1. Mean pain score at 6 weeks was not statistically different between the opioid and placebo groups.
2. Risk of opioid misuse after 52 weeks was higher in the opioid group compared to the placebo group.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Opioid analgesics are commonly used for acute low back and neck pain, despite limited efficacy. Aside from the questionable efficacy, a major concern of regular opioid use is the risk of serious adverse events which could increase mortality and healthcare costs. This randomized controlled trial aimed to assess the safety and efficacy of a short-term opioid analgesic course for acute low back and neck pain. Patients were assigned to either the opioid or placebo group and assessed after 6 weeks. The primary outcome was pain severity at 6 weeks, as evaluated using the Brief Pain Inventory, while key secondary outcomes pertained to patient safety. According to study results, there was no significant difference in pain severity between the opioid and placebo groups, although adverse events were slightly more common in the opioid group. Although this study was well done, it was limited by patients who discontinued the trial or were lost-to-follow-up. In addition, there were no available data on the use of guideline-directed non-opioid analgesia among study participants.
Click to read the study in The Lancet
Relevant Reading: Reducing Opioid Use for Chronic Pain With a Group-Based Intervention
In-depth [randomized-controlled trial]: Between Feb 29, 2016, and Mar 10, 2022, 1349 patients were screened for eligibility across 157 primary care or emergency department sites in Sydney, Australia. Included were patients with acute low back or neck pain with at least moderate severity. Altogether, 347 patients (151 in the opioid group and 159 in the placebo group) were included in the final analysis. Participants allocated to the opioid group were started on 2.5 mg naloxone and 5 mg oxycodone twice a day, and titration was allowed up to a maximum of 10 mg twice daily. They also received guideline-recommended standard of care, while the control group received guideline-recommended care with a matched placebo. The primary outcome of pain severity at 6 weeks was not significantly different between the opioid group (2.78, standard error [SE] 0.20) compared to placebo (2.25, SE 0.19; adjusted mean difference 0.53, 95% confidence interval [CI] 0.00-1.07, p=0.051). Additionally, more patients in the opioid group reported more than one adverse event than those in the placebo group (35% vs. 30%, p=0.30). Furthermore, the risk of opioid misuse after 52 weeks was greater among the opioid group (20%) compared to placebo (10%, p=0.049). Overall, findings from this study suggest that opioids should not be recommended for acute non-specific low back pain or neck pain, indicating a need to reconsider their frequent use for such conditions.
Image: PD
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