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

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Primary and study completion dates: Oct 2026 to Oct 2027v7
  2. Primary completion date: Jul 2025 to Oct 2026
    • Study completion date: Aug 2025 to Oct 2026
    v6
  3. Re-verified, no change to tracked fieldsv5
  4. Start date changed from estimate of Jul 2023 to Jul 5, 2023v4
  5. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Start date: May 2023 to Jul 2023
    • Study sites: 0 to 2
    • Primary completion date: May 2025 to Jul 2025
    • Study completion date: Jun 2025 to Aug 2025
  6. Secondary endpoints: details revised at 1 of 7 entries
    • Study title shortened, about 3 words
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05721027
Lead Sponsor Montefiore Medical Center
Conditions
(from sponsor)		 Radiculopathy, Lumbosacral Region, Back Pain With Radiation, Low Back Pain
Related terms Back Pain, Low Back Pain, Radiculopathy
Enrollment 132 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov