Overview
Ibuprofen With or Without Acetaminophen for Low Back Pain
Status:
Completed
Completed
Trial end date:
2019-09-30
2019-09-30
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Montefiore Medical CenterTreatments:
Acetaminophen
Ibuprofen
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