MigraineNCT06662461
Ultrasound Guided Block of Stellate Ganglion Versus Greater Occipital Nerve in Resistant Migraine and Correlation to Calcitonin Gene Related Peptide
A study testing ultrasound guided Greater occipital nerve block and Ultrasound guided Stellate ganglion block in people with Migraine, run by Ain Shams University at 1 site in Egypt.
Trial summary
To investigate the efficacy of Ultrasound guided Stellate Ganglion block in chronic resistant migraine patients in comparison to Greater Occipital Nerve Block correlating its effect to serum CGRP level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- ultrasound guided Greater occipital nerve block and Ultrasound guided Stellate 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 siteEgypt
- Study dates
- 1 Feb 2024to Mar 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals diagnosed with chronic resistant migraine after using or intolerability to 2 or more of anti-migraine drugs for at least 3 months
Who cannot join
- Patients with a space-occupying lesion.
- Coagulation disorders.
- Systemic or local infection and drug allergies.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Hospital
Cairo
Ass.Prof.Mai Fathy, +2001023868846, maifathy@med.asu.edu.eg
About this study
Official title: Efficacy of Ultrasound Guided Block of Stellate Ganglion Versus Greater Occipital Nerve in Chronic Resistant Migraine Patients and Its Correlation to Calcitonin Gene Related Peptide (CGRP)
To investigate the efficacy of Ultrasound guided Stellate Ganglion block in chronic resistant migraine patients in comparison to Greater Occipital Nerve Block correlating its effect to serum CGRP level.
Read the detailed description
40 Patients diagnosed with Chronic resistant migraine to 2 anti-migraine drugs for 3 months will be evaluated for inclusion and exclusion. Eligible patients with resistance or intolerability to 2 drugs or more will be classified into two groups by using simple randomization methods through Using a computer-generated random number sequence.
Each group will contain 20 patients one group will undergo ultrasound guided bilateral Greater Occipital nerve Block and the other group will undergo ultrasound guided bilateral Stellate Ganglion Block
- Conditions
- Migraine
- Being tested
- ultrasound guided Greater occipital nerve block, Ultrasound guided Stellate ganglion block
- Keywords
- occipital nerve block, stellate ganglion block, migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided Greater occipital nerve blockProcedure or surgery
Patients will be positioned in a prone position with their neck slightly flexed.
The trapezius , semispinalis, obliqus capitis muscles will be revealed on short-axis view.
A 25- or 21 gauge is used, with puncture point 1-1.5 cm away from the ultrasound probe.
Under the guidance of the ultrasound, GOB will performed by injection using 40 mg triamcinolone and 1ml of 2% lidocaine.
Ultrasound guided Stellate ganglion blockProcedure or surgery
Patients are positioned in a lateral position with their necks slightly hyperextended. Assisted by ultrasound imaging equipment the C7 level is confirmed. The thyroid gland, carotid artery, compressible internal jugular vein, vertebral artery, brachial plexus and the oval-shaped structure of the longus collis muscle are revealed on this short-axis view.
A 25- or 21 gauge is used and the puncture point is 1-1.5 cm away from the ultrasound probe The tip of the needle reach the surface of the longus collis muscle and the 5 o'clock position of the carotid artery. Under the guidance of the ultrasound, SGB is performed by injection using 40 mg triamcinolone and 1ml of 2% lidocaine.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided bilateral Greater Occipital nerve Block | Active comparator | Not described Receives: Procedure: ultrasound guided Greater occipital nerve block |
| Ultrasound guided bilateral Stellate Ganglion Block | Active comparator | Not described Receives: Procedure: Ultrasound guided Stellate ganglion block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Headache impact test (HIT-6)
Each of the six questions of the HIT-6 receives a score from 6-13. The final HIT-6 score can range from 36 to 78. A higher score indicates more disability due to headache.
Measured: 3 months
changes in Migraine disability assessment test (MIDAS)
The MIDAS questionnaire is based on five disability questions that focus on lost time in three domains: school work or work for pay; household work or chores; and family, social, and leisure activities. The scoring is:
0-5: little or no disability 6-10: mild disability 11-20: moderate disability 21+: severe disability
Measured: 3 months
changes in Numeric Rating Scale (NRS)
a score used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Measured: 3 months
Secondary outcomes (1)
Changes in circulating CGRP level
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Feb 2024
- Primary completion1 Nov 2024 (estimated)
- Study completionMar 2025 (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.
- More trials run by Ain Shams 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Ahmed Mohamed ElSadek, Sherien Mohamed Farag, Noha Lotfy Soliman, Mohamed Amir Tork, Ahmed Mohamed Abdelfattah Sharawy
- Responsible party
- Principal investigator, Mai Fathy Ahmed Fahmy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662461
- Sponsor's protocol ID
- FMASU MD14/2024
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ultrasound Guided Block of Stellate Ganglion Versus Greater Occipital Nerve in Chronic Resistant Migraine Patients and Its Correlation to Calcitonin Gene Related Peptide (CGRP)
- ClinicalTrials.gov ID
- NCT06662461
- Acronym / sponsor ID
- FMASU MD14/2024
- Conditions
- Migraine
- Keywords
- occipital nerve block, stellate ganglion block, migraine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Ahmed Mohamed ElSadek, Sherien Mohamed Farag, Noha Lotfy Soliman, Mohamed Amir Tork, Ahmed Mohamed Abdelfattah Sharawy
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 29 Oct 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.
To investigate the efficacy of Ultrasound guided Stellate Ganglion block in chronic resistant migraine patients in comparison to Greater Occipital Nerve Block correlating its effect to serum CGRP level.
Detailed description
40 Patients diagnosed with Chronic resistant migraine to 2 anti-migraine drugs for 3 months will be evaluated for inclusion and exclusion. Eligible patients with resistance or intolerability to 2 drugs or more will be classified into two groups by using simple randomization methods through Using a computer-generated random number sequence.
Each group will contain 20 patients one group will undergo ultrasound guided bilateral Greater Occipital nerve Block and the other group will undergo ultrasound guided bilateral Stellate Ganglion Block
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided bilateral Greater Occipital nerve Block | Active comparator | Procedure: ultrasound guided Greater occipital nerve block |
| Ultrasound guided bilateral Stellate Ganglion Block | Active comparator | Procedure: Ultrasound guided Stellate ganglion block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals diagnosed with chronic resistant migraine after using or intolerability to 2 or more of anti-migraine drugs for at least 3 months
Key exclusion criteria (3 listed)
- Patients with a space-occupying lesion.
- Coagulation disorders.
- Systemic or local infection and drug allergies.
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 |
|---|---|---|
| ultrasound guided Greater occipital nerve blockPatients will be positioned in a prone position with their neck slightly flexed. The trapezius , semispinalis, obliqus capitis muscles will be revealed on short-axis view. A 25- or 21 gauge is used, with puncture point 1-1.5 cm away from the ultrasound probe. Under the guidance of the ultrasound, GOB will performed by injection using 40 mg triamcinolone and 1ml of 2% lidocaine. | Procedure or surgery | Ultrasound guided bilateral Greater Occipital nerve Block |
| Ultrasound guided Stellate ganglion blockPatients are positioned in a lateral position with their necks slightly hyperextended. Assisted by ultrasound imaging equipment the C7 level is confirmed. The thyroid gland, carotid artery, compressible internal jugular vein, vertebral artery, brachial plexus and the oval-shaped structure of the longus collis muscle are revealed on this short-axis view. A 25- or 21 gauge is used and the puncture point is 1-1.5 cm away from the ultrasound probe The tip of the needle reach the surface of the longus collis muscle and the 5 o'clock position of the carotid artery. Under the guidance of the ultrasound, SGB is performed by injection using 40 mg triamcinolone and 1ml of 2% lidocaine. | Procedure or surgery | Ultrasound guided bilateral Stellate Ganglion Block |
Primary outcome
Changes in Headache impact test (HIT-6)
Time frame: 3 months
Each of the six questions of the HIT-6 receives a score from 6-13. The final HIT-6 score can range from 36 to 78. A higher score indicates more disability due to headache.
changes in Migraine disability assessment test (MIDAS)
Time frame: 3 months
The MIDAS questionnaire is based on five disability questions that focus on lost time in three domains: school work or work for pay; household work or chores; and family, social, and leisure activities. The scoring is: 0-5: little or no disability 6-10: mild disability 11-20: moderate disability 21+: severe disability
changes in Numeric Rating Scale (NRS)
Time frame: 3 months
a score used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
1 secondary outcome
Changes in circulating CGRP level
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 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 ultrasound guided Greater occipital nerve block and Ultrasound guided Stellate ganglion block in people with Migraine, run by Ain Shams 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 1 inclusion and 3 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 30 Oct 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mai Fathy Ass.Prof.Mai Fathy (+2001023868846, maifathy@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Headache impact test (HIT-6) (time frame: 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?
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 30 Oct 2024.