Proximal and Distal Approach GON RFT in Migraine
Primary Purpose
Migraine Disorders, Headache Migraine Chronic
Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Greater occipital nerve radiofrequency
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Disorders focused on measuring greater occipital nerve block, radiofrequency
Eligibility Criteria
Inclusion Criteria: Primary migraine hedache, first interventional treatment for headache Exclusion Criteria: Preganancy, malignancy
Sites / Locations
- Diskapi Training and Research Hospital
- Dişkapi Reserch and Education Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Proximal block
Distal block
Arm Description
GON block is performed at C2 vertebra level
GON block is performed at occipital protuberence
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05888298
First Posted
February 10, 2023
Last Updated
June 1, 2023
Sponsor
Diskapi Teaching and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05888298
Brief Title
Proximal and Distal Approach GON RFT in Migraine
Official Title
Proximal and Distal Approach GON RFT in Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders, Headache Migraine Chronic
Keywords
greater occipital nerve block, radiofrequency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Proximal block
Arm Type
Active Comparator
Arm Description
GON block is performed at C2 vertebra level
Arm Title
Distal block
Arm Type
Other
Arm Description
GON block is performed at occipital protuberence
Intervention Type
Procedure
Intervention Name(s)
Greater occipital nerve radiofrequency
Intervention Description
Greater nerve block and radiofrequency will be performed at the C2 vertebra level or occipital protuberance
Primary Outcome Measure Information:
Title
The MIDAS (Migraine Disability Assessment) questionnaire
Description
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.
Time Frame
Change from Baseline MIDAS at 3 months
Title
VAS Visual analog scale
Description
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.
Time Frame
Change from Baseline MIDAS at 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Primary migraine hedache, first interventional treatment for headache
Exclusion Criteria:
Preganancy, malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damla Yuruk
Organizational Affiliation
Diskapi TRH
Official's Role
Study Director
Facility Information:
Facility Name
Diskapi Training and Research Hospital
City
Ankara
Country
Turkey
Facility Name
Dişkapi Reserch and Education Hospital
City
Ankara
Country
Turkey
12. IPD Sharing Statement
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Proximal and Distal Approach GON RFT in Migraine
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