Cervical spine manipulation (CSM) is a popular manipulative therapy employed by chiropractors, osteopaths, physiotherapists and other healthcare professionals. It remains controversial because its benefits are in doubt and its safety is questionable. CSM carries the risk of serious neurovascular complications, primarily due to vertebral artery dissection (VAD) and subsequent vertebrobasilar stroke.
Chinese physicians recently reported a rare case of a ‘locked-in syndrome’ (LIS) due to bi-lateral VAD after CSM treated by arterial embolectomy. A 36-year-old right-handed man was admitted to our hospital with numbness and weakness of limbs after receiving treatment with CSM. Although the patient remained conscious, he could not speak but could communicate with the surrounding by blinking or moving his eyes, and turned to complete quadriplegia, complete facial and bulbar palsy, dyspnoea at 4 hours after admission. He was diagnosed with LIS. Cervical and brain computed tomography angiography revealed bi-lateral VADs. Aorto-cranial digital subtraction angiography showed a vertebro-basilar thrombosis which was blocking the left vertebral artery, and a stenosis of right vertebral artery. The patient underwent emergency arterial embolectomy; subsequently he was treated with antiplatelet therapy and supportive therapy in an intensive care unit and later in a general ward. After 27 days, the patient’s physical function gradually improved. At discharge, he still had a neurological deficit with muscle strength grade 3/5 and hyperreflexia of the limbs.
The authors concluded that CSM might have potential severe side-effect like LIS due to bilaterial VAD, and arterial embolectomy is an important treatment choice. The practitioner must be aware of this complication and should give the patients informed consent to CSM, although not all stroke cases temporally related to CSM have pre-existing craniocervical artery dissection.
Informed consent is an ethical imperative with any treatment. There is good evidence to suggest that few clinicians using CSM obtain informed consent from their patients before starting their treatment. This is undoubtedly a serious violation of medical ethics.
So, why do they not obtain informed consent?
To answer this question, we need to consider what informed consent would mean. It would mean, I think, conveying the following points to the patient in a way that he or she can understand them:
- the treatment I am suggesting can, in rare cases, cause very serious problems,
- there is little good evidence to suggest that it will ease your condition,
- there are other therapies that might be more effective.
Who would give his or her consent after receiving such information?
I suspect it would be very few patients indeed!
AND THAT’S THE REASON, I FEAR, WHY MANY CLINICIANS USING CSM PREFER TO BEHAVE UNETHICALLY AND FORGET ABOUT INFORMED CONSENT.
17 Responses to Another serious complication after neck manipulation + a reminder of the importance of informed consent
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@ Edzard
Thank you for writing a nicely balanced post.
CSM and possible neurovascular complication have been reported on Chiropractic. But, as far as I know, CSM is also perfomed on Ostheopathy. Is there any case report about neurovascular complications that have followed CSM on ostheopathy?
CSM is associated with neurovascular complication on Chiropractic. Is there any adverse events of CSM on Ostheopathy?
“@ Edzard
Thank you for writing a nicely balanced post.”
Ordinarily I wouldn’t ask, however, what you mean is not always clear; are you giving the prof a backhander or do you actually mean it?
@ Frank
I mean it
Will you be writing about the serious complications that occur after taking Medications of all kinds? Or are they too common and boring for you?
my expertise is in alt med – and that’s also the subject of this blog.
GOT IT?
Then Perhaps a comparison study would be interesting. GOT IT?
@Owain
You are reading this blog very selectively. A mere five days ago Edzard started an entire thread about your repeatedly made and tedious comment. But I guess folk who think that medicine is out to kill patients while fairies only bring good don’t have the reading skills to look at a few recent posts.
Actually I stumbled across the article while on twitter. Came straight to it and read it and commented. there was nothing selective about my reading. I did what any member of the public who might have been on twitter at the same time might have done. And THAT is exactly why what is written is dangerous. It takes this out of context and turns ONE adverse effect into a generalisation about the safety of the profession. these things are SOOOO incredibly rare that they are statistically insignificant. But they cause great damage to a profession which otherwise helps the lives of countless people. These articles therefore put others who may benefit from care off going for treatment, and in so doing maintain them in pain and suffering. So in trying to “inform the public” and “help” people, Edzard is actually just causing additional suffering to those who have no idea of how to read research with a critical eye. More harm than good is done with these blogsites.
