Naproxen with cyclobenzaprine, oxycodone/acetaminophen, or placebo for treating acute low back pain: A randomized clinical trial

Importance Low back pain (LBP) is responsible for more than 2.5 million visits to US emergency departments (EDs) annually. These patients are usually treated with nonsteroidal anti-inflammatory drugs, acetaminophen, opioids, or skeletal muscle relaxants, often in combination. Objective To compare functional outcomes and pain at 1 week and 3 months after an ED visit for acute LBP among patients randomized to a 10-day course of (1) naproxen + placebo; (2) naproxen + cyclobenzaprine; or (3) naproxen + oxycodone/acetaminophen. Design, Setting, and Participants This randomized, double-blind, 3-group studywas conducted at one urban ED in the Bronx, New York City. Patients who presented with nontraumatic, nonradicular LBP of 2 weeks' duration or less were eligible for enrollment upon ED discharge if they had a score greater than 5 on the Roland-Morris Disability Questionnaire (RMDQ). The RMDQ is a 24-item questionnaire commonly used to measure LBP and related functional impairment on which 0 indicates no functional impairment and 24 indicates maximum impairment. Beginning in April 2012, a total of 2588 patients were approached for enrollment. Of the 323 deemed eligible for participation, 107 were randomized to receive placebo and 108 each to cyclobenzaprine and to oxycodone/acetaminophen. Follow-up was completed in December 2014. Interventions All participants were given 20 tablets of naproxen, 500mg, to be taken twice a day. They were randomized to receive either 60 tablets of placebo; cyclobenzaprine, 5mg; or oxycodone, 5mg/acetaminophen, 325mg. Participants were instructed to take 1 or 2 of these tablets every 8 hours, as needed for LBP. They also received a standardized 10-minute LBP educational session prior to discharge. Main Outcomes and Measures The primary outcomewas improvement in RMDQ between ED discharge and 1 week later. Results Demographic characteristicswere comparable among the 3 groups.At baseline, medianRMDQscore in the placebo groupwas 20(interquartile range [IQR],17-21), in the cyclobenzaprine group 19 (IQR,17-21), and in the oxycodone/acetaminophen group 20(IQR,17- 22).At 1-week follow-up, the meanRMDQimprovementwas 9.8 in the placebo group, 10.1 in the cyclobenzaprine group, and 11.1 in the oxycodone/acetaminophen group. Between-group difference in meanRMDQimprovement for cyclobenzaprine vs placebowas0.3 (98.3%CI, -2.6 to 3.2; P = .77), for oxycodone/acetaminophen vs placebo, 1.3 (98.3%CI, -1.5 to 4.1; P = .28), and for oxycodone/acetaminophen vs cyclobenzaprine,0.9 (98.3%CI, -2.1 to 3.9; P = .45). Conclusions and Relevance Among patients with acute, nontraumatic, nonradicular LBP presenting to the ED, adding cyclobenzaprine or oxycodone/acetaminophen to naproxen alone did not improve functional outcomes or pain at 1-week follow-up. These findings do not support use of these additional medications in this setting.