Migraine DisordersPhase 4NCT04491474
Comparison of Great Occipital Nerve and Supraorbital Nerve Blockade Methods at Treatment of Acute Migraine Attack in the Emergency Department
A Phase 4 study testing Lidocaine Hydrochloride in people with Migraine Disorders, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Aim Acute migraine attack is a clinical condition that is frequently encountered in emergency departments and varies from patient to patient in terms of treatment modalities. There are many different treatments whose effectiveness has been proven by concrete evidence(1). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Lidocaine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2020to 14 Mar 2021
- Phase
- Phase 4
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meeting the criteria of International Headache Society (IHS CLASSIFICATION ICHD-3) migraine criteria with or without aura
- Not taking medication before applying to the hospital
- Over 18 years
- Under 50 years
- Patients with a history of migraine
- The number of migraine attacks per month should be between 2 and 8
Show all 9Show fewer
- Having a headache-free period of at least 48 hours between migraine attacks
- Diagnosis of migraine at least 1 year ago
- Migraine prophylaxis is finished and the last dose should be taken 1 month or more
Who cannot join
- Pregnancy
- Epilepsy, History of Arrhythmia
- Implantation in the skull, Cardiac pacemaker
- Patients with a brain tumor or in an acute cerebrovascular accident clinic
- Patients with a history of head injury
- Past medical history of psychiatric illness
Show all 11Show fewer
- Patients with a fever> 38, Patients with suspected meningitis
- Patients with acute changes of consciousness or signs of meningeal irritation
- Hypertension (Patients with Blood Pressure> 160/110)
- Headaches due to excessive drug use
- Patients with headache> 15 days monthly
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kartal Dr. Lutfi Kırdar City Hospital
Istanbul, 34890
About this study
Official title: Comparison of Great Occipital Nerve and Supraorbital Nerve Blockade Treatment Methods Individually and in Combination With Placebo in an Acute Migraine Attack in the Emergency Department, a Prospective, Double Blind, Randomized Controlled Study
Aim Acute migraine attack is a clinical condition that is frequently encountered in emergency departments and varies from patient to patient in terms of treatment modalities. There are many different treatments whose effectiveness has been proven by concrete evidence(1). Drug treatments applied to patients are generally given intravenously or intramuscularly. Non-steroidal anti-inflammatory drugs, metoclopramide and intravenous magnesium therapy is generally used for treatment in emergency departments (1). The effectiveness of supraorbital nerve blockade and great occipital nerve blockade in migraine treatment and prophylaxis has been proven in many studies(2-6). The aim of this study is to discuss the effectiveness of supraorbital and great occipital nerve blockade treatments in acute migraine attack, when combined or used individually.
Read the detailed description
Study Design The study was designed as a double-blind, prospective, randomized controlled clinical trial.
First of all patients who meet the International Headache Society (IHS CLASSIFICATION ICHD-3) migraine with or without aura criteria will be included to the study (7). Secondary it is mandatory to meet our inclusion criteria, and not to include exclusion criteria, with written informed consent to be in the study. The study will be carried out with 160 patients.
Patients who meet these conditions will be randomly divided into 4 groups. First group bilateral GON blockade and bilateral isotonic injection into the SON region,second group bilateral SON blockade and bilateral isotonic injection into the GON region,Group 3 bilateral GON blockade and bilateral SON blockade and last investigators planned to give bilateral GON and SON region saline injection to group 4.
While performing these procedures, 1 ml of 2% lidocaine and 1 ml of saline will be used for 2 ml of 1% lidocaine for nerve block. Also 2 ml of saline will be used for placebo effect. For blocking the GON region 0.75 ml of 1% lidocaine will be applied and 0.75 ml of saline for placebo effect(8). During applying to the SON region 0.25 ml of 1% lidocaine for blockage and 0.25 ml of saline for placebo effect will be used(8). The GON injection site was planned to be 2 cm lateral and 2 cm below the occipital protrusion and the SON injection site was planned as the area with frontal incisor in the orbital arch (8).
Patients will be followed up in the emergency room for 120 minutes. In the study, 1 large box will be used to ensure double blindness and randomization. There will be 2 more small boxes in it. Small boxes will be named as '' G '' and '' S '' containing the names of the nerve regions. There will be 8 injectors in each small box. There will be 8 syringes in each small box, 4 of them containing saline and 4 contains 1% lidocaine. The injectors will be numbered with the name of the box in which they are located (such as G1, G2… G8 or S1, S2… S8). In the study, 8 patients will be treated daily. In the following days, injector numbers will be written as numbers in progress (such as G9, G10..G16 and S9, S10… S16). The contents of these injectors prepared by the pharmacist will also be recorded by the pharmacist. Envelopes with random number injector combinations will be offered to patients. The combination in the envelope chosen by the patient will be applied. Injector numbers will be recorded to the data form. When the study is finished, these numbers will be checked and it will be determined which patient is given which treatment.
- Conditions
- Migraine Disorders
- Being tested
- Lidocaine Hydrochloride, Placebo
- Keywords
- migraine attack, nerve blockade, emergency medicine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine HydrochlorideDrug
While performing these procedures, 1 ml of 2% lidocaine hydrochloride and 1 ml of %0.9 saline will be used for creating a solution of 2 ml of 1% lidocaine for nerve block. Also 2 ml of saline will be used for placebo effect. For blocking the GON region 0.75 ml of 1% lidocaine will be applied and 0.75 ml of saline for placebo effect(8). During applying to the SON region 0.25 ml of 1% lidocaine for blockage and 0.25 ml of saline for placebo effect will be used(8). The GON injection site was planned to be 2 cm lateral and 2 cm below the occipital protrusion and the SON injection site was planned as the area with frontal incisor in the orbital arch
PlaceboDrug
There will be injection of %0.9 saline to bilaterally great occipital nerve and to bilaterally supraorbital nerve.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | bilateral great occipital nerve blockade and bilateral isotonic injection into the supraorbital region. Receives: Drug: Lidocaine Hydrochloride |
| Group 2 | Active comparator | bilateral supraorbital nerve blockade and bilateral isotonic injection into the great occipital nerve region Receives: Drug: Lidocaine Hydrochloride |
| Group 3 | Active comparator | bilateral great occipital nerve blockade and bilateral supraorbital nerve blockade Receives: Drug: Lidocaine Hydrochloride |
| Group 4 | Sham comparator | saline injection to bilateral great occipital nerve and supraorbital nerve region Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of great occipital nerve and supraorbital nerve blockade methods at treatment of acute migraine attack in the emergency department, a prospective randomized controlled double blind study
VAS (Visual Analog Scale) with 100mm length, which writes start and end points, will be used as the pain assessment scale. In this scale, 0 shows the lightest pain in the form of a straight line and 100 mm indicates the most pain. This scale will be described to the participant and asked to mark the intensity of pain on the line.
VAS values of the participants for 0 minutes, 30 minutes, 60 minutes and 120 minutes will be taken and evaluated separately. If there is no relief in the pain of the participants at the 30th minute, it is planned to administer meperidine (0.75 mcg / kg) as in similar studies as a recovery therapy(4). These patients will then be excluded from the study. Participants will be discharged after 120 minutes if they express that their pain has passed or they do not need more analgesics.
Measured: 0-30th minute- 60th minute-120th minute visual analog scale pain measurements.
Secondary outcomes (1)
Pain assessment according to Likert type verbal scale
Secondary the participants will be asked about their responses to treatment with a scoring method from 1 to 5 according to Likert-type verbal scale, which is a verbal assessment method at 0 and 120 minutes of treatment. On this scale, they will be asked to say 1: I have a lot of pain, 2: I have a pain, 3: moderate relief, 4: I am good, 5: I am very good, and they will be asked to choose a number to evaluate their pain. This will also be recorded.
Measured: 0 minute and 120th minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start15 Aug 2020
- Primary completion14 Mar 2021
- Study completion14 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Migraine DisordersStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nihat Mujdat Hokenek, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491474
- Sponsor's protocol ID
- 2020/514/169/20
- Status last verified
- Mar 2021
- First submitted
- 17 Jul 2020
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: İf there is reasonable requests, I can share that time to support investigations about nerve blockade.
Publications
Ruiz Pinero M, Mulero Carrillo P, Pedraza Hueso MI, de la Cruz Rodriguez C, Lopez Mesonero L, Guerrero Peral AL. Pericranial nerve blockade as a preventive treatment for migraine: Experience in 60 patients. Neurologia. 2016 Sep;31(7):445-51. doi: 10.1016/j.nrl.2014.10.001. Epub 2014 Dec 24. English, Spanish.
PubMed 25543956Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
PubMed 23771276Marmura 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 25600718Ashkenazi A, Levin M. Greater occipital nerve block for migraine and other headaches: is it useful? Curr Pain Headache Rep. 2007 Jun;11(3):231-5. doi: 10.1007/s11916-007-0195-3.
PubMed 17504651Young W, Cook B, Malik S, Shaw J, Oshinsky M. The first 5 minutes after greater occipital nerve block. Headache. 2008 Jul;48(7):1126-8. doi: 10.1111/j.1526-4610.2008.01146.x. Epub 2008 Jun 28.
PubMed 18549410Govindappagari S, Grossman TB, Dayal AK, Grosberg BM, Vollbracht S, Robbins MS. Peripheral nerve blocks in the treatment of migraine in pregnancy. Obstet Gynecol. 2014 Dec;124(6):1169-1174. doi: 10.1097/AOG.0000000000000555.
PubMed 25415168Okmen K, Dagistan Y, Dagistan E, Kaplan N, Cancan E. Efficacy of the greater occipital nerve block in recurrent migraine type headaches. Neurol Neurochir Pol. 2016;50(3):151-4. doi: 10.1016/j.pjnns.2016.01.015. Epub 2016 Feb 6.
PubMed 27154440Ozer D, Boluk C, Turk Boru U, Altun D, Tasdemir M, Koseoglu Toksoy C. Greater occipital and supraorbital nerve blockade for the preventive treatment of migraine: a single-blind, randomized, placebo-controlled study. Curr Med Res Opin. 2019 May;35(5):909-915. doi: 10.1080/03007995.2018.1532403. Epub 2018 Oct 31.
PubMed 30285507Diener HC, Tassorelli C, Dodick DW, Silberstein SD, Lipton RB, Ashina M, Becker WJ, Ferrari MD, Goadsby PJ, Pozo-Rosich P, Wang SJ, Mandrekar J; International Headache Society Clinical Trials Standing Committee. Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults: Fourth edition. Cephalalgia. 2019 May;39(6):687-710. doi: 10.1177/0333102419828967. Epub 2019 Feb 26.
PubMed 30806518
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Great Occipital Nerve and Supraorbital Nerve Blockade Treatment Methods Individually and in Combination With Placebo in an Acute Migraine Attack in the Emergency Department, a Prospective, Double Blind, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04491474
- Acronym / sponsor ID
- 2020/514/169/20
- Conditions
- Migraine Disorders
- Keywords
- migraine attack, nerve blockade, emergency medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 14 Mar 2021 (actual)
- Study completion
- 14 Mar 2021 (actual)
- First posted
- 29 Jul 2020 (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.
Aim Acute migraine attack is a clinical condition that is frequently encountered in emergency departments and varies from patient to patient in terms of treatment modalities. There are many different treatments whose effectiveness has been proven by concrete evidence(1). Drug treatments applied to patients are generally given intravenously or intramuscularly. Non-steroidal anti-inflammatory drugs, metoclopramide and intravenous magnesium therapy is generally used for treatment in emergency departments (1). The effectiveness of supraorbital nerve blockade and great occipital nerve blockade in migraine treatment and prophylaxis has been proven in many studies(2-6). The aim of this study is to discuss the effectiveness of supraorbital and great occipital nerve blockade treatments in acute migraine attack, when combined or used individually.
Detailed description
Study Design The study was designed as a double-blind, prospective, randomized controlled clinical trial.
First of all patients who meet the International Headache Society (IHS CLASSIFICATION ICHD-3) migraine with or without aura criteria will be included to the study (7). Secondary it is mandatory to meet our inclusion criteria, and not to include exclusion criteria, with written informed consent to be in the study. The study will be carried out with 160 patients.