Think that medicine is out to kill patients? HAHA what ever gave you that impression. I’m just stating facts about pharmacology, not stating my (positive) opinion on it’s efficacy. I myself have taken prescription medications regularly,and they have saved my life, and I’m thankful for them.
I have 3 Doctors in my family. My Brother is a consultant and so is my sister in Law, while I was recommended by a Consultant neurologist to become a Chiropractor in the first place. If you think it’s all fairies and hocus pocus, you may want to read the Chiropractic syllabus. You may be shocked to know what we know Frank.
I always wonder who put the ‘twit’ in twitter. You’re right that it seems to contort and distort everything. You might find it worth looking through the many threads about chiropratic on this blog, just to see how often the same points are made (on both sides of a discussion).
You may be shocked to know I have read the on-line syllabus for a few chiropractic colleges. Mixed with a lot of reasonable anatomy and physiology there is always a heavy dose of nonsense exuding from the backs of various necks. The principal chiropractic necks have to be those of DD Palmer, jailed for practising medicine without a licence, and his son, JB. Palmerian nonsense still pervades all chiropractic courses at one level or another. Your consultant neurologist who recommended you to be a chiropractor was either jealous of its successful business model or had reason to suspect you, personally, might not have what it takes to qualify as a proper doctor.
As for adverse events “are SOOOO incredibly rare that they are statistically insignificant”, I can only repeat what has been asked scores of times elsewhere on this blog. How do you know that? There seems nowhere to be any effective system of monitoring or follow up for chiropractic adverse events. Please put down your smart phone, sit at a computer with decent web access and take the time to read the chiropractic posts on this blog. You will find your complacent attitude to adverse events in chiropractic has already been covered ad nauseum. You will find comments from several individuals with anecdotes about their adverse experiences with chiropractic. The impression of exceptional rarity is not borne out even on the anecdotal level.
It has already been explained ad nauseum that what matters is not the number of adverse events, it’s the risk:benefit ratio. If there’s no proven benefit then any level of risk is unacceptable. Which takes us straight back to the fundamental question. Where is the (scientifically robust) evidence to show that chiropractic is anything beyond a theatrical placebo?
“There is always a heavy dose of nonsense exuding from the backs of various necks. The principal chiropractic necks have to be those of DD Palmer, jailed for practising medicine without a licence, and his son, JB. Palmerian nonsense still pervades all chiropractic courses at one level or another”
The Subluxation model is taught as a historical concept, and we are taught that there is no evidence behind it.
“Your consultant neurologist who recommended you to be a chiropractor was either jealous of its successful business model or had reason to suspect you, personally, might not have what it takes to qualify as a proper doctor.”
Questioning whether or not I have the intelligence to be “a real doctor” is a low jab, and one I won’t even rise to. The fact that you choose to say “ad nauseum” every other sentence does not make you sound intelligent.
“There seems nowhere to be any effective system of monitoring or follow up for chiropractic adverse events.”
A little research would have pointed you in the direction of CPIRLS – The Chiropractic Patient Incident Reporting and Learning System – http://www.cpirls.org
“It has already been explained ad nauseum that what matters is not the number of adverse events, it’s the risk:benefit ratio. If there’s no proven benefit then any level of risk is unacceptable. Which takes us straight back to the fundamental question. Where is the (scientifically robust) evidence to show that chiropractic is anything beyond a theatrical placebo?”
I receive the New Scientist magazine on a weekly basis, and there was an interesting article this week on the fact that we need to find a new way of thinking, a new way to reason from cause to effect by Michael Brooks. Here is the web link though I recommend you buy a copy, as you may not be a subscriber – https://www.newscientist.com/article/2078286-a-new-kind-of-logic-how-to-upgrade-the-way-we-think/
In it the author describes how big research data is often misleading, with assumptions made in statistical analysis, which often lead to conclusions that are inaccurate. This is made EVEN MUDDIER when it is not possible to have a control group. The problem with Chiropractic is that it is far more than just SPINAL MANIPULATION. As is the same with Osteopathy. We don’t just walk up to people and “crack their neck” as the horror stories would have you believe. So you can’t subject it to rigorous scientific research methods.
How do you do a “Sham manipulation”? A manipulation should be accompanied by an audible release, caused by a property of fluid dynamics known as Cavitation. If this sound is absent, then a manipulation has not been performed essentially, but then the patient knows this. So they KNOW they haven’t had a manipulation. You would have to find a control group who has NEVER heard of spinal manipulation, or chiropractors, or osteopaths. Who don’t know what to expect, who haven’t checked online about spinal manipulation to see what it is. How do you control that?
