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Completed

NCT Number: NCT03861611

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

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)

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Key information

Conditions

Back Pain Without Radiation Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac

Drug

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

Ibuprofen

Drug

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

Diclofenac

Drug

Participants may be randomized to receive Diflofenac oral medication 50 mg, every 8 hours for 5 days as needed

Educational intervention

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 4, 2019
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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