Osteopathic Manipulative Treatment for Headaches

Overseen By Sheldon Yao, D.O

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: New York Institute of Technology

Must be taking: Pain medications

Disqualifiers: Neoplasm, Brain surgery, Stroke, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether osteopathic manipulative treatment (OMT) or light touch can reduce headaches and decrease pain medication use. Participants will receive either OMT, which uses hands-on techniques to relieve tension, or a light touch method. Researchers will compare the effects of these treatments on headache frequency and medication use by analyzing participant feedback. Individuals who have experienced headaches or migraines for at least three months and use pain medication more than 10 times a month might be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that may improve headache management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it aims to see if osteopathic treatment can reduce the use of pain medication, so you might be encouraged to reduce them during the study.

What prior data suggests that osteopathic manipulative treatment and light touch are safe for headache management?

Research shows that osteopathic manipulative treatment (OMT) is generally safe for most people. A review of studies on OMT found it well-tolerated, with few reports of serious side effects. Some individuals might experience mild discomfort or muscle soreness, but these symptoms usually resolve quickly. In another study, OMT helped with migraines, and participants did not report any major safety concerns. Overall, existing evidence supports the safe use of OMT for treating headaches and other conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Osteopathic Manipulative Treatment (OMT) for headaches because it offers a hands-on approach that differs from conventional treatments like medications or injections. Unlike standard drug therapies that often focus on reducing pain chemically, OMT involves physical techniques to address somatic dysfunctions in the body, potentially providing relief through improved structural alignment and circulation. This method is non-invasive, avoids pharmaceutical side effects, and targets the root physical contributors to headaches, making it an attractive alternative for patients seeking holistic options.

What evidence suggests that osteopathic manipulative treatment is effective for headaches?

This trial will compare Osteopathic Manipulative Treatment (OMT) with a Sham Light touch arm. Studies have shown that OMT can effectively reduce headache symptoms. Research indicates that OMT, a hands-on method focusing on the body's muscles and bones, can help relieve tension headaches and migraines. For example, one study found that patients experienced fewer and less intense headaches after OMT sessions. Another study suggested that OMT might help people with chronic migraines use less pain medication. Overall, evidence supports OMT as a promising non-drug option for managing headaches. ^{2 6 7 8 9}

Who Is on the Research Team?

Sheldon Yao, D.O

Principal Investigator

New York Institute of Technology

Are You a Good Fit for This Trial?

This trial is for individuals who frequently experience headaches and may be using pain medication, including opioids. Participants should have a history of primary headache disorders but not currently be receiving OMT. They must not have conditions that would interfere with the treatment or assessment.

Inclusion Criteria

I am considered fit for osteopathic manipulative treatment by a doctor.

I use pain medication for headaches more than 10 times a month.

I have had headaches or migraines for at least 3 months.

Exclusion Criteria

Acute psychiatric diagnosis

Pregnancy

History of substance use disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Observation

Participants are observed for baseline headache frequency and medication use

2 weeks

1 visit (in-person)

Treatment

Participants receive either osteopathic manipulative treatment (OMT) or a light touch sham protocol

6 weeks

Weekly visits (in-person)

Washout

Participants undergo a washout period to assess the lasting effects of the treatment

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for changes in headache frequency and medication use post-treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Osteopathic Manipulative Treatment (OMT)
• Sham Light touch arm

Trial Overview The study aims to determine if regular sessions of osteopathic manipulative treatment (OMT) can reduce headache frequency or the need for pain medication compared to a sham light touch protocol in a randomized controlled setting.

How Is the Trial Designed?

