Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-03 @ 3:12 AM
Study NCT ID:
NCT01816334
Status:
COMPLETED
Last Update Posted:
2016-03-24
First Post:
2013-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Nonsteroidal Antiinflammatory (NSAI)Drug and Glucocorticoids in Acute Sciatica
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012585', 'term': 'Sciatica'}], 'ancestors': [{'id': 'D020426', 'term': 'Sciatic Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'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': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D007660', 'term': 'Ketoprofen'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-23', 'studyFirstSubmitDate': '2013-03-14', 'studyFirstSubmitQcDate': '2013-03-19', 'lastUpdatePostDateStruct': {'date': '2016-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean visual analogue scale (VAS) for leg pain (radicular pain) in 3 groups', 'timeFrame': 'From day 0 to day 5', 'description': 'VAS is measured in millimiters (0 to 100). This pain score is recommended in rheumatologic units in France.'}], 'secondaryOutcomes': [{'measure': 'Mean visual analogue scale (VAS) for back pain in 3 groups', 'timeFrame': 'From day 0 to day 5', 'description': 'VAS is measured in millimeters (0 to 100).'}, {'measure': 'Assess drug compliance', 'timeFrame': 'From day 0 to day 5', 'description': 'Drug compliance is estimated based on the proportion of the treatment actually administered.'}, {'measure': 'The effect of treatment on the EIFEL Questionnaire', 'timeFrame': 'At baseline, 1 and 3 months after intervention', 'description': 'The EIFEL questionnaire is the translation of the Roland Morris Disability Questionnaire (RMDQ) and has been validated in acute low back pain.'}, {'measure': "Improvement in Lasegue's sign compared to baseline", 'timeFrame': 'At baseline, Day 1,2,3,4 and 5 of study period', 'description': "Lasegue's sign is the lumbar pain experienced by the patient on passive movement of the legs during flexion of hip joint i.e. passive straight leg raising. It is assessed as either 'Positive' or 'Negative' sign."}, {'measure': "Assess Schober's test", 'timeFrame': 'From Day 0 to Day 5', 'description': "Schober's test is a test used in rheumatology to measure the ability of patient to flex their lower back"}, {'measure': 'Analgesic consumption', 'timeFrame': 'At baseline, day 0, 1, 2, 3, 4 and day 5, 1 and 3 months', 'description': 'Analgesic consumption between active treatment group and placebo group was registered and differences between groups were calculated and presented as percentual differences.'}, {'measure': 'Surgery or lumbar epidural injection', 'timeFrame': 'At 1 and 3 months after intervention', 'description': 'Number of patient having surgery and/or lumbar epidural injection during study period'}, {'measure': 'Clinical tolerance: adverse events and/or high blood pressure', 'timeFrame': 'at baseline, day 1, 2 3, 4 and 5', 'description': 'Number of adverse events and/or high blood pressure between intervention group.'}, {'measure': 'Biological tolerance', 'timeFrame': 'at baseline, day 3 and 5', 'description': 'measures of leukocytes, erythrocytes, hemoglobin, platelets, serum sodium, potassium, glucose, plasma creatinine between intervention group'}, {'measure': 'Glycemic levels', 'timeFrame': 'at baseline, day 1 to 5', 'description': 'monitoring of glycemic status is measured for each day of treatment'}, {'measure': 'Number of days of hospitalisation sick leave, number of days lost to illness', 'timeFrame': 'At baseline, 1 and 3 months', 'description': 'To assess the cost of sciatica for society'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['sciatica', 'Anti-Inflammatory Agents, Non-Steroidal', 'Glucocorticoids'], 'conditions': ['Sciatica']}, 'referencesModule': {'references': [{'pmid': '21525139', 'type': 'BACKGROUND', 'citation': 'Roncoroni C, Baillet A, Durand M, Gaudin P, Juvin R. Efficacy and tolerance of systemic steroids in sciatica: a systematic review and meta-analysis. Rheumatology (Oxford). 