Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-03-01 @ 9:54 PM
Study NCT ID:
NCT02343432
Status:
COMPLETED
Last Update Posted:
2015-01-22
First Post:
2014-11-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is the Efficacy of Epidural Steroid Injections Related to the Different Volume Injections?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-02-01', 'releaseDate': '2015-12-28'}, {'resetDate': '2018-04-17', 'releaseDate': '2018-03-21'}], 'estimatedResultsFirstSubmitDate': '2015-12-28'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-15', 'studyFirstSubmitDate': '2014-11-08', 'studyFirstSubmitQcDate': '2015-01-15', 'lastUpdatePostDateStruct': {'date': '2015-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS (visual analog scale) [O= no pain, 10 = unbearable pain]', 'timeFrame': '2 weeks'}, {'measure': 'SLET(straight leg elevation test) [0° = worst, 85° = best]', 'timeFrame': '2 weeks'}, {'measure': 'Oswestry Disability Index; ODI [0% to 20%:minimal disability , 80% to 100%:bed bound patients]', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anesthesia', 'Adverse Effect', 'Spinal', 'Epidural'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '16449834', 'type': 'BACKGROUND', 'citation': 'Runu R, Sinha NK, Pai R, Shankar PR, Vijayabhaskar P. Our experience with epidural steroid injections in management of low backpain and sciatica. Kathmandu Univ Med J (KUMJ). 2005 Oct-Dec;3(4):349-54.'}]}, 'descriptionModule': {'briefSummary': 'This study was aimed to investigate the impact of using different epidural volumes.\n\nPatients with acute discogenic pain were included in the study.', 'detailedDescription': 'Objectives: This study was aimed to investigate the impact of using different epidural volumes.\n\nMethods: Seventy five patients with acute discogenic pain were included in the study.The patients were randomly assigned to three groups. All patients received a single epidural dose of triamcinolone \\[80 mg\\] and 12.5 mg bupivacaine combination. The patients in Group 1, Group 2 and Group 3 received a volume of 10 mL, 15 mL, and 20 mL by epidural injections, respectively. The efficacy of treatment was assessed with VAS (visual analog scale) \\[O= no pain, 10 = unbearable pain\\], SLET(straight leg elevation test) \\[0° = worst, 85° = best\\], and Oswestry Disability Index; ODI \\[0% to 20%:minimal disability , 80% to 100%:bed bound patients\\] before and 2 weeks after the EPSI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute discogenic pain with less than three months duration not responding to other modalities of conservative management \\[NSAIDs, physiotherapy, bracing, etc.\\],\n* radiological disc bulging accompanying unilateral root impingement symptoms,\n* an Oswestry daily activity score more than 20 percent, and\n* resistance to treatment.\n\nExclusion Criteria:\n\n* Patients with bilateral root impingement symptoms, neurological deficits, and/or history of previous lumbar disc surgery, severe cardiac, pulmonary, gastrointestinal, renal diseases, glaucoma, urinary retention, and/or known allergy to the drugs used in the study were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT02343432', 'briefTitle': 'Is the Efficacy of Epidural Steroid Injections Related to the Different Volume Injections?', 'organization': {'class': 'OTHER', 'fullName': 'Yeditepe University Hospital'}, 'officialTitle': 'Is the Efficacy of Epidural Steroid Injections Related to the Different Volume Injections? :A Randomised, Clinical Trial', 'orgStudyIdInfo': {'id': '03-2008/23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Epidural Volume 10mL', 'description': 'Epidural Volume 10mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 10mL Intervention: Drug: Bupivacaine 12.5mg', 'interventionNames': ['Drug: Triamcinolone', 'Drug: Epidural Volume', 'Drug: Bupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Epidural Volume 15mL', 'description': 'Epidural Volume 15mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 15 mL Intervention: Drug: Bupivacaine 12.5mg', 'interventionNames': ['Drug: Triamcinolone', 'Drug: Epidural Volume', 'Drug: Bupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Epidural Volume 20mL', 'description': 'Epidural Volume 20mL, Intervention: Drug: Triamcinolone 80 mg Intervention: Drug: Epidural Volume 20 mL Intervention: Drug: Bupivacaine 12.5mg', 'interventionNames': ['Drug: Triamcinolone', 'Drug: Epidural Volume', 'Drug: Bupivacaine']}], 'interventions': [{'name': 'Triamcinolone', 'type': 'DRUG', 'otherNames': ['Kelanocort'], 'description': 'Triamcinolone', 'armGroupLabels': ['Epidural Volume 10mL', 'Epidural Volume 15mL', 'Epidural Volume 20mL']}, {'name': 'Epidural Volume', 'type': 'DRUG', 'description': 'Epidural Volume', 'armGroupLabels': ['Epidural Volume 10mL', 'Epidural Volume 15mL', 'Epidural Volume 20mL']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'otherNames': ['Marcaine'], 'description': 'Bupivacaine', 'armGroupLabels': ['Epidural Volume 10mL', 'Epidural Volume 15mL', 'Epidural Volume 20mL']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lütfiye Budak', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Gaziantep'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neslihan Uztüre', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Gaziantep', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'assistant proffessor', 'investigatorFullName': 'Neslihan Uztüre', 'investigatorAffiliation': 'Yeditepe University Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-12-28', 'type': 'RELEASE'}, {'date': '2016-02-01', 'type': 'RESET'}, {'date': '2018-03-21', 'type': 'RELEASE'}, {'date': '2018-04-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Neslihan Uztüre, assistant proffessor, Yeditepe University Hospital'}}}}