A Randomized, Double-Blind, Placebo-Controlled Trial of Naproxen With or Without Orphenadrine or Methocarbamol for Acute Low Back Pain - 21/02/18
, David Cisewski, MD, MS a, Eddie Irizarry, MD a, Michelle Davitt, MD a, Clemencia Solorzano, PharmD b, Adam Nassery, MD a, Scott Pearlman, MD a, Deborah White, MD a, E. John Gallagher, MD aAbstract |
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.
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| Please see page 349 for the Editor’s Capsule Summary of this article. |
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| Supervising editor: Steven M. Green, MD |
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| Author contributions: BWF and EJG conceived the study. BWF, DC, MD, AN, SP, and DW reviewed the literature in preparation for the trial. BWF, DC, CS, and EJG designed the trial. BWF, EI, and CS supervised the conduct of the trial and data collection. BWF, DC, EI, AN, SP, and DW managed the data. BWF, DC, MD, SP, and DW analyzed the data. BWF, DC, and AN drafted the article, and all authors contributed substantially to its revision. BWF takes responsibility for the paper as a whole. |
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| All authors attest to meeting the four ICMJE.org authorship criteria: (1) Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND (2) Drafting the work or revising it critically for important intellectual content; AND (3) Final approval of the version to be published; AND (4) Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. |
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| Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org/). The authors have stated that no such relationships exist. This publication was supported in part by the Harold and Muriel Block Institute for Clinical and Translational Research at Einstein and Montefiore grant (UL1TR001073). |
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| Trial registration number: NCT02665286 |
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Vol 71 - N° 3
P. 348 - mars 2018 Retour au numéro
Article précédent
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