Osteopathic Manipulative Treatment and Migraine Headaches

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-02

Study Completion Date

2022-03-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Migraine Migraine Disorders Headache Disorders Headache, Migraine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Interventional group: 70 patients with chronic migraine who consent to OMT will receive four standardized osteopathic manipulative treatments over the course of twelve weeks. 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: 70 patients with the diagnosis of migraine headache will complete a MIDAS and HIT-6 questionnaire at week 0 and week 12 on standard of care for migraine treatment. 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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interventional Group receiving 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.

Group Type EXPERIMENTAL

Osteopathic Manipulative Therapy (OMT)

Intervention Type PROCEDURE

Osteopathic Manipulative Therapy (OMT) is a non-pharmacological, noninvasive form of manual medicine. Osteopathic physicians receive special training in the musculoskeletal system to detect somatic dysfunction. Osteopathic physicians then move a patient's muscles and joints using techniques that include stretching, gentle pressure and resistance to improve muscle tonicity, treat structural abnormalities, relieve joint restriction, and decrease activation of the pain proprioception pathway.

OMT Standardized Protocol A:

1. Occipital- Alanto release
2. Muscle energy and soft tissue to mid trapezius muscle
3. Muscle energy to cervical spine in all three planes of flexion/extension, rotation and side bending
4. Screening for tender points of C2-C6 at transverse and spinous processes and treatment with counterstain if tender point identified
5. Soft tissue to cervical paraspinal muscles
6. Myo-fascial release of frontal forehead
7. CV4 cranial technique

Control Group with 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.

Group Type OTHER

Standard of care

Intervention Type OTHER

Receiving standard of care for migraine headaches with pharmacological medications, with no more than two prophylactic medications during the study period. Participants may also take abortive migraine medications.

Interventions

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Osteopathic Manipulative Therapy (OMT)

Osteopathic Manipulative Therapy (OMT) is a non-pharmacological, noninvasive form of manual medicine. Osteopathic physicians receive special training in the musculoskeletal system to detect somatic dysfunction. Osteopathic physicians then move a patient's muscles and joints using techniques that include stretching, gentle pressure and resistance to improve muscle tonicity, treat structural abnormalities, relieve joint restriction, and decrease activation of the pain proprioception pathway.

OMT Standardized Protocol A:

1. Occipital- Alanto release
2. Muscle energy and soft tissue to mid trapezius muscle
3. Muscle energy to cervical spine in all three planes of flexion/extension, rotation and side bending
4. Screening for tender points of C2-C6 at transverse and spinous processes and treatment with counterstain if tender point identified
5. Soft tissue to cervical paraspinal muscles
6. Myo-fascial release of frontal forehead
7. CV4 cranial technique

Intervention Type PROCEDURE

Standard of care

Receiving standard of care for migraine headaches with pharmacological medications, with no more than two prophylactic medications during the study period. Participants may also take abortive migraine medications.

Intervention Type OTHER

Other Intervention Names

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OMT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes