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

Capital Medical University

Status: Enrolling

Conditions: Chronic Migraine

Treatments: Procedure: Stellate Ganglion Block (SGB); Drug: standardized drug treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06322407

KY2023-263-03-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 206 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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206 participants in 2 patient groups

Stellate Ganglion Block plus standardized drug treatment group

Experimental group

Description:

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;

Treatment:

Drug: standardized drug treatment

Procedure: Stellate Ganglion Block (SGB)

standardized drug treatment group

Active Comparator group

Description:

The patients will only receive Topiramate plus ibuprofen as standardized drug treatment according to the guidelines for the treatment of CM.

Treatment:

Drug: standardized drug treatment