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

Primary Purpose

Sciatica

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
methylprednisolone
Ketoprofen
Sodium Chloride
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sciatica focused on measuring sciatica, Anti-Inflammatory Agents, Non-Steroidal, Glucocorticoids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • CHU Hôpital Sud
  • CH d'Uriage

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

methylprednisolone

Ketoprofen

sodium chloride

Arm Description

administration of 60 mg of methylprednisolone at 8:00 am and 100 ml of 0.9 % sodium chloride (placebo) at 6:00 pm

administration of 100 mg of ketoprofen at 8:00 am and at 6:00 pm

administration of 100 ml of 0.9% sodium chloride (placebo) at 8:00 am and at 6:00 pm

Outcomes

Primary Outcome Measures

Mean visual analogue scale (VAS) for leg pain (radicular pain) in 3 groups
VAS is measured in millimiters (0 to 100). This pain score is recommended in rheumatologic units in France.

Secondary Outcome Measures

Mean visual analogue scale (VAS) for back pain in 3 groups
VAS is measured in millimeters (0 to 100).
Assess drug compliance
Drug compliance is estimated based on the proportion of the treatment actually administered.
The effect of treatment on the EIFEL Questionnaire
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
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
Schober's test is a test used in rheumatology to measure the ability of patient to flex their lower back
Analgesic consumption
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
Number of patient having surgery and/or lumbar epidural injection during study period
Clinical tolerance: adverse events and/or high blood pressure
Number of adverse events and/or high blood pressure between intervention group.
Biological tolerance
measures of leukocytes, erythrocytes, hemoglobin, platelets, serum sodium, potassium, glucose, plasma creatinine between intervention group
Glycemic levels
monitoring of glycemic status is measured for each day of treatment
Number of days of hospitalisation sick leave, number of days lost to illness
To assess the cost of sciatica for society

Full Information

First Posted
March 14, 2013
Last Updated
March 23, 2016
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT01816334
Brief Title
Safety and Efficacy of Nonsteroidal Antiinflammatory (NSAI)Drug and Glucocorticoids in Acute Sciatica
Acronym
TéAGS
Official Title
Safety and Efficacy of Nonsteroidal Antiinflammatory Drug and Glucocorticoids in Acute Sciatica
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sciatica
Keywords
sciatica, Anti-Inflammatory Agents, Non-Steroidal, Glucocorticoids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
methylprednisolone
Arm Type
Active Comparator
Arm Description
administration of 60 mg of methylprednisolone at 8:00 am and 100 ml of 0.9 % sodium chloride (placebo) at 6:00 pm
Arm Title
Ketoprofen
Arm Type
Active Comparator
Arm Description
administration of 100 mg of ketoprofen at 8:00 am and at 6:00 pm
Arm Title
sodium chloride
Arm Type
Placebo Comparator
Arm Description
administration of 100 ml of 0.9% sodium chloride (placebo) at 8:00 am and at 6:00 pm
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Intervention Type
Drug
Intervention Name(s)
Ketoprofen
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride
Primary Outcome Measure Information:
Title
Mean visual analogue scale (VAS) for leg pain (radicular pain) in 3 groups
Description
VAS is measured in millimiters (0 to 100). This pain score is recommended in rheumatologic units in France.
Time Frame
From day 0 to day 5
Secondary Outcome Measure Information:
Title
Mean visual analogue scale (VAS) for back pain in 3 groups
Description
VAS is measured in millimeters (0 to 100).
Time Frame
From day 0 to day 5
Title
Assess drug compliance
Description
Drug compliance is estimated based on the proportion of the treatment actually administered.
Time Frame
From day 0 to day 5
Title
The effect of treatment on the EIFEL Questionnaire
Description
The EIFEL questionnaire is the translation of the Roland Morris Disability Questionnaire (RMDQ) and has been validated in acute low back pain.
Time Frame
At baseline, 1 and 3 months after intervention
Title
Improvement in Lasegue's sign compared to baseline
Description
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.
Time Frame
At baseline, Day 1,2,3,4 and 5 of study period
Title
Assess Schober's test
Description
Schober's test is a test used in rheumatology to measure the ability of patient to flex their lower back
Time Frame
From Day 0 to Day 5
Title
Analgesic consumption
Description
Analgesic consumption between active treatment group and placebo group was registered and differences between groups were calculated and presented as percentual differences.
Time Frame
At baseline, day 0, 1, 2, 3, 4 and day 5, 1 and 3 months
Title
Surgery or lumbar epidural injection
Description
Number of patient having surgery and/or lumbar epidural injection during study period
Time Frame
At 1 and 3 months after intervention
Title
Clinical tolerance: adverse events and/or high blood pressure
Description
Number of adverse events and/or high blood pressure between intervention group.
Time Frame
at baseline, day 1, 2 3, 4 and 5
Title
Biological tolerance
Description
measures of leukocytes, erythrocytes, hemoglobin, platelets, serum sodium, potassium, glucose, plasma creatinine between intervention group
Time Frame
at baseline, day 3 and 5
Title
Glycemic levels
Description
monitoring of glycemic status is measured for each day of treatment
Time Frame
at baseline, day 1 to 5
Title
Number of days of hospitalisation sick leave, number of days lost to illness
Description
To assess the cost of sciatica for society
Time Frame
At baseline, 1 and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
CHU Hôpital Sud
City
Echirolles
ZIP/Postal Code
38130
Country
France
Facility Name
CH d'Uriage
City
Uriage
ZIP/Postal Code
38410
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
21525139
Citation
Roncoroni C, Baillet A, Durand M, Gaudin P, Juvin R. Efficacy and tolerance of systemic steroids in sciatica: a systematic review and meta-analysis. Rheumatology (Oxford). 2011 Sep;50(9):1603-11. doi: 10.1093/rheumatology/ker151. Epub 2011 Apr 27.
Results Reference
background
PubMed Identifier
17909211
Citation
Chou R, Huffman LH; American Pain Society; American College of Physicians. Medications for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007 Oct 2;147(7):505-14. doi: 10.7326/0003-4819-147-7-200710020-00008. Erratum In: Ann Intern Med. 2008 Feb 5;148(3):247-8.
Results Reference
background
PubMed Identifier
11132976
Citation
Vroomen PC, de Krom MC, Slofstra PD, Knottnerus JA. Conservative treatment of sciatica: a systematic review. J Spinal Disord. 2000 Dec;13(6):463-9. doi: 10.1097/00002517-200012000-00001.
Results Reference
background
PubMed Identifier
9165992
Citation
Koes BW, Scholten RJ, Mens JM, Bouter LM. Efficacy of non-steroidal anti-inflammatory drugs for low back pain: a systematic review of randomised clinical trials. Ann Rheum Dis. 1997 Apr;56(4):214-23. doi: 10.1136/ard.56.4.214.
Results Reference
background
PubMed Identifier
17415595
Citation
Luijsterburg PA, Verhagen AP, Ostelo RW, van Os TA, Peul WC, Koes BW. Effectiveness of conservative treatments for the lumbosacral radicular syndrome: a systematic review. Eur Spine J. 2007 Jul;16(7):881-99. doi: 10.1007/s00586-007-0367-1. Epub 2007 Apr 6.
Results Reference
background

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

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