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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how osteopathic manipulative treatment, a hands-on technique, can help people with neck pain and headaches. Researchers aim to determine if this treatment can reduce neck muscle stiffness, improve jaw movement, affect the body's automatic functions, and alter pain pressure thresholds. They will gather information using methods like ultrasound, motion capture, and surveys. The trial seeks participants who have experienced neck pain or headaches for over a month and have not undergone spine surgery or have certain medical conditions. As an unphased trial, it offers a unique opportunity to contribute to understanding a potential new treatment for neck pain and headaches.

Will I have to stop taking my current medications?

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

What prior data suggests that osteopathic manipulative treatment is safe for individuals with TMJ dysfunction?

Research has shown that osteopathic manipulative treatment (OMT) is generally well-tolerated. Studies have found that OMT can improve quality of life, reduce pain, and aid sleep without causing major side effects. For instance, one study found that individuals who received OMT experienced less body pain and noticed improvements in sleep and jaw function. Another study highlighted benefits such as reduced pain and better functioning of the autonomic nervous system, which controls heart rate and digestion.

While these findings are promising, individual experiences can vary. So far, OMT has not been linked to any serious side effects, suggesting it is a safe option for many people, although personal tolerance and results can differ. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Osteopathic Manipulative Treatment (OMT) is unique because it focuses on using hands-on techniques to improve movement and relieve pain by targeting the body's musculoskeletal system. Unlike standard treatments for TMJ dysfunction, which often involve medication, dental splints, or surgery, OMT uses a non-invasive approach to address the root cause of the dysfunction. Researchers are excited about OMT because it offers a holistic alternative that may reduce the need for medication, decrease side effects, and provide a more natural way to restore function and alleviate discomfort in patients with TMJ issues.

What evidence suggests that osteopathic manipulative treatment is effective for TMJ dysfunction?

Research has shown that osteopathic manipulative treatment (OMT), which participants in this trial will receive, can help with issues related to the temporomandibular joint (TMJ). Studies have found that OMT reduces pain and improves the function of the jaw and surrounding areas. For those with TMJ issues, OMT has improved quality of life by reducing discomfort and easing movement. Additionally, evidence suggests that OMT may alleviate muscle tightness in the head and neck. Overall, OMT is considered an effective option for addressing TMJ problems. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28029069/

Effectiveness of osteopathic manipulative treatment versus ... This pilot study demonstrates the reduction of pain, the improvement of temporomandibular joint dysfunction and the positive impact on quality of life.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1360859209001156

Osteopathic manual therapy versus conventional ... Our findings suggest that OMT is a valid option for the treatment of TMD. Introduction. Temporomandibular disorders (TMD) are a collective term that includes ...

3. degruyterbrill.com degruyterbrill.com/document/doi/10.7556/jaoa.2017.063/html?srsltid=AfmBOoo1XC79XI475ZL_ZGEgS1wNhb3Hq9YL6scCIGy24iqW0G2tqYpL

Effectiveness of OMT and OCMM for Temporomandibular ... Researchers at the Medical University of Vienna conducted a randomized clinical trial to compare the effectiveness of OMTh with osteopathy in ...

4. mdpi.com mdpi.com/2077-0383/14/8/2544

The Effect of Osteopathic Manipulative Treatment Adjunct ... The application of OMT adjunct to splint treatment increases quality of life and sleep, reduces bodily pain, and improves condyle–disc positions over the MRIs ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06471426

The Effect of Osteopathic Treatment on Craniocervico ... The goal of this clinical trial is to measure the effects of osteopathic manipulative treatment (OMT) on tissues of the craniocervico-mandibular unit (CCMU) ...

6. withpower.com withpower.com/trial/phase-temporomandibular-joint-disorders-3-2024-a4cd2

Osteopathic Treatment for TMJ Dysfunction Cranial osteopathic manipulative medicine (OMM) shows potential benefits in reducing pain, improving sleep patterns, and enhancing autonomic nervous system ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9143587/

Osteopathic Manipulative Medicine: A Brief Review of the ... Other studies have shown that MFR has been successful with temporomandibular joint (TMJ) ... Effect of Osteopathic Cranial Manipulative Medicine ...