Predictors of GON Blockade Success in Migraine

Официальное название

Predictive Factors for the Success of Greater Occipital Nerve Block in Migraine: A Multicenter Prospective Study

Обзор

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

Вмешательства

• Процедура Greater Occipital Nerve (GON) Blockade
  The greater occipital nerve block (GONB) will be performed using anatomical landmarks (distal approach). The injection point is located at the medial one-third of the line between the external occipital protuberance and the mastoid process. A 26-gauge insulin needle will be used for the procedure. The block will be administered bilaterally with 0.5% bupivacaine, 1.5 ml per side (total 3 ml). The intervention will be repeated once weekly for a total of four sessions

Первичные конечные точки

• Number of days with headache [Срок оценки: Baseline,1st month and 3rd month]

Вторичные конечные точки (6)

• The 6-Item Headache Impact Test (HIT-6) [Срок оценки: Baseline,1st month and 3rd month]
• Global Rating of Change (GROC) [Срок оценки: 1st month and 3rd month]
• Numeric Rating Scale [Срок оценки: Baseline,1st month and 3rd month]
• Number of migraine attacks [Срок оценки: Baseline, 1st month and 3rd month]
• Duration of migraine attacks [Срок оценки: Baseline, 1st month and 3rd month]
• Analgesic consumption [Срок оценки: Baseline, 1st month and 3rd month]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Başakşehir Çam and Sakura City Hospital — Istanbul

Идентификаторы

NCT: NCT07170111 · 25.06.2025.242

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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