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

NCT06322407 | Recruiting

• 1 other identifier: KY2023-263-03-02
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Migraine

Keywords

Chronic Migraine; Stellate Ganglion Block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Proportion of patients achieved≥50% reduction in monthly migraine days

  1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery

• Total 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

  at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery

• Patients satisfaction (PS)

  1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery

• The six item headache impact test (HIT-6)

  at baseline, 1 month, 2 months, 3 months, 4 month，5 month and 6 month after surgery

Study Arms (2)

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;

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

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.

Drug: standardized drug treatment

Interventions

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

Also known as: Ultrasound-guided Stellate Ganglion Block (SGB)

Stellate Ganglion Block plus standardized drug treatment group

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.

Also known as: topiramate plus ibuprofen

Stellate Ganglion Block plus standardized drug treatment group; standardized drug treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Interventions

Topiramate; Ibuprofen

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single (Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Day surgery and Pain Management

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 21, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)