Greater Occipital NerveNCT06121037
Greater Occipital Nerve Pulsed Radiofrequency for the Treatment of Combined Migraine and Cervicogenic Headache (New Approach)
A study testing proximal ultrasound-guided GON radiofrequency ablation and distal ultrasound-guided GON radiofrequency ablation in people with Greater Occipital Nerve and Pulsed Radiofrequency, run by Assiut University at 1 site in Egypt.
Trial summary
Combined migraine and cervicogenic headache present significant challenges in clinical management due to their complex and overlapping pathophysiologies. Both conditions involve the trigeminocervical complex, suggesting a potential shared anatomical and neurobiological basis Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Greater Occipital Nerve, Pulsed Radiofrequency
- What is being tested?
- proximal ultrasound-guided GON radiofrequency ablation and distal ultrasound-guided GON radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Sep 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with combined migraine and cervicogenic headache according to The International Classification of Headache Disorders (ICHD)
- Age between 18 and 65 years.
- Willingness to participate and provide informed consent
Who cannot join
- Previous neurosurgical procedures for headache management.
- Patients with contraindications for the RF technique
- Pregnancy or lactation
- History of psychiatric disorders or substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Greater Occipital Nerve Pulsed Radiofrequency for the Treatment of Combined Migraine and Cervicogenic Headache (New Approach): Randomized Clinical Trial
Combined migraine and cervicogenic headache present significant challenges in clinical management due to their complex and overlapping pathophysiologies. Both conditions involve the trigeminocervical complex, suggesting a potential shared anatomical and neurobiological basis
Read the detailed description
Traditional treatment approaches for these headaches often include pharmacological interventions, but in cases of refractory or inadequate response, interventional techniques targeting the greater occipital nerve (GON) have gained attention.
Radiofrequency ablation (RFA) has gained recognition as a potential therapeutic option for patients with refractory combined migraine and cervicogenic headaches. The proximal and distal ultrasound-guided approaches are widely utilized for GON RFA. These approaches aim to disrupt pain signals transmitted by the GON and provide relief of pain for these headache disorders
- Conditions
- Greater Occipital Nerve, Pulsed Radiofrequency
- Being tested
- proximal ultrasound-guided GON radiofrequency ablation, distal ultrasound-guided GON radiofrequency ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proximal ultrasound-guided GON radiofrequency ablationProcedure or surgery
proximal GON radiofrequency
distal ultrasound-guided GON radiofrequency ablationProcedure or surgery
distal GON radiofrequency
| Study group | Role | What they receive |
|---|---|---|
| Proximal group | Experimental | proximal ultrasound-guided GON radiofrequency ablation Receives: Procedure: proximal ultrasound-guided GON radiofrequency ablation |
| Distal group | Experimental | distal ultrasound-guided GON radiofrequency ablation Receives: Procedure: distal ultrasound-guided GON radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical rating score
0-10 scale, with 0 indicating no pain and 10 indicating the worst possible pain.
Measured: baseline and at follow-up visits (2 weeks.1, 2.3, and 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Jan 2022
- Primary completion1 Aug 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Greater Occipital NerveStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Mohammed AboelFadl, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121037
- Sponsor's protocol ID
- GON RF
- Status last verified
- Nov 2023
- First submitted
- 2 Nov 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Batistaki C, Madi AI, Karakosta A, Kostopanagiotou G, Arvaniti C. Pulsed Radiofrequency of the Occipital Nerves: Results of a Standardized Protocol on Chronic Headache Management. Anesth Pain Med. 2021 Oct 6;11(5):e112235. doi: 10.5812/aapm.112235. eCollection 2021 Oct.
PubMed 35075408Cohen SP, Peterlin BL, Fulton L, Neely ET, Kurihara C, Gupta A, Mali J, Fu DC, Jacobs MB, Plunkett AR, Verdun AJ, Stojanovic MP, Hanling S, Constantinescu O, White RL, McLean BC, Pasquina PF, Zhao Z. Randomized, double-blind, comparative-effectiveness study comparing pulsed radiofrequency to steroid injections for occipital neuralgia or migraine with occipital nerve tenderness. Pain. 2015 Dec;156(12):2585-2594. doi: 10.1097/j.pain.0000000000000373.
