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

NCT ID: NCT05289414

Last Updated: 2025-03-07

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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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

Conditions

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Cervicogenic Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two groups of patients diagnosed with cervicogenic headache Will be randomly subjected to either RF on greater occipital nerve or mid cervical medial branches
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
triple blind study (participant ,investigator and outcome assessor) will be masked and will not konw what is the type of treatment patients receive

Study Groups

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PRF on mid cervical medial branches

first group of patients will be sujected to pulsed radiofrequency on mid cervical medial branches

Group Type ACTIVE_COMPARATOR

Radiofrequency on mid cervical medial branches

Intervention Type DEVICE

patients with diagnosis of cervicogenic headache will be subjected to radiofrequency on mid cervical medial branches

PRF on greater occipital nerve

second group of patients will be subjected to pulsed radiofrequency on Greater occipital nerve

Group Type ACTIVE_COMPARATOR

Radiofrequency

Intervention Type DEVICE

patients with diagnosis of cervicogenic headache will be subjected to radiofrequency on Greater occipital nerve

Interventions

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Radiofrequency on mid cervical medial branches

patients with diagnosis of cervicogenic headache will be subjected to radiofrequency on mid cervical medial branches

Intervention Type DEVICE

Radiofrequency

patients with diagnosis of cervicogenic headache will be subjected to radiofrequency on Greater occipital nerve

Intervention Type DEVICE

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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HAAbdelhafeez

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tarek

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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Sjaastad O, Bakketeig LS. Prevalence of cervicogenic headache: Vaga study of headache epidemiology. Acta Neurol Scand. 2008 Mar;117(3):173-80. doi: 10.1111/j.1600-0404.2007.00962.x. Epub 2007 Nov 20.

Reference Type BACKGROUND
PMID: 18031563 (View on PubMed)

Chua NH, Vissers KC, Sluijter ME. Pulsed radiofrequency treatment in interventional pain management: mechanisms and potential indications-a review. Acta Neurochir (Wien). 2011 Apr;153(4):763-71. doi: 10.1007/s00701-010-0881-5. Epub 2010 Nov 30.

Reference Type BACKGROUND
PMID: 21116663 (View on PubMed)

Hamer JF, Purath TA. Response of cervicogenic headaches and occipital neuralgia to radiofrequency ablation of the C2 dorsal root ganglion and/or third occipital nerve. Headache. 2014 Mar;54(3):500-10. doi: 10.1111/head.12295. Epub 2014 Jan 16.

Reference Type BACKGROUND
PMID: 24433241 (View on PubMed)

Palea O, Andar HM, Lugo R, Granville M, Jacobson RE. Direct Posterior Bipolar Cervical Facet Radiofrequency Rhizotomy: A Simpler and Safer Approach to Denervate the Facet Capsule. Cureus. 2018 Mar 14;10(3):e2322. doi: 10.7759/cureus.2322.

Reference Type BACKGROUND
PMID: 29765790 (View on PubMed)

Other Identifiers

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PRF GON vs midcervical in CEH

Identifier Type: -

Identifier Source: org_study_id

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