Pulsed Radiofrquency Targeting Mid Cervical Medial Branches Versus GON for Cervicogenic Headache

March 5, 2025 updated by: HAAbdelhafeez, Assiut University

Clinical Efficacy of Pulsed Radiofrequency Treatment Targeting the Mid Cervical Medial Branches Versus Greater Occipital Nerve for Cervicogenic Headache

To detect the Clinical efficacy of pulsed radiofrequency treatment targeting the mid cervical medial branches versus greater occipital nerve for cervicogenic headache

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cervicogenic headache (CHA) is one of the secondary headache disorders. The prevalence of CHA was estimated to be ~4.1%, and most of the patients affected by CHA report un-resolved, recurrent throbbing pain.

it has been treated with many treatment modalities, such as the administration of medi-cines, physiotherapy, transcutaneous electrical nerve stimulation, and interventional pro-cedures. However, these treatments do not result in long-term relief for many patients and need to be repeated Pulsed radiofrequency treatment (PRF) is one of the modalities used to treat CHA

. CHA has been known to originate from the convergence of the 3 upper cervical and tri-geminal afferents, and therefore, many physicians have performed PRF targeting the upper cervical structures (occipital nerve, C2 dorsal root ganglion).

However, this results in only short-term pain relief in the posterior head, and it can lead to some complications, such as vascular and nerve injuries. Because of these limitations, we will attempt PRF targeting the mid-cervical medial branches

Study Type

Interventional

Enrollment (Actual)

43

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
        • Tarek

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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. medically stable outpatients with confirmed diagnosis of cervicogenic headache according to International Headache society
  2. Are reliable and willing to make themselves available for the duration of the study and are willing to follow up.
  3. Men or women older than 18years of age .
  4. clear written informed consent from each participant in the trial.

Exclusion Criteria: 1)pregnants, breastfeeding, or willing to be pregnant during the study.

2)presence of clinically significant medical or psychiatric condition that may increase the risk associated with the study 3)participation in any other type of medical research that may interfere with the interpretation of the study.

4)patients with haemocoagulation disorders, local infection or those who refused to consent

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PRF on mid cervical medial branches
first group of patients will be sujected to pulsed radiofrequency on mid cervical medial branches
Device: Radiofrequency on mid cervical medial branches
patients with diagnosis of cervicogenic headache will be subjected to radiofrequency on mid cervical medial branches
Active Comparator: PRF on greater occipital nerve
second group of patients will be subjected to pulsed radiofrequency on Greater occipital nerve
Device: Radiofrequency
patients with diagnosis of cervicogenic headache will be subjected to radiofrequency on Greater occipital nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analog scale (VAS)
Time Frame: 6 months
Assessment of pain will be done using VAS The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
visual analogue scale
Time Frame: 48 hours
48 hours
Visual analogue scale
Time Frame: 3 months
3 months
visual analogue scale
Time Frame: 1 month
1 month
visual analogue scale
Time Frame: 2 weeks
2 weeks
patient satisfactory score
Time Frame: 6 month
6 month

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)

September 1, 2022

Primary Completion (Actual)

November 1, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

March 13, 2022

First Submitted That Met QC Criteria

March 13, 2022

First Posted (Actual)

March 21, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 5, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRF GON vs midcervical in CEH

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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