A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain.
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)
- Back Pain Without Radiation
- Low Back Pain
- Eligible Ages
- Between 18 Years and 64 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- Flank pain, that is pain originating from tissues lateral to the paraspinal muscles.
- Not available for follow-up
- Chronic pain syndrome
- Allergic to or intolerant of investigational medications
- Contra-indications to investigational medications
- Phase 4
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Double (Participant, Investigator)
Ketorolac + Educational Intervention
|Participants may be randomized to receive Ketorolac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.||
Ibuprofen + Educational Intervention
|Participants may be randomized to receive Ibuprofen for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.||
Diclofenac + Educational Intervention
|Participants may be randomized to receive diclofenac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.||
- Montefiore Medical Center
Study ContactEddie Irizarry, MD
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.