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

• ClinicalTrials.gov Identifier: NCT03861611
• Recruitment Status: Completed
• First Posted: March 4, 2019
• Results First Posted: May 31, 2022
• Last Update Posted: May 31, 2022
• Sponsor: Montefiore Medical Center
• Information provided by (Responsible Party): Eddie Irizarry, Montefiore Medical Center

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)

Condition or disease	Intervention/treatment	Phase
Back Pain Without Radiation; Low Back Pain	Drug: Ketorolac; Drug: Ibuprofen; Drug: Diclofenac; Behavioral: Educational Intervention	Phase 4

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 Design

• 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

Arms and Interventions

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.	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.	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

Outcome Measures

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. 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.
2. 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
3. How Often Participants Used Assigned Medication [ Time Frame: 24 hours to 5 days ]

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, New York

Montefiore Medical Center

Bronx, New York, United States, 10467

Sponsors and Collaborators

Montefiore Medical Center

Investigators

• Principal Investigator: Eddie Irizarry, MD; Montefiore Medical Center

  Study Documents (Full-Text)

Documents provided by Eddie Irizarry, Montefiore Medical Center:

Study Protocol and Statistical Analysis Plan  [PDF] April 17, 2019

More Information

Additional Information:

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

• 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
• 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

Keywords provided by Eddie Irizarry, Montefiore Medical Center:

ketorolac; diclofenac; ibuprofen; low back pain; back pain

Additional relevant MeSH terms:

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