Safety and Efficacy of Nonsteroidal Antiinflammatory (NSAI)Drug and Glucocorticoids in Acute Sciatica
- Conditions
- Sciatica
- Interventions
- Registration Number
- NCT01816334
- Lead Sponsor
- University Hospital, Grenoble
- Brief Summary
The purpose of this study is to determine whether anti-inflammatory drugs or glucocorticoids are effective in the treatment of acute sciatica
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description methylprednisolone methylprednisolone administration of 60 mg of methylprednisolone at 8:00 am and 100 ml of 0.9 % sodium chloride (placebo) at 6:00 pm Ketoprofen Ketoprofen administration of 100 mg of ketoprofen at 8:00 am and at 6:00 pm methylprednisolone Sodium Chloride administration of 60 mg of methylprednisolone at 8:00 am and 100 ml of 0.9 % sodium chloride (placebo) at 6:00 pm sodium chloride Sodium Chloride administration of 100 ml of 0.9% sodium chloride (placebo) at 8:00 am and at 6:00 pm
- Primary Outcome Measures
Name Time Method Mean visual analogue scale (VAS) for leg pain (radicular pain) in 3 groups From day 0 to day 5 VAS is measured in millimiters (0 to 100). This pain score is recommended in rheumatologic units in France.
- Secondary Outcome Measures
Name Time Method Surgery or lumbar epidural injection At 1 and 3 months after intervention Number of patient having surgery and/or lumbar epidural injection during study period
Mean visual analogue scale (VAS) for back pain in 3 groups From day 0 to day 5 VAS is measured in millimeters (0 to 100).
Clinical tolerance: adverse events and/or high blood pressure at baseline, day 1, 2 3, 4 and 5 Number of adverse events and/or high blood pressure between intervention group.
Analgesic consumption At baseline, day 0, 1, 2, 3, 4 and day 5, 1 and 3 months Analgesic consumption between active treatment group and placebo group was registered and differences between groups were calculated and presented as percentual differences.
Assess drug compliance From day 0 to day 5 Drug compliance is estimated based on the proportion of the treatment actually administered.
The effect of treatment on the EIFEL Questionnaire At baseline, 1 and 3 months after intervention The EIFEL questionnaire is the translation of the Roland Morris Disability Questionnaire (RMDQ) and has been validated in acute low back pain.
Improvement in Lasegue's sign compared to baseline At baseline, Day 1,2,3,4 and 5 of study period 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.
Assess Schober's test From Day 0 to Day 5 Schober's test is a test used in rheumatology to measure the ability of patient to flex their lower back
Biological tolerance at baseline, day 3 and 5 measures of leukocytes, erythrocytes, hemoglobin, platelets, serum sodium, potassium, glucose, plasma creatinine between intervention group
Glycemic levels at baseline, day 1 to 5 monitoring of glycemic status is measured for each day of treatment
Number of days of hospitalisation sick leave, number of days lost to illness At baseline, 1 and 3 months To assess the cost of sciatica for society
Trial Locations
- Locations (2)
CH d'Uriage
🇫🇷Uriage, France
CHU Hôpital Sud
🇫🇷Echirolles, France