Comparing ibuprofen and dexamethasone for treating acute low back pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study is a randomized, double-blind, placebo-controlled trial that aims to evaluate the effectiveness of dexamethasone in addition to ibuprofen for patients experiencing acute radicular low back pain. Patients will be enrolled during an emergency department visit and will receive either dexamethasone or a placebo for two days, along with a seven-day supply of ibuprofen and educational support on managing low back pain. Follow-up assessments will occur via telephone at two and seven days post-treatment to monitor outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Present to ED primarily for management of acute radicular LBP, defined as pain or paresthesia originating from the lower back and radiating to the buttock and or leg in a radicular pattern. Some patients may not have prominent LBP but a radicular symptom--we will include these patients as well.
* Patient is to be discharged home.
* Age 18-70 Enrollment will be limited to adults \<70 years because of the increased risk of adverse medication effects in older adults.
* Pain duration \<2 week
* Prior to the acute attack of radicular LBP, back pain cannot occur more frequently than half of the days in the last 3 months. Patients with more frequent back pain/sciatica are at increased risk of poor pain and functional outcomes.10
* Non-traumatic cause of pain: no substantial and direct trauma to the back within the previous month
* Functionally impairing radicular LBP: A baseline score of \> 5 on the Roland-Morris Disability Questionnaire

Exclusion Criteria:

* Not available for follow-up
* Pregnant
* Chronic pain syndrome defined as use of any analgesic medication on a daily or near-daily basis
* Allergic to or intolerant of investigational medications
* Chronic steroid use
* Contra-indications to investigational medications: 1) known peptic ulcer disease, chronic dyspepsia, or history of gastrointestinal bleed 2) Severe heart failure (NYHA 2 or worse) 3) Chronic kidney disease (GFR \<60ml/min) 4) Current use of anti-coagulants 5) cirrhosis (Child Pugh A or worse) or hepatitis (transaminases 2x the upper limit of normal)

Where it's running

• Albert Einstein College of Medicine/Montefiore Medical Center - Weiler ED
  The Bronx, New York, United States Recruiting
• Montefiore Medical Center - Moses ED
  The Bronx, New York, United States Recruiting

Study contacts

• Principal investigator: Eddie Irizarry, MD — Montefiore Medical Center
• Study coordinator: Eddie Irizarry, MD
• Email: eddiriza@montefiore.org
• Phone: 718-920-6626

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.