Greater Occipital Nerve Block for Migraine With Medication Overuse Headache (GONB_MOH)
2026年5月11日 更新者：Pannathat Soontrapa、Mahidol University
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.
研究概览
研究类型
介入性
注册 (估计的)
130
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Pannathat Soontrapa, M.D.
- 电话号码：+6690-568-6388
- 邮箱：pannathat.soo@mahidol.ac.th
学习地点
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Bangkok
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Bangkok、Bangkok、泰国、10700
- Faculty of Medicine Siriraj Hospital, Mahidol University
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接触：
- Pannathat Soontrapa, M.D.
- 电话号码：662-4197101-2
- 邮箱：pannathat.soo@mahidol.edu
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首席研究员：
- Pannathat Soontrapa, M.D.
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Changwat Songkhla
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Hat Yai、Changwat Songkhla、泰国、90110
- Faculty of Medicine, Prince of Songkla University
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接触：
- Prut Koonalintip, M.D.
- 电话号码：6689-7846676
- 邮箱：koo.prut@gmail.com
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副研究员：
- Prut Koonalintip, M.D.
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Chiang Mai
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Chiang Mai、Chiang Mai、泰国、50200
- Faculty of Medicine, Chiang Mai University
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接触：
- Surat Tanprawate, M.D.
- 电话号码：6683-2032103
- 邮箱：surat.tan@cmu.ac.th
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副研究员：
- Surat Tanprawate, M.D.
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Active treatment (GONB)
Participants receive Greater Occipital Nerve Block (GONB) with 2% Lidocaine + methylprednisolone 80 mg
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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.
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安慰剂比较：Placebo group
Participants receive occipital injection with Normal Saline (0.9% NaCl).
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of patients with Medication Overuse Headache (MOH)
大体时间：At the end of month 1 and month 3 after detoxification.
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The percentage of participants diagnosed with Medication Overuse Headache (MOH) according to ICHD criteria.
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At the end of month 1 and month 3 after detoxification.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of patients achieving 50% improvement in migraine
大体时间：At the end of month 3.
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The percentage of patients with at least a 50% reduction in monthly headache days compared to baseline (month -1).
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At the end of month 3.
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Change in monthly headache days
大体时间：Baseline (month -1) and month 3.
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The mean change in the number of headache days per month from baseline to month 3.
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Baseline (month -1) and month 3.
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Change in mean headache severity
大体时间：Baseline (month -1) and month 3.
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The change in mean headache severity scores measured by the Visual Analog Scale (VAS).
0 being no pain and 10 being the worst pain
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Baseline (month -1) and month 3.
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Change in Migraine Disability Assessment (MIDAS) Score
大体时间：Baseline (month -1) and month 3.
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Evaluation of the change in disability caused by migraines using the MIDAS questionnaire.
MIDAS score ranges from 0 to 270 with the higher score, the worse disability.
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Baseline (month -1) and month 3.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
- 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.
- Gosalia H, Moreno-Ajona D, Goadsby PJ. Medication-overuse headache: a narrative review. J Headache Pain. 2024 May 31;25(1):89. doi: 10.1186/s10194-024-01755-w.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Koonalintip P, Phillips K, Wakerley BR. Medication-Overuse Headache: Update on Management. Life (Basel). 2024 Sep 11;14(9):1146. doi: 10.3390/life14091146.
- Vandenbussche N, Laterza D, Lisicki M, Lloyd J, Lupi C, Tischler H, Toom K, Vandervorst F, Quintana S, Paemeleire K, Katsarava Z. Medication-overuse headache: a widely recognized entity amidst ongoing debate. J Headache Pain. 2018 Jul 13;19(1):50. doi: 10.1186/s10194-018-0875-x.
- Shand B, Goicochea MT, Valenzuela R, Fadic R, Jensen R, Tassorelli C, Nappi G; COMOESTAS CONSORTIUM. Clinical and Demographical Characteristics of Patients with Medication Overuse Headache in Argentina and Chile: Analysis of the Latin American Section of COMOESTAS Project. J Headache Pain. 2015;16:83. doi: 10.1186/s10194-015-0561-1. Epub 2015 Sep 18.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年5月1日
初级完成 (估计的)
2028年11月1日
研究完成 (估计的)
2028年11月1日
研究注册日期
首次提交
2026年4月28日
首先提交符合 QC 标准的
2026年4月28日
首次发布 (实际的)
2026年5月5日
研究记录更新
最后更新发布 (实际的)
2026年5月13日
上次提交的符合 QC 标准的更新
2026年5月11日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.