MigraineNCT06243874
Comparison of Occipital Nerve and Sphenopalatine Ganglion Blockade
A study testing greater occipital nerve block and transnasal sphenopalatine ganglion block in people with Migraine, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Migraine is a chronic disorder that causes disability. Episodic migraine can be managed by prophylactic medical treatment or interventional pain procedures. Interventional methods used in migraine treatment are greater occipital nerve blockade, lesser occipital nerve blockade, supraorbital nerve blockade, infraorbital… 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 and transnasal sphenopalatine ganglion block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Jan 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
- Patients aged 18-65
- Diagnosing migraine according to the International Classification of Headache Disorders 3rd version (ICHD-3) criteria
- Patients diagnosed with episodic migraine
- Failure to provide pain palliation with at least 1 prophylactic medication
Who cannot join
- Presence of psychiatric disease that is unstable/not controlled by medical treatment
- Pregnant patients
- Those with bleeding diathesis
- Patients who are allergic to local anesthetics given during the procedure
- Patients with open skull defects who have undergone craniotomy
- Patients with previous nasal/sinus surgery
Show all 9Show fewer
- Patients with medication overuse headaches
- Presence of causes such as hypertension, vasculitis, malignancy, etc. that may cause headaches
- Patients who have received interventional headache treatment in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Greater Occipital Nerve Blockade and Sphenopalatine Ganglion Blockade in Patients With Episodic Migraine
Migraine is a chronic disorder that causes disability. Episodic migraine can be managed by prophylactic medical treatment or interventional pain procedures. Interventional methods used in migraine treatment are greater occipital nerve blockade, lesser occipital nerve blockade, supraorbital nerve blockade, infraorbital nerve blockade, sphenopalatine ganglion blockade, botulinum toxin injection and various radiofrequency applications. The effectiveness of greater occipital nerve blockade and transnasal sphenopalatine ganglion blockade in the treatment of migraine has been proven in various studies.We aimed to evaluate the effects of repetitive greater occipital nerve blockade and transnasal sphenopalatine ganglion blockade in patients with episodic migraine.
Read the detailed description
Migraine is a common primary headache and causes a significant personal, social and financial burden. Migraine is characterized by a semi-headache lasting 4-72 hours, accompanied by nausea/vomiting and photophobia/phonophobia. Migraine can be episodic or chronic. Non-steroidal anti-inflammatory drugs, triptan and ergotamine derivatives can be used in the treatment of acute migraine attacks. Beta-blockers, calcium channel blockers, antiepileptic drugs and antidepressant drugs are among the prophylactic medical treatments. When medical treatment cannot provide adequate pain palliation, in case of side effects or when the patient does not prefer medical treatment, interventional methods come to the fore. Interventional methods that applied in migraine treatment are greater occipital nerve blockade, lesser occipital nerve blockade, supraorbital nerve blockade, infraorbital nerve blockade, sphenopalatine ganglion blockade, botulinum toxin injection and various radiofrequency applications. The effectiveness of greater occipital nerve blockade and transnasal sphenopalatine ganglion blockade in the treatment of migraine has been proven in various studies.
It is stated that sphenopalatine ganglion blockade reduces the number of headache days and is effective in the treatment of acute migraine attacks. Although there are studies on the effectiveness of greater occipital nerve blockade and transnasal sphenopalatine ganglion blockade in migraine treatment, there are no studies comparing their superiority over each other. This study aims to evaluate the effects of repetitive greater occipital nerve blockade and transnasal sphenopalatine ganglion blockade on headache severity, number of days with headache, headache duration, functionality and medication use in patients with episodic migraine, and to compare whether they are superior to each other.
In this single center randomised study participants' episodic migraine will be diagnosed according to the International Classification of Headache Disorders 3rd version (ICHD-3) criteria. Demographic information of the patients, including age, gender, comorbidities, educational status, marital status and migraine duration, will be recorded. Pain intensity of patients will be evaluated using the Numeric Rating Scala (NRS 11) scale, and functionality will be evaluated using MIDAS. Before the procedure, the number of headache days in a 1-month period, headache severity, duration, amount of medication use (non-steroidal anti-inflammatory analgesic, triptan) and MIDAS score will be recorded. Participants will be randomized into 2 groups. When 21 participants are randomized in each group, participant 26 will be excluded from the list because it is in both groups. Group 1 greater occipital nerve block; It will be applied for participants 37, 27, 35, 13, 36, 18, 34, 33, 6, 12, 3, 25, 19, 1, 14, 9, 21, 38, 10, 2. Group 2 sphenopalatine block; It will be applied to patients 22, 1, 24, 11, 35, 33, 17, 14, 8, 31, 39, 5, 2, 28, 41, 36, 15, 7, 34, 27. Greater occipital nerve block will be applied to participant number 26 by repeating the procedure order since the number of participants in each group is equally divided.
Participants will receive greater occipital nerve blockade and transnasal sphenopalatine ganglion blockade once a week for the first month and then once a week for a further 1 month. At the 1st month, 2nd month and 3rd month follow-up visits of the participants, the number of headache days, average pain intensity and pain duration, MIDAS scores and the amount of medication used (non-steroidal anti-inflammatory analgesic, triptan) will be recorded with pain diaries. Participants' pain diaries, MIDAS scores and the amount of medication they use will be recorded. Additionally, possible complications in patients will also be recorded.
- Conditions
- Migraine
- Being tested
- greater occipital nerve block, transnasal sphenopalatine ganglion block
- Keywords
- pain, migraine, nerve block
- Medical subject headings
- Migraine Disorders, Pain
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
greater occipital nerve block
transnasal sphenopalatine ganglion blockProcedure or surgery
transnasal sphenopalatine ganglion block
| Study group | Role | What they receive |
|---|---|---|
| greater occipital nerve block | Active comparator | Following intravenous access and monitoring, participants are placed in the prone position. The medial 1/3 of the line between the protuberance occipital externa and the mastoid process is palpated. The intervention area is cleaned with antiseptic solution. Then, 2 cc of 2% lidocaine is injected into the palpated area after confirming that it is not in the vascular area by negative aspiration. Participants are observed for 30 minutes for possible complications.
The participant will receive a block once a week for the first month and then once a month for the next 2 months. Receives: Procedure: greater occipital nerve block |
| transnasal sphenopalatine ganglion block | Other | Following intravenous access and monitoring, patients are placed in the supine position. A cotton swab impregnated with 2 cc of 2% lidocaine is advanced from the nostril along the upper edge of the middle turbinate until it reaches the posterior wall of the nasopharynx. The stick impregnated with local anesthetic is kept in the target area for 20 minutes. Participants are observed for 30 minutes for possible complications.
The participant will receive a block once a week for the first month and then once a month for the next 2 months. Receives: Procedure: transnasal sphenopalatine ganglion block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale
Range pain severity 0-10, 0: No pain, 10: Worst Pain
Measured: Post treatment 3 months
Migraine attack duration
mean migraine attack duration (hours) that patients suffer in a month.
Measured: Post treatment 3 months
Number of migraine days
Number of migraine days that patients suffer in a month.
Measured: Post treatment 3 months
Secondary outcomes (2)
Migraine Disability Assessment (MIDAS) questionnaire
Four point likert for every question. Scores ranging from 0 to 5, little or no disability; Scores ranging from 6 to 10 indicate mild disability; Scores ranging from 11 to 20 indicate moderate disability; 21 or over, severe disability.
Measured: Post treatment 3 months
medication use
use of medication (non-steroidal anti-inflammatory analgesic, triptan) recorded during 3 months
Measured: Post treatment 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 Sep 2023
- Primary completion1 Nov 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Ankara 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanzade Aybuke Unal, Ankara University
- Investigators
- Hanzade A Unal, MD, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243874
- Sponsor's protocol ID
- 2023/381
- Status last verified
- Feb 2024
- First submitted
- 17 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marmura MJ, Silberstein SD, Schwedt TJ. The acute treatment of migraine in adults: the american headache society evidence assessment of migraine pharmacotherapies. Headache. 2015 Jan;55(1):3-20. doi: 10.1111/head.12499.
PubMed 25600718Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
PubMed 29368949Cady RK, Saper J, Dexter K, Cady RJ, Manley HR. Long-term efficacy of a double-blind, placebo-controlled, randomized study for repetitive sphenopalatine blockade with bupivacaine vs. saline with the Tx360 device for treatment of chronic migraine. Headache. 2015 Apr;55(4):529-42. doi: 10.1111/head.12546. Epub 2015 Mar 31.
PubMed 25828648Binfalah M, Alghawi E, Shosha E, Alhilly A, Bakhiet M. Sphenopalatine Ganglion Block for the Treatment of Acute Migraine Headache. Pain Res Treat. 2018 May 7;2018:2516953. doi: 10.1155/2018/2516953. eCollection 2018.
PubMed 29862074Malekian N, Bastani PB, Oveisgharan S, Nabaei G, Abdi S. Preventive effect of greater occipital nerve block on patients with episodic migraine: A randomized double-blind placebo-controlled clinical trial. Cephalalgia. 2022 May;42(6):481-489. doi: 10.1177/03331024211058182. Epub 2021 Nov 17.
PubMed 34786992Unal HA, Basari A, Celiker OS, Cakar Turhan KS, Asik I, Ozgencil GE. Comparison of Greater Occipital Nerve Blockade and Sphenopalatine Ganglion Blockade in Patients with Episodic Migraine. J Clin Med. 2024 May 21;13(11):3027. doi: 10.3390/jcm13113027.
PubMed 38892738
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Greater Occipital Nerve Blockade and Sphenopalatine Ganglion Blockade in Patients With Episodic Migraine
- ClinicalTrials.gov ID
- NCT06243874
- Acronym / sponsor ID
- 2023/381
- Conditions
- Migraine
- Keywords
- pain, migraine, nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 6 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.
Migraine is a chronic disorder that causes disability. Episodic migraine can be managed by prophylactic medical treatment or interventional pain procedures. Interventional methods used in migraine treatment are greater occipital nerve blockade, lesser occipital nerve blockade, supraorbital nerve blockade, infraorbital nerve blockade, sphenopalatine ganglion blockade, botulinum toxin injection and various radiofrequency applications. The effectiveness of greater occipital nerve blockade and transnasal sphenopalatine ganglion blockade in the treatment of migraine has been proven in various studies.We aimed to evaluate the effects of repetitive greater occipital nerve blockade and transnasal sphenopalatine ganglion blockade in patients with episodic migraine.
Detailed description
Migraine is a common primary headache and causes a significant personal, social and financial burden. Migraine is characterized by a semi-headache lasting 4-72 hours, accompanied by nausea/vomiting and photophobia/phonophobia. Migraine can be episodic or chronic. Non-steroidal anti-inflammatory drugs, triptan and ergotamine derivatives can be used in the treatment of acute migraine attacks. Beta-blockers, calcium channel blockers, antiepileptic drugs and antidepressant drugs are among the prophylactic medical treatments. When medical treatment cannot provide adequate pain palliation, in case of side effects or when the patient does not prefer medical treatment, interventional methods come to the fore. Interventional methods that applied in migraine treatment are greater occipital nerve blockade, lesser occipital nerve blockade, supraorbital nerve blockade, infraorbital nerve blockade, sphenopalatine ganglion blockade, botulinum toxin injection and various radiofrequency applications. The effectiveness of greater occipital nerve blockade and transnasal sphenopalatine ganglion blockade in the treatment of migraine has been proven in various studies.
It is stated that sphenopalatine ganglion blockade reduces the number of headache days and is effective in the treatment of acute migraine attacks. Although there are studies on the effectiveness of greater occipital nerve blockade and transnasal sphenopalatine ganglion blockade in migraine treatment, there are no studies comparing their superiority over each other. This study aims to evaluate the effects of repetitive greater occipital nerve blockade and transnasal sphenopalatine ganglion blockade on headache severity, number of days with headache, headache duration, functionality and medication use in patients with episodic migraine, and to compare whether they are superior to each other.
In this single center randomised study participants' episodic migraine will be diagnosed according to the International Classification of Headache Disorders 3rd version (ICHD-3) criteria. Demographic information of the patients, including age, gender, comorbidities, educational status, marital status and migraine duration, will be recorded. Pain intensity of patients will be evaluated using the Numeric Rating Scala (NRS 11) scale, and functionality will be evaluated using MIDAS. Before the procedure, the number of headache days in a 1-month period, headache severity, duration, amount of medication use (non-steroidal anti-inflammatory analgesic, triptan) and MIDAS score will be recorded. Participants will be randomized into 2 groups. When 21 participants are randomized in each group, participant 26 will be excluded from the list because it is in both groups. Group 1 greater occipital nerve block; It will be applied for participants 37, 27, 35, 13, 36, 18, 34, 33, 6, 12, 3, 25, 19, 1, 14, 9, 21, 38, 10, 2. Group 2 sphenopalatine block; It will be applied to patients 22, 1, 24, 11, 35, 33, 17, 14, 8, 31, 39, 5, 2, 28, 41, 36, 15, 7, 34, 27. Greater occipital nerve block will be applied to participant number 26 by repeating the procedure order since the number of participants in each group is equally divided.
Participants will receive greater occipital nerve blockade and transnasal sphenopalatine ganglion blockade once a week for the first month and then once a week for a further 1 month. At the 1st month, 2nd month and 3rd month follow-up visits of the participants, the number of headache days, average pain intensity and pain duration, MIDAS scores and the amount of medication used (non-steroidal anti-inflammatory analgesic, triptan) will be recorded with pain diaries. Participants' pain diaries, MIDAS scores and the amount of medication they use will be recorded. Additionally, possible complications in patients will also be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| greater occipital nerve block | Active comparator | Procedure: greater occipital nerve blockFollowing intravenous access and monitoring, participants are placed in the prone position. The medial 1/3 of the line between the protuberance occipital externa and the mastoid process is palpated. The intervention area is cleaned with antiseptic solution. Then, 2 cc of 2% lidocaine is injected into the palpated area after confirming that it is not in the vascular area by negative aspiration. Participants are observed for 30 minutes for possible complications. The participant will receive a block once a week for the first month and then once a month for the next 2 months. |
| transnasal sphenopalatine ganglion block | Other | Procedure: transnasal sphenopalatine ganglion blockFollowing intravenous access and monitoring, patients are placed in the supine position. A cotton swab impregnated with 2 cc of 2% lidocaine is advanced from the nostril along the upper edge of the middle turbinate until it reaches the posterior wall of the nasopharynx. The stick impregnated with local anesthetic is kept in the target area for 20 minutes. Participants are observed for 30 minutes for possible complications. The participant will receive a block once a week for the first month and then once a month for the next 2 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18-65
- Diagnosing migraine according to the International Classification of Headache Disorders 3rd version (ICHD-3) criteria
- Patients diagnosed with episodic migraine
- Failure to provide pain palliation with at least 1 prophylactic medication
Key exclusion criteria (9 listed)
- Presence of psychiatric disease that is unstable/not controlled by medical treatment
- Pregnant patients
- Those with bleeding diathesis
- Patients who are allergic to local anesthetics given during the procedure
- Patients with open skull defects who have undergone craniotomy
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 blockgreater occipital nerve block | Procedure or surgery | greater occipital nerve block |
| transnasal sphenopalatine ganglion blocktransnasal sphenopalatine ganglion block | Procedure or surgery | transnasal sphenopalatine ganglion block |
Primary outcome
Numeric Rating Scale
Time frame: Post treatment 3 months
Range pain severity 0-10, 0: No pain, 10: Worst Pain
Migraine attack duration
Time frame: Post treatment 3 months
mean migraine attack duration (hours) that patients suffer in a month.
Number of migraine days
Time frame: Post treatment 3 months
Number of migraine days that patients suffer in a month.
2 secondary outcomes
Migraine Disability Assessment (MIDAS) questionnaire
Time frame: Post treatment 3 months
medication use
Time frame: Post treatment 3 months
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 6 Feb 2024.
- Background: PubMed 25600718Marmura MJ, Silberstein SD, Schwedt TJ. The acute treatment of migraine in adults: the american headache society evidence assessment of migraine pharmacotherapies. Headache. 2015 Jan;55(1):3-20. doi: 10.1111/head.12499.
- Background: PubMed 29368949Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
- Background: PubMed 25828648Cady RK, Saper J, Dexter K, Cady RJ, Manley HR. Long-term efficacy of a double-blind, placebo-controlled, randomized study for repetitive sphenopalatine blockade with bupivacaine vs. saline with the Tx360 device for treatment of chronic migraine. Headache. 2015 Apr;55(4):529-42. doi: 10.1111/head.12546. Epub 2015 Mar 31.
- Background: PubMed 29862074Binfalah M, Alghawi E, Shosha E, Alhilly A, Bakhiet M. Sphenopalatine Ganglion Block for the Treatment of Acute Migraine Headache. Pain Res Treat. 2018 May 7;2018:2516953. doi: 10.1155/2018/2516953. eCollection 2018.
- Background: PubMed 34786992Malekian N, Bastani PB, Oveisgharan S, Nabaei G, Abdi S. Preventive effect of greater occipital nerve block on patients with episodic migraine: A randomized double-blind placebo-controlled clinical trial. Cephalalgia. 2022 May;42(6):481-489. doi: 10.1177/03331024211058182. Epub 2021 Nov 17.
- Derived from this study: PubMed 38892738Unal HA, Basari A, Celiker OS, Cakar Turhan KS, Asik I, Ozgencil GE. Comparison of Greater Occipital Nerve Blockade and Sphenopalatine Ganglion Blockade in Patients with Episodic Migraine. J Clin Med. 2024 May 21;13(11):3027. doi: 10.3390/jcm13113027.
- Individual participant dataSharing planned: No
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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.
Hanzade A Unal, MD principal investigator
Ankara 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 transnasal sphenopalatine ganglion block in people with Migraine, run by Ankara 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 4 inclusion and 9 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 6 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?
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?
Numeric Rating Scale (time frame: Post treatment 3 months). The study lists 3 primary outcomes in all. 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 NCT06243874, which also lists 6 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 6 Feb 2024.