Osteopathic Manipulative Treatment and Migraine Headaches

Not Applicable

• Conditions: Headache, Migraine; Migraine Disorders; Headache Disorders; Chronic Migraine
• Interventions: Procedure: Osteopathic Manipulative Therapy (OMT); Other: Standard of care

• Registration Number: NCT04976985
• Lead Sponsor: St. Luke's Hospital, Pennsylvania

Brief 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.

Detailed Description

According to the American Headache Society, Migraine headaches affect one billion people worldwide. In the United States, one in five women and one in sixteen men suffer from migraine headaches. Migraine is the sixth most disabling illness in the world. More than four million people have chronic daily migraines with at least 15 migraines per month. More than 90% of sufferers are unable to work or function normally during their migraine attacks. Unlike many other chronic diseases, migraine affects otherwise healthy, young and middle aged people. Headache accounts for the fourth or fifth most common reason for emergency department visits and the economic burden of migraine reaches $78 billion dollars per year.

Osteopathic Manipulative Therapy (OMT) is a non-pharmacological, non-invasive form of manual medicine. Headache has been shown to be associated with impairment of autonomic nervous system including autonomic nuclei responsible for pain perception. It has also been shown through research that persons with a migraine episode are known to release high levels of the pro-inflammatory agents, prostaglandins, dopamine and serotonin. The effect of OMT on headache can be two fold: First, by increasing parasympathetic tone, and second, by inhibiting pro-inflammatory substances. Therefore, OMT could theoretically counter balance both the release of pro-inflammatory markers as well as the autonomic nervous system leading to improved clinical outcomes. These outcomes include: decreasing patients' severity and frequency of their migraine headache, which, ultimately could improve subjects' productivity to society and decrease the economic burden of migraine sufferers.

Historically, OMT was believed to worsen migraine headaches, this study is being conducted to learn about how Osteopathic Manipulative Therapy can help migraine patients. Subjects receiving OMT could benefit from improved quality of life by reducing subject's severity and frequency of their migraine headache, which could improve their productivity to society and decrease the economic burden of migraine headaches. This could provide information to make Osteopathic Manipulative Therapy an acknowledged alternative therapy to improve quality of life for 3 million chronic migraine sufferers.

Study Timeline

• Study Start: 2018-10-02
• Status Verified: 2021-07
• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-26
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-08-03
• Primary Completion: 2022-03-30
• Study Completion: 2022-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. Age: 18-50
2. Gender: Male and Female
3. ICD 10 code of migraine with or without aura (G43.0, G43.1, G43.70, G43.71)
4. No change in prophylactic medication for both control and intervention group
5. No physical therapy for headaches, neck pain or for trapezius muscle during 12 weeks for both control and intervention group

Exclusion Criteria

1. Previous Surgery to neck or cranium, history of previous stroke
2. More than two daily prophylactic pharmacologic agents used for the indication of Migraine headache
3. Active cancer
4. Receiving BOTOX® for migraines or treatment within the last 4 months
5. If patient has contraindications for OMT for the intervention group such as clinical signs of fractures in cervical spine, ligament instability, or severe vertebral artery stenosis
6. If patient is poor candidate for OMT in intervention group such as the patient is unable to follow commands.
7. Seizure disorder or recent head trauma
8. Pregnant or become pregnant during the treatment period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional Group receiving Osteopathic Manipulative Therapy (OMT)	Osteopathic Manipulative Therapy (OMT)	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.
Control Group with Standard of Care	Standard of care	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.

Primary Outcome Measures

Name	Time	Method
Reduction in the Headache Impact Test (HIT-6) score in OMT intervention group compared to control group.	12 weeks	Reduction in the Headache Impact Test (HIT-6) score per the scoring system: Little or no impact: 49 or Less Some impact: 50-55 Substantial Impact: 56-59 Severe Impact: 60-78; minimum score: 36 Maximum score: 78
Reduction in the Migraine Disability Test (MIDAS) score in the OMT interventional group compared to control group.	12 weeks	Reduction in the Migraine Disability Test (MIDAS) score and level of disability per the MIDAS score scoring system: MIDAS Grade I (Little to no disability): 0-5 MIDAS Grade II(Mild Disability): 6-10 MIDAS Grade III (Moderate Disability): 11-20 MIDAS Grade IV (Severe Disability): 21+; minimum score: 0 maximum score: 21+ (no maximum)

Secondary Outcome Measures

Name	Time	Method
Headache Days	12 weeks	Reduction in the number of headache days over 12 weeks
Pain scale	12 weeks	Reduction in the pain scale (1-10) for migraine headaches

Trial Locations

Locations (1)

St. Luke's University Health Network; 🇺🇸 Bethlehem, Pennsylvania, United States