Naproxen With Cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo for Treating Acute Low Back Pain
The Article: Friedman, B.W., et al. “Naproxen With Cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo for Treating Acute Low Back Pain: A Randomized Clinical Trial”. JAMA. 2015; 314(15):1572-1580.
The Idea: To determine if a 10 day course of Flexeril or Percocet in combination with Naproxen is more effective than Naproxen as monotherapy for the treatment of acute, nontraumatic, nonradicular low back pain in terms of functional outcomes and pain at 1 week and 3 months after an ED visit for acute LBP.
The Study: A randomized, double blind, 3-group study conducted at one urban teaching hospital in the Bronx with >100,000 ED visits annually. Included in the analysis were 107 pts in the Naproxen & placebo group, 108 in the Flexeril & Naproxen group, and 108 in the Percocet & Naproxen group. Inclusion criteria consisted of patients ages 21-64 with acute back pain defined as occurring for <2 weeks & between lower border of scapula & the upper gluteal folds, that was nontraumatic & nonradicular, and that was “functionally impairing back pain” defined as a score >5 in the RMDQ (Roland-Morris Disability Questionnaire). The RMDQ is a 24 item questionnaire used to measure low back pain & functional impairment with 0 being no impairment and 24 being maximum impairment. Patients were excluded if they had radicular pain, direct trauma, pain >2 weeks, >1 LBP episode in a month, were pregnant/lactating, allergic, or had a history of chronic opiate use. Each patient was prescribed 500mg of Naproxen to take BID. In addition, they either got 60 tablets of a placebo, 5mg flexeril, or 5/325mg Percocet with instructions to take 1-2 tablets every 8 hours as needed. Each patient was provided 10 minutes of education including medication alternatives such as exercises, warm/cold compresses, PT, massage, acupuncture, etc. The primary outcome was improvement on the RMDQ of 5 points between the time of ED discharge and a 7-day telephone follow up. Other exploratory outcomes were assessed at 1 week and 3 months after ED discharge. Some of these additional outcomes included amount of pain in the last 24 hours, worst LBP, frequency of meds, frequency of symptoms. Also asked about their satisfaction with treatment measured by questioning whether the patient would take the same medication if their back pain recurred and were asked when they were able to resume regular activities/return to work.
The Results: Demographics amongst all 3 groups were comparable. Initial and subsequent baseline scores on the RMDQ were similar. At one week, approximately two-thirds of patients had improvement of back pain and function. The RMDQ scores improved by a mean of 9.8 in the Naproxen & placebo group, a mean of 10.1 in the Naproxen & Flexeril group, and a mean of 11.1 in the Naproxen & Percocet group. There was no statistically significant difference amongst the 3 treatment groups in terms of the primary outcomes. In terms of the other exploratory outcomes- 50% still required analgesics at the 1 week follow up, however 60% said they would still like to get the same medication if they had recurrence of back pain. 75% used the Naproxen daily, of these approximately 66% used it BID as prescribed. Fewer participants used the 2nd agent regularly- 33% used it more than once daily, 40% used it once or not at all. Most participants didn’t follow up with a PCP or use CAM.
At 3 months, 25% in each study group still reported LBP pain and use of meds; 2.3% reported opiate use. In terms of adverse effects, patients were more likely to have symptoms of drowsiness, dizziness, and N/V in the Percocet arm.
The Takeaway: For patients with acute (<2 weeks), nontraumatic, nonradicular low back pain, adding Cyclobenzaprine or Oxycodone/Acetaminophen to Naproxen did not improve functional outcomes or pain at 7 days. The findings do not support the addition of these medications to NSAID use for the treatment of acute LBP. Furthermore, doctors should inform their patients that passage of time is likely to bring improvement & eventual relief to most.