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Trial Title:
Ultrasound-guided Stellate Ganglion Block for Treatment of Chronic Migraine in Adult
NCT ID:
NCT06322407
Condition:
Chronic Migraine
Conditions: Official terms:
Ganglion Cysts
Migraine Disorders
Topiramate
Ibuprofen
Conditions: Keywords:
Chronic Migraine
Stellate Ganglion Block
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Masking description:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
Stellate Ganglion Block (SGB)
Description:
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
Arm group label:
Stellate Ganglion Block plus standardized drug treatment group
Other name:
Ultrasound-guided Stellate Ganglion Block (SGB)
Intervention type:
Drug
Intervention name:
standardized drug treatment
Description:
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.
Arm group label:
Stellate Ganglion Block plus standardized drug treatment group
Arm group label:
standardized drug treatment group
Other name:
topiramate plus ibuprofen
Summary:
To assess the 6-months effects and safety of stellate ganglion block(SGB) for Chronic
Migraine (CM) patients who failure to undergo preventive therapy and are seeking a more
suitable non-pharmacological therapy.
Detailed description:
The investigators aim to investigate whether the stellate ganglion block(SGB) is better
than traditional medication treatment and provides medical evidence for the clinical
application and promotion of SGB to provide a minimally invasive, safe, and effective
treatment for patients with chronic migraine(CM) who failed to receive standardized drug
treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age from 18 to 65 years;
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:
1. BMI <15 kg/m2 or >35 kg/m2；
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Tiantan Hospital
Address:
City:
Beijing
Zip:
100050
Country:
China
Status:
Recruiting
Contact:
Last name:
Fang Luo, M.D
Phone:
+86 13611326978
Email:
13611326978@163.com
Contact backup:
Last name:
Lu Liu
Phone:
+86 18618418228
Email:
emmaliulu@163.com
Start date:
June 3, 2024
Completion date:
December 3, 2025
Lead sponsor:
Agency:
Beijing Tiantan Hospital
Agency class:
Other
Source:
Beijing Tiantan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06322407
