Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-01-01 @ 5:18 PM
Study NCT ID:
NCT05235295
Status:
COMPLETED
Last Update Posted:
2022-11-01
First Post:
2022-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluoroscopic vs Ultrasound Guided Sacroiliac (SI) Joint Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-28', 'studyFirstSubmitDate': '2022-02-02', 'studyFirstSubmitQcDate': '2022-02-02', 'lastUpdatePostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in pain', 'timeFrame': 'Change from baseline pain score at 3 months', 'description': 'Pain assessment will be performed using the Visual Analogue Scale (VAS) score (0 = no pain, 10 = the most severe pain felt).'}], 'secondaryOutcomes': [{'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': 'Baseline to 3 months post-procedure', 'description': 'Mean Change from Baseline in functional disability scores based on Oswestry Disability Index. 0% to 20% indicate minimal disability, 21% to 40% indicate moderate disability, 41%-60% indicates severe disability, 61%-80% means crippled and 81%-100% indicates that the patient is either bed-bound or exaggerating his/her symptoms.'}, {'measure': 'Patient satisfaction Questionnaire', 'timeFrame': 'baseline to 3 months post-procedure', 'description': 'Satisfaction was measured on a 1 to 5 scale,Using score: 5-Excellent, 4-Very Good, 3-Good, 2-Fair, and 1-Poor'}, {'measure': 'Quantitative analgesic questionnaire', 'timeFrame': 'at 3 months post-procedure', 'description': 'A tool designed to record patient-reported pain medication use, create scores to quantify and compare it and track changes in analgesic drug use over time. A higher score indicates higher pain medication use'}, {'measure': 'Procedure time', 'timeFrame': 'Intraoperative', 'description': 'Procedure time was measured using a stopwatch. It was defined as the time from the start of the procedure, the initial image was obtained or first probe placement, until the end of the procedure defined as;transforaminal needle placement was seen clearly.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Chronic']}, 'descriptionModule': {'briefSummary': 'The investigators aimed to evaluate the effectiveness of intra-articular sacroiliac joint injection under fluoroscopy versus ultrasound guidance'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Low back and/or gluteal pain without radicular extension for more than 3 months\n* Tenderness over the SI joint\n* Pain score \\> 3 by Visual Analogue Scale\n\nExclusion Criteria:\n\n* Malignancy\n* Generalized or local infection\n* Coagulopathy\n* Allergy to drugs to be injected'}, 'identificationModule': {'nctId': 'NCT05235295', 'briefTitle': 'Fluoroscopic vs Ultrasound Guided Sacroiliac (SI) Joint Injection', 'organization': {'class': 'OTHER', 'fullName': 'Diskapi Teaching and Research Hospital'}, 'officialTitle': 'Fluoroscopic vs Ultrasound Guided Sacroiliac (SI) Joint Injection', 'orgStudyIdInfo': {'id': '126/05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluoroscopic-guided sacroiliac joint injection', 'interventionNames': ['Procedure: Flouroscopy-guided sacroiliac joint injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound-guided sacroiliac joint injection', 'interventionNames': ['Procedure: Ultrasound-guided sacroiliac joint injection']}], 'interventions': [{'name': 'Ultrasound-guided sacroiliac joint injection', 'type': 'PROCEDURE', 'description': 'Using ultrasound the sacral hiatus in transverse position was identified. Then, sliding laterally and cephalad in transverse position, the posterior superior iliac spine and the posterior sacroiliac joint were identified. The needle was advanced toward the posterior joint space from medial to lateral, using an in-plane technique.', 'armGroupLabels': ['Ultrasound-guided sacroiliac joint injection']}, {'name': 'Flouroscopy-guided sacroiliac joint injection', 'type': 'PROCEDURE', 'description': 'Using anterior posterior and contralateral oblique view the posterior joint line and inferior joint margin were identified and a needle was advanced at the point the posterior inferior joint line was most clearly seen.', 'armGroupLabels': ['Fluoroscopic-guided sacroiliac joint injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06110', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Diskapi Yildirim Beyazit Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diskapi Teaching and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Selin Guven Kose', 'investigatorAffiliation': 'Diskapi Teaching and Research Hospital'}}}}