Still using opioids for back pain?

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Following a short break, this week we return to the always interesting topic of pain management and we are tackling a major issue in acute and chronic pain management – back pain.

The study, titled “Opioid analgesia for acute low back pain and neck pain (the OPAL trial): a randomised placebo-controlled trial” by Jones et al, is a multicentric triple-blinded randomised controlled trial conducted in Sydney, Australia, across 157 research sites.

The study included patients who had a complain of either neck pain, low back pain, or both of at least moderate intensity, lasting less than 12 weeks and preceded by at least a month of being pain-free.

Patients were excluded if they had known or suspected serious spinal pathology, contraindications to opioid analgesics, had taken a prescription opioid analgesic for the current episode of back pain at a dose higher than 15 mg of oral morphine equivalents per day for 5 or more consecutive days, had spinal surgery in the preceding 6 months or were scheduled for interventional procedures for low back pain or neck pain during the 6-week treatment period, were underage or were breastfeeding.

A total of 346 patients were enrolled in the trial – 174 were assigned to the opioid group and 172 were assigned to the placebo group.

Patients in the opioid group received modified release (MR) tablets of oxycodone/naloxone at a dose of 5/2.5mg and were instructed to take them twice a day. The dose was escalated up to 10mg of oxycodone, depending on the individual patient characteristics and response to treatment. Treatment continued until a patient reported a pain score of 0-1/10 for 3 consecutive days, or for a maximum of 6 weeks.

Patients in the placebo group received placebo tablets that looked identical to oxycodone/naloxone pills, but contained no active ingredients.

Patients in both groups received individualised guideline-directed care for back pain, including non-opioid analgesics, in addition to opioid/placebo therapy.

Both patient groups had similar baseline characteristics, with no statistically significant difference in age, BMI, pain location and employment status between groups.

Following 6 weeks of treatment, there was no statistically significant difference in pain scores between the opioid and the placebo group (2.78 vs 2.25, p = 0.051).

There was also no statistically significant difference in pain scores between groups in the 12-week follow up analysis (2.58 for opioids vs 2.1 for placebo, p = 0.083). However, in the 52-week follow up analysis, pain scores were significantly lower in the placebo group (1.81 vs 2.37 in the opioid group, p = 0.041).

In the disability/functioning score analyses, there were no significant differences in the degree of physical functioning between groups at 6 weeks. However, when condition-specific scales (Roland Morris Disability Questionnaire for low-back pain) were analyzed, patients in the placebo group reported a significantly higher level of functionality.

There was no statistically significant difference between groups regarding time to recovery, work absenteeism, or health-care utilisation during the treatment period.

Regarding safety outcomes, no statistically significant difference between groups in the incidence of side-effects was reported.

Significantly more patients in the opioid group were at risk of opioid misuse (scoring 9 or more on current opioid misuse measure scale) in the 52-week follow up period (20% vs 10%, p = 0.049).

It is important to note that compliance was generally low in both groups – only 55% of patients in the opioid group and 56% in the placebo group were taking the pills as prescribed and instructed. However, this likely reflects the “real-world” conditions of our daily practice.

Only 37% of patients in the opioid group and 42% patients in the placebo group used concomitant NSAIDs, while 25% of patients in the opioid group and 26% of patients in the placebo group applied simple analgesia.

 

Summary

This multi-center, triple-blinded randomized controlled trial demonstrated no significant improvements in back pain with taking opioids compared to placebo over a 6 week period, while showing an increased risk of opioid misuse at 52 week follow up in patients who were prescribed opioids.

That’s it for this week, stay safe, keep reading and think twice before pulling the trigger on prescribing opioids for back pain.

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