A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain. (NCT03861611) | Clinical Trial Compass
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 range
18 Years – 64 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline to Day 5 in Functional Impairment