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Ibuprofen With or Without Acetaminophen for Low Back Pain

NCT03554018 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-02-28

Study results available
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Summary

This is a randomized clinical trial comparing two interventions for acute low back pain:

1. Ibuprofen + acetaminophen
2. Ibuprofen + placebo

Participants will include patients who present to an emergency room for management of low back pain. Medication will be dispensed to participants at the time of emergency room discharge. Data will be collected from participants by telephone for 1 week.

Conditions

  • Low Back Pain

Interventions

DRUG

Acetaminophen

Acetaminophen 500-1000mg every 6 hours

DRUG

Ibuprofen 600 mg

Ibuprofen 600mg every 6 hours

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)

DRUG

Placebo oral capsule

To match acetaminophen, patients will take one or two capsules every 6 hours

Sponsors & Collaborators

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Benjamin W Friedman, MD, MS · Montefiore Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-10-16
Primary Completion
2019-09-30
Completion
2019-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03554018 on ClinicalTrials.gov