Phase 4 N=198 Randomized Double-blind Treatment

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

Back Pain Without Radiation · Low Back Pain

Bottom Line

View on ClinicalTrials.gov: NCT03861611 ↗

Enrolled (actual)

198

Serious AEs

0.5%

Results posted

May 2022

Primary outcome: Primary: Change From Baseline to Day 5 in Functional Impairment — 11.9; 9.4; 10.9 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Ketorolac (Drug); Ibuprofen (Drug); Diclofenac (Drug); Educational Intervention (Behavioral)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Montefiore Medical Center
Primary completion: Feb 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Day 5 in Functional Impairment	11.9; 9.4; 10.9	—
SECONDARY Worst LBP 2 Days After ED Visit	8; 10; 13; 29; 18; 25	—
SECONDARY Frequency of LBP 2 Days After ED Visit	6; 7; 10; 18; 10; 14	—
SECONDARY How Often Participants Used Assigned Medication	2; 1; 0; 3; 5; 3	—

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)

Eligibility Criteria

Inclusion Criteria

Men or women age 18-64.
Present to ED primary for management of Low Back Pain (LBP)
Functionally impairing back pain: A baseline score of greater than 5 on the Roland-Morris Disability Questionnaire
Musculoskeletal etiology of low back.
Non-radicular pain.
Pain duration <2 weeks (336 hours).
Non-traumatic LBP
Participant is to be discharged home.

Exclusion Criteria

Flank pain, that is pain originating from tissues lateral to the paraspinal muscles.
Not available for follow-up
Pregnant
Chronic pain syndrome
Allergic to or intolerant of investigational medications
Contra-indications to investigational medications

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03861611). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.