A groundbreaking randomized controlled trial has revealed that opioids do not provide short-term relief for acute low back or neck pain and may lead to worse outcomes in the long term. These findings mark a significant milestone and have the potential to change clinical practice.
Christine Lin, PhD, senior author of the study from the University of Sydney, described the trial as “landmark” with “practice-changing” results. Before this trial, there was insufficient evidence to determine whether opioids were effective for acute low back and neck pain, despite being widely used for these conditions.
The results of the OPAL (Opioids for the Management of Acute Pain in the Lower Back, Neck, or Shoulder) study were published online in The Lancet. The trial involved 157 primary care or emergency department sites in Australia and included 347 adults who had been experiencing low back pain, neck pain, or both for 12 weeks or less.
Participants were randomly assigned to receive either guideline-recommended care, which included reassurance and advice to stay active, along with an opioid (oxycodone up to 20 mg daily), or an identical placebo for up to 6 weeks. Naloxone was provided to help prevent opioid-induced constipation and improve blinding.
The primary outcome was pain severity at 6 weeks, measured with the pain severity subscale of the Brief Pain Inventory (on a 10-point scale).
After 6 weeks, it was found that opioid therapy did not offer more relief for acute back or neck pain, nor did it improve functionality compared to the placebo. The mean pain score at 6 weeks was 2.78 in the opioid group and 2.25 in the placebo group, with no significant difference.
Interestingly, at the 1-year mark, mean pain scores in the placebo group were slightly lower than in the opioid group (1.8 vs. 2.4). Moreover, patients randomly allocated to receive opioid therapy for 6 weeks had double the risk of opioid misuse at 1 year compared to those assigned to receive the placebo.
Specifically, at 1 year, 20% of patients who received opioids were at risk of misuse, as indicated by the Current Opioid Misuse Measure (COMM) scale, compared to 10% of patients in the placebo group.
These findings have led to a reevaluation of the use of opioids for acute low back and neck pain. The study’s authors suggest that patients and doctors should be informed about these results and that opioids should not be recommended for acute low back and neck pain. Instead, they emphasize that most people with these conditions recover well with time, typically within 6 weeks, through simple management strategies such as staying active, avoiding bed rest, and using heat packs for short-term pain relief.
The study has prompted calls to re-examine clinical guidelines and practices that recommend opioids for acute back and neck pain when other drug treatments fail or are contraindicated. As many as two-thirds of patients with such pain receive opioids, and these findings may lead to a reconsideration of these practices.
Funding for the OPAL study was provided by the National Health and Medical Research Council, the University of Sydney Faculty of Medicine and Health, and SafeWork SA. The study authors reported no relevant financial relationships.
