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

Phase 4

Completed

Interventions: Drug: Ketorolac
Drug: Ibuprofen
Drug: Diclofenac
Behavioral: Educational Intervention

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 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Ketorolac + Educational Intervention	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	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	Educational Intervention	Participants may be randomized to receive diclofenac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Ketorolac + Educational Intervention	Ketorolac	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	Ibuprofen	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	Diclofenac	Participants may be randomized to receive diclofenac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Day 5 in Functional Impairment	Baseline to 5 days	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).

Secondary Outcome Measures

Name	Time	Method
Worst LBP 2 Days After ED Visit	2 days after Emergency department 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.
Frequency of LBP 2 Days After ED Visit	2 days after Emergency department 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
How Often Participants Used Assigned Medication	24 hours to 5 days