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

Chronic Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06322407
• Other study ID #: KY2023-263-03-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 206
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Migraine
• Ganglion Cysts
• Migraine Disorders

Intervention

Procedure:
• 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

Drug:
• 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 medication overuse headache.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Total effective rate	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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