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

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

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)

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Back Pain Without Radiation
• Intervention / Treatment: Drug: Ketorolac; Behavioral: Educational Intervention; Drug: Ibuprofen; Drug: Diclofenac

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.

• Study Type: Interventional
• Enrollment (Actual): 198
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.	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; Drug: Ibuprofen; Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed
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.	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; Drug: Diclofenac; Participants may be randomized to receive Diflofenac oral medication 50 mg, every 8 hours for 5 days as needed

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Eddie Irizarry, MD, Montefiore Medical Center

Publications and helpful links

Helpful Links

• National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2019
• Primary Completion (Actual): February 2, 2021
• Study Completion (Actual): February 2, 2021

Study Registration Dates

• First Submitted: March 1, 2019
• First Submitted That Met QC Criteria: March 1, 2019
• First Posted (Actual): March 4, 2019

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: low back pain; back pain; ibuprofen; ketorolac; diclofenac
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketorolac; Diclofenac; Ibuprofen
• Other Study ID Numbers: 2019-10026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan to share

Drug and device information, study documents

• 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