Patients who meet these conditions will be randomly divided into 4 groups. First group bilateral GON blockade and bilateral isotonic injection into the SON region,second group bilateral SON blockade and bilateral isotonic injection into the GON region,Group 3 bilateral GON blockade and bilateral SON blockade and last investigators planned to give bilateral GON and SON region saline injection to group 4.
While performing these procedures, 1 ml of 2% lidocaine and 1 ml of saline will be used for 2 ml of 1% lidocaine for nerve block. Also 2 ml of saline will be used for placebo effect. For blocking the GON region 0.75 ml of 1% lidocaine will be applied and 0.75 ml of saline for placebo effect(8). During applying to the SON region 0.25 ml of 1% lidocaine for blockage and 0.25 ml of saline for placebo effect will be used(8). The GON injection site was planned to be 2 cm lateral and 2 cm below the occipital protrusion and the SON injection site was planned as the area with frontal incisor in the orbital arch (8).
Patients will be followed up in the emergency room for 120 minutes. In the study, 1 large box will be used to ensure double blindness and randomization. There will be 2 more small boxes in it. Small boxes will be named as '' G '' and '' S '' containing the names of the nerve regions. There will be 8 injectors in each small box. There will be 8 syringes in each small box, 4 of them containing saline and 4 contains 1% lidocaine. The injectors will be numbered with the name of the box in which they are located (such as G1, G2… G8 or S1, S2… S8). In the study, 8 patients will be treated daily. In the following days, injector numbers will be written as numbers in progress (such as G9, G10..G16 and S9, S10… S16). The contents of these injectors prepared by the pharmacist will also be recorded by the pharmacist. Envelopes with random number injector combinations will be offered to patients. The combination in the envelope chosen by the patient will be applied. Injector numbers will be recorded to the data form. When the study is finished, these numbers will be checked and it will be determined which patient is given which treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Lidocaine Hydrochloridebilateral great occipital nerve blockade and bilateral isotonic injection into the supraorbital region. |
| Group 2 | Active comparator | Drug: Lidocaine Hydrochloridebilateral supraorbital nerve blockade and bilateral isotonic injection into the great occipital nerve region |
| Group 3 | Active comparator | Drug: Lidocaine Hydrochloridebilateral great occipital nerve blockade and bilateral supraorbital nerve blockade |
| Group 4 | Sham comparator | Drug: Placebosaline injection to bilateral great occipital nerve and supraorbital nerve region |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Meeting the criteria of International Headache Society (IHS CLASSIFICATION ICHD-3) migraine criteria with or without aura
- Not taking medication before applying to the hospital
- Over 18 years
- Under 50 years
- Patients with a history of migraine
Key exclusion criteria (11 listed)
- Pregnancy
- Epilepsy, History of Arrhythmia
- Implantation in the skull, Cardiac pacemaker
- Patients with a brain tumor or in an acute cerebrovascular accident clinic
- Patients with a history of head injury
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 |
|---|---|---|
| Lidocaine HydrochlorideWhile performing these procedures, 1 ml of 2% lidocaine hydrochloride and 1 ml of %0.9 saline will be used for creating a solution of 2 ml of 1% lidocaine for nerve block. Also 2 ml of saline will be used for placebo effect. For blocking the GON region 0.75 ml of 1% lidocaine will be applied and 0.75 ml of saline for placebo effect(8). During applying to the SON region 0.25 ml of 1% lidocaine for blockage and 0.25 ml of saline for placebo effect will be used(8). The GON injection site was planned to be 2 cm lateral and 2 cm below the occipital protrusion and the SON injection site was planned as the area with frontal incisor in the orbital arch | Drug | Group 1, Group 2, Group 3 |
| PlaceboThere will be injection of %0.9 saline to bilaterally great occipital nerve and to bilaterally supraorbital nerve. | Drug | Group 4 |
Primary outcome
Comparison of great occipital nerve and supraorbital nerve blockade methods at treatment of acute migraine attack in the emergency department, a prospective randomized controlled double blind study
Time frame: 0-30th minute- 60th minute-120th minute visual analog scale pain measurements.
