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Randomized Controlled Trial
. 2018 Mar;71(3):348-356.e5.
doi: 10.1016/j.annemergmed.2017.09.031. Epub 2017 Oct 28.

A Randomized, Double-Blind, Placebo-Controlled Trial of Naproxen With or Without Orphenadrine or Methocarbamol for Acute Low Back Pain

Benjamin W Friedman  1 , David Cisewski  2 , Eddie Irizarry  2 , Michelle Davitt  2 , Clemencia Solorzano  3 , Adam Nassery  2 , Scott Pearlman  2 , Deborah White  2 , E John Gallagher  2
Affiliations
Randomized Controlled Trial

A Randomized, Double-Blind, Placebo-Controlled Trial of Naproxen With or Without Orphenadrine or Methocarbamol for Acute Low Back Pain

Benjamin W Friedman et al. Ann Emerg Med. 2018 Mar.

Abstract

Study objective: In US emergency departments (EDs), patients with low back pain are often treated with nonsteroidal anti-inflammatory drugs and muscle relaxants. We compare functional outcomes among patients randomized to a 1-week course of naproxen+placebo versus naproxen+orphenadrine or naproxen+methocarbamol.

Methods: This was a randomized, double-blind, comparative effectiveness trial conducted in 2 urban EDs. Patients presenting with acute, nontraumatic, nonradicular low back pain were enrolled. The primary outcome was improvement on the Roland-Morris Disability Questionnaire (RMDQ) between ED discharge and 1 week later. All patients were given 14 tablets of naproxen 500 mg, to be used twice a day, as needed for low back pain. Additionally, patients were randomized to receive a 1-week supply of orphenadrine 100 mg, to be used twice a day as needed, methocarbamol 750 mg, to be used as 1 or 2 tablets 3 times per day as needed, or placebo. All patients received a standardized 10-minute low back pain educational session before discharge.

Results: Two hundred forty patients were randomized. Baseline demographic characteristics were comparable. The mean RMDQ score of patients randomized to naproxen+placebo improved by 10.9 points (95% confidence interval [CI] 8.9 to 12.9). The mean RMDQ score of patients randomized to naproxen+orphenadrine improved by 9.4 points (95% CI 7.4 to 11.5). The mean RMDQ score of patients randomized to naproxen+methocarbamol improved by 8.1 points (95% CI 6.1 to 10.1). None of the between-group differences surpassed our threshold for clinical significance. Adverse events were reported by 17% (95% CI 10% to 28%) of placebo patients, 9% (95% CI 4% to 19%) of orphenadrine patients, and 19% (95% CI 11% to 29%) of methocarbamol patients.

Conclusion: Among ED patients with acute, nontraumatic, nonradicular low back pain, combining naproxen with either orphenadrine or methocarbamol did not improve functional outcomes compared with naproxen+placebo.

Trial registration: ClinicalTrials.gov NCT02665286.

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Conflict of interest statement

We have no conflicts of interest to report.

Figures

Figure 1
Figure 1
CONSORT flow diagram
Figure 2
Figure 2
Figure 2a. Spaghetti pot of RMDQ scores over time. Placebo arm Figure 2b. Spaghetti plot of RMDQ scores over time. Orphenadrine arm Figure 2c. Spaghetti plot of RMDQ scores over time. Methocarbamol arm
Figure 2
Figure 2
Figure 2a. Spaghetti pot of RMDQ scores over time. Placebo arm Figure 2b. Spaghetti plot of RMDQ scores over time. Orphenadrine arm Figure 2c. Spaghetti plot of RMDQ scores over time. Methocarbamol arm
Figure 2
Figure 2
Figure 2a. Spaghetti pot of RMDQ scores over time. Placebo arm Figure 2b. Spaghetti plot of RMDQ scores over time. Orphenadrine arm Figure 2c. Spaghetti plot of RMDQ scores over time. Methocarbamol arm
See this image and copyright information in PMC

References

    1. Friedman BW, Chilstrom M, Bijur PE, Gallagher EJ. Diagnostic testing and treatment of low back pain in United States emergency departments: a national perspective. Spine (Phila Pa. 1976;35(24):E1406–11. - PMC - PubMed
    1. Friedman BW, O’Mahony S, Mulvey L, Davitt M, Choi H, Xia S, et al. One-week and 3-month outcomes after an emergency department visit for undifferentiated musculoskeletal low back pain. Annals of emergency medicine. 2012;59(2):128–33. e3. - PubMed
    1. Friedman BW, Dym AA, Davitt M, Holden L, Solorzano C, Esses D, et al. Naproxen With Cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo for Treating Acute Low Back Pain: A Randomized Clinical Trial. JAMA. 2015;314(15):1572–80. - PubMed
    1. Friedman BW, Irizarry E, CS, Khankel N, Zapata J, Zias E, et al. Diazepam is no better than placebo when added to naproxen for acute low back pain. Annals of emergency medicine. 2017 - PMC - PubMed
    1. Roelofs PD, Deyo RA, Koes BW, Scholten RJ, van Tulder MW. Nonsteroidal anti-inflammatory drugs for low back pain: an updated Cochrane review. Spine. 2008;33(16):1766–74. - PubMed

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