Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-22 @ 9:37 PM
Study NCT ID:
NCT04167956
Status:
UNKNOWN
Last Update Posted:
2020-10-28
First Post:
2019-10-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial of Ultrasound Combined With Computed Tomography Guided Lumbar Sympathetic Ganglion Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 246}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-26', 'studyFirstSubmitDate': '2019-10-17', 'studyFirstSubmitQcDate': '2019-11-18', 'lastUpdatePostDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The success rate of block', 'timeFrame': 'through study completion, an average of 7 days', 'description': 'Numerical rating score（NRS） less than 4'}], 'secondaryOutcomes': [{'measure': 'The skin temperature', 'timeFrame': '10 minutes', 'description': 'The skin temperature'}, {'measure': 'The toe perfusion index', 'timeFrame': '10 minutes', 'description': 'The toe perfusion index'}, {'measure': 'The number of patients satisfied with the first angiography', 'timeFrame': 'immediately', 'description': 'The number of patients satisfied with the first angiography'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lumbar sympathetic', 'ultrasound'], 'conditions': ['Pain, Chronic', 'Sympathetic Disorder', 'Ultrasound Therapy']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of ultrasound combined with CT-guided sympathetic ganglion block for refractory pain caused by sympathetic neuropathy of the lower extremities.', 'detailedDescription': 'To evaluate the safety and efficacy of ultrasound combined with CT-guided sympathetic ganglion block for refractory pain caused by sympathetic neuropathy of the lower extremities. Patients with lumbar sympathetic block were enrolled and randomized to a conventional CT-guided group and an ultrasound-guided CT-guided group. By comparing the traditional CT guided and ultrasound combined with CT guided two programs, the radiation dose, block success rate, treatment time, etc. received by patients with lumbar sympathetic block were observed to understand whether ultrasound combined with CT guidance is a way to reduce radiation exposure. Under the premise of the dose, the method of blocking the success rate can still be guaranteed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1.18\\~80 years old; 2.Pain disorders requiring lumbar sympathetic block（Such as,Lower limb vascular disfunction,Diabetic polyneuropathy,Postherpetic neuralgia,Complex regional pain syndrome I and II,Cancer related neuropathic pain including Peripheral neuropathy caused by chemotherapy or other lower extremity sympathetic neuropathy）,conservative treatment for 3 months or longer can not be cured; 3.Numerical rating score≥4.\n\nExclusion Criteria:\n\n1. Body mass index\\> 30 kg / m2;\n2. History of internal fixation in posterior lumbar laminectomy or any serious anatomic variation, such as scoliosis and tumors;\n3. History of lumbar sympathetic neurochemistry or thermal neurolysis;\n4. Pregnancy;\n5. The puncture site is infected;\n6. Coagulation dysfunction;\n7. Allergic to local anesthetic or contrast agent;\n8. Cognitive impairment or inability to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT04167956', 'briefTitle': 'Clinical Trial of Ultrasound Combined With Computed Tomography Guided Lumbar Sympathetic Ganglion Block', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Clinical Trial of Ultrasound Combined With Computed Tomography Guided Lumbar Sympathetic Ganglion Block for the Safety and Efficacy of Patients With Refractory Pain Caused by Sympathetic Neuropathy of Lower Extremities', 'orgStudyIdInfo': {'id': 'ym20191016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ultrasound combined with CT guided', 'description': 'ultrasound combined with CT guided lumbar sympathetic ganglion block in patients with intractable pain caused by sympathetic neuropathy of lower extremities', 'interventionNames': ['Device: ultrasound and CT']}, {'type': 'SHAM_COMPARATOR', 'label': 'CT guided', 'description': 'CT guided lumbar sympathetic ganglion block in patients with intractable pain caused by sympathetic neuropathy of lower extremities', 'interventionNames': ['Device: ultrasound and CT']}], 'interventions': [{'name': 'ultrasound and CT', 'type': 'DEVICE', 'description': 'Experimental: ultrasound combined with CT guided Active Comparator: CT guided', 'armGroupLabels': ['CT guided', 'ultrasound combined with CT guided']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Yan, Doctor', 'role': 'CONTACT', 'email': 'zryanmin@zju.edu.cn', 'phone': '13757118632', 'phoneExt': '13252017900'}], 'facility': 'The second affiliated hospital of Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Min Yan, Doctor', 'role': 'CONTACT', 'email': 'zryanmin@zju.edu.cn', 'phone': '13757118632'}], 'overallOfficials': [{'name': 'Min Yan, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, {'name': "First People's Hospital of Hangzhou", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}