RecruitingNot ApplicableNCT06322407

Ultrasound-guided Stellate Ganglion Block for Treatment of Chronic Migraine in Adult

A Prospective, Randomized, Controlled, Blinded-endpoint Study to Evaluate the Efficacy and Safety of Stellate Ganglion Block for CM Treatment

Sponsor

Beijing Tiantan Hospital

Enrollment

206 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Migraine

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

Age from 18 to 65 years;
Diagnosed with CM according to the International Classification of Headache Disorders, 3rd (ICHD-3) criteria \[Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38:1-211\].
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 Criteria12

BMI <15 kg/m2 or >35 kg/m2；
Previous SGB treatment；
History of other neurological disorders；
History of severe cardiopulmonary, hepatic or renal dysfunction；
History of allergies to any of the study drugs；
Patients with chronic use of opioids；
Preoperative coagulation abnormalities (activated partial thromboplastin time greater than 1.5 time normal value)；
Infection or mass near the puncture site；
Neck anatomic structural changes (caused by radiotherapy or surgery);
Pregnant or breast feeding;
Psychological disorders;
Refusal to sign informed consent.

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Interventions

PROCEDUREStellate 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

DRUGstandardized 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.