Safety and Efficacy of Nonsteroidal Antiinflammatory (NSAI)Drug and Glucocorticoids in Acute Sciatica
NCT ID: NCT01816334
Last Updated: 2016-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2013-01-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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methylprednisolone
administration of 60 mg of methylprednisolone at 8:00 am and 100 ml of 0.9 % sodium chloride (placebo) at 6:00 pm
methylprednisolone
Sodium Chloride
Ketoprofen
administration of 100 mg of ketoprofen at 8:00 am and at 6:00 pm
Ketoprofen
sodium chloride
administration of 100 ml of 0.9% sodium chloride (placebo) at 8:00 am and at 6:00 pm
Sodium Chloride
Interventions
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methylprednisolone
Ketoprofen
Sodium Chloride
Eligibility Criteria
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Inclusion Criteria
* Acute low back pain\> 48 hours;
* Non-deficit patients;
* Initial VAS\> 40/100;
* Consent of patient
* Conflict disco-radicular concordance with the clinical computed tomography scan or magnetic resonance imaging.
* No of contraindications to methylprednisolone, ketoprofen;
* No registration to another protocol;
Exclusion Criteria
* Diabetic patient;
* Patient with syndrome from narrowing of the lumbar vertebral canal
* Patient with a history of lumbar surgery \<1 year;
* Patient with a Cauda equina syndrome or major motor disability;
* Crural neuralgia
* Patient with a deficit;
* Suspicion of sciatica secondary, ie not conflict-related disco-root: infectious neuritis, fracture on spinal bone tumor ...
associated treatment or pathology contra-indicating administration methylprednisolone, ketoprofen.
18 Years
ALL
Yes
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Locations
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CHU Hôpital Sud
Échirolles, , France
CH d'Uriage
Uriage-les-Bains, , France
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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1201
Identifier Type: -
Identifier Source: org_study_id
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