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

Ataturk University

Status: Completed

Conditions: Migraine

Treatments: Drug: Topiramate; Drug: Flunarizine; Procedure: Greater Occipital Nerve Block

Study type: Interventional

Funder types: Other

Identifiers

NCT03712917

2019/22-3

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 15 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Migraine diagnosis according to ICHD-2
2. Ages between 15 -45 Volunteering
3. Monthly attack number between 5-14
4. BMI between 18-30
5. w/o history of nephrolithiasis
6. w/o history of DM, peripheral vascular disease
7. w/o history of chronic systemic diseases (lung, heart,liver, kidney)
8. w/o any detected CNS disease (including MS, movement disorders, CVD, primary or secondary tumors)
9. w/o history of acute or chronic psychiatric disease
10. w/o history of antiplatelet and anticoagulant medication
11. w/o any combination of medication overuse headache or other primary headaches
12. w/o previous medication of flunarizine and topiramate
13. w/o previous application of GONB

Exclusion criteria

1. Pregnancy

2. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Greater Occipital Nerve Block

Active Comparator group

Description:

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.

Treatment:

Procedure: Greater Occipital Nerve Block

Topiramate

Active Comparator group

Description:

Topiramate is administered twice a day at a dose of 25 mg/day, which is increased to 100 mg/day in the second week.

Treatment:

Drug: Topiramate

Flunarizine

Active Comparator group

Description:

Flunarizine is introduced with a single dose of 10 mg/day.

Treatment:

Drug: Flunarizine