Skip to main content
Clinical Trials/NCT05888298
NCT05888298
Active, not recruiting
Not Applicable

Proximal and Distal Approach GON RFT in Migraine

Diskapi Teaching and Research Hospital2 sites in 1 country60 target enrollmentSeptember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Migraine Disorders
Sponsor
Diskapi Teaching and Research Hospital
Enrollment
60
Locations
2
Primary Endpoint
The MIDAS (Migraine Disability Assessment) questionnaire
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2022
End Date
December 28, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Damla Yürük

director

Diskapi Teaching and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • Primary migraine hedache, first interventional treatment for headache

Exclusion Criteria

  • Preganancy, malignancy

Outcomes

Primary Outcomes

The MIDAS (Migraine Disability Assessment) questionnaire

Time Frame: 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

Time Frame: 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.

Study Sites (2)

Loading locations...

Similar Trials