Chronic Migraine, HeadacheNCT06247592
Pulse Radiofrequency and Occipital Nerve Block for Chronic Migraine Patients
A study testing Greater occipital nerve block and Greater occipital nerve pulse radiofrequency in people with Chronic Migraine, Headache and Block, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the effect of nerve blockade and radiofrequency treatment applied to the nerve on pain in chronic migraine patients will be investigated. Occipital nerve blockade group (control group): Depending on the location of the pain, blockade will be applied unilaterally or bilaterally with 5 cc of 2% prilocaine… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Migraine, Headache, Block, Occipital Neuralgia
- What is being tested?
- Greater occipital nerve block and Greater occipital nerve pulse radiofrequency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Sep 2023to 10 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients between 18-60 years of age diagnosed with chronic migraine according to IHS criteria
Who cannot join
- Pregnancy
- Major psychiatric disorder
- Bleeding diathesis
- Local infection
- Allergy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Esra Ertilav
Aydin, 09100
Esra ERTİLAV, Assoc. Prof., +905301408950, eertilav@gmail.com
About this study
Official title: Comparison of Greater Occipital Nerve Block and Pulse Radiofrequency in Patients With Chronic Migraine
In this study, the effect of nerve blockade and radiofrequency treatment applied to the nerve on pain in chronic migraine patients will be investigated.
Occipital nerve blockade group (control group): Depending on the location of the pain, blockade will be applied unilaterally or bilaterally with 5 cc of 2% prilocaine for each sıde.
Pulse Radiofrequency application to the greater occipital nerve will be applicated after radiofrequency cannula placed near the greater occipital nerve location with 42 degree, for 240 seconds.
Read the detailed description
Patients between the ages of 18-60 years, who were resistant to medical treatment and diagnosed with chronic migraine according to ICHD-3 beta criteria (migraine pain for more than 15 days in the last 3 months) who applied to the Neurology and Algology outpatient clinic were included in the study.
All procedures were performed with the patient in the prone position, using anatomical landmarks in the target areas. For Gon Blockade, the target point for the greater occipital nerve was identified along a line connecting the external occipital protuberance to the mastoid process (usually 1.5-3 cm lateral to the midline) and one-third of the distance medial to the artery at the level of the superior nuchal process. After local anesthesia with skin-subcutaneous 1% lidocaine, bone contact was obtained using a 25-gauge needle. For Pulse Radiofrequency, the target point for the greater occipital nerve was determined as one third of the distance medial to the artery along a line connecting the external occipital protuberance to the mastoid process (usually 1.5-3 cm lateral to the midline) and at the level of the superior nuchal process. After local anesthesia with skin-subcutaneous 1% lidocaine, a 5 cm long 20 gauge radiofrequency needle with a 5 mm active tip was inserted close to the targeted nerve. Sensory and motor electrical stimulation was performed to elicit a compatible paresthesia response in the occipital distribution. Pulsed radiofrequency was applied at 42 degrees C for 240 seconds. Patients were observed after the procedure. Patients were observed before and after the procedure.
- Conditions
- Chronic Migraine, Headache, Block, Occipital Neuralgia
- Being tested
- Greater occipital nerve block, Greater occipital nerve pulse radiofrequency
- Keywords
- chronic migraine, greater occipital nerve block, pulse radio frequency, pain management
- Medical subject headings
- Headache, Bites and Stings, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Greater occipital nerve blockProcedure or surgery
Pulse Radiofrequency application to the greater occipital nerve will be applicated after radiofrequency cannula placed near the greater occipital nerve location at 42 degree, for 240 seconds.
Greater occipital nerve pulse radiofrequencyProcedure or surgery
The greater occipital nerve will be blocked with 5 cc 2% prilocaine.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency group | Experimental | Pulse radiofrequency will be applied at 42 degrees for 240 seconds with a channel placed near the greater occipital nerve. Receives: Procedure: Greater occipital nerve pulse radiofrequency |
| Block group | Active comparator | Nerve blockade will be applied to the greater occipital nerve with 5 cc 2% prilocaine. Receives: Procedure: Greater occipital nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Relief
Compare the efficacy of blockade procedure applied to the greater occipital nerve with pulse radiofrequency therapy in terms of pain relief with Visual Analog Scale in chronic migraine patients.The visual analog scale (VAS) is numbered from 0 to 10. 10 is the most severe pain 0: no pain at all
Measured: 1 and 3 months
Secondary outcomes (1)
Disability, Quality of life
Compare the efficacy of occipital nerve block with pulse radiofrequency therapy in terms of disability and quality of life with MIDAS (Migraine Disability Assessment) questionnaire win chronic migraine patients. The MIDAS classification is numbered from 0 to 4. 4 means severe disability 0: no disability at all
Measured: 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start26 Sep 2023
- Primary completion10 Mar 2024 (estimated)
- Study completion10 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Migraine, HeadacheStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Ertilav, Aydin Adnan Menderes University
- Investigators
- Esra Ertilav, Principal investigator, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247592
- Sponsor's protocol ID
- 2023/03
- Status last verified
- Feb 2024
- First submitted
- 5 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: YES
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Greater Occipital Nerve Block and Pulse Radiofrequency in Patients With Chronic Migraine
- ClinicalTrials.gov ID
- NCT06247592
- Acronym / sponsor ID
- 2023/03
- Conditions
- Chronic Migraine, Headache, Block, Occipital Neuralgia
- Keywords
- chronic migraine, greater occipital nerve block, pulse radio frequency, pain management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 10 Mar 2024 (estimated)
- Study completion
- 10 Apr 2024 (estimated)
- First posted
- 8 Feb 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.
