Proximal and Distal Approach GON RFT in Migraine

Sponsor
Diskapi Teaching and Research Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05888298
Collaborator
(none)
60
2
2
12.9
30
2.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Greater occipital nerve radiofrequency
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Proximal and Distal Approach GON RFT in Migraine
Actual Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 28, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Primary migraine hedache, first interventional treatment for headache
Exclusion Criteria:
  • Preganancy, malignancy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Diskapi Training and Research Hospital Ankara Turkey
2 Dişkapi Reserch and Education Hospital Ankara Turkey

Sponsors and Collaborators

  • Diskapi Teaching and Research Hospital

Investigators

  • Study Director: Damla Yuruk, Diskapi TRH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Damla Yürük, director, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier:
NCT05888298
Other Study ID Numbers:
  • GONRFT
First Posted:
Jun 5, 2023
Last Update Posted:
Jun 5, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Damla Yürük, director, Diskapi Teaching and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 5, 2023