Migraine
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREMigraine surgery
Surgical decompression of neuromuscular structures causing migraine headaches.
Sponsors
Vanderbilt University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years or older * Cleared by neurology and headache specialists for surgery * Patient cleared by neurology for not having medication overuse headaches * Patient able to localize a consistent trigger site where the migraines start * Patient has been suffering from migraine for more than 2 years * Botox injections or nerve blocks have worked for migraine relief in the past * Patients formally diagnosed with migraine headaches by a neurologist * Migraines impact quality of life per MIDAS survey * No history of Mania, Bipolar disorder, Major Dispersive disorder, or suicidal ideation
Exclusion criteria
* High dose opioid medication use * Does not meet criteria for migraine diagnosis * History of prior surgery for migraines
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in International Classification of Headache Disorders Diagnostic criteria: Frequency | 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative | Frequency * Number of migraine headaches per day * Number of migraine headaches per week |
| Change in International Classification of Headache Disorders Diagnostic criteria: Duration | 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative | Duration -How long the migraine headaches last in minutes |
| Change in International Classification of Headache Disorders Diagnostic criteria: Location | 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative | Location * Area of head that hurts with migraines. * Options include front, side, top, and back. |
| Change in International Classification of Headache Disorders Diagnostic criteria: Quality | 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative | Quality * Description of the migraine pain. * Options include sharp, stabbing, dull, pulsating, and burning. |
| Change in International Classification of Headache Disorders Diagnostic criteria: Severity | 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative | Severity \- Migraine headache severity graded on a 0-10 scale, with 10 being the most severe. |
| Change in International Classification of Headache Disorders Diagnostic criteria: Laterality | 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative | Laterality * Side of the head that is impacted with migraine headaches * Options include right, left, or both. |
| Change in International Classification of Headache Disorders Diagnostic criteria: Associated Symptoms | 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative | Associated symptoms * Question to record associated symptoms that occur with migraine headaches * Options include nausea, vomiting, photophobia, photophobia, and aura symptoms |
| Change in International Classification of Headache Disorders Diagnostic criteria: Exacerbating factors | 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative | Exacerbating factors * Open ended question to record anything that makes the migraine headaches worse. * Examples include medications, environmental triggers (light, noise, etc), and lifestyle (stress, exercise, etc) |
| Change in International Classification of Headache Disorders Diagnostic criteria: Relieving factors | 1 month intervals at 1 month, 1 year, 2 years, and 5 years post-operative | Relieving factors * Open ended question to record anything that makes the migraine headaches better. * Examples include medications, avoidance of environmental triggers (light, noise, etc), and lifestyle changes (stress avoidance, exercise, etc) |
Outcome results
None listed