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

Not Applicable

Completed

Conditions: Medication Overuse Headache
Chronic Migraine, Headache

Interventions: Drug: Topamax
Procedure: Greater Occipital Nerve Block + Supratrochlear Nerve Block

Registration Number: NCT03767062

Lead Sponsor: Ataturk University

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: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 90

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topiramate	Topamax	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.
Greater Occipital +Supratrochlear Nerve Block	Greater Occipital Nerve Block + 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.

Primary Outcome Measures

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

Secondary Outcome Measures