NCT03554018

Ibuprofen With or Without Acetaminophen for Low Back Pain

Ibuprofen With or Without Acetaminophen for Acute, Non-radicular Low Back Pain: A Randomized Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2018-10-16
• Primary completion: 2019-09-30
• Completion: 2019-09-30
• First posted: 2018-06-12
• Last updated: 2024-02-28
• Results posted: 2021-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study