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Trial record 5 of 126 for:    Recruiting, Not yet recruiting Studies | Back Pain | United States

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

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ClinicalTrials.gov Identifier: NCT03861611
Recruitment Status : Recruiting
First Posted : March 4, 2019
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Eddie Irizarry, Montefiore Medical Center

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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)




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03861611


Contacts
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Contact: Eddie Irizarry, MD 718-920-6626 eddiriza@montefiore.org
Contact: Benjamin Friedman, MD, MS 718-920-6626 befriedm@montefiore.org

Locations
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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
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Principal Investigator: Eddie Irizarry, MD Montefiore Medical Center

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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    Key Record Dates
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

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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:
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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