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NCT03861611 · ClinicalTrials.gov registry record · Phase 4
A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain.
A Phase 4 study of Low Back Pain and Back Pain Without Radiation, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 198
- Enrollment target
- 1
- Study location
NCT03861611: Completed Phase 4 study of Low Back Pain and Back Pain Without Radiation, sponsored by Montefiore Medical Center.
NCT03861611 is a Phase 4 study of Low Back Pain and Back Pain Without Radiation that has completed, run by Montefiore Medical Center. The registered enrollment target is 198 participants, below the 502-participant average among 122 other Low Back Pain trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03861611, a Phase 4 study of Low Back Pain and Back Pain Without Radiation, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 198 participants
- Enrollment target
- 1
- Study location
Study Summary
Purpose: This is a randomized clinical trial comparing the effects of three different medications for acute low back pain (LBP):Ketorolac, Ibuprofen, Diclofenac Hypothesis: A daily regimen of ketorolac will provide greater relief of LBP than ibuprofen or diclofenac 5 days after an emergency department (ED) visit, as measured by the Roland Morris Disability Questionnaire (RMQ)
Primary Outcome
The change will be assessed by Roland Morris Disability Questionnaire between the baseline ED visit and the five day follow-up. The Roland-Morris Questionnaire (RMQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale (0-24).
Conditions Studied
Interventions
- DRUG Ketorolac
- DRUG Ibuprofen
- BEHAVIORAL Educational Intervention
- DRUG Diclofenac
Study Locations (1)
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 198 participants |
| Start Date | 2019-07-12 |
| Est. Completion | 2021-02-02 |
| Phase | Phase 4 |
What the finished NCT03861611 record still lists
NCT03861611 is an interventional study that assigns participants to a tested intervention. The registered 198 participants enrollment target is mid-sized for trials with a published cap, below the 502-participant average among 122 other Low Back Pain trials with a reported enrollment target (61% lower).
The record links to 2 conditions, with Low Back Pain appearing as the primary indexed condition, and to 4 interventions - of which Ketorolac is the first listed.
NCT03861611 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03861611 about?
NCT03861611 is a clinical study titled "A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain.". Purpose: This is a randomized clinical trial comparing the effects of three different medications for acute low back pain (LBP):Ketorolac, Ibuprofen, Diclofenac Hypothesis: A daily regimen of ketorolac will provide greater relief of LBP than ibuprofen or diclofenac 5 days after an emergency departm...
What is the current status of trial NCT03861611?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 198 participants. The study started on 2019-07-12. Estimated completion is 2021-02-02.
What conditions does trial NCT03861611 study?
This clinical trial studies the following conditions: Low Back Pain, Back Pain Without Radiation.
What interventions are being tested in trial NCT03861611?
The interventions under investigation include: Ketorolac (DRUG), Ibuprofen (DRUG), Educational Intervention (BEHAVIORAL), Diclofenac (DRUG).
Who is sponsoring clinical trial NCT03861611?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03861611 being conducted?
This trial has 1 study location 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 NCT03861611's enrollment target sits among peer trials
198 32nd of 122 higher than 89 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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