CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 198 enrolled
Drug / intervention
Ketorolac +3 moredrug
Likely dose
Ketorolac 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03861611
NCT03861611Phase 4Completed

A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain. A Randomized Trial

Montefiore Medical Center·interventional·Posted Mar 4, 2019·Updated May 31, 2022

In Brief

A Phase 4 clinical trial evaluating Ketorolac, Ibuprofen, and 2 other interventions for Back Pain Without Radiation and Low Back Pain. Completed, enrolled 198 participants across 1 site.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedMar 4, 2019
Enrollment StartJul 12, 2019
Primary CompletionFeb 2, 2021
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.3 years ago

Interventions

Ketorolacdrug

Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed

Ibuprofendrug

Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed

Diclofenacdrug

Participants may be randomized to receive Diflofenac oral medication 50 mg, every 8 hours for 5 days as needed

Educational Interventionbehavioral

Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information