Osteopathic Manual Therapy (OMT) and Brain Structure and Function in Primary Headache Patients: A… (NCT06841627) | Clinical Trial Compass
CompletedNot Applicable
Osteopathic Manual Therapy (OMT) and Brain Structure and Function in Primary Headache Patients: A Pilot Study
United States31 participantsStarted 2025-08-05
Plain-language summary
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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* current diagnosis of primary headache (migraine, tension-type, cluster) from a healthcare provider
* have experienced at least one headache episode a month for the previous 1 year (or longer)
* age of PH onset was less than 50 years, currently taking medication for headaches.
Exclusion Criteria:
* presence of headaches due to some other underlying medical condition (secondary headaches)
* traumatic brain injury
* fibromyalgia, epilepsy
* diagnosis of a neurodegenerative disorder
* history of brain tumor or cancer
* history of cervical radiculopathy (pinched nerve in the neck)
* currently undergoing manual therapy type treatment or have a a treatment within 2 weeks of enrollment(chiropractic, OMT, massage, PT)
* currently pregnant
* have had an injection to treat headaches within the previous 3 months from study enrollment
* contraindications to MRI.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Brain Structural and Functional Changes
Timeframe: From enrollment to the end of treatment at 5 weeks
Trial details
NCT IDNCT06841627
SponsorEdward Via Virginia College of Osteopathic Medicine