Study Results
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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NOT_YET_RECRUITING
NA
460 participants
INTERVENTIONAL
2025-09-15
2026-12-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GON Block Group
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
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
Eligibility Criteria
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Inclusion 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Umraniye Education and Research Hospital
OTHER_GOV
Gaziantep City Hospital
OTHER
Namik Kemal University School of Medicine, Tekirdag
OTHER
Bakırçay University, Faculty of Medicine
UNKNOWN
Başakşehir Çam & Sakura City Hospital
OTHER_GOV
Responsible Party
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Tuba Tanyel Saraçoğlu
Medical Doctor
Locations
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Başakşehir Çam and Sakura City Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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25.06.2025.242
Identifier Type: -
Identifier Source: org_study_id
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