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Completed

NCT Number: NCT01816334

Safety and Efficacy of Nonsteroidal Antiinflammatory (NSAI)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

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Key information

Conditions

Sciatica Mononeuropathies Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Sciatic Neuropathy Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CH d'Uriage, Uriage-les-Bains, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

methylprednisolone

Drug

Ketoprofen

Drug

Sodium Chloride

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

Safety and Efficacy of Nonsteroidal Antiinflammatory Drug and Glucocorticoids in Acute Sciatica

Acronym: TéAGS

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Mar 22, 2013
Registry last updated
Mar 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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