Clinical trial NCT05289414: Pulsed Radiofrquency Targeting Mid Cervical Medial Branches Versus GON for Cervicogenic Headache
Official title: Clinical Efficacy of Pulsed Radiofrequency Treatment Targeting the Mid Cervical Medial Branches Versus Greater Occipital Nerve for Cervicogenic Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervicogenic Headache
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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

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

Eligibility criteria: 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

Primary outcomes:
measure: visual analog scale (VAS)
timeFrame: 6 months
Secondary outcomes:
measure: Visual analogue scale
timeFrame: 3 months
measure: visual analogue scale
timeFrame: 1 month
measure: visual analogue scale
timeFrame: 2 weeks
measure: visual analogue scale
timeFrame: 48 hours
measure: patient satisfactory score
timeFrame: 6 month
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Tarek
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.