Greater Occipital Nerve Block for Migraine With Medication Overuse Headache

Обзор

Migraine is among the leading causes of disability worldwide. Inappropriate use of acute medications in the setting of primary headache, particularly migraine can result in a debilitating condition known as medication overuse headache (MOH). Treatment of MOH is challenging and the primary therapeutic approach is reducing painkillers which helps decrease the number of headache days. As a part of the detoxification process to discontinue acute medications, bridging therapy is often needed to reduce withdrawal headache. Currently, there are data supporting the use of greater occipital nerve block as a preventive treatment in chronic migraine, but no placebo-controlled trial has evaluated the efficacy of greater occipital nerve block in MOH. Therefore, this research aims to demonstrate the efficacy of greater occipital nerve block in detoxification of migraine patients with MOH. Patients will be recruited from Headache Clinic at 3 centers in Thailand from February 2026 to January 2028. After recruitment, patients will be randomized into 2 groups at a 1:1 ratio using a block of four, namely group A and B. A 5-mL syringe of 2 mL of lidocaine 2% and 2 mL of methylprednisolone 40 mg/mL (80 mg) will be prepared for each patient in group while a 5-mL syringe of 4 mL normal saline will be prepared for each patient in group B. Monthly headache days, duration, severity, acute medication type and number of usage days and relative headache status according to a 5-point Likert scale will be investigated at the 2 weeks, 1st, 2nd and 3rd month, MIDAS at the end of 3rd month.

Вмешательства

• Препарат Lidocaine 2% and Methylprednisolone 80 mg
  A 4-mL injection containing 2 mL of lidocaine 2% and 2 mL of methylprednisolone 40 mg/mL (80 mg). The injection is administered at the medial third of the distance between the external occipital protuberance and the mastoid process.
• Другое Placebo
  A 4-mL injection of 0.9% Normal Saline administered at the medial third of the distance between the external occipital protuberance and the mastoid process.

Первичные конечные точки

• Percentage of patients with Medication Overuse Headache (MOH) [Срок оценки: At the end of month 1 and month 3 after detoxification.]

Вторичные конечные точки (4)

• Percentage of patients achieving 50% improvement in migraine [Срок оценки: At the end of month 3.]
• Change in monthly headache days [Срок оценки: Baseline (month -1) and month 3.]
• Change in mean headache severity [Срок оценки: Baseline (month -1) and month 3.]
• Change in Migraine Disability Assessment (MIDAS) Score [Срок оценки: Baseline (month -1) and month 3.]

Критерии участия

Критерии включения

• Patients who have a diagnosis of migraine with medication overuse headache according to ICHD-3 criteria confirmed by a neurologist
• Female patients will be screened for pregnancy planning and married female patients must undergo a urine pregnancy test

Критерии исключения

• Patients who have other types of headache disorders other than migraine
• Patients who have a previous history of allergy to corticosteroid or lidocaine
• Patients who had previous skull surgery
• Pregnant women
• Patients with a history of uncontrolled depression, or psychosis
• Patients who get or plan to get CGRP-targeted therapies or botulinum toxin injection
• Patients with an increased risk of bleeding or underlying bleeding disorders

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Таиланд · 3 центра

• Faculty of Medicine Siriraj Hospital, Mahidol University — Bangkok
• Faculty of Medicine, Prince of Songkla University — Hat Yai
• Faculty of Medicine, Chiang Mai University — Chiang Mai

Публикации

• GBD 2023 Headache Collaborators. Global, regional, and national burden of headache disorders, 1990-2023: a systematic analysis for the Global Burden of Disease Study 2023. Lancet Neurol. 2025 Dec;24(12):1005-1015. doi: 10.1016/S1474-4422(25)00402-8. PMID 41240916
• Arab A, Khoshbin M, Karimi E, Saberian G, Saadatnia M, Khorvash F. Effects of greater occipital nerve block with local anesthetic and triamcinolone for treatment of medication overuse headache: an open-label, parallel, randomized, controlled clinical trial. Neurol Sci. 2022 Jan;43(1):549-557. doi: 10.1007/s10072-021-05295-y. Epub 2021 May 4. PMID 33945036
• Stewart WF, Lipton RB, Dowson AJ, Sawyer J. Development and testing of the Migraine Disability Assessment (MIDAS) Questionnaire to assess headache-related disability. Neurology. 2001;56(6 Suppl 1):S20-8. doi: 10.1212/wnl.56.suppl_1.s20. PMID 11294956
• Inan LE, Inan N, Unal-Artik HA, Atac C, Babaoglu G. Greater occipital nerve block in migraine prophylaxis: Narrative review. Cephalalgia. 2019 Jun;39(7):908-920. doi: 10.1177/0333102418821669. Epub 2019 Jan 6. PMID 30612462
• Chowdhury D, Tomar A, Deorari V, Duggal A, Krishnan A, Koul A. Greater occipital nerve blockade for the preventive treatment of chronic migraine: A randomized double-blind placebo-controlled study. Cephalalgia. 2023 Feb;43(2):3331024221143541. doi: 10.1177/03331024221143541. PMID 36739512
• Diener HC, Marmura MJ, Tepper SJ, Cowan R, Starling AJ, Diamond ML, Hirman J, Mehta L, Brevig T, Sperling B, Cady R. Efficacy, tolerability, and safety of eptinezumab in patients with a dual diagnosis of chronic migraine and medication-overuse headache: Subgroup analysis of PROMISE-2. Headache. 2021 Jan;61(1):125-136. doi: 10.1111/head.14036. Epub 2020 Dec 13. PMID 33314079
• Silberstein SD, Cohen JM, Seminerio MJ, Yang R, Ashina S, Katsarava Z. The impact of fremanezumab on medication overuse in patients with chronic migraine: subgroup analysis of the HALO CM study. J Headache Pain. 2020 Sep 21;21(1):114. doi: 10.1186/s10194-020-01173-8. PMID 32958075
• Dodick DW, Doty EG, Aurora SK, Ruff DD, Stauffer VL, Jedynak J, Dong Y, Pearlman EM. Medication overuse in a subgroup analysis of phase 3 placebo-controlled studies of galcanezumab in the prevention of episodic and chronic migraine. Cephalalgia. 2021 Mar;41(3):340-352. doi: 10.1177/0333102420966658. Epub 2020 Nov 3. PMID 33143451

Идентификаторы

NCT: NCT07568496 · Si321/2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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