Safety and Efficacy of Nonsteroidal Antiinflammatory (NSAI)Drug and Glucocorticoids in Acute Sciatica

Study Overview
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Brief Summary
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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

Official Title
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Safety and Efficacy of Nonsteroidal Antiinflammatory Drug and Glucocorticoids in Acute Sciatica

Conditions
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Sciatica

Intervention / Treatment
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* Drug: methylprednisolone
* Drug: Ketoprofen
* Drug: Sodium Chloride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: methylprednisolone<br>administration of 60 mg of methylprednisolone at 8:00 am and 100 ml of 0.9 % sodium chloride (placebo) at 6:00 pm | Drug: methylprednisolone<br> <br> Drug: Sodium Chloride<br> <br> |
| Active Comparator: Ketoprofen<br>administration of 100 mg of ketoprofen at 8:00 am and at 6:00 pm | Drug: Ketoprofen<br> <br> |
| Placebo Comparator: sodium chloride<br>administration of 100 ml of 0.9% sodium chloride (placebo) at 8:00 am and at 6:00 pm | Drug: Sodium Chloride<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sciatica, Anti-Inflammatory Agents, Non-Steroidal, Glucocorticoids