NCT05289414

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 21, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 7, 2025

Status Verified

March 1, 2025

Enrollment Period

2.2 years

First QC Date

March 13, 2022

Last Update Submit

March 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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."

    6 months

Secondary Outcomes (5)

  • Visual analogue scale

    3 months

  • visual analogue scale

    1 month

  • visual analogue scale

    2 weeks

  • visual analogue scale

    48 hours

  • patient satisfactory score

    6 month

Study Arms (2)

PRF on mid cervical medial branches

ACTIVE COMPARATOR

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

Device: Radiofrequency on mid cervical medial branches

PRF on greater occipital nerve

ACTIVE COMPARATOR

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

Device: Radiofrequency

Interventions

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

PRF on mid cervical medial branches

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

PRF on greater occipital nerve

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tarek

Asyut, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 18031563BACKGROUND
  • 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.

    PMID: 21116663BACKGROUND
  • 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.

    PMID: 24433241BACKGROUND
  • 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.

    PMID: 29765790BACKGROUND

MeSH Terms

Conditions

Post-Traumatic Headache

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
triple blind study (participant ,investigator and outcome assessor) will be masked and will not konw what is the type of treatment patients receive
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: two groups of patients diagnosed with cervicogenic headache Will be randomly subjected to either RF on greater occipital nerve or mid cervical medial branches
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 13, 2022

First Posted

March 21, 2022

Study Start

September 1, 2022

Primary Completion

November 1, 2024

Study Completion

December 31, 2024

Last Updated

March 7, 2025

Record last verified: 2025-03

Locations