October 28, 2015
JAMA : The Journal of the American Medical Association
TAKE-HOME MESSAGE
- Patients with acute non-traumatic, non-radicular low-back pain for
- In patients presenting to the emergency department with acute low-back pain, the addition of cyclobenzaprine or oxycodone/acetaminophen to naproxen had no clinical benefit over naproxen alone.
Primary Care
Written by David Rakel MD, FAAFP
NSAIDS work well for acute back pain, but does adding a muscle relaxer or opioid plus acetaminophen work better?
This study randomized 323 people presenting to a New York City emergency department with acute, non-traumatic, non-radicular low-back pain. All were given naproxen 500 mg twice daily. The add-on medication was to be taken 1 to 2 tablets every 8 hours as needed and included placebo, 5 mg of cyclobenzaprine, or oxycodone 5 mg/acetaminophen 325 mg.
At 7 days following presentation, there was no significant difference in pain or function among the three groups, but there was more harm. Of the oxycodone/acetaminophen group, 43% had side effects, with a number needed to harm (NNH) of 5.3. Of the cyclobenzaprine group, 33% had side effects with a NNH of 7.8. A total of 21% of the naproxen plus placebo group had side effects.
The clinical take-home from this study is valuable and straightforward. Naproxen alone works just as well as naproxen with a muscle relaxer or naproxen with an opioid plus acetaminophen. Naproxen alone was cheaper and safer. It worked best when it was combined with time as 2/3 of patients improved in 1 week in all three groups.
Abstract
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 study was 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, 500 mg, to be taken twice a day. They were randomized to receive either 60 tablets of placebo; cyclobenzaprine, 5 mg; or oxycodone, 5 mg/acetaminophen, 325 mg. 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 outcome was improvement in RMDQ between ED discharge and 1 week later.
RESULTS
Demographic characteristics were comparable among the 3 groups. At baseline, median RMDQ score in the placebo group was 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 mean RMDQ improvement was 9.8 in the placebo group, 10.1 in the cyclobenzaprine group, and 11.1 in the oxycodone/acetaminophen group. Between-group difference in mean RMDQ improvement for cyclobenzaprine vs placebo was 0.3 (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.