Migraine
Conditions
Keywords
migraine, GON block, greater occipital nerve, greater occipital nerve block, predictive factors
Brief summary
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
Interventions
PROCEDUREGreater 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
Sponsors
Umraniye Education and Research Hospital
Gaziantep City Hospital
Namik Kemal University School of Medicine, Tekirdag
Bakırçay University, Faculty of Medicine
Başakşehir Çam & Sakura City Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of days with headache | Baseline,1st month and 3rd month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Rating of Change (GROC) | 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. |
| Numeric Rating Scale | 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 |
| The 6-Item Headache Impact Test (HIT-6) | 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. |
| Duration of migraine attacks | Baseline, 1st month and 3rd month | — |
| Analgesic consumption | Baseline, 1st month and 3rd month | — |
| Number of migraine attacks | Baseline, 1st month and 3rd month | — |
Countries
Turkey (Türkiye)
Contacts
Primary ContactTuba Tanyel Saraçoğlu
Outcome results
None listed