PubMed 26447705
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Greater Occipital Nerve Pulsed Radiofrequency for the Treatment of Combined Migraine and Cervicogenic Headache (New Approach): Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06121037
- Acronym / sponsor ID
- GON RF
- Conditions
- Greater Occipital Nerve, Pulsed Radiofrequency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 7 Nov 2023 (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.
Combined migraine and cervicogenic headache present significant challenges in clinical management due to their complex and overlapping pathophysiologies. Both conditions involve the trigeminocervical complex, suggesting a potential shared anatomical and neurobiological basis
Detailed description
Traditional treatment approaches for these headaches often include pharmacological interventions, but in cases of refractory or inadequate response, interventional techniques targeting the greater occipital nerve (GON) have gained attention.
Radiofrequency ablation (RFA) has gained recognition as a potential therapeutic option for patients with refractory combined migraine and cervicogenic headaches. The proximal and distal ultrasound-guided approaches are widely utilized for GON RFA. These approaches aim to disrupt pain signals transmitted by the GON and provide relief of pain for these headache disorders
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proximal group | Experimental | Procedure: proximal ultrasound-guided GON radiofrequency ablationproximal ultrasound-guided GON radiofrequency ablation |
| Distal group | Experimental | Procedure: distal ultrasound-guided GON radiofrequency ablationdistal ultrasound-guided GON radiofrequency ablation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with combined migraine and cervicogenic headache according to The International Classification of Headache Disorders (ICHD)
- Age between 18 and 65 years.
- Willingness to participate and provide informed consent
Key exclusion criteria (4 listed)
- Previous neurosurgical procedures for headache management.
- Patients with contraindications for the RF technique
- Pregnancy or lactation
- History of psychiatric disorders or substance abuse
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 |
|---|---|---|
| proximal ultrasound-guided GON radiofrequency ablationproximal GON radiofrequency | Procedure or surgery | Proximal group |
| distal ultrasound-guided GON radiofrequency ablationdistal GON radiofrequency | Procedure or surgery | Distal group |
Primary outcome
Numerical rating score
Time frame: baseline and at follow-up visits (2 weeks.1, 2.3, and 6 months)
0-10 scale, with 0 indicating no pain and 10 indicating the worst possible pain.
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 8 Nov 2023.
- Background: PubMed 35075408Batistaki C, Madi AI, Karakosta A, Kostopanagiotou G, Arvaniti C. Pulsed Radiofrequency of the Occipital Nerves: Results of a Standardized Protocol on Chronic Headache Management. Anesth Pain Med. 2021 Oct 6;11(5):e112235. doi: 10.5812/aapm.112235. eCollection 2021 Oct.
- Background: PubMed 26447705Cohen SP, Peterlin BL, Fulton L, Neely ET, Kurihara C, Gupta A, Mali J, Fu DC, Jacobs MB, Plunkett AR, Verdun AJ, Stojanovic MP, Hanling S, Constantinescu O, White RL, McLean BC, Pasquina PF, Zhao Z. Randomized, double-blind, comparative-effectiveness study comparing pulsed radiofrequency to steroid injections for occipital neuralgia or migraine with occipital nerve tenderness. Pain. 2015 Dec;156(12):2585-2594. doi: 10.1097/j.pain.0000000000000373.
- 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 proximal ultrasound-guided GON radiofrequency ablation and distal ultrasound-guided GON radiofrequency ablation in people with Greater Occipital Nerve and Pulsed Radiofrequency, 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 3 inclusion and 4 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 8 Nov 2023. 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?
Numerical rating score (time frame: baseline and at follow-up visits (2 weeks.1, 2.3, and 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 NCT06121037, which also lists 2 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 8 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.