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RECRUITING Phase 4

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

NCT05721027 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • BEHAVIORAL Educational Intervention
  • DRUG Ibuprofen 400 mg
  • DRUG Dexamethasone Oral

Study Locations (2)

New York

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

Trial Details

FieldValue
Enrollment Target 132 participants
Start Date 2023-07-05
Est. Completion 2026-10
Phase Phase 4

Sponsor

Montefiore Medical Center

280 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05721027

The ClinicalTrials.gov registry entry for NCT05721027 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Montefiore Medical Center, which has 280 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Low Back Pain appearing as the primary indexed condition, and to 3 interventions — of which Educational Intervention is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05721027 reports 2 study locations spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05721027 about?

NCT05721027 is a clinical study titled "Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.". 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...

What is the current status of trial NCT05721027?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 132 participants. The study started on 2023-07-05. Estimated completion is 2026-10.

What conditions does trial NCT05721027 study?

This clinical trial studies the following conditions: Low Back Pain, Radiculopathy, Lumbosacral Region, Back Pain With Radiation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05721027?

The interventions under investigation include: Educational Intervention (BEHAVIORAL), Ibuprofen 400 mg (DRUG), Dexamethasone Oral (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05721027?

This trial is sponsored by Montefiore Medical Center, which has 280 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05721027 being conducted?

This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial