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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01816334
First Posted: March 22, 2013
Last Update Posted: March 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Grenoble
March 14, 2013
March 22, 2013
March 24, 2016
January 2013
December 2015   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01816334 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Nonsteroidal Antiinflammatory (NSAI)Drug and Glucocorticoids in Acute Sciatica
Safety and Efficacy of Nonsteroidal Antiinflammatory Drug and Glucocorticoids in Acute Sciatica
The purpose of this study is to determine whether anti-inflammatory drugs or glucocorticoids are effective in the treatment of acute sciatica
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Sciatica
  • Drug: methylprednisolone
  • Drug: Ketoprofen
  • Drug: Sodium Chloride
  • 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
    Interventions:
    • Drug: methylprednisolone
    • Drug: Sodium Chloride
  • Active Comparator: Ketoprofen
    administration of 100 mg of ketoprofen at 8:00 am and at 6:00 pm
    Intervention: Drug: Ketoprofen
  • Placebo Comparator: sodium chloride
    administration of 100 ml of 0.9% sodium chloride (placebo) at 8:00 am and at 6:00 pm
    Intervention: Drug: Sodium Chloride

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
January 2016
December 2015   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01816334
1201
Yes
Not Provided
Not Provided
University Hospital, Grenoble
University Hospital, Grenoble
Not Provided
Not Provided
University Hospital, Grenoble
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP