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
  Purpose

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


Condition Intervention Phase
Sciatica
Drug: methylprednisolone
Drug: Ketoprofen
Drug: Sodium Chloride
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Nonsteroidal Antiinflammatory Drug and Glucocorticoids in Acute Sciatica

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 144
Study Start Date: January 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01816334

Locations
France
CHU Hôpital Sud Recruiting
Echirolles, France, 38130
Contact: DURAND       mdurand1@chu-grenoble.fr   
Principal Investigator: Robert JUVIN, MD PhD         
Sub-Investigator: Anne Sudre, MD         
Sub-Investigator: Athan Baillet, MD, PhD         
CH d'Uriage Not yet recruiting
Uriage, France, 38410
Contact: DURAND       mdurand1@chu-grenoble.fr   
Principal Investigator: Sylvie GROS CLAUDE, MD         
Sponsors and Collaborators
University Hospital, Grenoble
  More Information

Publications:
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01816334     History of Changes
Other Study ID Numbers: 1201
Study First Received: March 14, 2013
Last Updated: March 19, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

Additional relevant MeSH terms:
Sciatica
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Ketoprofen
Anti-Inflammatory Agents
Prednisolone hemisuccinate
Prednisolone phosphate
Glucocorticoids
Anti-Inflammatory Agents, Non-Steroidal
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Hormones

ClinicalTrials.gov processed this record on September 22, 2014