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| Name | Class |
|---|---|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| Qinghai People's Hospital | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRP+Lidocaine group | 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 |
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| Lidocaine group | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No interventions | Other | It is a observational study |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 50% responder rate | the proportion of patients who achieved a ≥50% reduction in monthly headache days. | at weeks 4, 8, 12. |
| Mean VAS score during headache attack | evaluation of the average severity of headache days |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Fang Luo, M.D. | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fang Luo | Beijing | Beijing Municipality | 100070 | China |
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| Not have interventions |
| Other |
It is a observational study |
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| at baseline and weeks 4, 8, 12. |
| Analgesic consumption | including the number of days, the specific drug used, and the dose of drugs. | at baseline and weeks 4, 8, 12. |
| Patient satisfaction (PS) scores | It ranges from 0 to 10 points, and 0 indicates unsatisfactory, while 10 points indicate very satisfactory.A higher scores mean a better satisfaction | at weeks 4, 8, 12. |
| Headache impact test version 6 (HIT-6) | 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 | at baseline and weeks 4, 8,12. |
| Migraine disability assessment (MIDAS) scores | 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. | at baseline and weeks 4, 8, 12. |
| Hospital anxiety and depression scale (HADS) scores | 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 | at baseline and weeks 4, 8, 12. |
| Pittsburgh sleep quality index (PSQI) scores | 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. | at baseline and weeks 4, 8, 12 |
| Adverse events | 9. including SGB-related complication and medication-related complication. | at day 0, 1, weeks 1, 4, 8, 12 |