'Landmark' Trial Shows Opioids for Back, Neck Pain No Better Than Placebo

Megan Brooks

June 29, 2023

Opioids do not relieve acute low back or neck pain in the short term and lead to worse outcomes in the long term, results of the first randomized controlled trial testing the efficacy and safety of a short course of opioids for acute nonspecific low back/neck pain suggest.

After 6 weeks, there was no significant difference in pain scores of patients who took opioids compared to those who took placebo. After 1 year, patients given the placebo had slightly lower pain scores. Also, patients using opioids were at greater risk of opioid misuse after 1 year.

This is a "landmark" trial with "practice-changing" results, senior author Christine Lin, PhD, with the University of Sydney, told Medscape Medical News.

"Before this trial, we did not have good evidence on whether opioids were effective for acute low back pain or neck pain, yet opioids were one of the most commonly used medicines for these conditions," Lin explained.

On the basis of these results, "opioids should not be recommended at all for acute low back pain and neck pain," Lin said.

Results of the OPAL study were published online June 28 in The Lancet.

Rigorous Trial

The trial was conducted in 157 primary care or emergency department sites in Australia and involved 347 adults who had been experiencing low back pain, neck pain, or both for 12 weeks or less.

They were randomly allocated (1:1) to receive guideline-recommended care (reassurance and advice to stay active) plus an opioid (oxycodone up to 20 mg daily) or 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 (10-point scale).

After 6 weeks, opioid therapy offered no more relief for acute back/neck pain or functional improvement than placebo.

The mean pain score at 6 weeks was 2.78 in the opioid group, vs 2.25 in the placebo group (adjusted mean difference, 0.53; 95% CI, –0.00 to 1.07; P = .051). At 1 year, mean pain scores in the placebo group were slightly lower than in the opioid group (1.8 vs 2.4).

In addition, there was a doubling of the risk of opioid misuse at 1 year among patients randomly allocated to receive opioid therapy for 6 weeks compared with those allocated to receive placebo for 6 weeks.

At 1 year, 24 (20%) of 123 of the patients who received opioids were at risk of misuse, as indicated by the Current Opioid Misuse Measure (COMM) scale, compared with 13 (10%) of 128 patients in the placebo group (P = .049). The COMM is a widely used measure of current aberrant drug-related behavior among patients with chronic pain who are being prescribed opioid therapy.

Results Raise "Serious Questions"

"I believe the findings of the study will need to be disseminated to the doctors and patients, so they receive this latest evidence on opioids," Lin told Medscape Medical News.

"We need to reassure doctors and patients that most people with acute low back pain and neck pain recover well with time (usually by 6 weeks), so management is simple ― staying active, avoiding bed rest, and, if necessary, using a heat pack for short term pain relief. If drugs are required, consider anti-inflammatory drugs," Lin added.

The authors of a linked comment say the OPAL trial "raises serious questions about the use of opioid therapy for acute low back and neck pain."

Mark Sullivan, MD, PhD, and Jane Ballantyne, MD, with the University of Washington, Seattle, note that current clinical guidelines recommend opioids for patients with acute back and neck pain when other drug treatments fail or are contraindicated.

"As many as two-thirds of patients might receive an opioid when presenting for care of back or neck pain. It is time to re-examine these guidelines and these practices," Sullivan and Ballantyne conclude.

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 have disclosed no relevant financial relationships. Sullivan and Ballantyne are board members (unpaid) of Physicians for Responsible Opioid Prescribing and have been paid consultants in opioid litigation.

Lancet. Published online June 28, 2023. Abstract

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