Peripheral Nerve Block and Topiramate in the Treatment of Medication Overuse Headaches

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Effects of Peripheral Nerve Block and Topiramate in the Treatment of Medication Overuse Headaches: A Randomised Parallel Group Study

Conditions
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Medication Overuse Headache, Chronic Migraine, Headache

Intervention / Treatment
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* Drug: Topamax
* Procedure: Greater Occipital Nerve Block + Supratrochlear Nerve Block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic migraine diagnosis according to International Classification of Headache-2 Disorders (ICHD) w/o pregnancy or breastfeeding. w/o acute or chronic psychiatric disorders. w/o nephrolithiasis. w/o medication of anticoagulant and antiaggregant. w/o allergy to topiramate or bupivacaine. w/o prophylaxis within the last three months with any of; propranolol, nebivolol, topiramate, valproate, venlafaxine, duloxetine, amitriptyline, flunarizine. w/o previous history of peripheral nerve block, botulinum toxin or acupuncture. w/o history of multiple sclerosis, movement disorders, epilepsy, stroke, and tumor. J-w/o chronic systemic diseases including hypertension, cardiac insufficiency, diabetes, pulmonary disease, kidney disease, liver disease, and peripheral arterial disease. Exclusion Criteria: Lost to follow up within the pretreatment period during the detoxification therapy after the detoxification therapy could not tolerate the peripheral nerve block or topiramate

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topiramate<br>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. | Drug: Topamax<br>* An antiepileptic agent used for migraine prophylaxis.<br>|
| Active Comparator: Greater Occipital +Supratrochlear Nerve Block<br>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<br>* An injection to paralyze the occipital and supratrochlear nerves.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale | Range Pain 0-10, 0: No pain, 10: Worst Pain | Post treatment (4 weeks later) | 
| Attack Frequencies | Number of headaches patients suffer in a month. | Post treatment (4 weeks later) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication overuse headache; Greater occipital nerve block; supratrochlear nerve block; topiramate.