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



Status:Not yet recruiting
Conditions:Back Pain, Back Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 64
Updated:3/6/2019
Start Date:June 2019
End Date:December 2019
Contact:Eddie Irizarry, MD
Email:eddiriza@montefiore.org
Phone:718-920-6626

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

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)

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.

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
We found this trial at
1
site
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Eddie Irizarry, MD
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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