Repetitive GON Blockade for Menstrual Migraine
Perimenstrual Repetitive Greater Occipital Nerve Blockade for Menstrual Migraine: A Randomized, Double-Blind, Placebo-Controlled Trial
研究概览
详细说明
Menstrual migraine (MM) is a highly prevalent and challenging migraine subtype triggered by fluctuations in estrogen and progesterone levels, particularly estrogen withdrawal during the perimenstrual period
- This hormonal withdrawal sensitizes the trigeminovascular system and promotes the release of neuropeptides such as calcitonin gene-related peptide (CGRP)
- Currently, there are no licensed prophylactic medications specifically developed for MM, making alternative and non-systemic treatments necessary
This study investigates the efficacy of a targeted peripheral neuromodulation approach using bilateral greater occipital nerve (GON) blockade. The underlying clinical rationale is that GON blockade timed to the perimenstrual period can modulate nociceptive transmission at the trigeminocervical complex (TCC) and decrease peripheral nerve excitability, thereby limiting the impact of cyclic hormonal fluctuations on the trigeminovascular system
. In this trial, a Latin square experimental design is utilized to ensure balanced randomization between the active treatment and placebo groups
- Unlike single-injection protocols, the intervention is specifically synchronized with the patients' menstrual cycles, involving injections twice a month over a three-month period (seven days before menstruation and on the first day of menstruation)
- By evaluating this specific timing and repetitive protocol, the study aims to establish whether perimenstrual-targeted GON blockade can serve as an effective, non-systemic, short-term prophylactic strategy for patients suffering from this refractory migraine subtype.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Istanbul
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Istanbul、Istanbul、土耳其(türkiye)、34668
- Saglik Bilimleri Universitesi
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Diagnosed with pure menstrual migraine or menstrually related migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) diagnostic criteria.
- A documented history of migraine attacks during the perimenstrual period (between days -2 and +3 relative to the onset of menstruation) in at least two of the last three menstrual cycles.
Exclusion Criteria:
- Diagnosis of chronic migraine.
- Presence of an additional primary or secondary headache disorder.
- Pregnant or lactating.
- Known hypersensitivity to local anesthetics.
- Received an occipital nerve blockade within the last three months.
- Presence of a significant neurological or systemic disease that could affect the outcome evaluation.
学习计划
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:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Active Treatment: 0.5% Bupivacaine
Patients receive bilateral greater occipital nerve (GON) blockade using 0.5% bupivacaine.
Injections are administered twice a month for three months (seven days before the expected onset of menstruation and on the first day of menstruation).
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Bilateral greater occipital nerve (GON) blockade using a local anesthetic.
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安慰剂比较:Placebo: Normal Saline
Patients receive bilateral greater occipital nerve (GON) blockade using an equivalent volume of normal saline.
Injections are administered twice a month for three months, following the same schedule as the active treatment group.
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Bilateral greater occipital nerve (GON) blockade using placebo (normal saline).
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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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Change in headache severity evaluated using the Visual Analog Scale (VAS)
大体时间:Baseline, Month 3, and Month 6
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Headache severity measured by VAS.
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Baseline, Month 3, and Month 6
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Change in monthly migraine attack frequency
大体时间:Baseline, Month 3, and Month 6
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Baseline, Month 3, and Month 6
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Change in number of headache days per month
大体时间:Baseline, Month 3, and Month 6
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Baseline, Month 3, and Month 6
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Change in mean attack duration in hours
大体时间:Baseline, Month 3, and Month 6
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Baseline, Month 3, and Month 6
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Change in monthly analgesic consumption
大体时间:Baseline, Month 3, and Month 6
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Baseline, Month 3, and Month 6
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Change in Migraine Disability Assessment (MIDAS) scores
大体时间:Baseline, Month 3, and Month 6
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Baseline, Month 3, and Month 6
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- E66291034-202.3.02-5953
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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