Ibuprofen With or Without Acetaminophen for Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Acetaminophen; Ibuprofen 600 mg; Educational intervention; Placebo oral capsule
Intervention description: Acetaminophen 500-1000mg every 6 hours; Ibuprofen 600mg every 6 hours; 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); To match acetaminophen, patients will take one or two capsules every 6 hours
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No

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.
    

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