Outcomes of Following Surgical Decompression for the Treatment of Migraine
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in International Classification of Headache Disorders Diagnostic criteria: Location
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •High dose opioid medication use
- •Does not meet criteria for migraine diagnosis
- •History of prior surgery for migraines
结局指标
主要结局
Change in International Classification of Headache Disorders Diagnostic criteria: Location
时间窗: 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: Exacerbating factors
时间窗: 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: Frequency
时间窗: 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
时间窗: 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: Quality
时间窗: 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
时间窗: 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
时间窗: 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: Relieving factors
时间窗: 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)
Change in International Classification of Headache Disorders Diagnostic criteria: Associated Symptoms
时间窗: 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
次要结局
未报告次要终点
研究者
Brian Drolet
Assistant Professor Department of Plastic Surgery
Vanderbilt University Medical Center