Osteopathic Manipulative Therapy for Headaches

Overseen By Adil Bashir, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Edward Via Virginia College of Osteopathic Medicine

Must be taking: Headache medications

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Osteopathic Manipulative Therapy (OMT), a hands-on treatment, can help people with chronic headaches by altering brain pain processing. Researchers aim to determine if OMT can reduce headache pain and disability, potentially making it a recommended treatment option. Suitable participants have been diagnosed with primary headaches, such as migraines or tension headaches, experience at least one headache a month for the past year, and currently take headache medications. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research on headache treatment.

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 prior data suggests that Osteopathic Manipulative Therapy is safe for treating headaches?

Research has shown that Osteopathic Manipulative Therapy (OMT) is generally safe for treating headaches. Studies have found that OMT effectively reduces pain and improves mobility in adults. It has been used to lessen the severity and frequency of migraine headaches, enhancing patient productivity.

Additionally, using OMT to ease physical tension has relieved migraine symptoms for about a month. These findings suggest that OMT is well-tolerated and offers a useful way to manage headaches with minimal risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Osteopathic Manual Therapy (OMT) is unique because it offers a hands-on approach to treating headaches, which sets it apart from the usual pharmaceutical options like pain relievers or triptans. This therapy involves using the practitioner's hands to move muscles and joints with techniques that can improve circulation and alleviate muscle tension. Researchers are excited about OMT because it targets the physical causes of headaches directly, potentially providing relief without the side effects associated with medication. This non-invasive approach could offer a new avenue for those seeking alternatives to traditional drug treatments.

What evidence suggests that Osteopathic Manual Therapy is effective for headaches?

Research shows that Osteopathic Manipulative Therapy (OMT), which participants in this trial will receive, can help manage headaches. Studies have found that OMT can reduce the severity and frequency of migraine headaches. This may result in less pain and an easier daily routine. Some individuals experience immediate relief, with fewer headaches and less nausea. Evidence also suggests that OMT might reduce the need for migraine medication. Overall, OMT appears to be a promising option for relieving headaches. ^{1 2 3 4 6}

Who Is on the Research Team?

Daniel Cawley, DC

Principal Investigator

Edward Via College of Osteopathic Medicine

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Osteopathic Manual Therapy (OMT)

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.

How Is the Trial Designed?

Group I: OMT Treatment Group Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Edward Via Virginia College of Osteopathic Medicine

Lead Sponsor

Trials

24

Recruited

2,700+

Auburn University MRI Research Center

Collaborator

Trials

3

Recruited

60+

Published Research Related to This Trial

In a pilot study involving 44 patients with frequent episodic tension-type headaches, osteopathic manipulative therapy (OMTh) significantly reduced headache frequency by approximately 40% after one month and 50% after three months compared to sham therapy.

The results suggest that OMTh may be a preferred treatment option for patients who experience side effects from medications or have trouble adhering to pharmacological treatments, highlighting its potential as an effective non-drug intervention for headache management.

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]

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]

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]

Osteopathic manipulative treatment (OMT) is a safe and effective non-invasive option for headache sufferers, particularly for those who prefer to avoid pharmaceuticals or have contraindications to them.

OMT has shown benefits for various headache types, including migraines and tension-type headaches, making it a versatile treatment option tailored to individual patient needs.

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]

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]

Osteopathic manipulative treatment (OMT) has been shown to significantly improve headache symptoms, including tension-type headaches (TTH) and migraines, based on a review of 15 studies, most of which were randomized controlled trials.

Myofascial release was the most commonly used technique in these studies, indicating its potential effectiveness in providing quick relief from headache symptoms, making OMT a valuable alternative or complementary therapy for patients seeking non-pharmaceutical options.

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]

Osteopathic manipulative treatment (OMT) may help reduce the frequency of migraine episodes and decrease the need for medication, based on a review of five studies focused on headache management.

The evidence supporting OMT's effectiveness is currently low due to the presence of bias in the studies reviewed, indicating a need for more rigorous research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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