Duloxetine for Patients With Low Back Pain Who Fail to Improve With Oral NSAIDs. A Randomized Placebo-controlled Exploratory Study
Montefiore Medical Center
Summary
This research study will help determine whether a medication called duloxetine can improve back pain. It is well documented that many participants who come to the ER with acute low back pain still have low back pain 3 months later. The investigator team will attempt to determine whether duloxetine can help prevent this.
Description
Participants will be eligible to take duloxetine/placebo if insufficient relief of pain after using naproxen for 48 hours has been reported.
Eligibility
- Age range
- 18–64 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Present to Emergency Department (ED) 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 ED visit, must be a diagnosis consistent with non-traumatic, non-radic…
Interventions
- DrugNaproxen
Naproxen 500mg twice daily for 16 days
- DrugDuloxetine
Duloxetine 60mg daily for 14 days
Location
- Montefiore Medical CenterThe Bronx, New York