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

March 23, 2016 updated by: University Hospital, Grenoble

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Echirolles, France, 38130
        • Chu Hopital Sud
      • Uriage, France, 38410
        • CH d'Uriage

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From day 0 to day 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From day 0 to day 5
Assess drug compliance
Time Frame: From day 0 to day 5
Drug compliance is estimated based on the proportion of the treatment actually administered.
From day 0 to day 5
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.
At baseline, 1 and 3 months after intervention
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.
At baseline, Day 1,2,3,4 and 5 of study period
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
From Day 0 to Day 5
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.
At baseline, day 0, 1, 2, 3, 4 and day 5, 1 and 3 months
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
At 1 and 3 months after intervention
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.
at baseline, day 1, 2 3, 4 and 5
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
at baseline, day 3 and 5
Glycemic levels
Time Frame: at baseline, day 1 to 5
monitoring of glycemic status is measured for each day of treatment
at baseline, day 1 to 5
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
At baseline, 1 and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

March 14, 2013

First Submitted That Met QC Criteria

March 19, 2013

First Posted (Estimate)

March 22, 2013

Study Record Updates

Last Update Posted (Estimate)

March 24, 2016

Last Update Submitted That Met QC Criteria

March 23, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1201 (1201 XDOZ, local number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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