Predictors of GON Blockade Success in Migraine

NCT ID: NCT07170111

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2026-12-01

Brief Summary

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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

Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GON Block Group

Group Type EXPERIMENTAL

Greater Occipital Nerve (GON) Blockade

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Umraniye Education and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Gaziantep City Hospital

OTHER

Sponsor Role collaborator

Namik Kemal University School of Medicine, Tekirdag

OTHER

Sponsor Role collaborator

Bakırçay University, Faculty of Medicine

UNKNOWN

Sponsor Role collaborator

Başakşehir Çam & Sakura City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tuba Tanyel Saraçoğlu

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Başakşehir Çam and Sakura City Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Tuba Tanyel Saraçoğlu

Role: CONTACT

+90 212 909 60 00

Facility Contacts

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Tuba Tanyel Saraçoğlu

Role: primary

+90 212 909 60 00

Other Identifiers

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25.06.2025.242

Identifier Type: -

Identifier Source: org_study_id

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