2011 Sep;50(9):1603-11. doi: 10.1093/rheumatology/ker151. Epub 2011 Apr 27.'}, {'pmid': '17909211', 'type': 'BACKGROUND', 'citation': 'Chou R, Huffman LH; American Pain Society; American College of Physicians. Medications for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007 Oct 2;147(7):505-14. doi: 10.7326/0003-4819-147-7-200710020-00008.'}, {'pmid': '11132976', 'type': 'BACKGROUND', 'citation': 'Vroomen PC, de Krom MC, Slofstra PD, Knottnerus JA. Conservative treatment of sciatica: a systematic review. J Spinal Disord. 2000 Dec;13(6):463-9. doi: 10.1097/00002517-200012000-00001.'}, {'pmid': '9165992', 'type': 'BACKGROUND', 'citation': 'Koes BW, Scholten RJ, Mens JM, Bouter LM. Efficacy of non-steroidal anti-inflammatory drugs for low back pain: a systematic review of randomised clinical trials. Ann Rheum Dis. 1997 Apr;56(4):214-23. doi: 10.1136/ard.56.4.214.'}, {'pmid': '17415595', 'type': 'BACKGROUND', 'citation': 'Luijsterburg PA, Verhagen AP, Ostelo RW, van Os TA, Peul WC, Koes BW. Effectiveness of conservative treatments for the lumbosacral radicular syndrome: a systematic review. Eur Spine J. 2007 Jul;16(7):881-99. doi: 10.1007/s00586-007-0367-1. Epub 2007 Apr 6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether anti-inflammatory drugs or glucocorticoids are effective in the treatment of acute sciatica'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* sciatica \\<8 weeks resistant to all treatments in ambulatory\n* Acute low back pain\\> 48 hours;\n* Non-deficit patients;\n* Initial VAS\\> 40/100;\n* Consent of patient\n* Conflict disco-radicular concordance with the clinical computed tomography scan or magnetic resonance imaging.\n* No of contraindications to methylprednisolone, ketoprofen;\n* No registration to another protocol;\n\nExclusion Criteria:\n\n* Pregnant, parturient, lactating mother;\n* Diabetic patient;\n* Patient with syndrome from narrowing of the lumbar vertebral canal\n* Patient with a history of lumbar surgery \\<1 year;\n* Patient with a Cauda equina syndrome or major motor disability;\n* Crural neuralgia\n* Patient with a deficit;\n* Suspicion of sciatica secondary, ie not conflict-related disco-root: infectious neuritis, fracture on spinal bone tumor ...\n\nassociated treatment or pathology contra-indicating administration methylprednisolone, ketoprofen.'}, 'identificationModule': {'nctId': 'NCT01816334', 'acronym': 'TéAGS', 'briefTitle': 'Safety and Efficacy of Nonsteroidal Antiinflammatory (NSAI)Drug and Glucocorticoids in Acute Sciatica', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Safety and Efficacy of Nonsteroidal Antiinflammatory Drug and Glucocorticoids in Acute Sciatica', 'orgStudyIdInfo': {'id': '1201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'methylprednisolone', 'description': 'administration of 60 mg of methylprednisolone at 8:00 am and 100 ml of 0.9 % sodium chloride (placebo) at 6:00 pm', 'interventionNames': ['Drug: methylprednisolone', 'Drug: Sodium Chloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ketoprofen', 'description': 'administration of 100 mg of ketoprofen at 8:00 am and at 6:00 pm', 'interventionNames': ['Drug: Ketoprofen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'sodium chloride', 'description': 'administration of 100 ml of 0.9% sodium chloride (placebo) at 8:00 am and at 6:00 pm', 'interventionNames': ['Drug: Sodium Chloride']}], 'interventions': [{'name': 'methylprednisolone', 'type': 'DRUG', 'armGroupLabels': ['methylprednisolone']}, {'name': 'Ketoprofen', 'type': 'DRUG', 'armGroupLabels': ['Ketoprofen']}, {'name': 'Sodium Chloride', 'type': 'DRUG', 'armGroupLabels': ['methylprednisolone', 'sodium chloride']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38130', 'city': 'Échirolles', 'country': 'France', 'facility': 'CHU Hôpital Sud', 'geoPoint': {'lat': 45.14603, 'lon': 5.71441}}, {'zip': '38410', 'city': 'Uriage-les-Bains', 'country': 'France', 'facility': "CH d'Uriage", 'geoPoint': {'lat': 45.13786, 'lon': 5.82577}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}