Opioids Confer Risk without Improved Pain Control

Clinical question: How effective and safe are opioids for the treatment of acute, non-specific low back and neck pain?

Background: Despite the lack of evidence of the effectiveness of opioids for the treatment of low back and neck pain, patients presenting with these symptoms are often prescribed opioid analgesics. This is the first placebo-controlled, randomized trial to measure the short- and long-term efficacy and side effects associated with opioid use for spinal pain.

Study design: Triple-blinded, randomized controlled trial

Setting: Primary care and emergency department sites in Sydney, Australia

Synopsis: A total of 347 patients presenting with 12 weeks or less of low back or neck pain of at least moderate intensity, and without known or suspected serious spinal pathology, were enrolled. 174 participants received guideline-recommended care plus modified-release oxycodone-naloxone with a dose of up to 20 mg oxycodone daily, and 173 participants received guideline-recommended care plus placebo. Naloxone was added to oxycodone to reduce opioid-related constipation and improve blinding. Treatment continued until adequate improvement or for a maximum of six weeks. Mean pain scores at six and 12 weeks did not statistically differ between the two groups, though at 52 weeks mean pain scores slightly favored placebo. The proportion of participants reporting adverse events did not differ between the two groups. The risk of opioid misuse did not differ early in the trial but was significantly higher in the opioid group at week 52, with 20% of opioid recipients at risk of misuse compared with 10% of placebo recipients. The participant population limits its transferability to the hospital setting and to situations besides acute non-specific spinal pain.

Bottom line: Short courses of opioids for acute, non-specific low back and neck pain did not result in improved pain control but did increase the long-term risk of opioid misuse.

Citation: Jones CMP, et al. Opioid analgesia for acute low back pain and neck pain (the OPAL trial): a randomised placebo-controlled trial. Lancet. 2023;402(10398):304-12. Erratum in: Lancet. 2023;402(10402):612.

Dr. Nolan

Dr. Lewis

Dr. Nolan is a clinical assistant professor and Dr. Lewis is a clinical associate professor at The Ohio State University Wexner Medical Center in Columbus, Ohio.