Peripheral Nerve Block and Topiramate in the Treatment of Medication Overuse Headaches
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|ClinicalTrials.gov Identifier: NCT03767062|
Recruitment Status : Completed
First Posted : December 6, 2018
Results First Posted : January 22, 2020
Last Update Posted : January 22, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Medication Overuse Headache Chronic Migraine, Headache||Drug: Topamax Procedure: Greater Occipital Nerve Block + Supratrochlear Nerve Block||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Comparison of Effects of Peripheral Nerve Block and Topiramate in the Treatment of Medication Overuse Headaches: 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: Topiramate
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.
An antiepileptic agent used for migraine prophylaxis.
Active Comparator: Greater Occipital +Supratrochlear Nerve Block
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.
Procedure: Greater Occipital Nerve Block + Supratrochlear Nerve Block
An injection to paralyze the occipital and supratrochlear nerves.
- Visual Analog Scale [ Time Frame: Post treatment (4 weeks later) ]Range Pain 0-10, 0: No pain, 10: Worst Pain
- Attack Frequencies [ Time Frame: Post treatment (4 weeks later) ]Number of headaches patients suffer in a month.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03767062
|Erzurum, Turkey, 25000|