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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University Hospital, Grenoble
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01816334
First received: March 14, 2013
Last updated: March 19, 2013
Last verified: March 2013

March 14, 2013
March 19, 2013
January 2013
June 2014   (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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
    VAS is measured in millimeters (0 to 100).
  • Assess drug compliance [ Time Frame: From day 0 to day 5 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Number of adverse events and/or high blood pressure between intervention group.
  • Biological tolerance [ Time Frame: at baseline, day 3 and 5 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.
 
Recruiting
144
September 2014
June 2014   (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.

Both
18 Years and older
Yes
France
 
NCT01816334
1201
Yes
University Hospital, Grenoble
University Hospital, Grenoble
Not Provided
Not Provided
University Hospital, Grenoble
March 2013

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