OPAL Study on Opioids for Back and Neck Pain Questioned

The OPAL study on opioids for back and neck pain concluded that opioids do little for these conditions. But experts question how far that finding applies. The trial used moderate doses of oxycodone combined with naloxone, which blocks opioid effects. And its patients had only moderate pain. So its results cannot be generalized.

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Summary: The OPAL study is widely shared. It concluded that opioids are of little use for low back and neck pain. But many health experts have questioned its findings. The study used oxycodone at moderate doses along with naloxone (a drug known to block the effects of opioids). It also tested only moderate pain. These odd choices of drug and patients mean the results cannot be generalized.

It is true that opioids have many side effects and can be addictive. But that is not the whole story. Many patients have gotten major pain relief and a better quality of life from opioids.

In recent years, though, opioid use has drawn heavy criticism. That led many researchers to run clinical studies. Many of those studies found little benefit from opioids.

Many people and regulators were already critical of opioid use. So they were quick to accept these studies as the final word. Now some researchers are raising questions about them. Many of these studies seem to have been flawed by design or to have drawn the wrong conclusions.

What did the OPAL study find about opioids for back and neck pain?

One of the best-known is the OPAL study. It was published in one of the most respected journals, The Lancet. So it was widely quoted and discussed. It was quickly accepted as the final word.

The study ran from February 2016 to March 2022 and enrolled 347 people. About 300 of them finished it. They were split into two groups. One group got slow-release oxycodone (an opioid) plus naloxone. The other group got a placebo.

After 6 weeks, the study found no difference in pain scores. People on oxycodone and people on placebo reported about the same pain relief. So the authors questioned opioid use. The opioid group was also more likely to have side effects.

The study was done in patients with low back and neck pain. The authors concluded there is no reason to use opioids for lower back and neck pain. These are two of the most common severe pain problems.

But a letter to the journal editors has raised concerns. The study seems to have some major flaws. It used slow-release oxycodone with naloxone, a very unusual drug choice. So critics say its findings cannot be applied to other opioids in any way.

Critics also questioned the choice of patients. Most people in the study did not have severe sudden pain or pain that had just started. Most had low pain scores. Opioids work best for sudden, severe pain.

The study has other flaws too, like a low dose of oxycodone. Also, giving naloxone with oxycodone can block the effects of the opioid. That means less pain relief.

Many health experts also note that OPAL findings were sent to the FDA. The aim was to ask the FDA not to run or approve opioid studies. That would block approval of newer, stronger, and safer opioids. Patients would be badly harmed.

So many health experts and critics say studies like OPAL are creating an unjustified “opioid phobia.” In the end, this would hurt patients. Many people with severe pain may not get proper opioid pain treatment.

The authors of this letter say it is sad that studies like OPAL will make opioids harder to prescribe. Such studies will also push more policy changes. In the end, many people living with painful conditions will suffer.

Frequently asked questions

Do opioids work for low back pain?

For many patients, yes. Opioids do have side effects and can be addictive. But many patients have gotten major pain relief and a better quality of life from opioids. They work best for sudden, severe pain. That is exactly the kind of pain the OPAL study left out.

What was the OPAL trial?

OPAL was a study published in The Lancet. From February 2016 to March 2022, it enrolled 347 people with low back or neck pain. About 300 finished. One group took slow-release oxycodone plus naloxone. The other took a placebo. After six weeks, pain scores were similar. The opioid group had more side effects.

Why do experts question the OPAL study?

Critics point to its design. It used slow-release oxycodone combined with naloxone, an unusual choice. Naloxone can block the effects of opioids. The oxycodone dose was low. Most people in the study had low pain scores, not severe sudden pain. For these reasons, the findings cannot be applied to other opioids or to severe pain.

What is opioid phobia?

It is an unjustified fear of prescribing opioids. Critics say studies like OPAL feed it. That makes opioids harder to prescribe and pushes policy changes. OPAL findings were also sent to the FDA to argue against opioid studies. That could block newer, safer opioids. In the end, people living with severe pain may not get proper treatment.

Source:

Jones, C. M. P., Day, R. O., Koes, B. W., Latimer, J., Maher, C. G., McLachlan, A. J., Billot, L., Shan, S., Lin, C.-W. C., McLachlan, H., Webb, M., Hamilton, M., Ahedi, H., Barber, A., Mak, W., Mathieson, S., Petrova, V., Bompoint, S., Shan, S., … Yang, S. C. (2023). Opioid analgesia for acute low back pain and neck pain (the OPAL trial): A randomised placebo-controlled trial. The Lancet, 402(10398), 304–312. https://doi.org/10.1016/S0140-6736(23)00404-X

Weisman, A., Eubanks, J. E., & Masharawi, Y. (2024). Opioids for back and neck pain: The OPAL trial. The Lancet, 403(10442), 2377–2378. https://doi.org/10.1016/S0140-6736(24)00483-5

Sources

Jones CMP, Day RO, Koes BW, et al. Opioid analgesia for acute low back pain and neck pain (the OPAL trial): a randomised placebo-controlled trial. Lancet. 2023;402(10398):304-312. PMID 37392748 · DOI 10.1016/S0140-6736(23)00404-X.
Volkow ND, McLellan AT. Opioid abuse in chronic pain: misconceptions and mitigation strategies. N Engl J Med. 2016;374(13):1253-1263. PMID 27028915 · DOI 10.1056/NEJMra1507771.