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Completed

NCT Number: NCT03767062

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

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.

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Key information

Conditions

Medication Overuse Headache Brain Diseases Central Nervous System Diseases Chronic Migraine, Headache Headache Headache Disorders Headache Disorders, Secondary Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mustafa Ceylan

Erzurum, 25000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topamax

Drug

An antiepileptic agent used for migraine prophylaxis.

Greater Occipital Nerve Block + Supratrochlear Nerve Block

Procedure

An injection to paralyze the occipital and supratrochlear nerves.

Primary outcomes

  1. Visual Analog Scale

    Time frame: Post treatment (4 weeks later)

    Range Pain 0-10, 0: No pain, 10: Worst Pain

  2. Attack Frequencies

    Time frame: Post treatment (4 weeks later)

    Number of headaches patients suffer in a month.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 6, 2018
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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