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Osteopathic Manipulative Treatment and Migraine Headaches
N/A
Waitlist Available
Led By Abby Rhoads, DO
Research Sponsored by St. Luke's Hospital, Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
In this study the investigators hypothesize, that Osteopathic Manipulative Therapy (OMT) will reduce migraine disability and severity scores when compared to standard of care including prophylactic pharmacological agents with treatment over 12 week time frame. The investigators aim to decrease severity and disability of migraine by utilizing Osteopathic Manipulative Therapy. This would ultimately reduce the utilization of office or emergency department visits, decrease the large economic burden the United States faces for migraine patients as well as improve quality of life for the 3 million chronic migraine patients.
Eligible Conditions
- Migraine
- Chronic Headaches
- Headache Disorders
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Reduction in the Headache Impact Test (HIT-6) score in OMT intervention group compared to control group.
Reduction in the Migraine Disability Test (MIDAS) score in the OMT interventional group compared to control group.
Secondary study objectives
Headache Days
Pain scale
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Interventional Group receiving Osteopathic Manipulative Therapy (OMT)Experimental Treatment1 Intervention
70 patients with chronic migraine who consent to OMT will receive four standardized osteopathic manipulative treatment protocol over the course of twelve weeks at week 0,2,6,10. MIDAS and HIT-6 Questionnaires will be obtained at time of consent prior to first treatment and again at the conclusion of treatment period of twelve weeks.
Group II: Control Group with Standard of CareExperimental Treatment1 Intervention
70 patients with the diagnosis of migraine headache who are receiving the standard of care medications will complete a MIDAS and HIT-6 questionnaire at week 0 and week 12. A new prophylactic medication may be started at time of initial questionnaires and the patient can be on up to two prophylactic medications, with no changes during the 12 week period.
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Who is running the clinical trial?
St. Luke's Hospital, PennsylvaniaLead Sponsor
18 Previous Clinical Trials
3,086 Total Patients Enrolled
Abby Rhoads, DOPrincipal InvestigatorSt. Luke's Hospital and Health Network, Pennsylvania