Sciatica
Conditions
Keywords
sciatica, Anti-Inflammatory Agents, Non-Steroidal, Glucocorticoids
Brief summary
The purpose of this study is to determine whether anti-inflammatory drugs or glucocorticoids are effective in the treatment of acute sciatica
Interventions
DRUGmethylprednisolone
DRUGKetoprofen
DRUGSodium Chloride
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| 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 |
| 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 |
Countries
France
Outcome results
None listed