Clinical trial NCT01816334: Safety and Efficacy of Nonsteroidal Antiinflammatory (NSAI)Drug and Glucocorticoids in Acute Sciatica
Official title: Safety and Efficacy of Nonsteroidal Antiinflammatory Drug and Glucocorticoids in Acute Sciatica
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sciatica
Keywords: sciatica
Anti-Inflammatory Agents, Non-Steroidal
Glucocorticoids
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2013-03-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether anti-inflammatory drugs or glucocorticoids are effective in the treatment of acute sciatica


Eligibility criteria: Inclusion Criteria:

* sciatica \<8 weeks resistant to all treatments in ambulatory
* 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:

* Pregnant, parturient, lactating mother;
* 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.

Primary outcomes:
measure: Mean visual analogue scale (VAS) for leg pain (radicular pain) in 3 groups
timeFrame: From day 0 to day 5
Secondary outcomes:
measure: Mean visual analogue scale (VAS) for back pain in 3 groups
timeFrame: From day 0 to day 5
measure: Assess drug compliance
timeFrame: From day 0 to day 5
measure: The effect of treatment on the EIFEL Questionnaire
timeFrame: At baseline, 1 and 3 months after intervention
measure: Improvement in Lasegue's sign compared to baseline
timeFrame: At baseline, Day 1,2,3,4 and 5 of study period
measure: Assess Schober's test
timeFrame: From Day 0 to Day 5
measure: Analgesic consumption
timeFrame: At baseline, day 0, 1, 2, 3, 4 and day 5, 1 and 3 months
measure: Surgery or lumbar epidural injection
timeFrame: At 1 and 3 months after intervention
measure: Clinical tolerance: adverse events and/or high blood pressure
timeFrame: at baseline, day 1, 2 3, 4 and 5
measure: Biological tolerance
timeFrame: at baseline, day 3 and 5
measure: Glycemic levels
timeFrame: at baseline, day 1 to 5
measure: Number of days of hospitalisation sick leave, number of days lost to illness
timeFrame: At baseline, 1 and 3 months
Other outcomes:
Locations:
city: Echirolles
country: France
facility: CHU Hôpital Sud
city: Uriage
country: France
facility: CH d'Uriage
Study officials:
References:
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.
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.
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.
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.
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.