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

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Completed; Phase 4

Conditions: Sciatica

Treatments: Drug: Sodium Chloride; Drug: methylprednisolone; Drug: Ketoprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT01816334

1201

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 3 patient groups, including a placebo group

methylprednisolone

Active Comparator group

Description:

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

Treatment:

Drug: methylprednisolone

Drug: Sodium Chloride

Ketoprofen

Active Comparator group

Description:

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

Treatment:

Drug: Ketoprofen

sodium chloride

Placebo Comparator group

Description:

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

Treatment:

Drug: Sodium Chloride