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Predictors of GON Blockade Success in Migraine

ConditionMigraine
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBaşakşehir Çam & Sakura City Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Greater Occipital Nerve (GON) Blockade

    Procedure/Surgery

    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

Treatment groups

460 Participants
are divided into 1 treatment group
Group A: GON Block GroupExperimental treatment 1 intervention

Trial outcomes

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)

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
2

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
3

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
4

Number of migraine attacks

Time frame
Baseline, 1st month and 3rd month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Başakşehir Çam & Sakura City Hospital

Lead sponsor

Umraniye Education and Research Hospital

Collaborator

Gaziantep City Hospital

Collaborator

Namik Kemal University School of Medicine, Tekirdag

Collaborator

Bakırçay University, Faculty of Medicine

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: