Cervicogenic HeadacheNCT05289414
Pulsed Radiofrquency Targeting Mid Cervical Medial Branches Versus GON for Cervicogenic Headache
A study testing Radiofrequency on mid cervical medial branches and Radiofrequency in people with Cervicogenic Headache, run by Assiut University at 1 site in Egypt.
Trial summary
To detect the Clinical efficacy of pulsed radiofrequency treatment targeting the mid cervical medial branches versus greater occipital nerve for cervicogenic headache Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Radiofrequency on mid cervical medial branches and Radiofrequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)patients with haemocoagulation disorders, local infection or those who refused to consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Cervicogenic Headache
- Being tested
- Radiofrequency on mid cervical medial branches, Radiofrequency
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency on mid cervical medial branchesDevice
patients with diagnosis of cervicogenic headache will be subjected to radiofrequency on mid cervical medial branches
RadiofrequencyDevice
patients with diagnosis of cervicogenic headache will be subjected to radiofrequency on Greater occipital nerve
| Study group | Role | What they receive |
|---|---|---|
| PRF on mid cervical medial branches | Active comparator | first group of patients will be sujected to pulsed radiofrequency on mid cervical medial branches Receives: 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 Receives: Device: Radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 6 months
Secondary outcomes (5)
Visual analogue scale
Measured: 3 months
visual analogue scale
Measured: 1 month
visual analogue scale
Measured: 2 weeks
visual analogue scale
Measured: 48 hours
patient satisfactory score
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start1 Sep 2022
- Primary completion1 Nov 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HAAbdelhafeez, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289414
- Sponsor's protocol ID
- PRF GON vs midcervical in CEH
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2022
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 18031563Chua 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.
PubMed 21116663Hamer 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.
PubMed 24433241Palea 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.
PubMed 29765790
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Pulsed Radiofrequency Treatment Targeting the Mid Cervical Medial Branches Versus Greater Occipital Nerve for Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT05289414
- Acronym / sponsor ID
- PRF GON vs midcervical in CEH
- Conditions
- Cervicogenic Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| PRF on mid cervical medial branches | Active comparator | Device: Radiofrequency on mid cervical medial branchesfirst group of patients will be sujected to pulsed radiofrequency on mid cervical medial branches |
| PRF on greater occipital nerve | Active comparator | Device: Radiofrequencysecond group of patients will be subjected to pulsed radiofrequency on Greater occipital nerve |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency on mid cervical medial branchespatients with diagnosis of cervicogenic headache will be subjected to radiofrequency on mid cervical medial branches | Device | PRF on mid cervical medial branches |
| Radiofrequencypatients with diagnosis of cervicogenic headache will be subjected to radiofrequency on Greater occipital nerve | Device | PRF on greater occipital nerve |
Primary outcome
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."
5 secondary outcomes
Visual analogue scale
Time frame: 3 months
visual analogue scale
Time frame: 1 month
visual analogue scale
Time frame: 2 weeks
visual analogue scale
Time frame: 48 hours
patient satisfactory score
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Background: PubMed 18031563Sjaastad 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.
- Background: PubMed 21116663Chua 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.
- Background: PubMed 24433241Hamer 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.
- Background: PubMed 29765790Palea 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency on mid cervical medial branches and Radiofrequency in people with Cervicogenic Headache, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analog scale (VAS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05289414, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.