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

NCT03861611 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2022-05-31

Study results available
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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)

Conditions

  • Back Pain Without Radiation
  • Low Back Pain

Interventions

DRUG

Ketorolac

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

DRUG

Ibuprofen

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

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

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Eddie Irizarry, MD · Montefiore Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-12
Primary Completion
2021-02-02
Completion
2021-02-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03861611 on ClinicalTrials.gov