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

Last updated: May 4, 2022
Sponsor: Montefiore Medical Center
Overall Status: Completed

Phase

4

Condition

Chronic Pain

Treatment

N/A

Clinical Study ID

NCT03861611
2019-10026
  • Ages 18-64
  • All Genders

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)

Eligibility Criteria

Inclusion

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 theRoland-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

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

Study Design

Total Participants: 198
Study Start date:
July 12, 2019
Estimated Completion Date:
February 02, 2021

Study Description

More than 2.5 million patients present to US emergency departments (ED) annually with low back pain. Up to half of ED patients with acute, new onset low back pain (LBP) report persistent moderate or severe pain one week after the ED visit. Non-steroidal anti-inflammatory drugs (NSAIDs) are an effective treatment of acute LBP, though their impact is only modest.Given the poor pain and functional outcomes that persist beyond an ED visit for acute LBP, this clinical trial proposes to determine whether there is a difference in efficacy between the NSAIDs ketorolac, ibuprofen, and diclofenac and for the treatment of acute, non-traumatic, non-radicular low back pain.

Connect with a study center

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

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