Comparison of Therapeutic Effects of Greater Occipital Nerve Block, Topiramate, and Flunarizine on Episodic Migraine
|ClinicalTrials.gov Identifier: NCT03712917|
Recruitment Status : Completed
First Posted : October 19, 2018
Last Update Posted : April 2, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Procedure: Greater Occipital Nerve Block Drug: Topiramate Drug: Flunarizine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Comparison of Therapeutic Effects of Greater Occipital Nerve Block, Topiramate, and Flunarizine on Episodic Migraine: A Randomised Parallel Group Study|
|Actual Study Start Date :||March 1, 2019|
|Actual Primary Completion Date :||March 31, 2019|
|Actual Study Completion Date :||March 31, 2019|
Active Comparator: 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.
Procedure: Greater Occipital Nerve Block
An enjection to paralyze the occipital nerve.
Active Comparator: 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.
An antiepileptic agent used for migraine prophylaxis.
Active Comparator: Flunarizine
Flunarizine is introduced with a single dose of 10 mg/day.
A calcium overload blocker agent used for migraine prophylaxis.
- Visual Analog Scale [ Time Frame: 4 weeks ]Range Pain 0-10, 0: No pain, 10: Worst Pain
- Attack frequencies [ Time Frame: 4 weeks ]Number of headaches patients suffer in a month.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712917
|Ataturk University Resarch Hospital|
|Erzurum, Turkey, 25000|