Safety and Efficacy of Nonsteroidal Antiinflammatory (NSAI)Drug and Glucocorticoids in Acute Sciatica (TéAGS)
|ClinicalTrials.gov Identifier: NCT01816334|
Recruitment Status : Completed
First Posted : March 22, 2013
Last Update Posted : March 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Sciatica||Drug: methylprednisolone Drug: Ketoprofen Drug: Sodium Chloride||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Safety and Efficacy of Nonsteroidal Antiinflammatory Drug and Glucocorticoids in Acute Sciatica|
|Study Start Date :||January 2013|
|Primary Completion Date :||December 2015|
|Study Completion Date :||January 2016|
Active Comparator: methylprednisolone
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 Drug: Sodium Chloride|
Active Comparator: Ketoprofen
administration of 100 mg of ketoprofen at 8:00 am and at 6:00 pm
Placebo Comparator: sodium chloride
administration of 100 ml of 0.9% sodium chloride (placebo) at 8:00 am and at 6:00 pm
|Drug: Sodium Chloride|
- Mean visual analogue scale (VAS) for leg pain (radicular pain) in 3 groups [ Time Frame: From day 0 to day 5 ]VAS is measured in millimiters (0 to 100). This pain score is recommended in rheumatologic units in France.
- Mean visual analogue scale (VAS) for back pain in 3 groups [ Time Frame: From day 0 to day 5 ]VAS is measured in millimeters (0 to 100).
- Assess drug compliance [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Surgery or lumbar epidural injection [ Time Frame: At 1 and 3 months after intervention ]Number of patient having surgery and/or lumbar epidural injection during study period
- Clinical tolerance: adverse events and/or high blood pressure [ Time Frame: at baseline, day 1, 2 3, 4 and 5 ]Number of adverse events and/or high blood pressure between intervention group.
- Biological tolerance [ Time Frame: at baseline, day 3 and 5 ]measures of leukocytes, erythrocytes, hemoglobin, platelets, serum sodium, potassium, glucose, plasma creatinine between intervention group
- Glycemic levels [ Time Frame: 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 [ Time Frame: At baseline, 1 and 3 months ]To assess the cost of sciatica for society
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01816334
|CHU Hôpital Sud|
|Echirolles, France, 38130|
|Uriage, France, 38410|