A Randomized, Placebo Controlled Trial of Ibuprofen + Metaxalone, Tizanidine, Or Baclofen for Acute Low Back Pain
HHS Public Access Author manuscript Author ManuscriptAuthor Manuscript Author Ann Emerg Manuscript Author Med. Author Manuscript Author manuscript; available in PMC 2020 October 01. Published in final edited form as: Ann Emerg Med. 2019 October ; 74(4): 512–520. doi:10.1016/j.annemergmed.2019.02.017. A randomized, placebo controlled trial of ibuprofen + metaxalone, tizanidine, or baclofen for acute low back pain Benjamin W. Friedman, MD MS1, Eddie Irizarry, MD1, Clemencia Solorzano, PharmD2, Eleftheria Zias, RPh2, Scott Pearlman, MD1, Andrew Wollowitz, MD1, Michael P. Jones, MD1, Purvi D. Shah, MD MSc1, E. John Gallagher, MD1 1Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore, Bronx, NY, USA 2Pharmacy Department, Montefiore, Bronx, NY, USA Abstract Background: Patients with low back pain (LBP) are often treated with non-steroidal antiinflammatory drugs (NSAID) and skeletal muscle relaxants (SMR). We compared functional outcomes and pain among acute LBP patients randomized to a one week course of ibuprofen + placebo versus ibuprofen + one of three SMRs: baclofen, metaxalone, or tizanidine. Methods: This was a randomized, double-blind, parallel group, 4-arm study conducted in two urban emergency departments (ED). Patients with non-radicular LBP for <=two weeks were eligible if they had a score >5 on the Roland-Morris Disability Questionnaire (RMDQ), a 24-item inventory of functional impairment due to LBP. All participants received 21 tablets of ibuprofen 600mg, to be taken TID, as needed. Additionally, they were randomized to baclofen 10mg, metaxalone 400mg, tizanidine 2mg, or placebo. Participants were instructed to take one or two of these capsules, TID, as needed. All participants received a 10 minute educational session.
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