How would you be able to gain ethical consent to manipulate people’s necks without telling them what you’re doing? It is just IMPOSSIBLE to TRULY research the effects of spinal manipulation.
Sadly you are left with retrospective studies where patients who had serious adverse effects, classically the old Vertebral artery dissection, had their files checked to see if they saw a chiropractor before hand,often this was the case, ET VOILA! You have your cause and effect.
Blindly ignoring the fact that an identically “statistically significant” amount of those patients ALSO visited a medical doctor (usually a GP) before hand. As neck pain is often a symptom of a stroke in progress, sadly these patients are often doomed before they even get to the doctor’s office. But it’s too late. The blame is made, (though usually the doctor gets away with it).
I won’t be commenting any further. I have no more time for your tragic witch hunt.
Luckily our patients through positive word of mouth help our professions to thrive. What they think and feel is most important.
Have a nice, positive, helpful and constructive day.
Owain wrote: “The Subluxation model is taught as a historical concept, and we are taught that there is no evidence behind it.”
@ Owain
Really? Are you sure about that?
I know that the UK General Chiropractic Council claims the same, but it’s got itself in a real mess about it:
https://skepticbarista.wordpress.com/2010/08/30/gcc-subluxation-pressure/
Also, here’s a recent Facebook post from a chiropractor:
QUOTE
“An absolutely amazing day spent with these students from the AECC [Anglo European College of Chiropractic], sharing the communication and business strategies of chiropracTIC.
Can’t wait until May to share the Philosophy and Personal Development seminar with them.”
Link: https://twitter[DOT]com/TorChrBirkeland/status/701430252095021056
For readers who may not know, here’s the background to the ‘TIC’, as emphasised in chiropracTIC…
QUOTE
“Historically, BJ Palmer talked about the chiropracTOR and chiropracTIC and his discussion was about how a stance or strategy that may have been to the benefit of the TOR (i.e., insurance reimbursement) may have been bad for the TIC because it moved the TOR away from the principles of chiropracTIC. The TIC is the philosophy of chiropractic and from that philosophy evolves our passion and our communications. Indeed, it drives the TOR’s psychology and procedures as well. The TIC is the WHY the TOR does what he or she does. The TIC takes chiropractic beyond the musculo-skeletal realm and places it firmly in the arena of vitalism.”
Ref: http://drstevehoffman.com/blog/?p=1708
IOW, the GCC’s stance, and your own, Owain, don’t stand up to scrutiny.
Owain wrote: “A little research would have pointed you in the direction of CPIRLS – The Chiropractic Patient Incident Reporting and Learning System – http://www.cpirls.org ”
That system has a huge reliability problem:
http://www.ebm-first.com/chiropractic/uk-chiropractic-issues/1888-british-chiropractic-association-members-attitudes-towards-the-chiropractic-reporting-and-learning-system-a-qualitative-study.html
As Professor Ernst stated recently, it’s worse than useless.
Finally, to assert that “Luckily our patients through positive word of mouth help our professions to thrive. What they think and feel is most important”, serves only to demolish your credibility.
I’m not sure if you have seen this, but would be interested in your opinion Prof Ernst.
http://www.cureus.com/articles/4155-systematic-review-and-meta-analysis-of-chiropractic-care-and-cervical-artery-dissection-no-evidence-for-causation
That systematic review was looked at here:
https://www.sciencebasedmedicine.org/chiropractic-and-stroke-no-evidence-for-causation-but-still-reason-for-concern/
It found plenty of reasons to continue to avoid neck manipulation.
Comparing authors of the above articles, Harriet Hall of Science Based Medicine is a biased and poorly educated neophyte, in comparison to the Harvard Professors who wrote the systematic review.
@ GibleyGibley
What about addressing the arguments? Please point out the errors in Dr Hall’s reasoning with regard to the following:
QUOTE
“They [the authors] report that they found a small association between chiropractic care and cervical artery dissection, but then they discount their own finding and try to rationalize it away. They say the evidence is low quality; I agree. They say they found no evidence of causation; I agree. But then they try to say there is no convincing evidence of even the association that they themselves found.
They found no evidence for causation. On the other hand, they found no evidence against it.
