Greater Occipital Nerve Block Versus Pulse Radiofrequency in Migraine (GON-B/PRF)

April 2, 2024 updated by: Dr. Ülkü Sabuncu, Adiyaman University Research Hospital

Comparison of the Clinical Effectiveness of Repeated Ultrasound-guided Greater Occipital Nerve Blocks and Greater Occipital Nerve Pulse RF in the Treatment of Migraine

The aim of the study is to evaluate the clinical efficacy of the repeated greater occipital nerve(GON) blokcs with GON pulse radiofreaquency (PRF)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The nerve blocks will be performed at the Cervical-2 (C2) level with ultrasound guidance.Also , the PRF will be done as above proximally.

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06680
        • Recruiting
        • Ankara City Hospital Bilkent
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ICHD- migraine with minimum 4 attacks
  • no benefit with proflactic therapies

Exclusion Criteria:

  • primary headhache other than migraine according to ICHD
  • the change of medical teatment of migrane in last 1 month.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Repeated greater occipital nerve block
In this arm, all the participiants will receive ultrasound guided greater occipital nerve block for a week, for 4 weeks with ultrasound guidiance at the level C2
Other: Greater occipital nerve block
The nerve block will be done by ultrasound guidiance at the C2 level with a 22 gauge 5 cm needle inplane direction. The pulse radiofrequency will be done as defined with a radiofrequency cannula- 5 cm with an active tip of 2mm.
Other Names:
  • Pulse radiofrequency
Experimental: Greater occipital nerve pulse radiofrequency
In this arm, all the participiants will receive ultrasound guided greater occipital nerve pulse radiofrequency with ultrasound guidiance at the level C2
Other: Greater occipital nerve block
The nerve block will be done by ultrasound guidiance at the C2 level with a 22 gauge 5 cm needle inplane direction. The pulse radiofrequency will be done as defined with a radiofrequency cannula- 5 cm with an active tip of 2mm.
Other Names:
  • Pulse radiofrequency

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NRS
Time Frame: Before the application then every month following the intervention for 3 months
Numeric rating scala
Before the application then every month following the intervention for 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: Before the application then every month following the intervention for 3 months
vertigo, dizzines, hypotension , bleeding, local pain ect.
Before the application then every month following the intervention for 3 months
the frequency of headhache
Time Frame: Before the application then every month following the intervention for 3 months
how many times the headhache occured
Before the application then every month following the intervention for 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adiyaman University Research Hospital

Collaborators

Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2023

Primary Completion (Estimated)

March 30, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

March 27, 2024

First Submitted That Met QC Criteria

April 2, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E1-22-3155

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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