Ibuprofen With or Without Acetaminophen for Low Back Pain

NCT ID: NCT03554018

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-16
• Study Completion Date: 2019-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Acetaminophen

Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.

Group Type: EXPERIMENTAL

Acetaminophen

Intervention Type: DRUG

Acetaminophen 500-1000mg every 6 hours

Ibuprofen 600 mg

Intervention Type: DRUG

Ibuprofen 600mg every 6 hours

Educational intervention

Intervention Type: BEHAVIORAL

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)

Placebo

Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.

Group Type: ACTIVE_COMPARATOR

Ibuprofen 600 mg

Intervention Type: DRUG

Ibuprofen 600mg every 6 hours

Educational intervention

Intervention Type: BEHAVIORAL

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)

Placebo oral capsule

Intervention Type: DRUG

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

Interventions

Acetaminophen

Acetaminophen 500-1000mg every 6 hours

Intervention Type: DRUG

Ibuprofen 600 mg

Ibuprofen 600mg every 6 hours

Intervention Type: DRUG

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)

Intervention Type: BEHAVIORAL

Placebo oral capsule

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Present to emergency room primary for management of LBP, defined as pain originating between the lower border of the scapulae and the upper gluteal folds. Flank pain, that is pain originating from tissues lateral to the paraspinal muscles, will not be included.

• Musculoskeletal etiology of low back. Patients with non-musculoskeletal etiologies such as urinary tract infection, ovarian cysts, or influenza like illness will be excluded. The primary clinical diagnosis, at the conclusion of the emergency room visit, must be a diagnosis consistent with non-traumatic, non-radicular, musculoskeletal low back pain.
• Patient is to be discharged home.
• Age 18-69
• Non-radicular pain. Patients will be excluded if the pain radiates below the gluteal folds in a radicular pattern.
• Pain duration <2 weeks (336 hours).
• Prior to the acute attack of LBP, back pain cannot occur more frequently than once per month.
• Non-traumatic LBP: no substantial and direct trauma to the back within the previous month
• Functionally impairing back pain: A baseline score of > 5 on the Roland-Morris Disability Questionnaire

Exclusion Criteria

• Not available for follow-up
• Pregnant
• Chronic pain syndrome defined as use of any analgesic medication on a daily or near-daily basis
• Allergic to or intolerant of investigational medications

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin W Friedman, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2018-9182

Identifier Type: -

Identifier Source: org_study_id