Purpose

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)

Conditions

Eligibility

Eligible Ages
Between 18 Years and 64 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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)

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467
Contact:
Eddie Irizarry, MD

More Details

Status
Recruiting
Sponsor
Montefiore Medical Center

Study Contact

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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.