Comparison of Therapeutic Effects of Greater Occipital Nerve Block, Topiramate, and Flunarizine on Episodic Migraine: A Randomised Parallel Group Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Attack Frequencies
研究概览
简要总结
Background: Preventive drug therapy in migraine aims to reduce the attack frequency, severity and duration of headache. Flunarizine and topiramate are widely used in the prevention of migraine attacks. Greater occipital nerve block (GONB) is an alternative treatment option for the prophylactic treatment of migraine. In this study, investigators compared the effectiveness of GONB, topiramate, and flunarizine in terms of reduction in post-treatment VAS scores and attack frequencies in patients with episodic migraine in a four-week period.
Material and Methods: At least one hundred and twenty migraine patients are aimed to be randomly divided into three treatment groups, namely flunarizine (n=40, estimated), topiramate (n=40, estimated) and GONB (n=40, estimated). The patients will be followed up for four weeks and the attack frequencies and VAS scores will be recorded weekly. At the end of the fourth week, the response rates based on 50% and 75% or more reduction in the VAS scores and attack frequencies will be calculated. Group-wise comparisons will be assessed statistically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Migraine diagnosis according to ICHD-2
- •Ages between 15 -45 Volunteering
- •Monthly attack number between 5-14
- •BMI between 18-30
- •w/o history of nephrolithiasis
- •w/o history of DM, peripheral vascular disease
- •w/o history of chronic systemic diseases (lung, heart,liver, kidney)
- •w/o any detected CNS disease (including MS, movement disorders, CVD, primary or secondary tumors)
- •w/o history of acute or chronic psychiatric disease
- •w/o history of antiplatelet and anticoagulant medication
- •w/o any combination of medication overuse headache or other primary headaches
- •w/o previous medication of flunarizine and topiramate
- •w/o previous application of GONB
排除标准
- •Lost to follow up
- •exited with his/her own will
- •detected primary headache during follow up
- •cessation due to adverse effects of topiramate
- •cessation due to adverse effects of flunarizine
研究组 & 干预措施
Greater Occipital Nerve Block
The GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg), and 1 ml 0,9% NaCl. The solution is administered using a 22G × 1¼" (0.7 × 40mm) injector with the patient lying prone on the table. Injection is applied to medial of the occipital artery localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. The scalp is cleaned with iodine before the procedure, and the injections are performed bilaterally at a volume of 2 mL after negative aspiration for blood.
干预措施: Greater Occipital Nerve Block (Procedure)
Topiramate
Topiramate is administered twice a day at a dose of 25 mg/day, which is increased to 100 mg/day in the second week.
干预措施: Topiramate (Drug)
Flunarizine
Flunarizine is introduced with a single dose of 10 mg/day.
干预措施: Flunarizine (Drug)
结局指标
主要结局
Attack Frequencies
时间窗: Post treatment 4 weeks
Number of headaches patients suffer in a month.
Visual Analog Scale
时间窗: Post treatment 4 weeks
Range Pain 0-10, 0: No pain, 10: Worst Pain
次要结局
未报告次要终点
研究者
Mustafa Ceylan
Principal İnvastigator
Ataturk University