Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT06653218
Status:
RECRUITING
Last Update Posted:
2025-08-05
First Post:
2024-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Stellate Ganglion Block With Lidocaine Combined Platelet-rich Plasma to Treat Chronic Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-03', 'studyFirstSubmitDate': '2024-10-20', 'studyFirstSubmitQcDate': '2024-10-20', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the change from baseline in mean headache days across the 1-month follow-up period.', 'timeFrame': '1-month period', 'description': 'the change from baseline in mean headache days across the 1-month follow-up period.'}], 'secondaryOutcomes': [{'measure': '50% responder rate', 'timeFrame': 'at weeks 4, 8, 12.', 'description': 'the proportion of patients who achieved a ≥50% reduction in monthly headache days.'}, {'measure': 'Mean VAS score during headache attack', 'timeFrame': 'at baseline and weeks 4, 8, 12.', 'description': 'evaluation of the average severity of headache days'}, {'measure': 'Analgesic consumption', 'timeFrame': 'at baseline and weeks 4, 8, 12.', 'description': 'including the number of days, the specific drug used, and the dose of drugs.'}, {'measure': 'Patient satisfaction (PS) scores', 'timeFrame': 'at weeks 4, 8, 12.', 'description': 'It ranges from 0 to 10 points, and 0 indicates unsatisfactory, while 10 points indicate very satisfactory.A higher scores mean a better satisfaction'}, {'measure': 'Headache impact test version 6 (HIT-6)', 'timeFrame': 'at baseline and weeks 4, 8,12.', 'description': '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'}, {'measure': 'Migraine disability assessment (MIDAS) scores', 'timeFrame': 'at baseline and weeks 4, 8, 12.', 'description': '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.'}, {'measure': 'Hospital anxiety and depression scale (HADS) scores', 'timeFrame': 'at baseline and weeks 4, 8, 12.', 'description': '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'}, {'measure': 'Pittsburgh sleep quality index (PSQI) scores', 'timeFrame': 'at baseline and weeks 4, 8, 12', 'description': '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.'}, {'measure': 'Adverse events', 'timeFrame': 'at day 0, 1, weeks 1, 4, 8, 12', 'description': '9\\. including SGB-related complication and medication-related complication.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Platelet-rich Plasma', 'Chronic Migraine'], 'conditions': ['Platelet-rich Plasma', 'Chronic Migraine']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 18 to 75 years;\n2. BMI between 15 and 35 kg/m2 ;\n3. 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);\n4. Visual Analogue Scale (VAS; range, 0-10; 0 = no pain and 10 = worst possible pain; higher scores indicate more severe pain) score≥4;\n5. Scheduled for lidocaine acting on SGB treatment for CM；\n6. Signed informed consent.\n\nExclusion Criteria:\n\n1. Previously received SGB treatment;\n2. Combined with other types of headaches;\n3. Platelet count \\<105\\*109/L, use of anticoagulants or antiplatelet agent, coagulation disorders or bleeding disorders;\n4. Infection or mass near the puncture site;\n5. A history of other neurological disorders;\n6. A history of severe cardiopulmonary, hepatic or renal dysfunction;\n7. A history of psychological disorders;\n8. A history of narcotic drug abuse;\n9. Changes in neck anatomic structure caused by radiotherapy or surgery;\n10. A history of allergies to any research drugs;\n11. Pregnancy or lactation period.'}, 'identificationModule': {'nctId': 'NCT06653218', 'briefTitle': 'Efficacy and Safety of Stellate Ganglion Block With Lidocaine Combined Platelet-rich Plasma to Treat Chronic Migraine', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'KY-2023-263-03-06'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PRP+Lidocaine group', 'description': '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', 'interventionNames': ['Other: No interventions']}, {'label': 'Lidocaine group', 'description': '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', 'interventionNames': ['Other: Not have interventions']}], 'interventions': [{'name': 'No interventions', 'type': 'OTHER', 'description': 'It is a observational study', 'armGroupLabels': ['PRP+Lidocaine group']}, {'name': 'Not have interventions', 'type': 'OTHER', 'description': 'It is a observational study', 'armGroupLabels': ['Lidocaine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100070', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fang Luo', 'role': 'CONTACT', 'email': '13611326978@163.com', 'phone': '59976661'}], 'facility': 'Fang Luo', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Lu Liu, M.D.', 'role': 'CONTACT', 'email': 'emmaliulu@163.com', 'phone': '+8618618418228'}], 'overallOfficials': [{'name': 'Fang Luo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tiantan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'not yet decided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, {'name': "Qinghai People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Department of pain management', 'investigatorFullName': 'Fang Luo', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}