Actively Recruiting
Ultrasound-Guided Stellate Ganglion Block Compared to Standard Drug Treatment for Chronic Migraine in Adults: A Randomized Controlled Study
Led by Beijing Tiantan Hospital · Updated on 2025-01-17
206
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects and safety of stellate ganglion block (SGB) compared to traditional medication treatment for adults with chronic migraine who have not responded well to preventive drug therapies. This study aims to provide medical evidence supporting the use of a minimally invasive, safe, and effective non-drug treatment option for these patients. The trial focuses on patients aged 18 to 65 years diagnosed with chronic migraine according to established criteria who have failed or been intolerant to up to three prior prophylactic treatments. Participants will be randomly assigned to receive either the stellate ganglion block procedure or standardized drug treatment. The SGB involves an ultrasound-guided injection of 1% lidocaine near the stellate ganglion by experienced physicians while the patient lies in a supine position with the neck slightly extended. The drug treatment group will start topiramate at a low dose, increasing weekly during a 4-week period up to an effective dose or until side effects limit dosing, along with ibuprofen as needed for acute migraine attacks but limited to 10 times per month to avoid medication overuse headache. During the study, researchers will monitor changes in the average number of migraine days per month over a 6-month period. Participants will undergo regular assessments to track effectiveness and safety, including monitoring for side effects and adherence to treatment. The total participation duration is 6 months, during which the impact of the treatments on chronic migraine symptoms and patient well-being will be evaluated.
CONDITIONS
Official Title
Ultrasound-guided Stellate Ganglion Block for Treatment of Chronic Migraine in Adult
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 18 to 65 years
- Diagnosed with chronic migraine according to International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria
- No prior preventive migraine treatment or failed/intolerant to up to three prior prophylactic treatments including metoprolol/propranolol, amitriptyline, or flunarizine
You will not qualify if you...
- Body mass index (BMI) less than 15 kg/m2 or greater than 35 kg/m2
- Previous stellate ganglion block treatment
- History of other neurological disorders
- History of severe cardiopulmonary, liver, or kidney problems
- Allergic reaction to any study drugs
- Chronic opioid use
- Blood clotting problems with certain abnormal test results
- Infection or mass near injection site
- Neck structural changes from surgery or radiation
- Pregnant or breastfeeding
- Psychological disorders
- Refusal to sign informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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