20 Participants Needed

Osteopathic Manipulative Treatment for Headaches

SY
Overseen BySheldon Yao, D.O
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: New York Institute of Technology
Must be taking: Pain medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to see if osteopathic manipulation or light touch can reduce either or both frequency of headaches or use of pain medication. Osteopathic manipulative treatment (OMT) has been shown to help headache symptoms. The investigators like to see if regular OMT sessions can help reduce headache discomfort and also reduce use of pain medication like over-the-counter medications, migraine medications, and opioids. In this randomized controlled trial, a set sequence of OMT will be compared to light touch sham protocol. Investigators will compare participant responses to questionnaires that assess items including pain levels and reported pain medication use for the course of the study period to see if there are any shifts.

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.

Is osteopathic manipulative treatment (OMT) safe for humans?

Research on osteopathic manipulative treatment (OMT) suggests that while it is generally considered safe, there is limited information on the frequency and severity of any adverse events (unwanted effects). More studies are needed to better understand the safety profile of OMT.12345

How is Osteopathic Manipulative Treatment (OMT) different from other treatments for headaches?

Osteopathic Manipulative Treatment (OMT) is unique because it is a non-invasive, hands-on therapy that does not involve medication, making it suitable for patients who prefer to avoid pharmaceuticals or cannot use them due to side effects. It focuses on techniques like myofascial release to improve tissue movement and relieve headache symptoms, offering an alternative or complementary option to traditional drug treatments.15678

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

Research suggests that osteopathic manipulative treatment (OMT) can be a helpful option for people with headaches, especially for those who prefer not to use medication or for whom medication is not suitable. However, more high-quality studies are needed to confirm its effectiveness.156910

Who Is on the Research Team?

SY

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

I have had brain surgery or a brain-related health event like a stroke.
I have been diagnosed with a tumor.
Acute psychiatric diagnosis
See 3 more

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?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Osteopathic Manipulation armExperimental Treatment1 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 armPlacebo Group1 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

Find a Clinic Near You

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.
A Short Review of the Treatment of Headaches Using Osteopathic Manipulative Treatment.Whalen, J., Yao, S., Leder, A.[2019]
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.
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) 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.
Osteopathy for primary headache patients: a systematic review.Cerritelli, F., Lacorte, E., Ruffini, N., et al.[2020]

Citations

A Short Review of the Treatment of Headaches Using Osteopathic Manipulative Treatment. [2019]
Pilot trial of osteopathic manipulative therapy for patients with frequent episodic tension-type headache. [2016]
Osteopathy for primary headache patients: a systematic review. [2020]
Awareness and interest in osteopathic manipulative treatment in allopathic medical students. [2023]
Effectiveness of osteopathic manipulative treatment for pediatric conditions: A systematic review. [2022]
Characterizing Adverse Events Reported Immediately After Osteopathic Manipulative Treatment. [2022]
Efficacy and safety of osteopathic manipulative treatment: an overview of systematic reviews. [2022]
Defining the landscape of patient harm after osteopathic manipulative treatment: synthesis of an adverse event model. [2023]
Osteopathic Manipulative Treatment and the Management of Headaches: A Scoping Review. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Osteopathic Manipulative Therapy in Patients With Chronic Tension-Type Headache: A Pilot Study. [2022]
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