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Opioids and Back and Neck Pain: OPAL Study – Exposing Biased, Flawed Research and Misleading Claims

opioids and back and neck pain

Today in the media, I see a story on opioids and back and neck pain titled Opioids don’t help acute back and neck pain – and could be harmful, Australian research finds.

Here’s the study summary the article refers to in the Lancet
and I finally found the full study. You can read that here.

The study declares opioids are not effective for back and neck pain, and the study’s authors are calling for back pain guidelines to be changed on the basis of this work, and for opioids to NEVER be prescribed for back pain.

I have a number of problems with this, as anyone with a modicum of common sense would.  But first, I’ll explain the study.

The study recruited 347 people who presented to the emergency department or their GP with mild to moderate acute back or neck pain (duration of less than 12 weeks). They were randomly assigned to either a short course of oxycodone-naloxone tablets, or a placebo, for up to a period of 6 weeks.  They were also given advice to advice to stay active and avoid bed rest as per treatment guidelines and were reassured that their pain would improve.   The primary outcome was pain severity at six weeks.

One of the lead authors, Professor Christine Lin of the University of Sydney, is a prominent anti-opioid zealot, often in the media talking about the perils of opioids.

Immediately on reading the above, alarm bells are ringing. There are four separate problems that jump out at me.  But I will defer to the experts and let them explain it.

Doctor Michael Vagg, who is one of the most respected pain management physicians in Australia, has pointed out that the study has several major flaws.  He is quoted in the ABC article as saying the study:

 “was not anywhere near strong enough to prompt a change in guidelines, and that opioids still had a place as long as they were used judiciously and for a short period of time.”

As Dr Vagg points out the study used Targin, a combination of oxycodone and naloxone, to treat acute back and neck pain.  Targin is an extended-release (ER) opioid pain medication, and it is not used for acute pain, and/or in opioid naïve patients.

Dr Vagg stated:

“They studied oxycodone and naloxone in a modified-release formulation. But modified-use opioids have never been on-label for use in acute pain and they are not recommended as such… to which I and everyone in pain medicine would say ‘We figured that out ages ago’. That’s not how you use opioids in acute pain.”

Targin would never be prescribed in the ER, or by a GP, for acute pain.  The study is a complete sham because it is testing a medication that is not approved for acute pain.  It does not represent real world clinical medicine.  Therefore, it is worse than useless and absolutely should not inform clinical practice or clinical guidelines.

Why did the study’s authors choose to use a medication that is not approved for acute pain, and is never used in that setting?

Dr Caitlin Jones, lead author, said the combination medication of oxycodone and naloxone were used to avoid unblinding of the study, due to opioid-induced constipation.

Anyone with two brain cells to rub together knows that this is not true, it’s an excuse. Albeit a creative one.

The authors deliberately designed their study with a medication that is never used in the treatment of acute back and neck pain, or any acute pain at all.  Did they expect that no one would notice?  The use of extended-release oxycodone-naloxone renders the study meaningless and it represents nothing but a colossal waste of research dollars.

Dr Vagg was quoted as saying :

“In layman’s terms, they’ve done a study where they tried to look at doing push-ups to help with back pain and then they’ve decided that all exercise is no good for the back pain.”

Next, very obvious, problem:  the study is very small, only 347 people. And almost 20% of those dropped out or were lost to follow up.  You do NOT change treatment guidelines based on a study of less than 300 people.

Problem number three (these are not in order of importance). You do not give opioids for mild or moderate pain.  Opioids are for severe pain. If you give opioids for mild or moderate pain, all you will get is very unpleasant side effects including dizziness, nausea and constipation.  Again, this is not representative of what would happen in the real world.  People with mild to moderate back pain would be reassured that their pain will improve over time and be advised to keep active, and not use bed rest.

Number four – opioids are never a first line treatment.  The authors state that 70% of people who attend the ER are given opioids, but they are using old data – 2017.  In 2023, this is no longer the case.  Regulation changes in 2018, and again in 2020, have made opioid prescribing a rarity, in the ED, at the GPs office, everywhere.  The pendulum has swung too far here in Australia, and people are struggling to get proper pain relief.  Just as happened in the US after the 2016 CDC guidelines were released.

Opioids are a treatment of last resort.  Professor Vagg said the first line of treatment before opioids would be paracetamol, short-acting and long-acting anti-inflammatories such as ibuprofen or diclofenac, and then move up to celecoxib or an injectable ketorolac.

“By the time you get to giving opioids, there’s usually a lot of other stuff that can be given first. Give that a chance to work for you before you move on to using opioids.”

So, again. This study does not represent real world medicine.

Problem number five: The primary outcome of the study was pain intensity at six weeks.  This completely ignores the time period where opioids are most useful – the initial few days after injury.  Perhaps the first week.  That’s when opioids can reduce severe pain, and allow the person to stay active, and avoid the trap of bed rest.  After six weeks, the vast majority of back pain will have resolved, no matter what treatment was given. Even if NO treatment was given.  Pain severity at six weeks is meaningless. 

The did measure pain severity at 2 weeks and found pain levels to be similar between placebo and pain medication. Again, that’s to be expected. Even by two weeks, most back or neck pain would have resolved on its own, regardless of the treatment type. 

