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

• ClinicalTrials.gov Identifier: NCT03861611
• Recruitment Status: Recruiting
• First Posted: March 4, 2019
• Last Update Posted: July 15, 2019
• 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)
• Estimated 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
• Estimated Primary Completion Date: January 2020
• Estimated Study Completion Date: January 2020

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 NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)
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 NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)
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 NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)

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.

Secondary Outcome Measures :

1. Worsening LBP after ED visit [ Time Frame: 48 hours and 5 days after Emergency department visit ]
   Worsening LBP over the previous 24 hours, using a four point ordinal scale: severe, moderate, mild, or none
2. Frequency of LBP after ED visit [ Time Frame: 48 hours and 5 days ]
   Frequency will be assessed using the five point Likert scale: Not at all, Rarely, Sometimes, Usually, Always
3. Analgesic or NSAID usage [ Time Frame: 24 hours to 5 days ]
   Usage of NSAID and analgesic medications

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

Contacts

Contact: Eddie Irizarry, MD; 718-920-6626; eddiriza@montefiore.org

Contact: Benjamin Friedman, MD, MS; 718-920-6626; befriedm@montefiore.org

Locations

United States, New York

Montefiore Medical Center; Recruiting

Bronx, New York, United States, 10467

Contact: Eddie Irizarry, MD

Principal Investigator: Eddie Irizarry, MD

Sponsors and Collaborators

Montefiore Medical Center

Investigators

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

More Information

• Responsible Party: Eddie Irizarry, Assistant Professor of Emergency Medicine, Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT03861611 History of Changes
• Other Study ID Numbers: 2019-10026
• First Posted: March 4, 2019
• Last Update Posted: July 15, 2019
• Last Verified: July 2019

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; Signs and Symptoms; Ibuprofen; Ketorolac; Ketorolac Tromethamine; Diclofenac; 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