Back to resultsA Comparison of NSAIDs for Acute, Non-radicular Low Back Pain.
Primary Purpose
Back Pain Without Radiation, Low Back Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketorolac
Ibuprofen
Diclofenac
Educational Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Back Pain Without Radiation focused on measuring ketorolac, diclofenac, ibuprofen, low back pain, 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
Sites / Locations
- Montefiore Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Ketorolac + Educational Intervention
Ibuprofen + Educational Intervention
Diclofenac + Educational Intervention
Arm Description
Participants may be randomized to receive Ketorolac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Participants may be randomized to receive Ibuprofen for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Participants may be randomized to receive diclofenac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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
How Often Participants Used Assigned Medication
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03861611
Brief Title
A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain.
Official Title
A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain. A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 12, 2019 (Actual)
Primary Completion Date
February 2, 2021 (Actual)
Study Completion Date
February 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain Without Radiation, Low Back Pain
Keywords
ketorolac, diclofenac, ibuprofen, low back pain, back pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
198 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketorolac + Educational Intervention
Arm Type
Experimental
Arm Description
Participants may be randomized to receive Ketorolac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Arm Title
Ibuprofen + Educational Intervention
Arm Type
Experimental
Arm Description
Participants may be randomized to receive Ibuprofen for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Arm Title
Diclofenac + Educational Intervention
Arm Type
Experimental
Arm Description
Participants may be randomized to receive diclofenac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Intervention Description
Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Intervention Description
Participants may be randomized to receive Diflofenac oral medication 50 mg, every 8 hours for 5 days as needed
Intervention Type
Behavioral
Intervention Name(s)
Educational Intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Change From Baseline to Day 5 in Functional Impairment
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).
Time Frame
Baseline to 5 days
Secondary Outcome Measure Information:
Title
Worst LBP 2 Days After ED Visit
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.
Time Frame
2 days after Emergency department visit
Title
Frequency of LBP 2 Days After ED Visit
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
Time Frame
2 days after Emergency department visit
Title
How Often Participants Used Assigned Medication
Time Frame
24 hours to 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eddie Irizarry, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share
Links:
URL
http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp
Description
National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information
Learn more about this trial
A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain.
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