Proximal and Distal Approach GON RFT in Migraine

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Migraine Disorders; Headache Migraine Chronic
• Intervention / Treatment: Procedure: Greater occipital nerve radiofrequency

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Dişkapi Reserch and Education Hospital
  • Ankara, Turkey
    • Diskapi Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Primary migraine hedache, first interventional treatment for headache

Exclusion Criteria:

• Preganancy, malignancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Proximal block; GON block is performed at C2 vertebra level	Procedure: Greater occipital nerve radiofrequency; Greater nerve block and radiofrequency will be performed at the C2 vertebra level or occipital protuberance
Other: Distal block; GON block is performed at occipital protuberence	Procedure: Greater occipital nerve radiofrequency; Greater nerve block and radiofrequency will be performed at the C2 vertebra level or occipital protuberance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The MIDAS (Migraine Disability Assessment) questionnaire	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.	Change from Baseline MIDAS at 3 months
VAS Visual analog scale	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.	Change from Baseline MIDAS at 3 months

Collaborators and Investigators

• Sponsor: Diskapi Teaching and Research Hospital
• Investigators: Study Director: Damla Yuruk, Diskapi TRH

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): December 22, 2023
• Study Completion (Estimated): December 28, 2023

Study Registration Dates

• First Submitted: February 10, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: radiofrequency; greater occipital nerve block
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: GONRFT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No