Osteopathic Manipulative Therapy for Headaches

Recruiting in Palo Alto (17 mi)

Overseen by Daniel Cawley, DC

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Edward Via Virginia College of Osteopathic Medicine

Must be taking: Headache medications

Disqualifiers: Secondary headaches, Traumatic brain injury, Epilepsy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Chronic headaches are associated with changes in brain structure and function that may be associated with increased suffering and disability. Understanding how Osteopathic Manipulative Therapy (OMT) affects these changes would reveal new insight into how the brain processes pain and returns to normal function. Also, demonstrating these changes would provide evidence regarding how OMT causes a reduction in pain and disability, supporting the recommendation for OMT as a primary treatment option for headaches.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current headache medications. It seems you can continue your current medication, as the eligibility criteria include those currently taking medication for headaches.

What data supports the effectiveness of the treatment Osteopathic Manual Therapy (OMT) for headaches?

Research shows that Osteopathic Manual Therapy (OMT) can help reduce the frequency, intensity, and duration of tension-type headaches and migraines. It is a non-drug option that may be beneficial for those who prefer not to use medication or have not found relief with other treatments. ^{1 2 3 4 5}

Is osteopathic manipulative therapy (OMT) safe for humans?

Research suggests that osteopathic manipulative therapy (OMT) is generally safe for humans, with limited reports of adverse events (unwanted effects). ^{1 2 3 6 7}

How is Osteopathic Manual Therapy (OMT) different from other headache treatments?

Osteopathic Manual Therapy (OMT) is unique because it is a non-invasive, hands-on treatment that focuses on improving body mechanics and function, unlike conventional headache treatments that often rely on medications. It is particularly beneficial for patients who prefer not to use drugs or have not found relief with other treatments. ^{1 2 3 4 5}

Research Team

Daniel Cawley, DC

Principal Investigator

Edward Via College of Osteopathic Medicine

Eligibility Criteria

This trial is for individuals who frequently experience primary headaches, including cluster headaches. Participants should be interested in exploring Osteopathic Manipulative Therapy (OMT) as a treatment option. Specific eligibility criteria are not provided, but typically include age range, headache frequency and severity, and no contraindications for OMT.

Inclusion Criteria

I have been diagnosed with a primary headache disorder, get headaches monthly, started before I was 50, and am on medication.

I don't have pulmonary hypertension and I get fewer than 6 headaches a year.

Exclusion Criteria

I have been diagnosed with a brain disorder that gets worse over time.

Pregnancy

I have had a brain tumor or brain cancer in the past.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Osteopathic Manual Therapy (OMT) to assess its effects on brain structure and function in primary headache patients

5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Osteopathic Manual Therapy (OMT) (Behavioural Intervention)

Trial Overview The study investigates how Osteopathic Manipulative Therapy (OMT), a hands-on body manipulation technique, affects brain structure and function in patients with chronic headaches. The goal is to understand if OMT can reduce pain and disability by influencing the brain's processing of pain.

Participant Groups

Group I: OMT Treatment Group Experimental Treatment 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Auburn University MRI Center and Edward Via College of Medicine Auburn, AL

Who Is Running the Clinical Trial?

Edward Via Virginia College of Osteopathic Medicine

Lead Sponsor

Trials

24

Patients Recruited

2,700+

Auburn University MRI Research Center

Collaborator

Trials

3

Patients Recruited

60+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Short Review of the Treatment of Headaches Using Osteopathic Manipulative Treatment. Whalen, J., Yao, S., Leder, A.[2019]

In a pilot study involving 26 patients with postconcussion syndrome (PCS), osteopathic manipulative treatment (OMT) resulted in a significant immediate reduction in headache pain intensity, as measured by the Visual Analog Scale (VAS).

While the treatment group showed improvement in headache impact scores (HIT-6), this change was not statistically significant compared to the control group, indicating that while OMT may provide immediate relief, its long-term efficacy for PCS-related headaches remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteopathic manipulative medicine in the management of headaches associated with postconcussion syndrome. Esterov, D., Thomas, A., Weiss, K.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteopathy for primary headache patients: a systematic review. Cerritelli, F., Lacorte, E., Ruffini, N., et al.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot trial of osteopathic manipulative therapy for patients with frequent episodic tension-type headache. Rolle, G., Tremolizzo, L., Somalvico, F., et al.[2016]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteopathic Manipulative Treatment and the Management of Headaches: A Scoping Review. Jara Silva, CE., Joseph, AM., Khatib, M., et al.[2023]

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]

References

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

A Short Review of the Treatment of Headaches Using Osteopathic Manipulative Treatment. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Osteopathic manipulative medicine in the management of headaches associated with postconcussion syndrome. [2021]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Osteopathy for primary headache patients: a systematic review. [2020]

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

Pilot trial of osteopathic manipulative therapy for patients with frequent episodic tension-type headache. [2016]

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

Osteopathic Manipulative Treatment and the Management of Headaches: A Scoping Review. [2023]

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]