NCT05721027

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Radiculopathy, Lumbosacral Region
• Back Pain With Radiation
• Low Back Pain

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-07-05
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2023-02-09
• Last updated: 2026-04-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study