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

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. Identifier: NCT01816334
Recruitment Status : Completed
First Posted : March 22, 2013
Last Update Posted : March 24, 2016
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:
The purpose of this study is to determine whether anti-inflammatory drugs or glucocorticoids are effective in the treatment of acute sciatica

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Nonsteroidal Antiinflammatory Drug and Glucocorticoids in Acute Sciatica
Study Start Date : January 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sciatica Steroids
Drug Information available for: Ketoprofen

Arm Intervention/treatment
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
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
Drug: Sodium Chloride

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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).

  2. Assess drug compliance [ Time Frame: From day 0 to day 5 ]
    Drug compliance is estimated based on the proportion of the treatment actually administered.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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

  8. 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.

  9. 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

  10. Glycemic levels [ Time Frame: at baseline, day 1 to 5 ]
    monitoring of glycemic status is measured for each day of treatment

  11. 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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01816334

CHU Hôpital Sud
Echirolles, France, 38130
CH d'Uriage
Uriage, France, 38410
Sponsors and Collaborators
University Hospital, Grenoble

Responsible Party: University Hospital, Grenoble Identifier: NCT01816334     History of Changes
Other Study ID Numbers: 1201
First Posted: March 22, 2013    Key Record Dates
Last Update Posted: March 24, 2016
Last Verified: March 2016

Keywords provided by University Hospital, Grenoble:
Anti-Inflammatory Agents, Non-Steroidal

Additional relevant MeSH terms:
Neurologic Manifestations
Nervous System Diseases
Sciatic Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Anti-Inflammatory Agents
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents, Non-Steroidal
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents