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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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
• Препарат 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

Первичные конечные точки

• the change from baseline in mean monthly migraine days [Срок оценки: 6-month period]

Вторичные конечные точки (8)

• Proportion of patients achieved≥50% reduction in monthly migraine days [Срок оценки: 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery]
• Total effective rate [Срок оценки: 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery]
• The mean Numeric Rating Scale(NRS) score during headache attack [Срок оценки: at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery]
• Patients satisfaction (PS) [Срок оценки: 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery]
• The six item headache impact test (HIT-6) [Срок оценки: at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery]
• the Migraine Disability Assessment score(MIDAS) [Срок оценки: at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery]
• The Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery]
• adverse events [Срок оценки: at 0 day , 1 week, 2 week, 3 week, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Tiantan Hospital — Пекин

Идентификаторы

NCT: NCT06322407 · KY2023-263-03-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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