Clinical trial NCT03767062
Conditions: Medication Overuse Headache Chronic Migraine, Headache
Keywords: Medication overuse headache; Greater occipital nerve block; supratrochlear nerve block; topiramate.
Sponsor: Ataturk University
Start date: 2019-03-01; Completion date: 2019-03-31
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Purpose: In this study, the investigators compared the effectiveness of peripheral nerve block (greater occipital nerve block with supratrochlear nerve block) versus topiramate as detoxification therapies in chronic migraine patients with medication overuse headache.

Methods: At least ninety chronic migraine patients with medication overuse headache are aimed to include in this study. Patients will be divided into the two groups. The first group will receive topiramate (n=45, estimated) and the second group will receive nerve block (n=45, estimated) as detoxification therapy. Patients' records regarding the visual analog scale (VAS) scores and headache frequencies are aimed to be collected before and after the therapy. Comparisons regarding VAS scores, headache frequencies, 50% responder rates and 75% responder rates will be performed in between topiramate and nerve block groups.

Detailed description:

Arms: arm 1: Topiramate will be introduced 25 mg/day b.i.d. for the first week and increased to 100 mg/day b.i.d. for the second week. arm 2: Greater occipital nerve block (GONB) will be applied to medial of the occipital artery which localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg) and 1 ml 0,9% sodium chloride (NaCl). The injection is performed using a 22 gauge (G) × 1¼" (0.7 × 40mm) injector when the patient is lying prone on the table. The scalp is cleaned with iodine before procedure and injections are performed bilaterally with a volume of 2 mL after negative aspiration for blood. Supratrochlear nerve block (STNB) is applied 1 cm medial to superior orbital fissure using a mixture of 8 mg bupivacaine and 1.4 ml 0,9% NaCl. STNB is performed bilaterally with a volume of 1.5 mL after negative aspiration for blood.
Interventions: intervention 1: Topamax intervention 2: Greater Occipital Nerve Block + Supratrochlear Nerve Block
Intervention descriptions: intervention 1: An antiepileptic agent used for migraine prophylaxis. intervention 2: An injection to paralyze the occipital and supratrochlear nerves.

Protocol documents:
Prot_SAP_000.pdf: 
Comparison of Effects of Peripheral Nerve Block and Topiramate in the 
Treatment of Medication Overuse Headaches 
 
 
 
 
 
07.07.2019 
Purpose 
In this study, we compared the effectiveness of peripheral nerve block (greater 
occipital nerve block with supratrochlear nerve block) versus topiramate as 
detoxification therapies in chronic migraine patients with medication overuse 
headache. 
Methods 
 Ninety chronic migraine patients with medication overuse headache were included in 
this study. Patients divided into the two groups. The first group received topiramate 
and the second group received nerve block as detoxification therapy. Patients’ 
records regarding the VAS scores and headache frequencies were collected before 
and after the therapy. Comparisons regarding VAS scores, headache frequencies, 
50% responder rates and 75% responder rates were performed in between 
topiramate and nerve block groups. 
Data collection 
 The study was carried on by 2 neurologists. The first neurologist obtained the data 
regarding the migraine features from each patient included. Each patient kept a diary 
documenting frequency, visual analog scale (VAS) as the number of headache 
attacks in the preceding 4 weeks. At the end of the fourth week, forms were collected 
by first neurologist and patients were referred the second neurologist for treatment 
regimens were to be introduced. Detoxification process was maintained in the 
inpatient clinic for ten days and preventive treatment was started simultaneously by 


the second neurologist. After discharge, new forms were delivered and collected by 
the first neurologist after 4 weeks. All patients were informed about possible adverse 
reactions and those caused discontinuation of therapy were noted.  
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. Mann Whitney U was utilized to compare the data that were not 
normally distributed. Nominal categorical data were assessed using the chisquare 
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 statistically significant.