Predictive Factors for the Success of Greater Occipital Nerve Block in Migraine: A Multicenter Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- Number of days with headache
研究概览
简要总结
This multicenter, prospective cohort study aims to identify clinical and demographic predictors that influence the success of greater occipital nerve (GON) block in patients with migraine.
Patients will be evaluated at baseline, on each injection day, and at one- and three-month follow-ups. Study parameters include demographics, migraine type and duration, comorbidities, headache characteristics, treatment history, and validated outcome measures such as the Numeric Rating Scale (NRS), Headache Impact Test-6 (HIT-6), and Global Rating of Change (GRoC).
The goal is to establish predictive factors of treatment success in order to optimize patient selection and contribute robust multicenter evidence to individualized migraine management
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of migraine for at least 6 months, according to ICHD-3 criteria
- •Age between 18 and 65 years
- •Inadequate response to preventive therapy used regularly for at least 3 months
- •Planned treatment with greater occipital nerve block (GONB) and provision of signed informed consent
- •Receiving GONB treatment for the first time
排除标准
- •Pregnancy or breastfeeding
- •Presence of malignancy
- •Coagulopathy or anticoagulant therapy
- •Local infection, open wound, or history of surgery at the injection site preventing the procedure
- •History of severe neurological or psychiatric disorders
- •Receipt of interventional treatment (e.g., Botox, acupuncture, neural therapy, nerve blocks) within the last 3 months
- •Use of steroids or immunosuppressive therapy
- •Start of a new preventive therapy within the last 3 months
- •Inability to comply with keeping a headache diary
- •Known hypersensitivity or allergy to bupivacaine
结局指标
主要结局
Number of days with headache
时间窗: Baseline,1st month and 3rd month
次要结局
- The 6-Item Headache Impact Test (HIT-6)(Baseline,1st month and 3rd month)
- Duration of migraine attacks(Baseline, 1st month and 3rd month)
- Global Rating of Change (GROC)(1st month and 3rd month)
- Numeric Rating Scale(Baseline,1st month and 3rd month)
- Number of migraine attacks(Baseline, 1st month and 3rd month)
- Analgesic consumption(Baseline, 1st month and 3rd month)
研究者
Tuba Tanyel Saraçoğlu
Medical Doctor
Başakşehir Çam & Sakura City Hospital