Status:
TERMINATED
Osteopathic Manipulative Techniques for the Treatment of Chronic Migraine Headaches
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Chronic Migraine, Headache
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
This study evaluates a standardized osteopathic manipulative therapy (OMT) as a treatment for chronic migraine headaches. It will determine the feasibility of enrolling patients in standardized osteop...
Detailed Description
In the United States, 12% of adults suffer from migraines. Migraines are categorized as episodic or chronic (CM). CM is less common than episodic, with a prevalence of 2%, but far more debilitating, w...
Eligibility Criteria
Inclusion
- To be included in this study patients must be:
- An adult ≥ 18 years of age and ≤ 60 years of age
- Enrolled for care at Penn State Hershey Family and Community Medicine as demonstrated by at least one primary care visit within the past 3 years
- Diagnosed with chronic migraine (as defined by the International Headache Society: "Headache occurring on 15 or more days/month for more than 3 months, which, on at least 8 days/month, has the features of migraine headache"
- Legally and physically able to consent in English
- Willing and able to complete seven in-person visits, each approximately 30 minutes in length, over the course of 21 weeks.
Exclusion
- Patients will be ineligible to participate in this study if they:
- Are diagnosed with secondary headache
- Are pregnant (as reported at the time of enrollment; no pregnancy test is required; patients who become pregnant during the study will be withdrawn from the study. (However, they may continue to receive non-study related OMT treatments through their primary care provider as OMT has been shown to be safe in pregnancy.))
- Are less than 18 or more than 60 years of age
- Are diagnosed with fibromyalgia.
- Have current or prior migraine or other headache treatment with onabotulinumtoxinA (Botox®)
- Have received any treatment of neck or head with onabotulinumtoxinA (Botox®) within the past year
- Have current or prior (within 12 months) treatment for any condition with Topiramate
- Are determined by the physician administering OMT to have a medical condition, history, or medication that is likely to decrease the efficacy or increase the risk of OMT. Not all patients with the following conditions will be excluded, but some patients with any of the following may be determined to be unlikely to benefit from OMT or at increased risk of OMT, and will be excluded.
- A history of surgery in the head or neck (except for: uncomplicated dental surgery that is more than 2 years prior and required no significant implantation (i.e., routine wisdom tooth extraction, braces, or root canal))
- Unstable mental health disorders
- Chronic chronic inflammatory disorders, severe osteoporosis, tumors, evidence of central nervous system pathology include facial palsy, abnormality in vision, speech or balance, paresthesia, or weakness
- Have had previous osteopathic treatment for migraine or other headache
- Have current or past substance abuse disorder
- Have current or pending disability payments, applications for disability or litigation for disability.
Key Trial Info
Start Date :
September 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04520425
Start Date
September 8 2022
End Date
June 30 2023
Last Update
August 14 2023
Active Locations (1)
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1
Penn State College of Medicine
Hershey, Pennsylvania, United States, 17033