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Radiofrquency Targeting Mid Cervical Medial Branches vs GON in Cervicogenic Headache

Primary Purpose

Cervicogenic Headache

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Radiofrequency
Greater occipital nerve block
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervicogenic Headache

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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). bilateral migraine headache

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Radiofrequency

    Greater occipital nerve vlock

    Arm Description

    first group of patients will be sujected to radiofrequency treatment

    second group of patients will be sujected to Greater occipital nerve block

    Outcomes

    Primary Outcome Measures

    visual analog scale (VAS)
    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."

    Secondary Outcome Measures

    Full Information

    First Posted
    March 13, 2022
    Last Updated
    July 1, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05289414
    Brief Title
    Radiofrquency Targeting Mid Cervical Medial Branches vs GON in 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

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2022 (Anticipated)
    Primary Completion Date
    December 1, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervicogenic Headache

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    two groups of patients diagnosed with cervicogenic headache Will be randomly subjected to either RF or greater occipital nerve block
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Masking Description
    triple blind study (participant ,investigator and outcome assessor) will be masked and will not konw what is the type of treatment patients receive
    Allocation
    Randomized
    Enrollment
    42 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Radiofrequency
    Arm Type
    Active Comparator
    Arm Description
    first group of patients will be sujected to radiofrequency treatment
    Arm Title
    Greater occipital nerve vlock
    Arm Type
    Active Comparator
    Arm Description
    second group of patients will be sujected to Greater occipital nerve block
    Intervention Type
    Device
    Intervention Name(s)
    Radiofrequency
    Intervention Description
    patients with diagnosis of cervicogenic headache will be subjected to radiofrequency treatment
    Intervention Type
    Procedure
    Intervention Name(s)
    Greater occipital nerve block
    Intervention Description
    patients with diagnosis of cervicogenic headache will be subjected to Greater occipital nerve block
    Primary Outcome Measure Information:
    Title
    visual analog scale (VAS)
    Description
    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."
    Time Frame
    10 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: medically stable outpatients with confirmed diagnosis of cervicogenic headache according to International Headache society Are reliable and willing to make themselves available for the duration of the study and are willing to follow up. Men or women older than 18years of age . 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). bilateral migraine headache 5)patients with haemocoagulation disorders, local infection or those who refused to consent
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tarek Ali Rageh
    Phone
    01010077712
    Email
    tarekrageh@aun.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed Ahmed Abdelhameed
    Phone
    01002629734
    Email
    moh78_abdelhamed@aun.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    18031563
    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.
    Results Reference
    background
    PubMed Identifier
    21116663
    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.
    Results Reference
    background
    PubMed Identifier
    24433241
    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.
    Results Reference
    background
    PubMed Identifier
    29765790
    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.
    Results Reference
    background

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    Radiofrquency Targeting Mid Cervical Medial Branches vs GON in Cervicogenic Headache

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