Actively Recruiting
Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.
Led by Montefiore Medical Center · Updated on 2026-04-13
132
Participants Needed
2
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Present to emergency department primarily for acute radicular low back pain, including pain or numbness radiating from lower back to buttock or leg
- To be discharged home after emergency visit
- Age between 18 and 70 years
- Pain duration less than 2 weeks
- Prior back pain less frequent than half the days in the last 3 months before current episode
- No significant trauma to back within the previous month
- Baseline disability score greater than 5 on Roland-Morris Disability Questionnaire
You will not qualify if you...
- Not available for follow-up
- Pregnant
- Chronic pain syndrome with daily or near-daily analgesic use
- Allergic or intolerant to study medications
- Chronic steroid use
- Contraindications to study medications including known peptic ulcer disease, chronic dyspepsia, or history of gastrointestinal bleed
- Severe heart failure (NYHA class 2 or worse)
- Chronic kidney disease with GFR less than 60 ml/min
- Current use of anti-coagulants
- Liver cirrhosis (Child Pugh A or worse) or hepatitis with elevated transaminases
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Albert Einstein College of Medicine/Montefiore Medical Center - Weiler ED
The Bronx, New York, United States, 10461
Actively Recruiting
2
Montefiore Medical Center - Moses ED
The Bronx, New York, United States, 10467
Actively Recruiting
Research Team
E
Eddie Irizarry, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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