NCT06653218|CompletedDMC
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Sponsor study identifier
observational
200
1 country
1
Study Start
October 20, 2024
Actual (reported)Primary Completion
June 30, 2025
Actual (reported)Study Completion
September 30, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 20, 2024
Actual (reported)October 20, 2024
Actual (reported)October 22, 2024
Actual (reported)June 30, 2025
Actual (reported)September 30, 2025
Actual (reported)the change from baseline in mean headache days across the 1-month follow-up period.
the change from baseline in mean headache days across the 1-month follow-up period.
1-month period
50% responder rate
at weeks 4, 8, 12.
Mean VAS score during headache attack
at baseline and weeks 4, 8, 12.
Analgesic consumption
at baseline and weeks 4, 8, 12.
Patient satisfaction (PS) scores
at weeks 4, 8, 12.
Headache impact test version 6 (HIT-6)
at baseline and weeks 4, 8,12.
Patients will be placed in the supine position, with slightly excessive neck extension to receive stellate ganglion block (SGB). And 2.5 ml of PRP combined with 2.5 ml of 1.0% lidocaine will be injected slowly into the ipsilateral stellate ganglion under the guide of ultrasound visualization technology
Patients will be placed in the supine position, with slightly excessive neck extension to receive stellate ganglion block (SGB). And 5 ml of 1.0% lidocaine will be injected slowly into the ipsilateral stellate ganglion under the guide of ultrasound visualization technology
It is a observational study
It is a observational study
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
We speculate that the reduction value in monthly headache days after PRP combined lidocaine acting on SGB is expected to 2.0, and the standard deviation (SD) for the PRP group is 9.0. Assuming a 20% rate of loss to follow-up and an additional 40% loss after PSM, a total of 200 participants will provide 90% power to use a 0.05 two tailed alpha to detect the significant difference in the monthly headache days. Three participating centers will compete to enroll patients.
Fang Luo
Beijing, Beijing Municipality, 100070, China
Fang Luo, M.D.
Beijing Tiantan Hospital
200 participants (actual enrollment reported by the registry).
First Submitted
October 20, 2024
First Posted
October 22, 2024
Study Start
October 20, 2024
Actual (reported)Correlation Between Gut Microbiota and Pancreatic Β-Cell Function in Diabetic Patients
Contact the study team to confirm eligibility.
Primary Completion
June 30, 2025
Actual (reported)Study Completion
September 30, 2025
Actual (reported)Last Updated
February 12, 2026
Record last verified: 2026-02
not yet decided
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Source: ClinicalTrials.gov.
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