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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03861611
• Other study ID #: 2019-10026
• Status: Completed
• Phase: Phase 4
• Start date: July 12, 2019
• Est. completion date: February 2, 2021

Study information

• Verified date: May 2022
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: February 2, 2021
• Est. primary completion date: February 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Back Pain Without Radiation
• Low Back Pain

Intervention

Drug:
• Ketorolac
Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed
• Ibuprofen
Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed
• 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

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	How Often Participants Used Assigned Medication		24 hours to 5 days

External Links

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