled and double blinded study. [2022]

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

Somatic dysfunction and use of osteopathic manual treatment techniques during ambulatory medical care visits: a CONCORD-PBRN study. [2014]