They say they are concerned that a false belief in a causal connection “may have significant adverse effects such as numerous episodes of litigation.” On the other hand, a lack of belief might prevent justified litigation where patients were harmed or killed.
They say neck pain and headache are confounders. They say patients with headache and neck pain more frequently visit chiropractors, and patients with cervical artery dissection more frequently have neck pain and headache, so the appearance of more cervical artery dissections after visits to chiropractors is spurious. They say the Cassidy study showed that visits to a primary care provider or a chiropractor were likely to be due to pain from an existing dissection. It did not. There is absolutely no evidence to support that speculation.
In fact, there are numerous “smoking gun” cases where patients consulted a chiropractor not for neck pain or headache, but for pain in parts of the body below the neck, such as shoulder pain or tailbone pain, and developed stroke symptoms on the chiropractor’s table at the time of neck manipulation. Sandra Nette had no pain at all; she felt fine and let the chiropractor manipulate her neck only because she falsely believed that regular maintenance adjustments were an effective means of keeping her healthy.
They fail to even mention the smoking gun cases or the evidence that the incidence of stroke rises with the proximity to the time of manipulation.
They make a big deal of Hill’s criteria for assigning causation to association. With a rare condition like VBA dissection, and with the characteristics of this condition, it would be very difficult to fulfill all of Hill’s criteria. We may never see that kind of proof, so we must rely on lesser quality evidence.
They cite cadaver studies to claim that SMT doesn’t place significant strain on the vertebral artery. And yet we know that very small strains can cause strokes in susceptible live patients. “Shampoo strokes” have been reported after hyperextension of the neck at beauty parlors.
Other considerations
The indications for neck manipulation are questionable. Upper cervical (NUCCA) chiropractors do neck manipulations on every patient, no matter what the complaint. Some chiropractors do neck manipulations for somatovisceral conditions rather than just for musculoskeletal conditions. Whatever the indications, chiropractors certainly have no business doing neck manipulations on a patient with an existing dissection, and they have not shown that they can reliably diagnose a stroke in progress. There are no tests to reliably identify patients at risk of dissection.
Underreporting is a problem. If a dissection is temporarily sealed by a clot that breaks loose several hours or days later, the connection with manipulation may be missed. Patients may never return to the chiropractor. I heard of at least one case where a patient developed stroke symptoms immediately following manipulation, was hospitalized for a disastrous stroke, and never let the chiropractor know what had happened.
Edzard Ernst weighs in
Edzard Ernst reported on a case of a man who had a stroke following chiropractic manipulation for chronic neck pain. Chronic, not a new symptom suggesting a stroke in progress. He also reported on a case of phrenic nerve injury from neck manipulation.
Ernst commented:
• There is no effective monitoring scheme to adequately record serious side-effects of chiropractic care.
• Therefore the incidence figures of such catastrophic events are currently still anyone’s guess.
• Publications by chiropractic interest groups seemingly denying this point are all fatally flawed.
• It is not far-fetched to fear that under-reporting of serious complications is huge.
• The reliable evidence fails to demonstrate that neck manipulations generate more good than harm.
• Until sound evidence is available, the precautionary principle leads most critical thinkers to conclude that neck manipulations have no place in routine health care.
The American Heart Association and American Stroke Association agree. They were concerned enough about the apparent association to have issued a joint scientific statement warning about it and recommending that patients be informed of the possible risk prior to manipulation.
Bottom line: A double standard
Edzard Ernst has said: Imagine a conventional therapy about which the current Cochrane review says that it has no proven effect for the condition in question. Imagine further that this therapy causes mild to moderate adverse effects in about 50% of all patients in addition to very dramatic complications which are probably rare but, as no monitoring system exists, of unknown frequency…
Now I ask you to imagine that there is a pharmaceutical drug that fits this description. Imagine that there are the same numbers of studies showing an association of that drug with a deadly side effect like stroke or death. The FDA would pull it off the market; they wouldn’t wait for definite evidence of causation that fulfilled all of Hill’s criteria. And I think the people who are making excuses for neck manipulation would want them to take that drug off the market. I don’t think they would want to take such a drug.
I wouldn’t risk taking a drug like that, and I wouldn’t risk neck manipulation.”
Ref (containing embedded refs): https://www.sciencebasedmedicine.org/chiropractic-and-stroke-no-evidence-for-causation-but-still-reason-for-concern/