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The purpose of this study is to determine whether anti-inflammatory drugs or glucocorticoids are effective in the treatment of acute sciatica
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| methylprednisolone | Active Comparator | administration of 60 mg of methylprednisolone at 8:00 am and 100 ml of 0.9 % sodium chloride (placebo) at 6:00 pm |
|
| Ketoprofen | Active Comparator | administration of 100 mg of ketoprofen at 8:00 am and at 6:00 pm |
|
| sodium chloride | Placebo Comparator | administration of 100 ml of 0.9% sodium chloride (placebo) at 8:00 am and at 6:00 pm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methylprednisolone | Drug |
| ||
| Ketoprofen |
| Measure | Description | Time Frame |
|---|---|---|
| Mean visual analogue scale (VAS) for leg pain (radicular pain) in 3 groups | VAS is measured in millimiters (0 to 100). This pain score is recommended in rheumatologic units in France. | From day 0 to day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean visual analogue scale (VAS) for back pain in 3 groups | VAS is measured in millimeters (0 to 100). | From day 0 to day 5 |
| Assess drug compliance | Drug compliance is estimated based on the proportion of the treatment actually administered. |
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Inclusion Criteria:
Exclusion Criteria:
associated treatment or pathology contra-indicating administration methylprednisolone, ketoprofen.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Hôpital Sud | Échirolles | 38130 | France | |||
| CH d'Uriage |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21525139 | Background | 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. | |
| 17909211 | Background | 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. |
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| ID | Term |
|---|---|
| D012585 | Sciatica |
| ID | Term |
|---|---|
| D020426 | Sciatic Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D007660 | Ketoprofen |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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|
| Sodium Chloride | Drug |
|
| From day 0 to day 5 |
| The effect of treatment on the EIFEL Questionnaire | The EIFEL questionnaire is the translation of the Roland Morris Disability Questionnaire (RMDQ) and has been validated in acute low back pain. | At baseline, 1 and 3 months after intervention |
| Improvement in Lasegue's sign compared to baseline | 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. | At baseline, Day 1,2,3,4 and 5 of study period |
| Assess Schober's test | Schober's test is a test used in rheumatology to measure the ability of patient to flex their lower back | From Day 0 to Day 5 |
| Analgesic consumption | Analgesic consumption between active treatment group and placebo group was registered and differences between groups were calculated and presented as percentual differences. | At baseline, day 0, 1, 2, 3, 4 and day 5, 1 and 3 months |
| Surgery or lumbar epidural injection | Number of patient having surgery and/or lumbar epidural injection during study period | At 1 and 3 months after intervention |
| Clinical tolerance: adverse events and/or high blood pressure | Number of adverse events and/or high blood pressure between intervention group. | at baseline, day 1, 2 3, 4 and 5 |
| Biological tolerance | measures of leukocytes, erythrocytes, hemoglobin, platelets, serum sodium, potassium, glucose, plasma creatinine between intervention group | at baseline, day 3 and 5 |
| Glycemic levels | monitoring of glycemic status is measured for each day of treatment | at baseline, day 1 to 5 |
| Number of days of hospitalisation sick leave, number of days lost to illness | To assess the cost of sciatica for society | At baseline, 1 and 3 months |
| Uriage-les-Bains |
| 38410 |
| France |
| 11132976 | Background | 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. |
| 9165992 | Background | 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. |
| 17415595 | Background | 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. |
| D009422 | Nervous System Diseases |
| D009437 | Neuralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |