Status:
COMPLETED
A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain.
Lead Sponsor:
Montefiore Medical Center
Conditions:
Back Pain Without Radiation
Low Back Pain
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
Brief 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 ketorol...
Detailed 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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2021
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT03861611
Start Date
July 12 2019
End Date
February 2 2021
Last Update
May 31 2022
Active Locations (1)
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1
Montefiore Medical Center
The Bronx, New York, United States, 10467