By Louise M. Klebanoff, MD
Assistant Professor of Clinical Neurology, Weill Cornell Medical College
Dr. Klebanoff reports no financial relationships relevant to this field of study.
Synopsis: In a trial comparing naproxyn alone to combinations with cyclobenzaprine or oxycodone/acetaminophen in patients with acute low back pain, there was no difference in outcome after 1 week.
Source: Friedman B, et al. Naproxyn with cyclobenzaprine, oxycodone/acetaminophen, or placebo for treating acute low back pain. A randomized clinical trial. JAMA 2015;314:1572-1580.
Acute, non-radicular, non-traumatic low back pain is a common medical condition accounting for 2.7 million (2.4%) emergency department visits annually. Patient are often treated with nonsteroidal anti-inflammatory agents, skeletal muscle relaxants, and/or opioid analgesics. There is minimal evidence-based support for any of these treatments. The authors conducted a randomized, double-blind, three-group clinical trial comparing naproxen and placebo with naproxen and cyclobenzaprine and naproxen and oxycodone/acetaminophen in patients with non-traumatic, non-radicular acute low back pain severe enough to cause functional impairment. The primary outcome was improvement on the Roland-Morris Disability Questionnaire (RMDQ), a 24-item questionnaire commonly used to measure acute low back pain and functional impairment. Subjects were interviewed by telephone at 7 days and 3 months following their emergency department visit.
The study took place over a 20-month period beginning in April 2012. A total of 323 patients were enrolled. The patients ranged from 21 to 64 years of age. The mean baseline scores on the RMQD ranged from 18.4 to 18.9 on the 24-point scale, indicating severe functional impairment. Patients were assigned to one of three groups. All patients received naproxen 500 mg to be taken every 12 hours. All patients were given 60 tablets of their assigned experimental medication, either 1) placebo, 2) cyclobenzaprine 5 mg, or 3) oxycodone/acetaminophen 5 mg/325 mg. The patients were instructed to take one or two tablets of their experimental medication every 8 hours as needed.
At 1-week follow-up, there was no significant difference between the three groups in terms of the primary outcome. The patients randomized to receive naproxen and placebo improved by a mean of 9.8% on the RMDQ, those randomized to receive naproxen and cyclobenzaprine improved by 10.1%, and those randomized to naproxen and oxycodone/acetaminophen improved by 11.1%. At the 1-week follow-up, regardless of study group, more than half of the patients continued to report low back pain severe enough to require pain medication. Patients randomized to oxycodone/acetaminophen were more likely than those randomized to placebo to report pain levels of mild or none. Adverse events were also more common in this group.
More than three-quarters of the study patients used naproxen daily, with two-thirds using it twice a day. There was significantly less compliance with the experimental medications, with only one-third of the study patients using the experimental medications more than once daily and nearly 40% using the experimental medication intermittently, only once, or not at all. At the 3-month follow-up, most patients had recovered. However, nearly one-fourth of patients in each study group still reported moderate or severe low back pain.
COMMENTARY
In this randomized, controlled study of treatment of acute, non-traumatic, non-radicular low back pain presenting to an emergency department, adding either cyclobenzaprine or oxycodone/acetaminophen to naproxen did not significantly improve pain or functional disability at 1 week or 3 months when compared to naproxen alone. By 3 months, most patients had recovered regardless of their randomly assigned treatment group. The study does not support the use of combination therapy for management of acute low back pain.
One concern in interpreting the study results is that the experimental medication was given on an as-needed basis; a large proportion of the study participants either did not take the experimental medication or did not take it regularly. It would be useful to see results from a similarly designed trial in which the experimental medications are given on a standing basis. In addition, considering the urban setting in which the study was performed, with an emergency department serving a socioeconomically depressed population with limited access to health care, the conclusions may not be applicable to a different patient population. Additional studies are needed to provide evidence for management of acute, non-traumatic, non-radicular low back pain, a common, disabling condition.
In a trial comparing naproxyn alone to combinations with cyclobenzaprine or oxycodone/acetaminophen in patients with acute low back pain, there was no difference in outcome after 1 week.
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