Efficacy and Safety of Stellate Ganglion Block With Lidocaine Combined Platelet-rich Plasma to Tr⦠(NCT06653218) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Safety of Stellate Ganglion Block With Lidocaine Combined Platelet-rich Plasma to Treat Chronic Migraine
China200 participantsStarted 2024-10-20
Plain-language summary
This is a multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study designed to compare the effectiveness and safety of lidocaine combined Platelet-rich plasma (PRP) acting on SGB versus lidocaine alone acting on SGB in patients with CM.
Who can participate
Age range18 Years β 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
β. Age between 18 to 75 years;
β. BMI between 15 and 35 kg/m2 ;
β. Diagnosed with CM in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3) criteria (Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211);
β. Visual Analogue Scale (VAS; range, 0-10; 0 = no pain and 10 = worst possible pain; higher scores indicate more severe pain) scoreβ₯4;
β. Scheduled for lidocaine acting on SGB treatment for CMοΌ
β. Signed informed consent.
Exclusion criteria
β. Previously received SGB treatment;
β. Combined with other types of headaches;
β. Platelet count \<105\*109/L, use of anticoagulants or antiplatelet agent, coagulation disorders or bleeding disorders;
β. Infection or mass near the puncture site;
β. A history of other neurological disorders;
β. A history of severe cardiopulmonary, hepatic or renal dysfunction;
β. A history of psychological disorders;
What they're measuring
1
the change from baseline in mean headache days across the 1-month follow-up period.