A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain.
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ClinicalTrials.gov Identifier: NCT03861611 |
Recruitment Status :
Completed
First Posted : March 4, 2019
Results First Posted : May 31, 2022
Last Update Posted : May 31, 2022
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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)
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Back Pain Without Radiation Low Back Pain | Drug: Ketorolac Drug: Ibuprofen Drug: Diclofenac Behavioral: Educational Intervention | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 198 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain. A Randomized Trial |
Actual Study Start Date : | July 12, 2019 |
Actual Primary Completion Date : | February 2, 2021 |
Actual Study Completion Date : | February 2, 2021 |
Arm | Intervention/treatment |
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Experimental: Ketorolac + Educational Intervention
Participants may be randomized to receive Ketorolac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
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Drug: Ketorolac
Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed Behavioral: Educational Intervention 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 |
Experimental: Ibuprofen + Educational Intervention
Participants may be randomized to receive Ibuprofen for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
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Drug: Ibuprofen
Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed Behavioral: Educational Intervention 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 |
Experimental: Diclofenac + Educational Intervention
Participants may be randomized to receive diclofenac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
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Drug: Diclofenac
Participants may be randomized to receive Diflofenac oral medication 50 mg, every 8 hours for 5 days as needed Behavioral: Educational Intervention 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 |
- Change From Baseline to Day 5 in Functional Impairment [ Time Frame: 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).
- Worst LBP 2 Days After ED Visit [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 24 hours to 5 days ]

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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03861611
United States, New York | |
Montefiore Medical Center | |
Bronx, New York, United States, 10467 |
Principal Investigator: | Eddie Irizarry, MD | Montefiore Medical Center |
Documents provided by Eddie Irizarry, Montefiore Medical Center:
Responsible Party: | Eddie Irizarry, Assistant Professor of Emergency Medicine, Montefiore Medical Center |
ClinicalTrials.gov Identifier: | NCT03861611 |
Other Study ID Numbers: |
2019-10026 |
First Posted: | March 4, 2019 Key Record Dates |
Results First Posted: | May 31, 2022 |
Last Update Posted: | May 31, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | No plan to share |
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 |
ketorolac diclofenac ibuprofen low back pain back pain |
Back Pain Low Back Pain Pain Neurologic Manifestations Ibuprofen Diclofenac Ketorolac Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |