MigraineGON-B/PRFNCT06345326
Greater Occipital Nerve Block Versus Pulse Radiofrequency in Migraine
A study testing Greater occipital nerve block in people with Migraine, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to evaluate the clinical efficacy of the repeated greater occipital nerve(GON) blokcs with GON pulse radiofreaquency (PRF) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Greater occipital nerve block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2023to 30 Apr 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICHD- migraine with minimum 4 attacks
- no benefit with proflactic therapies
Who cannot join
- primary headhache other than migraine according to ICHD
- the change of medical teatment of migrane in last 1 month.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara City Hospital Bilkent
Ankara, 06680
Sukriye Dadali, MD, +905333316636, sukriyedadali@gmail.com
About this study
Official title: Comparison of the Clinical Effectiveness of Repeated Ultrasound-guided Greater Occipital Nerve Blocks and Greater Occipital Nerve Pulse RF in the Treatment of Migraine
The aim of the study is to evaluate the clinical efficacy of the repeated greater occipital nerve(GON) blokcs with GON pulse radiofreaquency (PRF)
Read the detailed description
The nerve blocks will be performed at the Cervical-2 (C2) level with ultrasound guidance.Also , the PRF will be done as above proximally.
- Conditions
- Migraine
- Being tested
- Greater occipital nerve block
- Keywords
- migraine, greater occipital nerve block, pulse radiofrequency
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Greater occipital nerve blockOther
Also called Pulse radiofrequency
The nerve block will be done by ultrasound guidiance at the C2 level with a 22 gauge 5 cm needle inplane direction. The pulse radiofrequency will be done as defined with a radiofrequency cannula- 5 cm with an active tip of 2mm.
| Study group | Role | What they receive |
|---|---|---|
| Repeated greater occipital nerve block | Experimental | In this arm, all the participiants will receive ultrasound guided greater occipital nerve block for a week, for 4 weeks with ultrasound guidiance at the level C2 Receives: Other: Greater occipital nerve block |
| Greater occipital nerve pulse radiofrequency | Experimental | In this arm, all the participiants will receive ultrasound guided greater occipital nerve pulse radiofrequency with ultrasound guidiance at the level C2 Receives: Other: Greater occipital nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS
Numeric rating scala
Measured: Before the application then every month following the intervention for 3 months
Secondary outcomes (2)
Complications
vertigo, dizzines, hypotension , bleeding, local pain ect.
Measured: Before the application then every month following the intervention for 3 months
the frequency of headhache
how many times the headhache occured
Measured: Before the application then every month following the intervention for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start15 Jan 2023
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective observational
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara City Hospital Bilkent
- Responsible party
- Principal investigator, Dr. Ülkü Sabuncu, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345326
- Sponsor's protocol ID
- E1-22-3155
- Acronym
- GON-B/PRF
- Status last verified
- Mar 2024
- First submitted
- 27 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical Effectiveness of Repeated Ultrasound-guided Greater Occipital Nerve Blocks and Greater Occipital Nerve Pulse RF in the Treatment of Migraine
- ClinicalTrials.gov ID
- NCT06345326
- Acronym / sponsor ID
- GON-B/PRF / E1-22-3155
- Conditions
- Migraine
- Keywords
- migraine, greater occipital nerve block, pulse radiofrequency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Collaborators
- Ankara City Hospital Bilkent
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 3 Apr 2024 (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.
The aim of the study is to evaluate the clinical efficacy of the repeated greater occipital nerve(GON) blokcs with GON pulse radiofreaquency (PRF)
Detailed description
The nerve blocks will be performed at the Cervical-2 (C2) level with ultrasound guidance.Also , the PRF will be done as above proximally.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective observational
| Arm | Type | Receives |
|---|---|---|
| Repeated greater occipital nerve block | Experimental | Other: Greater occipital nerve blockIn this arm, all the participiants will receive ultrasound guided greater occipital nerve block for a week, for 4 weeks with ultrasound guidiance at the level C2 |
| Greater occipital nerve pulse radiofrequency | Experimental | Other: Greater occipital nerve blockIn this arm, all the participiants will receive ultrasound guided greater occipital nerve pulse radiofrequency with ultrasound guidiance at the level C2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ICHD- migraine with minimum 4 attacks
- no benefit with proflactic therapies
Key exclusion criteria (2 listed)
- primary headhache other than migraine according to ICHD
- the change of medical teatment of migrane in last 1 month.
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 |
|---|---|---|
| Greater occipital nerve blockAlso: Pulse radiofrequencyThe nerve block will be done by ultrasound guidiance at the C2 level with a 22 gauge 5 cm needle inplane direction. The pulse radiofrequency will be done as defined with a radiofrequency cannula- 5 cm with an active tip of 2mm. | Other | Greater occipital nerve pulse radiofrequency, Repeated greater occipital nerve block |
Primary outcome
NRS
Time frame: Before the application then every month following the intervention for 3 months
Numeric rating scala
2 secondary outcomes
Complications
Time frame: Before the application then every month following the intervention for 3 months
the frequency of headhache
Time frame: Before the application then every month following the intervention for 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Greater occipital nerve block in people with Migraine, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 3 Apr 2024. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS (time frame: Before the application then every month following the intervention for 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2024.