A Comparison of the Efficacy of 5% Lidocaine Anesthetic to Provide SPGB Vs. Elavil for the Treatment of Transformed Migraine
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number of Daily Headaches
研究概览
简要总结
This study will compare a local anesthetic technique that has been used to treat subjects suffering from transformed migraines (chronic migraines) versus medical management with traditional antidepressant Amitriptyline / Elavil.
Subjects will be randomized into one of two treatment groups to compare the safety and efficacy of the therapies. Subjects will recieve either sphenopalatine ganglion nerve block with 5% lidocaine gel into the nasopharynx or medical management with traditional antidepressants, Elavil, to produce a reduction in the frequency and severity of the headache.
We propose that there will be a difference in the outcomes when comparing the two methods of treating transformed migraines and that one research arm will result in more patient satisfaction and greater efficacy in the treatment of subjects
详细描述
Arm one will receive Sphenopalatine Ganglion Nerve Block weekly for 4 weeks
Arm two will receive Amitriptyline / Elavil daily for 30 Days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female age 18-90
- •Subject have formal medical diagnosis of migraine headache
- •Subjects currently require treatment for headache
- •Subjects who have received optimal medical management from migraines including triptans (Imitrex, Amerge and Relpax)
- •Subjects who have recieved optimal medical management for migraines including anticonvulsants (Depakote, Lamictal, klonopin
排除标准
- •Less than 18 years of age
- •Subjects will be excluded if they are already being treated with lidocaine (patch or other vehicle) for chronic pain
- •Untreated Heart Failure
- •Individuals unwilling to comply with study procedures and follow-up
研究组 & 干预措施
SPG Nerve Block with Lidocaine 5% gel
Sphenopalatine Ganglion Nerve Block (SPG Nerve Block) will be administed weekly for 4 weeks using 5% Lidocaine gel This intervention (a nerve block) will treat the headache for the time period investigated
干预措施: Amitriptyline (Drug)
Amitriptyline / Elavil
Amitriptyline / Elavil 10 mg once a day for one week then Amitriotyline 20 mg once a day for three weeks This intervention will treat the headache for the time period investigated
干预措施: Amitriptyline (Drug)
SPG Nerve Block with Lidocaine 5% gel
Sphenopalatine Ganglion Nerve Block (SPG Nerve Block) will be administed weekly for 4 weeks using 5% Lidocaine gel This intervention (a nerve block) will treat the headache for the time period investigated
干预措施: SPG Block with 5% Lidocaine gel (Procedure)
Amitriptyline / Elavil
Amitriptyline / Elavil 10 mg once a day for one week then Amitriotyline 20 mg once a day for three weeks This intervention will treat the headache for the time period investigated
干预措施: SPG Block with 5% Lidocaine gel (Procedure)
结局指标
主要结局
Number of Daily Headaches
时间窗: Study Day 1 through Study Day 30
The number of times per day that symptoms occur
次要结局
未报告次要终点
研究者
William Grubb, M.D.
Associate Prof.
Rutgers, The State University of New Jersey