Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-01 @ 8:45 PM
Study NCT ID:
NCT04964804
Status:
COMPLETED
Last Update Posted:
2021-07-16
First Post:
2021-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of Real-time Ultrasound-CT Fusion Imaging and Ultrasound-guided Selective Lumbar Nerve Root Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2016-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-06', 'studyFirstSubmitDate': '2021-06-27', 'studyFirstSubmitQcDate': '2021-07-06', 'lastUpdatePostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1 month VAS pain score', 'timeFrame': 'VAS pain scores were performed 1 month after surgery', 'description': 'Patients undergo VAS pain score after the sonographer performs selective lumbar nerve root block puncture'}, {'measure': '3 month VAS pain score', 'timeFrame': 'VAS pain scores were performed 3 month after surgery', 'description': 'Patients undergo VAS pain score after the sonographer performs selective'}, {'measure': '6 month VAS pain score', 'timeFrame': 'VAS pain scores were performed 6 month after surgery', 'description': 'Patients undergo VAS pain score after the sonographer performs selective'}, {'measure': '12 month VAS pain score', 'timeFrame': 'VAS pain scores were performed 12 month after surgery', 'description': 'Patients undergo VAS pain score after the sonographer performs selective'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The study is aimed at patients with low back and leg pain. The experimental group of patients underwent selective lumbar nerve root block puncture under real-time ultrasound-CT fusion imaging by sonographers, and the control group underwent puncture under the guidance of ultrasound alone by sonographers.', 'detailedDescription': 'A total of 60 patients with low back and leg pain were randomly divided into two groups, 30 people in each group. Patients in the experimental group underwent selective lumbar nerve root block puncture under the real-time ultrasound-CT fusion imaging of the sonographer, and the control group underwent puncture under the sole ultrasound guidance of the sonographer. This study was used to compare the difference between the effects of pure ultrasound guidance and ultrasound-CT fusion imaging guidance on selective lumbar nerve root block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients who need lumbar nerve root block treatment\n\nExclusion Criteria:\n\n1. Tumor patients\n2. Patients who have had lumbar spine surgery before'}, 'identificationModule': {'nctId': 'NCT04964804', 'briefTitle': 'Comparative Study of Real-time Ultrasound-CT Fusion Imaging and Ultrasound-guided Selective Lumbar Nerve Root Block', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Comparative Study of Real-time Ultrasound-CT Fusion Imaging and Ultrasound-guided Selective Lumbar Nerve Root Block', 'orgStudyIdInfo': {'id': 'M2016207'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'real-time ultrasound-CT fusion imaging', 'description': 'The experimental group of patients underwent selective lumbar nerve root block puncture under real-time ultrasound-CT fusion imaging by sonographers', 'interventionNames': ['Procedure: real-time ultrasound-CT fusion imaging']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ultrasound alone', 'description': 'The control group underwent puncture under the guidance of ultrasound alone by sonographers', 'interventionNames': ['Procedure: ultrasound alone']}], 'interventions': [{'name': 'real-time ultrasound-CT fusion imaging', 'type': 'PROCEDURE', 'description': 'selective lumbar nerve root block puncture under real-time ultrasound-CT fusion imaging', 'armGroupLabels': ['real-time ultrasound-CT fusion imaging']}, {'name': 'ultrasound alone', 'type': 'PROCEDURE', 'description': 'selective lumbar nerve root block puncture under the guidance of ultrasound alone', 'armGroupLabels': ['ultrasound alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Department of Ultrasound Diagnosis, Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Jinrui Wang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peking University Third Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}