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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: University Hospital, Grenoble

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: University Hospital, Grenoble

Dates:
Date Received: March 14, 2013
Date Started: January 2013
Date Completion:
Last Updated: March 23, 2016
Last Verified: March 2016