Clinical trial NCT03767062: Peripheral Nerve Block and Topiramate in the Treatment of Medication Overuse Headaches
Official title: Comparison of Effects of Peripheral Nerve Block and Topiramate in the Treatment of Medication Overuse Headaches: A Randomised Parallel Group Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Overuse Headache
Chronic Migraine, Headache
Keywords: Medication overuse headache; Greater occipital nerve block; supratrochlear nerve block; topiramate.
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 90
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Post treatment (4 weeks later)
measure: Attack Frequencies
timeFrame: Post treatment (4 weeks later)
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Mustafa Ceylan
Study officials:
References:
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. doi: 10.1212/01.wnl.0000069924.69078.8d.
citation: 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.
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. doi: 10.1111/j.1526-4610.2006.00684.x.
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.