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NCT05721027 · ClinicalTrials.gov registry record · Phase 4
Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.
A Phase 4 study of Low Back Pain and Radiculopathy, Lumbosacral Region, sponsored by Montefiore Medical Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 132
- Enrollment target
- 2
- Study locations
NCT05721027: Recruiting Phase 4 study of Low Back Pain and Radiculopathy, Lumbosacral Region, sponsored by Montefiore Medical Center.
NCT05721027 is a Phase 4 study of Low Back Pain and Radiculopathy, Lumbosacral Region that is actively recruiting participants, run by Montefiore Medical Center. The registered enrollment target is 132 participants, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (74% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05721027, a Phase 4 study of Low Back Pain and Radiculopathy, Lumbosacral Region, is actively recruiting participants, sponsored by Montefiore Medical Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 132 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
The change in RMDQ will be evaluated using the 24-item Roland Morris Low Back Pain Disability Questionnaire. The RMDQ is a 24-item patient-reported outcome measure that inquires about pain-related disability resulting from LBP. Items are scored 0 if left blank or 1 if endorsed, for a total RMDQ score ranging from 0 to 24. Higher scores represent higher levels of pain-related disability. The change will be calculated as a difference between the baseline ED visit and the two day follow-up visit (R
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2023-07-05 |
| Est. Completion | 2026-10 |
| Phase | Phase 4 |
What NCT05721027 shows while recruiting
NCT05721027 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (74% lower).
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.
NCT05721027 reports a single indexed study location in New York.
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.
What interventions are being tested in trial NCT05721027?
The interventions under investigation include: Educational Intervention (BEHAVIORAL), Ibuprofen 400 mg (DRUG), Dexamethasone Oral (DRUG).
Who is sponsoring clinical trial NCT05721027?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Low Back Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05721027's enrollment target sits among peer trials
132 46th of 122 higher than 77 of 122 other Low Back Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Low Back Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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