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

University Hospital, Grenoble50 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Sciatica

Interventions

methylprednisoloneDRUG

KetoprofenDRUG

Sodium ChlorideDRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

CHU Hôpital Sud

Échirolles, France

CH d'Uriage

Uriage-les-Bains, France

Outcomes

Primary Outcomes

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.

Time frame: From day 0 to day 5

Secondary Outcomes

Mean visual analogue scale (VAS) for back pain in 3 groups

VAS is measured in millimeters (0 to 100).

Time frame: From day 0 to day 5

Assess drug compliance

Drug compliance is estimated based on the proportion of the treatment actually administered.

Time frame: From day 0 to day 5

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.

Time frame: At baseline, 1 and 3 months after intervention

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.

Time frame: At baseline, Day 1,2,3,4 and 5 of study period

Assess Schober's test

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

Analgesic consumption

Analgesic consumption between active treatment group and placebo group was registered and differences between groups were calculated and presented as percentual differences.

Data from ClinicalTrials.gov

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