@article{ref1,
title="Opioid analgesia for acute low back pain and neck pain (the OPAL trial): a randomised placebo-controlled trial",
journal="Lancet",
year="2023",
author="Jones, Caitlin M. P. and Day, Richard O. and Koes, Bart W. and Latimer, Jane and Maher, Chris G. and McLachlan, Andrew J. and Billot, Laurent and Shan, Sana and Lin, Chung-Wei Christine and McLachlan, Hanan and Webb, Melissa and Hamilton, Melanie and Ahedi, Harbeer and Barber, Angie and Mak, Wendy and Mathieson, Stephanie and Petrova, Veronika and Bompoint, Severine and Shan, Sana and Murnion, Bridin and Buckley, Nicholas and Demirkol, Apo and Wrigley, Paul and Needs, Christopher and Brooks, Louise and Cantori, Samuel and Preisz, Paul and Aitken, James and Allan, Sujata and Burke, Michael and Cameron, Greg and Cepeda, Francisco Javier Valencia and Davis, Christopher and Dullur, Jayasree and Emmanuel, Joseph and Errey, Catherine and Fieuw-Makaroff, Sabine and Gaudry, Adam and Genua, L. and Longhurst, Ian and McCroary, Kenneth and Merhi, Diana and Nguyen, Tanya and Obayd, Zahra Rassoly and Penm, Michelle and Pobbathi, Sharan and Poh, William S. and Schnitzler, Paul and Shahnaz, Sabiha and Tan, Ven and Tang, Danny and Tan, Brian and Thu, Win Kyaw and Triantopolous, Thrasivolous and Venkatesan, Ramana and Wong, Wicky Chun Fai and Yang, Shu Ching",
volume="ePub",
number="ePub",
pages="ePub-ePub",
abstract="Background Opioid analgesics are commonly used for acute low back pain and neck pain, but supporting efficacy data are scarce. We aimed to investigate the efficacy and safety of a judicious short course of an opioid analgesic for acute low back pain and neck pain.  Methods OPAL was a triple-blinded, placebo-controlled randomised trial that recruited adults (aged ≥18 years) presenting to one of 157 primary care or emergency department sites in Sydney, NSW, Australia, with 12 weeks or less of low back or neck pain (or both) of at least moderate pain severity. Participants were randomly assigned (1:1) using statistician-generated randomly permuted blocks to guideline-recommended care plus an opioid (oxycodone-naloxone, up to 20 mg oxycodone per day orally) or guideline-recommended care and an identical placebo, for up to 6 weeks. The primary outcome was pain severity at 6 weeks measured with the pain severity subscale of the Brief Pain Inventory (10-point scale), analysed in all eligible participants who provided at least one post-randomisation pain score, by use of a repeated measures linear mixed model. Safety was analysed in all randomly assigned eligible participants. The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12615000775516).  Findings Between Feb 29, 2016, and March 10, 2022, 347 participants were recruited (174 to the opioid group and 173 to the placebo group). 170 (49%) of 346 participants were female and 176 (51%) were male. 33 (19%) of 174 participants in the opioid group and 25 (15%) of 172 in the placebo group had discontinued from the trial by week 6, due to loss to follow-up and participant withdrawals. 151 participants in the opioid group and 159 in the placebo group were included in the primary analysis. Mean pain score at 6 weeks was 2·78 (SE 0·20) in the opioid group versus 2·25 (0·19) in the placebo group (adjusted mean difference 0·53, 95% CI -0·00 to 1·07, p=0·051). 61 (35%) of 174 participants in the opioid group reported at least one adverse event versus 51 (30%) of 172 in the placebo group (p=0·30), but more people in the opioid group reported opioid-related adverse events (eg, 13 [7·5%] of 174 participants in the opioid group reported constipation vs six [3·5%] of 173 in the placebo group).  Interpretation Opioids should not be recommended for acute non-specific low back pain or neck pain given that we found no significant difference in pain severity compared with placebo. This finding calls for a change in the frequent use of opioids for these conditions.  Funding National Health and Medical Research Council, University of Sydney Faculty of Medicine and Health, and SafeWork SA.<p /> <p>Language: en</p>",
language="en",
issn="0140-6736",
doi="10.1016/S0140-6736(23)00404-X",
url="http://dx.doi.org/10.1016/S0140-6736(23)00404-X"
}