Comparison between steroids taken by mouth and steroids administered by lumbar epidural for sciatica pai

Not Applicable

• Conditions: Treatment for acute sciatica pain due to lumbar disc herniation; Musculoskeletal Diseases

• Registration Number: ISRCTN16495275
• Lead Sponsor: Federal University of Sao Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-24
• Last Update Posted: 12 April 2021
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Age over 18 years and who accepted to participate in the research by signing the Informed Consent Form
2. Symptoms suggestive of acute sciatica such as low back pain radiating to the lower limbs respecting the specific limits of the lumbar dermatomes and physical examination showing signs of root irration to the tensioning maneuvers
3. Minimum duration of symptoms greater than 72 hours
4. Maximum duration of symptoms less than 4 weeks
5. Oswestry Disability Index with a score greater than 30 points
6. Imaging exams (radiographs and magnetic resonance) compatible with the clinical picture presented by the patients

Exclusion Criteria

1. Refusal to sign the Informed Consent Form (ICF)
2. Patients who do not use medications and follow the guidelines of the research team
3. Patients with a clinical condition that requires immediate surgical intervention (for example, cauda equina syndrome)
4. Patients with a previous history of neoplasms or previous trauma (fractures or dislocations) in the spine
5. Patients with a previous history of spinal surgery
6. Patients with comorbidities that indicate chronic use of corticosteroids (autoimmune diseases, conditions of atopy) or that contraindicate the use of this medication class at any time (for example, type 2 diabetes mellitus, uncontrolled systemic arterial hypertension in the last month, pregnancy/puerperium, active peptic ulcer)
7. Previous history of allergy or intolerance to analgesics with local action and/or iodinated components used in TFEI

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index measured at baseline, 21 days and 60 days.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Pain measured using visual analogue scale at baseline, 21 days and 60 days<br> 2. Presence of neurological deficits - measurement of muscle strength (Global Strength Index, recommended by the Medical Research Council) and tactile sensitivity test compared to the contralateral side (as recommended in the sensitivity measurement protocols) at baseline, 21 days and 60 days<br>