Problem number six: They excluded people who had serious pathology, i.e. structural causes of their back or neck pain.  These people all had mild to moderate non-specific pain.  Opioids would not usually be prescribed for non-specific pain.  So again, not representative of real-world clinical medicine.

In my opinion, there’s also a lot to be learned by what the authors don’t say.  They don’t talk about how long people continued to take the opioid.  They gave doses of up to 20mg of oxycodone-naloxone daily, for up to six weeks.  I only have access to the summary; I can’t afford to buy the full study; no doubt the detail is there.  But this would be very important information. I’m willing to bet that most people found the oxycodone-naloxone unhelpful, and chose to discontinue very early on, due to side effects.  Again, that’s because opioids are only for SEVERE pain, see problem number three, above.

The don’t mention how many people went on to ‘persistent use’ or developed addiction.   Given that opioids are being demonised due to the risk of addiction, or ‘persistent use’, it would be interesting to know how many people became addicted from this study.  People like Professor Lin often quote numbers like 10-25% of people become addicted after an opioid is prescribed for pain.  So you’d expect that there’s be 35 – 87 people now addicted to oxycodone because of this study. 

 But that didn’t happen. 

I wonder why? Oh, that’s right, because addition to opioids when used for treating pain is very rare. 

Dr Vagg further stated:

“We need to get away from this idea that everybody who has any exposure to opioids for any reason is immediately going to turn into an addicted dope fiend. That anti-opioid hysteria is still around.”

But researchers like Professor Lin constantly inflate the risk of addiction, while doing mental gymnastics to design studies like this, to fool people into believing that opioids are not effective for pain.  That’s her strategy; exaggerate the risk of addiction, and diminish the effectiveness of opioids. It’s a strategy that has been used in the US since the CDCs 2016 Opioid Prescribing guidelines were released, and it has been shockingly successful. But that doesn’t make it true.

I am stunned by the arrogance of a research scientist who believes she knows more than medical doctors with many years of education and training, and many more years of clinical experience treating patients in pain.  How dare she presume that her tiny study, with its biases and very poor methodology, be used to change acute back and neck pain treatment guidelines.  Her hubris is astounding.

The authors went to great lengths to design a study that would make placebo look better than an opioid for pain. Thankfully, no one who prescribes opioids is fooled, and esteemed doctors like Dr Vagg have come out swinging to discredit this study, for those who have less understanding.

Dr Vagg treats people in pain every day. He is the true expert in pain management, has 20 years of experience and is a former Dean of the Faculty of Pain Medicine, Australian and New Zealand.  I am impressed, and very grateful, that he took the time discredit the conclusions this study draws. He makes it clear that no clinical decisions should be based on this piece of work. 

How or why the Lancet would publish this garbage, is beyond me. It lowers their credibility,  because even a quick skim of the study summary shows that it is biased and very poor quality and not representative of real-world practice. And therefore, worthless.

Unfortunately, this study is being reported on WIDELY in the media, and not one article questions its validity, or value.  Its churnalism; just print the press release, and don’t even think about checking the facts, or the quality of the sources.  This is how myths are built and lies become truths and ‘everybody knows that opioids don’t work for pain…’.  Most people only have time to read the headlines or maybe the conclusion, and these too, are deceptive and misleading.  

Speaking of which, the studies ‘interpretation’ reads:

Opioids should not be recommended for acute non-specific low back pain or neck pain given that we found no significant difference in pain severity compared with placebo. This finding calls for a change in the frequent use of opioids for these conditions.

What it should say is:

Extended Release Opioids should not be recommended for acute non-specific low back pain or neck pain because they are not approved for this indicationgiven that we found no significant difference in pain severity compared with placebo because non-specific back and neck pain generally resolves within six weeks regardless of treatment. This finding is meaningless and a complete waste of research dollars calls for a change in the frequent use of opioids for these conditions.

There.  Fixed it for you.

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3 thoughts on “Opioids and Back and Neck Pain: OPAL Study – Exposing Biased, Flawed Research and Misleading Claims”

  1. Bravo! I love when a little logic and critical thinking tear apart these highly biased agendas—agendas which have a direct or indirect torturous and deadly result on pain patients who need these FDA approved medications (meds that had been the Gold Standard of treatment for moderate to severe pain—& for likely millennia when accessed directly from the poppy plant), for not just some QOL, but to not have patients die in a myriad of ways—mine would be natural due to me having one of the most extreme forms of Autonomic Dysfunction & Dysrelexia Episodes my physicians have all ever seen, where even under-treated pain could kill me, but fully untreated absolutely would kill, and WDs will kill me almost immediately, just extremely quickly—patients have to suffer so fiercely, their only way of escape from it is to unalive themselves! We’ve seen far too much of that, and I think most of us would agree on that. Well, I hope so.

    And that we live in a country where there are safe, effective FDA Approved medications, that all it takes is a few easy peasy scribbles on a prescription pad or easy peasy taps on a keyboard, where any suffering as a result of NOT doing those two easy, legal aforementioned things, this is wholly unnecessary! And that they happen to be FDA approved, and have them on the news for this very reason, the level of negligence should absolutely be a litigious one! We’ve got to find a way to get them where it hurts!

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