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No participants enrolled since this study open. The Primary research member (medical school student) is no longer available to do this study
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Migraines are very common and affect over 35 million Americans a year. Migraines can be painful and affect daily life. The cause of migraine is multifactorial and not completely understood. Treatment usually includes different classes of medications, life style changes, physical therapy, acupuncture, nerve stimulators and avoiding common triggers (like bright lights, certain foods, or loud sounds).
For some patients, Botox injected into the muscles of the forehead and neck can significantly reduce pain. Unfortunately, this does not provide long-term relief as the effect of Botox lasts for 3 months. Since year 2000 surgery to treat a selected population of migraine patients has been gaining popularity and showing promising results. The surgery reduces the pressure on the peripheral nerves that are believed to cause migraine headaches by resecting the surrounding tissue (bone, fascia, muscle, and arteries). This surgery provides a more long-term and permanent relief.
The purpose of this study is to follow the effectiveness and outcomes of migraine surgery.
Migraines are very common and affect over 35 million Americans a year. Migraines can be painful and affect daily life. The cause of migraine is multifactorial and not completely understood. Treatment usually includes different classes of medications, life style changes, physical therapy, acupuncture, nerve stimulators and avoiding common triggers (like bright lights, certain foods, or loud sounds).
For some patients, Botox injected into the muscles of the forehead and neck can significantly reduce pain. Unfortunately, this does not provide long-term relief as the effect of Botox lasts for 3 months. Since year 2000 surgery to treat a selected population of migraine patients has been gaining popularity and showing promising results. The surgery reduces the pressure on the peripheral nerves that are believed to cause migraine headaches by resecting the surrounding tissue (bone, fascia, muscle, and arteries). This surgery provides a more long-term and permanent relief.
The purpose of this study is to follow the effectiveness and outcomes of migraine surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with migraines | Patients seen in clinic and assessed with Migraine Headache Diagnostic Criteria to ensure diagnosis. Patients track the characteristics of migraine headaches for one month before surgery. After this month, patients receive surgery in the operating room for migraine. After surgery, patients track the characteristics of migraine headaches for 3 months. Patients will then be asked to track the characteristics migraine headaches again at 1 year and 2 years and 5 years after surgery. For these time periods, patients only have to keep track of the characteristics for 1 month intervals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Migraine surgery | Procedure | Surgical decompression of neuromuscular structures causing migraine headaches. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in International Classification of Headache Disorders Diagnostic criteria: Frequency | Frequency
| 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative |
| Change in International Classification of Headache Disorders Diagnostic criteria: Duration | Duration -How long the migraine headaches last in minutes | 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative |
| Change in International Classification of Headache Disorders Diagnostic criteria: Location | Location
| 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative |
| Change in International Classification of Headache Disorders Diagnostic criteria: Quality | Quality
| 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative |
| Change in International Classification of Headache Disorders Diagnostic criteria: Severity | Severity - Migraine headache severity graded on a 0-10 scale, with 10 being the most severe. | 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative |
| Change in International Classification of Headache Disorders Diagnostic criteria: Laterality | Laterality
|
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Inclusion Criteria:
Exclusion Criteria:
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Patients with migraine headaches that meet above inclusion/exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Salam Kassis, MD | Vanderbilt University Medical Center | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22288302 | Background | Negro A, Rocchietti-March M, Fiorillo M, Martelletti P. Chronic migraine: current concepts and ongoing treatments. Eur Rev Med Pharmacol Sci. 2011 Dec;15(12):1401-20. | |
| 25254996 | Background | Janis JE, Barker JC, Javadi C, Ducic I, Hagan R, Guyuron B. A review of current evidence in the surgical treatment of migraine headaches. Plast Reconstr Surg. 2014 Oct;134(4 Suppl 2):131S-141S. doi: 10.1097/PRS.0000000000000661. |
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Individual participant data will not be shared
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative |
| Change in International Classification of Headache Disorders Diagnostic criteria: Associated Symptoms | Associated symptoms
| 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative |
| Change in International Classification of Headache Disorders Diagnostic criteria: Exacerbating factors | Exacerbating factors
| 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative |
| Change in International Classification of Headache Disorders Diagnostic criteria: Relieving factors | Relieving factors
| 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative |
| 7869073 | Background | Stewart WF, Simon D, Shechter A, Lipton RB. Population variation in migraine prevalence: a meta-analysis. J Clin Epidemiol. 1995 Feb;48(2):269-80. doi: 10.1016/0895-4356(94)00128-d. |
| 16388337 | Background | Leonardi M, Steiner TJ, Scher AT, Lipton RB. The global burden of migraine: measuring disability in headache disorders with WHO's Classification of Functioning, Disability and Health (ICF). J Headache Pain. 2005 Dec;6(6):429-40. doi: 10.1007/s10194-005-0252-4. Epub 2005 Dec 15. |
| 20966820 | Background | Guyuron B, Kriegler JS, Davis J, Amini SB. Five-year outcome of surgical treatment of migraine headaches. Plast Reconstr Surg. 2011 Feb;127(2):603-608. doi: 10.1097/PRS.0b013e3181fed456. |
| 28013487 | Background | Gfrerer L, Guyuron B. Surgical treatment of migraine headaches. Acta Neurol Belg. 2017 Mar;117(1):27-32. doi: 10.1007/s13760-016-0731-1. Epub 2016 Dec 24. |
| 19644260 | Background | Guyuron B, Reed D, Kriegler JS, Davis J, Pashmini N, Amini S. A placebo-controlled surgical trial of the treatment of migraine headaches. Plast Reconstr Surg. 2009 Aug;124(2):461-468. doi: 10.1097/PRS.0b013e3181adcf6a. |
| 10946944 | Result | Guyuron B, Varghai A, Michelow BJ, Thomas T, Davis J. Corrugator supercilii muscle resection and migraine headaches. Plast Reconstr Surg. 2000 Aug;106(2):429-34; discussion 435-7. doi: 10.1097/00006534-200008000-00030. |
| 23542247 | Result | Lee M, Monson MA, Liu MT, Reed D, Guyuron B. Positive botulinum toxin type a response is a prognosticator for migraine surgery success. Plast Reconstr Surg. 2013 Apr;131(4):751-757. doi: 10.1097/PRS.0b013e3182818b7f. |
| 15622223 | Result | Guyuron B, Kriegler JS, Davis J, Amini SB. Comprehensive surgical treatment of migraine headaches. Plast Reconstr Surg. 2005 Jan;115(1):1-9. |
| D009422 | Nervous System Diseases |