RecruitingPhase 4NCT05721027

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


Sponsor

Montefiore Medical Center

Enrollment

132 participants

Start Date

Jul 5, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study compares two pain relief approaches for adults who come to the emergency department with acute sciatica (radicular low back pain) — pain that shoots from the lower back into the leg. It tests whether adding a short course of dexamethasone (a steroid) to ibuprofen provides better relief than ibuprofen alone. You may be eligible if: - You are between 18 and 70 years old - You are being treated in the ER for acute sciatica with pain radiating to the buttock or leg - Your pain started less than 2 weeks ago - Your pain is not from a direct trauma to your back in the last month - Your back pain significantly limits your function (score above 5 on a disability questionnaire) - You will be sent home from the ER (not admitted) You may NOT be eligible if: - You are pregnant - You use pain medications daily or near-daily (chronic pain syndrome) - You have a known allergy to the study medications - You take steroids regularly or have contraindications to ibuprofen (stomach ulcers, severe heart failure, kidney disease, blood thinners, or cirrhosis) - You cannot be reached for follow-up Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIbuprofen 400 mg

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

DRUGDexamethasone Oral

Dexamethasone 16 mg PO during ED visit and next day

BEHAVIORALEducational 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

View Full Details on ClinicalTrials.gov

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NCT05721027


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