Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2026-01-01 @ 7:31 AM
Study NCT ID:
NCT05247892
Status:
COMPLETED
Last Update Posted:
2022-11-02
First Post:
2022-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Ultrasound Versus Fluoroscopy Guided S1 Injections and Radiofrequency
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': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-31', 'studyFirstSubmitDate': '2022-02-01', 'studyFirstSubmitQcDate': '2022-02-09', 'lastUpdatePostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain scores', 'timeFrame': 'baseline to 6 months post-procedure', 'description': 'Visual analog scale (VAS) for pain at the follow-up time periods. The visual analog scale is a numerical scale from 0 to 10; with 0 representing no pain and 10 representing the worst pain imaginable.'}], 'secondaryOutcomes': [{'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': 'baseline to 6 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 6 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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Chronic']}, 'descriptionModule': {'briefSummary': 'The investigators aim to compare the effect of ultrasound versus floroscopy guided pulsed radiofrequency treatment of the lumbar dorsal root ganglion (DRG) of S1 in patients with a chronic lumbosacral radicular pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persistent pain score ≥ 4 on VAS, not responding to traditional treatments\n* Radicular pain in lumbar region for 3 months or more,\n* Pattern of radiation suggestive for S1 pathology\n\nExclusion Criteria:\n\n* Patient refusal\n* Coagulopathy\n* Uncooperative patients\n* Malignant disorder or currently under treatment for a malignant disorder\n* Pregnancy\n* Leg pain due to localized hip or knee pathology'}, 'identificationModule': {'nctId': 'NCT05247892', 'briefTitle': 'Effectiveness of Ultrasound Versus Fluoroscopy Guided S1 Injections and Radiofrequency', 'organization': {'class': 'OTHER', 'fullName': 'Diskapi Teaching and Research Hospital'}, 'officialTitle': 'Effectiveness of Ultrasound Versus Fluoroscopy Guided S1 Injections and Radiofrequency for the Management of Radicular Pain', 'orgStudyIdInfo': {'id': '121/12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fluoroscopic-guided S1 Radiofrequency stimulation', 'interventionNames': ['Procedure: Fluoroscopic-guided S1 Radiofrequency stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Ultrasound-guided S1 Radiofrequency stimulation', 'interventionNames': ['Procedure: Ultrasound-guided S1 Radiofrequency stimulation']}], 'interventions': [{'name': 'Ultrasound-guided S1 Radiofrequency stimulation', 'type': 'PROCEDURE', 'description': 'Pulsed radiofrequency stimulation of the S1 dorsal root ganglia under ultrasound-guidance', 'armGroupLabels': ['Ultrasound-guided S1 Radiofrequency stimulation']}, {'name': 'Fluoroscopic-guided S1 Radiofrequency stimulation', 'type': 'PROCEDURE', 'description': 'Pulsed radiofrequency stimulation of the S1 dorsal root ganglia under fluoroscopy-guidance', 'armGroupLabels': ['Fluoroscopic-guided S1 Radiofrequency stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06110', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Diskapi Yildirim Beyazit Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diskapi Teaching and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Selin Guven Kose', 'investigatorAffiliation': 'Diskapi Teaching and Research Hospital'}}}}