Who is eligible for clinical trial NCT05721027?

Participants must meet the protocol's inclusion criteria for Radiculopathy, Lumbosacral Region. The stated age range is 18 Years to 70 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT05721027 provide travel or cost reimbursement?

The protocol indicates compensation for participation. See the verified compensation note below. Confirm stipend details with the site coordinator.

🏛️ Verified NIH Record • Updated 2026-04-07

Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain. (NCT05721027)

🟢 Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: Montefiore Medical Center

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (7 items).

Location: Albert Einstein College of Medicine/Montefiore Medical Center - Weiler ED — The Bronx, New York

Age range: 18 Years to 70 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

Albert Einstein College of Medicine/Montefiore Medical Center - Weiler ED — The Bronx, New York
Montefiore Medical Center - Moses ED — The Bronx, New York

📞 Contact the Study Coordinator

Phone: (718) 920-6626

Email: eddiriza@montefiore.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
💵 Compensation indicated: Every patient will receive a 7 day supply of ibuprofen and a low back pain education session.

Explore by condition: All Radiculopathy, Lumbosacral Region clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