Group I: Osteopathic Manipulation arm Experimental Treatment 1 Intervention

* All subjects receive osteopathic structural exam and screening for somatic dysfunction of the cranium, spine, sacrum, and ribs. * The OMT arm will have the following techniques performed for the stated time to total 14 minutes. 1. Thoracic inlet release: 45 seconds maximum 2. Suboccipital release: 1 minute maximum 3. Occipito-mastoid suture release: 1 minute maximum 4. Venous sinus drainage: 1 minute maximum 5. Balanced membranous tension: 1 minute maximum 6. Compression of the 4th Ventricle (CV4): 1 minute maximum 7. Cervical soft tissue: 1 minute maximum 8. Trapezius inhibition: 45 seconds maximum 9. Bilateral rib raising: 2 minutes max (1 min per side) 10. Sacroiliac gapping: 1 minute maximum 11. Sacral rock: 1 minute maximum 12. Seated bilateral thoracic and lumbar paraspinal articulation: 2 minutes maximum

Group II: Sham Light touch arm Placebo Group 1 Intervention

* All subjects receive osteopathic structural exam and screening for somatic dysfunction of the cranium, spine, sacrum, and ribs.. * The sham group will follow an established protocol of light systematic touch for the same duration as the OMT group. It consists of contacting a sequence of anatomical areas for 2 minutes each: right ankle, left knee, right hip, diaphragm, right shoulder, neck, and cranium. Total procedure time is 14 minutes.

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

Approved in United States as Osteopathic Manipulative Treatment for:

• Carpal Tunnel Syndrome

Approved in European Union as Osteopathic Manipulative Treatment for:

• Carpal Tunnel Syndrome

Who Is Running the Clinical Trial?

New York Institute of Technology

Lead Sponsor

Trials

56

Recruited

2,300+

Published Research Related to This Trial

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]

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 survey of 313 MD students revealed that only 31.1% were familiar with osteopathic manipulative treatment (OMT), but 82.1% expressed interest in a 2-week elective course on OMT, indicating a significant demand for education in this area.

Students who had prior exposure to OMT, such as observing it in clinical settings or having family treated by DO physicians, showed higher interest in learning about OMT, suggesting that familiarity may enhance interest in integrating OMT into their future practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Awareness and interest in osteopathic manipulative treatment in allopathic medical students. Darby, A., Parascando, JA., Lipinski, M., et al.[2023]

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]

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]

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) 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]

Citations

1. cureus.com cureus.com/articles/281505-exploring-the-impact-of-osteopathic-manipulative-treatment-on-chronic-migraine-relief-a-case-study

Exploring the Impact of Osteopathic Manipulative ... Osteopathic manipulative treatment is a hands-on intervention focusing primarily on manipulating the musculoskeletal system to restore ...

2. annfammed.org annfammed.org/content/21/Supplement_3/5587

A standardized osteopathic manipulative technique for the ... Non-pharmacologic treatments such as osteopathic manipulative treatment (OMT) are reported effective and may minimize AEs but current studies ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9462953/

Osteopathic Manipulative Treatment and the Management of ... ... manual therapy efficacy and/or effectiveness in treating TTH and migraine were analyzed. ... headaches, osteopathic manipulative treatment (omt) ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04976985

Osteopathic Manipulative Treatment and Migraine ... Osteopathic Manipulative Therapy (OMT) is a non-pharmacological, non-invasive form of manual medicine. Headache has been shown to be associated with impairment ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1746068913000023

Is osteopathic manipulative treatment effective in migraine? Is osteopathic manipulative treatment effective in migraine? Author links ... OMT in migraine and those are even more unclear if CAM are considered.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10642050/

Defining the landscape of patient harm after osteopathic ... In the United States, osteopathic manipulative treatment (OMT), is a popular complementary physical health approach for the treatment of ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1360859225000993

An overview of systematic reviews on the efficacy and ... Specifically, the following manual treatment methods were considered: osteopathic manipulative treatment (OMT), spinal manipulative therapy (SMT), myofascial ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11377354/

A Review on Osteopathic Manipulation in Patients With ... Osteopathic manipulative treatment (OMT) emerges as a promising complementary approach to the management of headaches. The reviewed studies ...

9. bmjopen.bmj.com bmjopen.bmj.com/content/12/4/e053468

Efficacy and safety of osteopathic manipulative treatment This systematic overview included a comprehensive literature search for evidence on the efficacy and safety of osteopathic manipulative treatment (OMT) for any ...