Greater Occipital Nerve Block for Migraine With Medication Overuse Headache
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 3
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
This is a single-blind study where participants are masked to the treatment assignment, while investigators are aware of the intervention provided.
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo group
Participants receive occipital injection with Normal Saline (0.9% NaCl).
干预措施: Placebo (Other)
结局指标
主要结局
未指定
次要结局
- Change in mean headache severity(Baseline (month -1) and month 3.)
- Change in Migraine Disability Assessment (MIDAS) Score(Baseline (month -1) and month 3.)
研究者
Pannathat Soontrapa
Lecturer
Mahidol University
