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Opioids = placebo in adults with acute nonspecific low back or neck pain (OPAL)
Clinical Question
Are opioids effective in alleviating pain in adults with acute nonspecific low back or neck pain?
Bottom line
In this rigorously conducted study, from week to week over a 6-week period, adults with acute low back or neck pain treated with opioids had similar pain relief as those treated with placebo. (LOE = 1b)
This POEM aligns with the Canadian Spine Society's Choosing Wisely Canada recommendation (Don’t use an opioid analgesic medication as first-line treatment for acute, uncomplicated, mechanical, back-dominant pain) and with the Opioid Wisely campaign.
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Government
Setting: Outpatient (any)
Synopsis
These researchers recruited adults with less than 12 weeks of new onset low back or neck pain who sought care from their primary care physician or in an emergency department. The patients could have radicular symptoms, but no alarm symptoms, and they had to have pain of at least moderate severity. The authors randomized the patients to receive an opioid (twice daily 5 mg oxycodone and 2.5 mg naloxone, titratable to 10 mg oxycodone; n = 174) or placebo (n = 172). The patients were treated until their pain score was 0 or 1 out of 10 for 3 consecutive days or for a maximum of 6 weeks. Although the researchers assessed the participants at 2, 4, 6, 12, 26, and 52 weeks after enrollment, the primary outcome was pain on a 10-point visual analog scale at 6 weeks. At baseline, both groups had similar pain ratings (5.7 and 5.6, respectively). After 6 weeks, more participants dropped out of the opioid group (19%) than the placebo group (15%). The remaining participants in both groups improved by a similar degree (2.8 and 2.2, respectively). At no point during the 52-week follow-up did the opioid-treated patients experience more pain relief than the placebo-treated patients. Indeed, at a few points in time, the placebo-treated patients had greater pain relief. The masking of participants worked — roughly half in each group could not guess their treatment assignment. Approximately one-third of participants in each group experienced adverse events, but serious adverse events were infrequent (4% and 2%, respectively). In pain studies, a change of 2 points on a 10-point scale is generally considered to be clinically meaningful. This study only reported average changes and did not report the proportion of participants in each group who achieved this threshold, thereby leaving the question of whether some patients respond better to opioids than others unanswered.
Reviewer
Henry C. Barry, MD, MS
Professor
Michigan State University
East Lansing, MI
Comments
Impact assessment
Excellent
I am reassured.
I am reassured.
.
.
pain management
it CBD !
opiod didn't cover the proper dosing schedule
Although I would not give an opiod and this supports my prescribing behavior, I do not believe that oxycodone 5 mg lasts 12 hours and so there were nadirs at least 2 times a day which would be a confounder in proving that the drug did not work. Shouldn't the drug in question be given on a q4-6 hour basis?
Opioids = placebo in adults with acute nonspecific low back
The final sentence is the most significant notation on the limitations of this study and reminds us not to throw out the baby with the bathwater..... "This study only reported average changes and did not report the proportion of participants in each group who achieved this threshold, thereby leaving the question of whether some patients respond better to opioids than others unanswered."
Low dose oxycodone. Issues around naloxone.
Oxycodone was used at low dose (5mg Q12H --> 10mg Q12H). Many patients needed 10mg Q6H at least initially.
All opioids are not the same. Some patients do not respond to oxycodone and a trial rotation to another opioid is reasonable.
The oxycodone was provided as a modified release formulation with Naloxone. So 5mg over 12 hours - equivalent to 1/2 of a Percocet every 6 hours. Again - low dose.
Naloxone (2.5mg BID to 5mg BID) can, even at low dose, be absorbed and can cause withdrawal or lack of efficacy. Entirely unclear why naloxone was used in this study.
Opioids = placebo in adults with acute nonspecific low back
Two comments: 1) I am not familiar with the combination use of oxycodone/naloxone as an analgesic. Presumably the naloxone is meant to protect against apnea in the case of an overdose but why wouldn't naloxone also interfere with the analgesic effect during regular use? 2) The review quotes that this study aligns with the Canadian Spine Society's Choosing Wisely Canada recommendation (Don’t use an opioid analgesic medication as first-line treatment for acute, uncomplicated, mechanical, back-dominant pain) and with the Opioid Wisely campaign.. Hmmm, I think the study aligns with "don't use opioids for acute back pain". Maybe Choosing wisely needs to strength its opinion on this issue.
No
No