MedDataX Logo

Proximal and Distal Approach GON RFT in Migraine

NCT ID: NCT05888298

Last Updated: 2023-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-12-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Migraine Disorders Headache Migraine Chronic

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

greater occipital nerve block radiofrequency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Proximal block

GON block is performed at C2 vertebra level

Group Type ACTIVE_COMPARATOR

Greater occipital nerve radiofrequency

Intervention Type PROCEDURE

Greater nerve block and radiofrequency will be performed at the C2 vertebra level or occipital protuberance

Distal block

GON block is performed at occipital protuberence

Group Type OTHER

Greater occipital nerve radiofrequency

Intervention Type PROCEDURE

Greater nerve block and radiofrequency will be performed at the C2 vertebra level or occipital protuberance

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Greater occipital nerve radiofrequency

Greater nerve block and radiofrequency will be performed at the C2 vertebra level or occipital protuberance

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Primary migraine hedache, first interventional treatment for headache

Exclusion Criteria

* Preganancy, malignancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Diskapi Teaching and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Damla Yürük

director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Damla Yuruk

Role: STUDY_DIRECTOR

Diskapi TRH

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Diskapi Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Dişkapi Reserch and Education Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GONRFT

Identifier Type: -

Identifier Source: org_study_id