In this study, the effect of nerve blockade and radiofrequency treatment applied to the nerve on pain in chronic migraine patients will be investigated.
Occipital nerve blockade group (control group): Depending on the location of the pain, blockade will be applied unilaterally or bilaterally with 5 cc of 2% prilocaine for each sıde.
Pulse Radiofrequency application to the greater occipital nerve will be applicated after radiofrequency cannula placed near the greater occipital nerve location with 42 degree, for 240 seconds.
Detailed description
Patients between the ages of 18-60 years, who were resistant to medical treatment and diagnosed with chronic migraine according to ICHD-3 beta criteria (migraine pain for more than 15 days in the last 3 months) who applied to the Neurology and Algology outpatient clinic were included in the study.
All procedures were performed with the patient in the prone position, using anatomical landmarks in the target areas. For Gon Blockade, the target point for the greater occipital nerve was identified along a line connecting the external occipital protuberance to the mastoid process (usually 1.5-3 cm lateral to the midline) and one-third of the distance medial to the artery at the level of the superior nuchal process. After local anesthesia with skin-subcutaneous 1% lidocaine, bone contact was obtained using a 25-gauge needle. For Pulse Radiofrequency, the target point for the greater occipital nerve was determined as one third of the distance medial to the artery along a line connecting the external occipital protuberance to the mastoid process (usually 1.5-3 cm lateral to the midline) and at the level of the superior nuchal process. After local anesthesia with skin-subcutaneous 1% lidocaine, a 5 cm long 20 gauge radiofrequency needle with a 5 mm active tip was inserted close to the targeted nerve. Sensory and motor electrical stimulation was performed to elicit a compatible paresthesia response in the occipital distribution. Pulsed radiofrequency was applied at 42 degrees C for 240 seconds. Patients were observed after the procedure. Patients were observed before and after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency group | Experimental | Procedure: Greater occipital nerve pulse radiofrequencyPulse radiofrequency will be applied at 42 degrees for 240 seconds with a channel placed near the greater occipital nerve. |
| Block group | Active comparator | Procedure: Greater occipital nerve blockNerve blockade will be applied to the greater occipital nerve with 5 cc 2% prilocaine. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients between 18-60 years of age diagnosed with chronic migraine according to IHS criteria
Key exclusion criteria (5 listed)
- Pregnancy
- Major psychiatric disorder
- Bleeding diathesis
- Local infection
- Allergy
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 blockPulse Radiofrequency application to the greater occipital nerve will be applicated after radiofrequency cannula placed near the greater occipital nerve location at 42 degree, for 240 seconds. | Procedure or surgery | Block group |
| Greater occipital nerve pulse radiofrequencyThe greater occipital nerve will be blocked with 5 cc 2% prilocaine. | Procedure or surgery | Radiofrequency group |
Primary outcome
Pain Relief
Time frame: 1 and 3 months
Compare the efficacy of blockade procedure applied to the greater occipital nerve with pulse radiofrequency therapy in terms of pain relief with Visual Analog Scale in chronic migraine patients.The visual analog scale (VAS) is numbered from 0 to 10. 10 is the most severe pain 0: no pain at all
1 secondary outcome
Disability, Quality of life
Time frame: 1 and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: No. YES
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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.
Esra Ertilav principal investigator
Aydin Adnan Menderes University
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 and Greater occipital nerve pulse radiofrequency in people with Chronic Migraine, Headache and Block, run by Aydin Adnan Menderes University 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 1 inclusion and 5 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 8 Feb 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?
Contact Esra Ertilav, Assoc.Prof. (+905301408950, eertilav@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Relief (time frame: 1 and 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 8 Feb 2024.