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

Ataturk University

Status: Completed

Conditions: Chronic Migraine, Headache; Medication Overuse Headache

Treatments: Procedure: Greater Occipital Nerve Block + Supratrochlear Nerve Block; Drug: Topamax

Study type: Interventional

Funder types: Other

Identifiers

NCT03767062

2018/22-3

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Chronic migraine diagnosis according to International Classification of Headache-2 Disorders (ICHD)
2. w/o pregnancy or breastfeeding.
3. w/o acute or chronic psychiatric disorders.
4. w/o nephrolithiasis.
5. w/o medication of anticoagulant and antiaggregant.
6. w/o allergy to topiramate or bupivacaine.
7. w/o prophylaxis within the last three months with any of; propranolol, nebivolol, topiramate, valproate, venlafaxine, duloxetine, amitriptyline, flunarizine.
8. w/o previous history of peripheral nerve block, botulinum toxin or acupuncture.
9. 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

1. Lost to follow up within the pretreatment period during the detoxification therapy after the detoxification therapy
2. could not tolerate the peripheral nerve block or topiramate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

Topiramate

Active Comparator group

Description:

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.

Treatment:

Drug: Topamax

Greater Occipital +Supratrochlear Nerve Block

Active Comparator group

Description:

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.

Treatment:

Procedure: Greater Occipital Nerve Block + Supratrochlear Nerve Block