Second-Order Peer Reviews of Clinically Relevant Articles for the Physiatrist: Naproxen with Cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo to Treating Acute Low Back Pain
The study is a double-blind randomized placebo-controlled trial with 3 study arms that include 323 patients. Eligible patients were enrolled at an urban emergency department (ED). Inclusion criteria included a history of LBP (defined as pain between the lower border of the scapulae and upper gluteal folds) present for 2 weeks or less, age between 21 and 64 years, and nonradicular “musculoskeletal LBP” that was “functionally limiting”. Ostensibly, another requirement was pain severe enough to warrant at visit to the ED. Patients also had a score of greater than 5 on the Roland Morris Disability Questionnaire (RMDQ). Patients with direct trauma or a known “medical cause” of LBP were excluded.
Patients were given a prescription of naproxen, 500 mg twice a day, and then also randomized to receive either placebo, cyclobenzaprine, or oxycodone/acetaminophen. They were instructed to take the trial medication as 1 or 2 tablets as needed every 8 hours.
The primary outcome was mean improvement in RMDQ between the time of ED discharge and 1 week later. A number of secondary outcomes were also evaluated; these included adverse medication reactions and pain at 3 months.