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NCT Number: NCT07170111

Predictors of GON Blockade Success in Migraine

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

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Greater Occipital Nerve (GON) Blockade

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

Primary outcomes

  1. Number of days with headache

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

Secondary outcomes

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

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

    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.

  2. Global Rating of Change (GROC)

    Time frame: 1st month and 3rd month

    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.

  3. Numeric Rating Scale

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

    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

  4. Number of migraine attacks

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

  5. Duration of migraine attacks

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

  6. Analgesic consumption

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

Study contacts

Contact information is provided by the study sponsor or research team.

Tuba Tanyel Saraçoğlu

CONTACT

[email protected]

+90 212 909 60 00

Sponsors and collaborators

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Other Gov

Collaborators

  • Bakırçay University, Faculty of Medicine
  • Gaziantep City Hospital
  • Namik Kemal University School of Medicine, Tekirdag
  • Umraniye Education and Research Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 12, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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