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

Lumbar transforaminal epidural injection versus systemic corticosteroids for the treatment of acute sciatica: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16495275
Enrollment
100
Registered
2021-03-24
Start date
2021-12-15
Completion date
Unknown
Last updated
2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment for acute sciatica pain due to lumbar disc herniation Musculoskeletal Diseases

Interventions

This is a prospective randomized clinical trial developed at the Orthopedics-Column outpatient clinic of Hospital São Paulo (EPM / UNIFESP) and its affiliated Hospital Municipal de Barueri.

Sponsors

Federal University of Sao Paulo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Oswestry Disability Index measured at baseline, 21 days and 60 days.

Secondary

MeasureTime frame
1. Pain measured using visual analogue scale at baseline, 21 days and 60 days 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

Countries

Brazil

Contacts

Public ContactGuilherme;Renato Porceban;Ueta

;

gporceban@gmail.com;uetarenato@gmail.com+55(16)982007111;+55(16)982007111

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026