Fang Luo
Beijing, Beijing Municipality, 100070, China
NCT Number: NCT06653218
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.
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Notify Me18 year–75 year
All sexes
Observational
Beijing, Beijing Municipality, 100070, China
Chronic migraine (CM) is a disabling disease that causes serious physical and emotional consequences. Previous studies had suggested the efficacy of stellate ganglion block (SGB) with lidocaine in the treatment of CM. However, the side effects related to repeated procedures limit its applications. Platelet-rich plasma (PRP) as an intervention treatment for chronic pain, has shown promising results to alleviate headache within the distribution range of the greater occipital nerve after trauma. So far, there has not been any report on PRP combined with lidocaine acting on SGB for CM. the investigators will conduct this multicenter, prospective, observational, propensity score matching, cohort, and assessor-blinded study to evaluate the efficacy and safety of lidocaine combined PRP acting on SGB versus lidocaine alone acting on SGB in patients with CM
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
It is a observational study
It is a observational study
Time frame: 1-month period
the change from baseline in mean headache days across the 1-month follow-up period.
Time frame: at weeks 4, 8, 12.
the proportion of patients who achieved a ≥50% reduction in monthly headache days.
Time frame: at baseline and weeks 4, 8, 12.
evaluation of the average severity of headache days
Time frame: at baseline and weeks 4, 8, 12.
including the number of days, the specific drug used, and the dose of drugs.
Time frame: at weeks 4, 8, 12.
It ranges from 0 to 10 points, and 0 indicates unsatisfactory, while 10 points indicate very satisfactory.A higher scores mean a better satisfaction
Time frame: at baseline and weeks 4, 8,12.
a six-item survey that assesses the adverse impact of headaches on social, role and cognitive functioning, vitality, and psychological distress.A larger score reflects a greater adverse impact. It ranges from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the respondent
Time frame: at baseline and weeks 4, 8, 12.
to evaluate headache-related disability using 4-week recall, and is associated with headache frequency and average pain score.The score ranges from 0 to 270. Higher scores indicate greater disability caused by headaches with scores of 21 or greater considered severe.
Time frame: at baseline and weeks 4, 8, 12.
a 14-item self-report instrument used to screen for anxiety and depression separately.The range of the scale is 0 to 21, with scores of 8 to 10 being indicative of a probable risk of anxiety or depression, whereas scores of 11 to 21 indicate a high risk of anxiety or depression
Time frame: at baseline and weeks 4, 8, 12
a 19-item self-report instrument that comprises 7 components used to assess quality of sleep. The range of the scale is 0 to 21,with a higher score indicating more severe sleep disturbances.
Time frame: at day 0, 1, weeks 1, 4, 8, 12
Beijing Tiantan Hospital
Other
Efficacy and Safety of Stellate Ganglion Block With Lidocaine Combined Platelet-rich Plasma to Treat Chronic Migraine: a Protocol of a Multi-center, Prospective, Propensity Score-matched, Cohort Analysis
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