Comparison of Therapeutic Effects of Greater Occipital Nerve Block, Topiramate, and Flunarizine on Episodic Migraine
- Conditions
- Migraine
- Interventions
- Registration Number
- NCT03712917
- Lead Sponsor
- Ataturk University
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Greater Occipital Nerve Block 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. Topiramate 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. Flunarizine Flunarizine Flunarizine is introduced with a single dose of 10 mg/day.
- Primary Outcome Measures
Name Time Method Attack Frequencies Post treatment 4 weeks Number of headaches patients suffer in a month.
Visual Analog Scale Post treatment 4 weeks Range Pain 0-10, 0: No pain, 10: Worst Pain
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ataturk University Resarch Hospital
🇹🇷Erzurum, Turkey