Clinical trial NCT03712917
Conditions: Migraine
Keywords: Migraine Greater Occipital Nerve Block Topiramate Flunarizine
Sponsor: Ataturk University
Start date: 2019-03-01; Completion date: 2019-03-31
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

Detailed description:

Arms: arm 1: 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. arm 2: Topiramate is administered twice a day at a dose of 25 mg/day, which is increased to 100 mg/day in the second week. arm 3: Flunarizine is introduced with a single dose of 10 mg/day.
Interventions: intervention 1: Greater Occipital Nerve Block intervention 2: Topiramate intervention 3: Flunarizine
Intervention descriptions: intervention 1: An enjection to paralyze the occipital nerve. intervention 2: An antiepileptic agent used for migraine prophylaxis. intervention 3: A calcium overload blocker agent used for migraine prophylaxis.

Protocol documents:
Prot_SAP_000.pdf: 
Comparison of Therapeutic Effects of Greater Occipital Nerve 
Blockade, Topiramate and Flunarazine in Episodic Migraine 
07.07.2019 
Objective: The preventive drug therapy in migraine is for reducing the attack 
frequency, severity and duration of the headache. Flunarizine and topiramate are 
widely used in the prevention of migraine attacks. Greater occipital nerve block 
(GONB) is an alternative treatment option which is used in the prophylactic treatment 
of migraine. In this study we compared the effectiveness of GONB, topiramate and 
flunarizine by means of reduction in post treatment VAS scores and attack 
frequencies in episodic migraine patients in a one month period. 
Material and Methods: One hundred and twenty migraine patients were  aimed to 
be divided into three treatment groups namely flunarazine, topiramate and GONB. 
Patients were followed for 4 weeks and attack frequencies and VAS scores were 
recorded weekly. At the end of fourth week, response rates, rates of 50% and 75% or 
more reduction in VAS and attack frerquencies were calculated. Gorups wise 
comparsions were assessed statistically. 
Treatment protocol 
 Flunarizine was introduced with a single dose of 10 mg/day. Topiramate was 
administered twice a day at a dose of 25 mg/day, which was increased to 100 
mg/day in the second week. The GONB solution was prepared with 1 ml 
triamcinolone (40mg), 2 ml bupivacaine (10 mg), and 1 ml 0,9% NaCl. The solution 
was administered using a 22G × 1¼" (0.7 × 40mm) injector with the patient lying 
prone on the table. Injection was 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 was cleaned with iodine before the procedure, and the 
injections were performed bilaterally at a volume of 2 mL after negative aspiration for 
blood. 
 
Statistical analysis  
Normality of distribution was assessed with the D’Agostino-Pearson test. Continuous 
variables with a normal distribution were assessed in two or more groups using the 
Student’s t-test and ANOVA test, respectively. Non-parametric counterparts of these 
tests (Mann Whitney U and Kruskal-Wallis tests) were utilized to compare the data 
that were not normally distributed. Nominal categorical data were assessed using the 
chi-square test. The pre- and post-treatment comparison of normally and non-
normally distributed data were undertaken using the paired t-test and the Wilcoxon 
test, respectively. A two-tailed p value of <0.05 was considered to be statistically 
significant.