Greater Occipital Nerve Pulsed Radiofrequency for the Treatment of Combined Migraine and Cervicogenic Headache (New Approach)

November 6, 2023 updated by: Ghada Mohammed AboelFadl, Assiut University

Greater Occipital Nerve Pulsed Radiofrequency for the Treatment of Combined Migraine and Cervicogenic Headache (New Approach): Randomized Clinical Trial

Combined migraine and cervicogenic headache present significant challenges in clinical management due to their complex and overlapping pathophysiologies. Both conditions involve the trigeminocervical complex, suggesting a potential shared anatomical and neurobiological basis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Traditional treatment approaches for these headaches often include pharmacological interventions, but in cases of refractory or inadequate response, interventional techniques targeting the greater occipital nerve (GON) have gained attention.

Radiofrequency ablation (RFA) has gained recognition as a potential therapeutic option for patients with refractory combined migraine and cervicogenic headaches. The proximal and distal ultrasound-guided approaches are widely utilized for GON RFA. These approaches aim to disrupt pain signals transmitted by the GON and provide relief of pain for these headache disorders

Study Type

Interventional

Enrollment (Actual)

60

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

  • Egypt
      • Assiut, Egypt, 715715
        • Assiut governorate

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:

  • Patients diagnosed with combined migraine and cervicogenic headache according to The International Classification of Headache Disorders (ICHD)
  • Age between 18 and 65 years.
  • Willingness to participate and provide informed consent

Exclusion Criteria:

  • Previous neurosurgical procedures for headache management.
  • Patients with contraindications for the RF technique
  • Pregnancy or lactation
  • History of psychiatric disorders or substance abuse

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Proximal group
proximal ultrasound-guided GON radiofrequency ablation
Procedure: proximal ultrasound-guided GON radiofrequency ablation
proximal GON radiofrequency
Experimental: Distal group
distal ultrasound-guided GON radiofrequency ablation
Procedure: distal ultrasound-guided GON radiofrequency ablation
distal GON radiofrequency

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical rating score
Time Frame: baseline and at follow-up visits (2 weeks.1, 2.3, and 6 months)
0-10 scale, with 0 indicating no pain and 10 indicating the worst possible pain.
baseline and at follow-up visits (2 weeks.1, 2.3, and 6 months)

Collaborators and Investigators

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

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 1, 2022

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

November 2, 2023

First Submitted That Met QC Criteria

November 2, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Estimated)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GON RF

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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