Predictors of GON Blockade Success in Migraine

N/ANot Yet RecruitingNCT07170111

Başakşehir Çam & Sakura City Hospital460 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

460

Conditions

Migraine

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Number of days with headache

Time frame: Baseline,1st month and 3rd month

Secondary Outcomes

The 6-Item Headache Impact Test (HIT-6)

The 6-Item Headache Impact Test (HIT-6) is a brief, validated questionnaire that assesses the adverse impact of headaches on daily functioning, with higher scores indicating greater impact.

Time frame: Baseline,1st month and 3rd month

Global Rating of Change (GROC)

The Global Rating of Change (GROC) is a patient-reported scale that measures perceived change in health status over time, typically ranging from very much worse to very much improved.

Time frame: 1st month and 3rd month

Numeric Rating Scale

A simple and widely used tool to assess pain intensity, where patients rate their pain on a scale from 0 to 10, with 0 meaning 'no pain' and 10 meaning 'the worst pain imaginable

Time frame: Baseline,1st month and 3rd month

Number of migraine attacks

Time frame: Baseline, 1st month and 3rd month

Duration of migraine attacks

Time frame: Baseline, 1st month and 3rd month

Analgesic consumption

Time frame: Baseline, 1st month and 3rd month

Predictors of GON Blockade Success in Migraine

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts