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)
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)
Brief Title
A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Back Pain Without Radiation
Low Back Pain
Eligibility Criteria
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
* 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
Inclusion Criteria
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.
* 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.
Gender
All
Gender Based
false
Keywords
ketorolac
diclofenac
ibuprofen
low back pain
back pain
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
64 Years
Minimum Age
18 Years
NCT Id
NCT03861611
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2019-10026
Overall Status
Completed
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain. A Randomized Trial
Primary Outcomes
Outcome Description
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).
Outcome Measure
Change From Baseline to Day 5 in Functional Impairment
Outcome Time Frame
Baseline to 5 days
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
2 days after Emergency department visit
Outcome Measure
Worst LBP 2 Days After ED Visit
Outcome Description
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
Outcome Time Frame
2 days after Emergency department visit
Outcome Measure
Frequency of LBP 2 Days After ED Visit
Outcome Time Frame
24 hours to 5 days
Outcome Measure
How Often Participants Used Assigned Medication
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
64
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Eddie Irizarry
Investigator Email
eddiriza@montefiore.org
Investigator Phone