Comparison of Therapeutic Effects of Greater Occipital Nerve Block, Topiramate, and Flunarizine on Episodic Migraine

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Therapeutic Effects of Greater Occipital Nerve Block, Topiramate, and Flunarizine on Episodic Migraine: A Randomised Parallel Group Study

Conditions
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Migraine

Intervention / Treatment
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* Procedure: Greater Occipital Nerve Block
* Drug: Topiramate
* Drug: Flunarizine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Pregnancy 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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Greater Occipital Nerve Block<br>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. | Procedure: Greater Occipital Nerve Block<br>* An enjection to paralyze the occipital nerve.<br>|
| Active Comparator: Topiramate<br>Topiramate is administered twice a day at a dose of 25 mg/day, which is increased to 100 mg/day in the second week. | Drug: Topiramate<br>* An antiepileptic agent used for migraine prophylaxis.<br>|
| Active Comparator: Flunarizine<br>Flunarizine is introduced with a single dose of 10 mg/day. | Drug: Flunarizine<br>* A calcium overload blocker agent used for migraine prophylaxis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale | Range Pain 0-10, 0: No pain, 10: Worst Pain | Post treatment 4 weeks | 
| Attack Frequencies | Number of headaches patients suffer in a month. | Post treatment 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Greater Occipital Nerve Block, Topiramate, Flunarizine