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Behavioural Intervention

Osteopathic Manipulative Treatment for Headaches

N/A

Waitlist Available

Led By Sheldon Yao, D.O

Research Sponsored by New York Institute of Technology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 to 75 years of age

Takes opioids or any other pain medication for headaches more than 10 times a month (including over the counter and prescription medications for headaches)

Must not have

History of brain/cranial surgery, cerebral vascular events/disease (e.g., stroke, Brain arteriovenous malformation (AVM), vertebral artery disease)

Current diagnosis of neoplasm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up to be completed at week 1 (initial visit), week 6 (midpoint of study), and week 10 (at completion of study)

Summary

This trial aims to investigate if osteopathic manipulation or light touch can help reduce the frequency of headaches and the use of pain medication. They will compare the effects of a specific osteopathic treatment with a light

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While OMT is generally considered safe, some may experience temporary discomfort, fatigue, or minor pain at the manipulation site. The sham light touch arm is expected to have minimal risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had brain surgery or a brain-related health event like a stroke.

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I have been diagnosed with a tumor.

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I have had headaches caused by a head injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ to be completed at week 1 (initial visit), week 6 (midpoint of study), and week 10 (at completion of study)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~to be completed at week 1 (initial visit), week 6 (midpoint of study), and week 10 (at completion of study)

This trial's timeline: 3 weeks for screening, Varies for treatment, and to be completed at week 1 (initial visit), week 6 (midpoint of study), and week 10 (at completion of study) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in analgesia use

Change in pain levels

Secondary study objectives

Change in quality of Life - Headache Impact Test (HIT-6)

Change in quality of Life - Headache disability index

Change in quality of Life - The 5-level EQ-5D version (EQ-5D-5L) was introduced by the EuroQol Group (EQ-5DL)

Trial Design

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.

0 / 6Eligibility criteria met