Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 69 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • 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)
Active Comparator
Placebo
Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.
  • 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

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467
Contact:
Benjamin Friedman, MD, MS
718-920-6626
befriedm@montefiore.org

More Details

NCT ID
NCT03554018
Status
Recruiting
Sponsor
Montefiore Medical Center

Study Contact

Benjamin W Friedman, MD, MS
17189206626
befriedm@montefiore.org

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.