VAS (Visual Analog Scale) with 100mm length, which writes start and end points, will be used as the pain assessment scale. In this scale, 0 shows the lightest pain in the form of a straight line and 100 mm indicates the most pain. This scale will be described to the participant and asked to mark the intensity of pain on the line. VAS values of the participants for 0 minutes, 30 minutes, 60 minutes and 120 minutes will be taken and evaluated separately. If there is no relief in the pain of the participants at the 30th minute, it is planned to administer meperidine (0.75 mcg / kg) as in similar studies as a recovery therapy(4). These patients will then be excluded from the study. Participants will be discharged after 120 minutes if they express that their pain has passed or they do not need more analgesics.
1 secondary outcome
Pain assessment according to Likert type verbal scale
Time frame: 0 minute and 120th minute
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 16 Mar 2021.
- Background: PubMed 25543956Ruiz Pinero M, Mulero Carrillo P, Pedraza Hueso MI, de la Cruz Rodriguez C, Lopez Mesonero L, Guerrero Peral AL. Pericranial nerve blockade as a preventive treatment for migraine: Experience in 60 patients. Neurologia. 2016 Sep;31(7):445-51. doi: 10.1016/j.nrl.2014.10.001. Epub 2014 Dec 24. English, Spanish.
- Background: PubMed 23771276Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
- Results publication: 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.
- Results publication: PubMed 17504651Ashkenazi A, Levin M. Greater occipital nerve block for migraine and other headaches: is it useful? Curr Pain Headache Rep. 2007 Jun;11(3):231-5. doi: 10.1007/s11916-007-0195-3.
- Results publication: PubMed 18549410Young W, Cook B, Malik S, Shaw J, Oshinsky M. The first 5 minutes after greater occipital nerve block. Headache. 2008 Jul;48(7):1126-8. doi: 10.1111/j.1526-4610.2008.01146.x. Epub 2008 Jun 28.
- Results publication: PubMed 25415168Govindappagari S, Grossman TB, Dayal AK, Grosberg BM, Vollbracht S, Robbins MS. Peripheral nerve blocks in the treatment of migraine in pregnancy. Obstet Gynecol. 2014 Dec;124(6):1169-1174. doi: 10.1097/AOG.0000000000000555.
- Results publication: PubMed 27154440Okmen K, Dagistan Y, Dagistan E, Kaplan N, Cancan E. Efficacy of the greater occipital nerve block in recurrent migraine type headaches. Neurol Neurochir Pol. 2016;50(3):151-4. doi: 10.1016/j.pjnns.2016.01.015. Epub 2016 Feb 6.
- Results publication: PubMed 30285507Ozer D, Boluk C, Turk Boru U, Altun D, Tasdemir M, Koseoglu Toksoy C. Greater occipital and supraorbital nerve blockade for the preventive treatment of migraine: a single-blind, randomized, placebo-controlled study. Curr Med Res Opin. 2019 May;35(5):909-915. doi: 10.1080/03007995.2018.1532403. Epub 2018 Oct 31.
- Results publication: PubMed 30806518Diener HC, Tassorelli C, Dodick DW, Silberstein SD, Lipton RB, Ashina M, Becker WJ, Ferrari MD, Goadsby PJ, Pozo-Rosich P, Wang SJ, Mandrekar J; International Headache Society Clinical Trials Standing Committee. Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults: Fourth edition. Cephalalgia. 2019 May;39(6):687-710. doi: 10.1177/0333102419828967. Epub 2019 Feb 26.
- Individual participant dataSharing planned: Yes. İf there is reasonable requests, I can share that time to support investigations about nerve blockade.
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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 Phase 4 study testing Lidocaine Hydrochloride in people with Migraine Disorders, run by Dr. Lutfi Kirdar Kartal Training and 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 9 inclusion and 11 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 16 Mar 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Comparison of great occipital nerve and supraorbital nerve blockade methods at treatment of acute migraine attack in the emergency department, a prospective randomized controlled double blind study (time frame: 0-30th minute- 60th minute-120th minute visual analog scale pain measurements.). 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 NCT04491474, which also lists 9 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 16 Mar 2021.