Ultrasound-guided Stellate Ganglion Block for Treatment of Chronic Migraine in Adult
NCT ID: NCT06322407
Last Updated: 2025-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
206 participants
INTERVENTIONAL
2024-06-01
2025-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Stellate Ganglion Block plus standardized drug treatment group
Besides orally topiramate plus ibuprofen as standardized drug treatment, patients will also receive SGBs plus standardized drug therapy; SGB will be performed once a week for 4 consecutive times in an individual series. The interval of each separate SGB procedure is 1 week. Every time patients with bilateral headache will be administered SGB alternately on each side at an interval of 40 min, and patients with unilateral headache will be administered SGB on the ipsilateral side;
Stellate Ganglion Block (SGB)
All SGB procedures will be performed by the same experienced physicians. Patients will be positioned in a supine position with the neck slightly hyperextended and receive a SGB procedure using the B-ultrasound visualization technique (Aurora A5 Ultrasound, Risco Tech Co., Ltd.). 1% lidocaine 5mL (Shanxi Jinxin Shuanghe Pharm Co., Ltd.) will be injected below the prevertebral fascia on the surface of longus colli muscle
standardized drug treatment
Topiramate(Topiramate, Xi'an Yangsen Pharmaceutical Co., Ltd) will be started at a low dose and then increased gradually until optimally effective, side effects become intolerable, or the maximum recommended dose is reached. During the 4-week up-titration phase, the intention will increase dose weekly in 25 mg increments with the aim of reaching 50-100 mg/day. Ibuprofen((Fenbid, Tianjin Shike Pharmaceutical Co., Ltd)will be chosen as acute treatment, but no more than 10 times per month to avoid medication overuse headache.
standardized drug treatment group
The patients will only receive Topiramate plus ibuprofen as standardized drug treatment according to the guidelines for the treatment of CM.
standardized drug treatment
Topiramate(Topiramate, Xi'an Yangsen Pharmaceutical Co., Ltd) will be started at a low dose and then increased gradually until optimally effective, side effects become intolerable, or the maximum recommended dose is reached. During the 4-week up-titration phase, the intention will increase dose weekly in 25 mg increments with the aim of reaching 50-100 mg/day. Ibuprofen((Fenbid, Tianjin Shike Pharmaceutical Co., Ltd)will be chosen as acute treatment, but no more than 10 times per month to avoid medication overuse headache.
Interventions
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Stellate Ganglion Block (SGB)
All SGB procedures will be performed by the same experienced physicians. Patients will be positioned in a supine position with the neck slightly hyperextended and receive a SGB procedure using the B-ultrasound visualization technique (Aurora A5 Ultrasound, Risco Tech Co., Ltd.). 1% lidocaine 5mL (Shanxi Jinxin Shuanghe Pharm Co., Ltd.) will be injected below the prevertebral fascia on the surface of longus colli muscle
standardized drug treatment
Topiramate(Topiramate, Xi'an Yangsen Pharmaceutical Co., Ltd) will be started at a low dose and then increased gradually until optimally effective, side effects become intolerable, or the maximum recommended dose is reached. During the 4-week up-titration phase, the intention will increase dose weekly in 25 mg increments with the aim of reaching 50-100 mg/day. Ibuprofen((Fenbid, Tianjin Shike Pharmaceutical Co., Ltd)will be chosen as acute treatment, but no more than 10 times per month to avoid medication overuse headache.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with CM according to the International Classification of Headache Disorders, 3rd (ICHD-3) criteria \[Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38:1-211\].
3. not received prior prophylactic migraine treatment or, due to lack of efficacy or tolerability, had failed or had not been suitable for up to three previous prophylactic treatments from the following: Metoprolol/propranolol, amitriptyline, and flunarizine.
Exclusion Criteria
2. Previous SGB treatment；
3. History of other neurological disorders；
4. History of severe cardiopulmonary, hepatic or renal dysfunction；
5. History of allergies to any of the study drugs；
6. Patients with chronic use of opioids；
7. Preoperative coagulation abnormalities (activated partial thromboplastin time greater than 1.5 time normal value)；
8. Infection or mass near the puncture site；
9. Neck anatomic structural changes (caused by radiotherapy or surgery);
10. Pregnant or breast feeding;
11. Psychological disorders;
12. Refusal to sign informed consent.
18 Years
65 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Responsible Party
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Fang Luo
Director of Department of Day surgery and Pain Management
Locations
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Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Countries
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Facility Contacts
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Other Identifiers
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KY2023-263-03-02
Identifier Type: -
Identifier Source: org_study_id
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