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

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

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

Conditions
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Back Pain Without Radiation, Low Back Pain

Intervention / Treatment
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* Drug: Ketorolac
* Drug: Ibuprofen
* Drug: Diclofenac
* Behavioral: Educational Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketorolac + Educational Intervention<br>Participants may be randomized to receive Ketorolac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention. | Drug: Ketorolac<br>* Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed<br>Behavioral: Educational Intervention<br>* Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information<br>|
| Experimental: Ibuprofen + Educational Intervention<br>Participants may be randomized to receive Ibuprofen for their LBP. Research personnel will provide each participant with a 15-minute educational intervention. | Drug: Ibuprofen<br>* Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed<br>Behavioral: Educational Intervention<br>* Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information<br>|
| Experimental: Diclofenac + Educational Intervention<br>Participants may be randomized to receive diclofenac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention. | Drug: Diclofenac<br>* Participants may be randomized to receive Diflofenac oral medication 50 mg, every 8 hours for 5 days as needed<br>Behavioral: Educational Intervention<br>* Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Day 5 in Functional Impairment | The change will be assessed by Roland Morris Disability Questionnaire between the baseline ED visit and the five day follow-up. The Roland-Morris Questionnaire (RMQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale (0-24). | Baseline to 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Worst LBP 2 Days After ED Visit | Participants were called 2 days after ED visit and asked to report their worst LBP experienced over the previous 24 hours, using a four point ordinal scale: severe, moderate, mild, or none. | 2 days after Emergency department visit | 
| Frequency of LBP 2 Days After ED Visit | Participants were called 2 days after ED visit and asked to report the frequency of LBP experienced over the previous 24 hours. Frequency was assessed using the five point Likert scale: Not at all, Rarely, Sometimes, Usually, Always | 2 days after Emergency department visit | 
| How Often Participants Used Assigned Medication |  | 24 hours to 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ketorolac, diclofenac, ibuprofen, low back pain, back pain