CompletedPhase 4

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

United States198 participantsStarted 2019-07-12

Plain-language 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)

Who can participate

Age range18 Years – 64 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change From Baseline to Day 5 in Functional Impairment

Timeframe: Baseline to 5 days

Trial details

NCT IDNCT03861611

SponsorMontefiore Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-02-02

Results submitted2022-04-05

View on ClinicalTrials.gov More Back Pain Without Radiation trials