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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stellate Ganglion Block plus standardized drug treatment group | Experimental | 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; |
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| standardized drug treatment group | Active Comparator | The patients will only receive Topiramate plus ibuprofen as standardized drug treatment according to the guidelines for the treatment of CM. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stellate Ganglion Block (SGB) | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| the change from baseline in mean monthly migraine days | The primary outcome is the change from baseline in mean monthly (defined as 4 weeks) migraine days across 6-months follow-up period, which will be assessed by a blinded independent central review (BICR). Baseline is defined as the number of migraine days during the last 28 days prior to the randomization date. A migraine day is defined as a calendar day with symptoms of a migraine attack lasting at least 30 min. | 6-month period |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieved≥50% reduction in monthly migraine days | Proportion of patients achieved≥50% reduction | 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery |
| Total effective rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Recruiting | Beijing | Beijing Municipality | 100050 | China |
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| ID | Term |
|---|---|
| D000077236 | Topiramate |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 |
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Parallel Assignment
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Single (Outcomes Assessor)
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| standardized drug treatment | Drug | 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. |
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Total effective rate = cure rate + markedly effective rate + effective rate
| 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 | The Numeric Rating Scale(NRS) scoring method typically uses a score range of 0-10, with 0 indicating no pain or symptoms and 10 indicating the most severe pain or symptoms. | at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery |
| Patients satisfaction (PS) | Patients satisfaction (PS) evaluated by PS scores, which typically uses a score range of 0-10, with 0 indicating no patient satisfaction and 10 indicating the most patient satisfaction. | 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery |
| The six item headache impact test (HIT-6) | The six item headache impact test (HIT-6) is a self-reported questionnaire measuring the "impact that headaches have on the ability to function on the job, at school, at home, and in social situations. | at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery |
| the Migraine Disability Assessment score(MIDAS) | MIDAS is a reliable and validated scale measuring migraine-related disability regarding the need for medical care.. Higher MIDAS scores indicate more days with disability | at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery |
| The Pittsburgh Sleep Quality Index (PSQI) | PSQI is a self-administered assessment of sleep disturbances that may affect sleep quality, including sleep apnoea, with a higher score indicating more severe sleep disturbances. | at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery |
| adverse events | Proportion of participants with adverse events (AEs) and serious adverse events | at 0 day , 1 week, 2 week, 3 week, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery |
| Carbohydrates |
| D007661 | Ketoses |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |