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

Chronic Migraine, Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03767062
• Other study ID #: 2018/22-3
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: March 31, 2019

Study information

• Verified date: January 2020
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Migraine, Headache
• Headache
• Headache Disorders, Secondary
• Medication Overuse Headache

Intervention

Drug:
• Topamax
An antiepileptic agent used for migraine prophylaxis.

Procedure:
• Greater Occipital Nerve Block + Supratrochlear Nerve Block
An injection to paralyze the occipital and supratrochlear nerves.

Locations

Country	Name	City	State
Turkey	Mustafa Ceylan	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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