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RECRUITING
NCT05721027
PHASE4

Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.

Sponsor: Montefiore Medical Center

View on ClinicalTrials.gov

Summary

This will be a placebo controlled, randomized, double-blind, comparative effectiveness study, in which we patients are enrolled during an emergency department (ED) visit for acute radicular low back pain (LBP) and followed by telephone two and seven days later. Patients will be randomized to receive an oral dose of dexamethasone for 2 consecutive days or placebo during an ED visit for acute radicular LBP. Every patient will receive a 7 day supply of ibuprofen and a low back pain education session.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2023-07-05

Completion Date

2026-10

Last Updated

2025-04-09

Healthy Volunteers

Yes

Interventions

DRUG

Ibuprofen 400 mg

Ibuprofen 400 mg PO every 8 hours as needed for 7 days

DRUG

Dexamethasone Oral

Dexamethasone 16 mg PO during ED visit and next day

BEHAVIORAL

Educational Intervention

Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information

Locations (2)

Albert Einstein College of Medicine/Montefiore Medical Center - Weiler ED

The Bronx, New York, United States

Montefiore Medical Center - Moses ED

The Bronx, New York, United States