Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
Study NCT ID:
NCT00371618
Status:
WITHDRAWN
Last Update Posted:
2015-10-21
First Post:
2006-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IPM Procedures With or Without Fluoroscopy: Outcome Comparison
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D019547', 'term': 'Neck 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '1998-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2004-05'}, 'lastUpdateSubmitDate': '2015-10-20', 'studyFirstSubmitDate': '2006-09-01', 'studyFirstSubmitQcDate': '2006-09-01', 'lastUpdatePostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To demonstrate clinically significant improvement in the patients undergoing procedures under fluoroscopy.'}, {'measure': 'To evaluate and compare the adverse event profile in both groups'}]}, 'conditionsModule': {'keywords': ['Fluoroscopy', 'Interventional Pain Management Procedures'], 'conditions': ['Low Back Pain', 'Neck Pain']}, 'descriptionModule': {'briefSummary': 'To determine clinically significant improvement in the patients undergoing procedures under fluoroscopy.\n\nTo evaluate and compare the adverse event profile in both groups', 'detailedDescription': 'For the target delivery of injectate, it is believed that fluoroscopy is mandatory. However, there is a view among some professionals that a procedure may be performed without fluoroscopy as effectively as under fluoroscopy. The outcomes among the two groups of patients have not been studied'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'currently enrolled patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients who have undergone the following procedures:\n\nCervical facet joint nerve blocks, thoracic facet joint nerve blocks, lumbar facet joint nerve blocks, lumbar interlaminar epidural steroid injections, cervical Interlaminar epidural steroid injections\n\nDuring 1998 to 2001 and 2004 to 2005\n\n\\-\n\nExclusion Criteria: Non-availability of appropriate data'}, 'identificationModule': {'nctId': 'NCT00371618', 'briefTitle': 'IPM Procedures With or Without Fluoroscopy: Outcome Comparison', 'organization': {'class': 'OTHER', 'fullName': 'Pain Management Center of Paducah'}, 'officialTitle': 'Comparison of Outcomes of Interventional Pain Management Procedures Performed With or Without Fluoroscopy: A Retrospective Analysis', 'orgStudyIdInfo': {'id': 'protocol 13'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fluoroscopy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '42003', 'city': 'Paducah', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Ambulatory Surgery Center', 'geoPoint': {'lat': 37.08339, 'lon': -88.60005}}], 'overallOfficials': [{'name': 'Laxmaiah Manchikanti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ambulatory Surgery Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pain Management Center of Paducah', 'class': 'OTHER'}}}}