Clinical trial NCT06322407: Ultrasound-guided Stellate Ganglion Block for Treatment of Chronic Migraine in Adult
Official title: A Prospective, Randomized, Controlled, Blinded-endpoint Study to Evaluate the Efficacy and Safety of Stellate Ganglion Block for CM Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Migraine
Keywords: Chronic Migraine
Stellate Ganglion Block
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: the change from baseline in mean monthly migraine days
timeFrame: 6-month period
Secondary outcomes:
measure: Proportion of patients achieved≥50% reduction in monthly migraine days
timeFrame: 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
measure: Total effective rate
timeFrame: 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
measure: The mean Numeric Rating Scale(NRS) score during headache attack
timeFrame: at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
measure: Patients satisfaction (PS)
timeFrame: 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
measure: The six item headache impact test (HIT-6)
timeFrame: at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
measure: the Migraine Disability Assessment score(MIDAS)
timeFrame: at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
measure: adverse events
timeFrame: at 0 day , 1 week, 2 week, 3 week, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
References: