Proximal and Distal Approach GON RFT in Migraine

Not Applicable

Active, not recruiting

• Conditions: Headache Migraine Chronic; Migraine Disorders
• Interventions: Procedure: Greater occipital nerve radiofrequency

• Registration Number: NCT05888298
• Lead Sponsor: Diskapi Teaching and Research Hospital

Brief Summary

Greater occipital nerve pulsed radiofrequency therapy is used in the treatment of migraine. This method is applied at the level of the proximal c2 vertebra and by approaching the nerve from the distal 1/3 medial of the occipital protuberant. The investigators aimed to compare the effectiveness of these two methods.

Detailed Description

Greater occipital nerve (GON) pulsed radiofrequency application is used in migraine headaches. The procedure is applied by approaching the occipital nerve trace with a radiofrequency needle, giving a pulsed radiofrequency current for 4 minutes, and then injecting 2.5 cc bupivacaine and saline. There are two types of applications. In the proximal/central approach, the injection is administered to the occipital nerve between the semispinalis capitis muscle and the obliquus capitis inferior, under ultrasound guidance, while in the distal approach, it is administered 1/3 cm medial to the occipital protuberant with a blind technique.

The investigators aim to compare the treatment response at 1 and 3 months between two patient groups treated with both methods. For this purpose, The investigators planned to follow up with 60 patients. GON RF will be performed with a proximal approach to half of the patients and a distal approach to the other half. Pain levels will be measured on the Visual Analogue Scale (VAS) in the 1st and 3rd months after the procedure. Migraine Disability Index (MIDAS) will be applied to the patients in the 1st week and 3rd month after the procedure. Thus, it will be determined whether there is a difference between the approaches in terms of pain palliation.

Patients who have undergone the procedure will be found from their file records and called by phone, when they come to the control, face to face and 1-3. In the months, the scales will be filled by calling by phone.

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2023-02-10
• Study First Submitted QC: 2023-06-01
• Study First Posted: 2023-06-05
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-21
• Primary Completion: 2023-12-22
• Last Update Posted: 2023-12-22
• Study Completion: 2023-12-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Primary migraine hedache, first interventional treatment for headache

Exclusion Criteria

• Preganancy, malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proximal block	Greater occipital nerve radiofrequency	GON block is performed at C2 vertebra level
Distal block	Greater occipital nerve radiofrequency	GON block is performed at occipital protuberence

Primary Outcome Measures

Name	Time	Method
The MIDAS (Migraine Disability Assessment) questionnaire	Change from Baseline MIDAS at 3 months	The MIDAS (Migraine Disability Assessment) questionnaire was put together to help you measure the impact the headaches. The information on this questionnaire is also helpful the primary care provider to determine the level of pain and disability caused by your headaches.
VAS Visual analog scale	Change from Baseline MIDAS at 3 months	Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control.

Trial Locations

Locations (2)

Dişkapi Reserch and Education Hospital; 🇹🇷 Ankara, Turkey

Diskapi Training and Research Hospital; 🇹🇷 Ankara, Turkey