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

NCT ID: NCT03767062

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2019-03-31

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.

Conditions

Medication Overuse Headache; Chronic Migraine, Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Topamax

Intervention Type: DRUG

An antiepileptic agent used for migraine prophylaxis.

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.

Group Type: ACTIVE_COMPARATOR

Greater Occipital Nerve Block + Supratrochlear Nerve Block

Intervention Type: PROCEDURE

An injection to paralyze the occipital and supratrochlear nerves.

Interventions

Topamax

An antiepileptic agent used for migraine prophylaxis.

Intervention Type: DRUG

Greater Occipital Nerve Block + Supratrochlear Nerve Block

An injection to paralyze the occipital and supratrochlear nerves.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

Mustafa Ceylan

Principal İnvastigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mustafa Ceylan

Erzurum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Zwart JA, Dyb G, Hagen K, Svebak S, Holmen J. Analgesic use: a predictor of chronic pain and medication overuse headache: the Head-HUNT Study. Neurology. 2003 Jul 22;61(2):160-4. doi: 10.1212/01.wnl.0000069924.69078.8d.

Reference Type: BACKGROUND

PMID: 12874392 (View on PubMed)

Grazzi L, Andrasik F, D'Amico D, Usai S, Kass S, Bussone G. Disability in chronic migraine patients with medication overuse: treatment effects at 1-year follow-up. Headache. 2004 Jul-Aug;44(7):678-83. doi: 10.1111/j.1526-4610.2004.04127.x.

Reference Type: BACKGROUND

PMID: 15209690 (View on PubMed)

Silberstein SD, Lipton RB, Dodick DW, Freitag FG, Ramadan N, Mathew N, Brandes JL, Bigal M, Saper J, Ascher S, Jordan DM, Greenberg SJ, Hulihan J; Topiramate Chronic Migraine Study Group. Efficacy and safety of topiramate for the treatment of chronic migraine: a randomized, double-blind, placebo-controlled trial. Headache. 2007 Feb;47(2):170-80. doi: 10.1111/j.1526-4610.2006.00684.x.

Reference Type: BACKGROUND

PMID: 17300356 (View on PubMed)

Tobin JA, Flitman SS. Occipital nerve blocks: effect of symptomatic medication: overuse and headache type on failure rate. Headache. 2009 Nov-Dec;49(10):1479-85. doi: 10.1111/j.1526-4610.2009.01549.x.

Reference Type: BACKGROUND

PMID: 19912347 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2018/22-3

Identifier Type: -

Identifier Source: org_study_id