New evidence on adverse effects of manual therapy comes from an unexpected source. Here is the abstract of the paper:
The aim of this study was to investigate if mild or moderate adverse events after manual therapy has an impact on the chance to recover from back/neck pain in men and women. A prospective cohort study of 771 patients with at least three treatment sessions in a randomized controlled trial performed in January 2010 – December 2013. Adverse events within 24 h after each treatment were measured with questionnaires and categorized as: no, mild or moderate, based on bothersomeness. Outcome measure was the perceived recovery at seven weeks and at three months follow-up. Odds Ratios (OR) and 95% confidence intervals (CI) were calculated by Logistic regression to investigate the associations between the exposure and outcome, and to test and adjust for potential confounding. There were no statistically significant associations observed between the experience of mild or moderate adverse events and being recovered at the seven weeks follow-up. The only statistically significant association observed at the three months follow-up was for mild adverse events in men with an OR of 2.44, 95% CI: 1.24–4.80 in comparison to men with no adverse events. This study indicates that mild adverse events after manual therapy may be related to a better chance to recover in men.
________________________________________________
In my view this is a rather boring analysis of a bizarre hypothesis … were it not for a result that cropped up almost unintendedly: AE were reported in 81% of women and 66% of men. No severe irreversible AE were reported, but 178 AEs were rated as moderate to severe. As only symptoms within 24 h after the first three treatment session were reported, the true figures might even be larger.
These figures are considerably higher than previously reported. Our own systematic review of prospective studies suggested that AEs occur in approximately half of all patients receiving spinal manipulation. It follows, I think, that we have to discuss the question about risk versus benefit of manual treatments (such as spinal manipulations) even more critically than before.
40 Responses to The majority of patients having manual therapy for back or neck pain report adverse events
Leave a Reply to Osteopathie Praxis im Klinikum Karlsruhe Cancel reply
This site uses Akismet to reduce spam. Learn how your comment data is processed.
Given the frequency of adverse events, it’s high time that providers of manual therapy (mostly chiropractors, osteopaths and some physiotherapists) stopped claiming that their treatments are “very safe”.
A couple of items Ernst didn’t mention:
One, this study was done at a student clinic…
“The study participants were patients (18–65 years old) seeking care for back and/or neck pain at the education clinic of the Scandinavian College of Naprapathic Manual Medicine in Stockholm, Sweden. Students in their seventh semester of the education delivered the treatments.”
Second, many of the AE were physical responses that are to be expected when one addresses acute and chronic MSK conditions.
“1. Tiredness, 2. Soreness in muscles, 3. Stiffness, 4. Increased pain,”
Third, although I’d have to dig into the paper, most patients expressed they had similar previous complaints (unclear if this refers to back and neck pain or the AE)
“Previous similar complaints 599 78%”
Forth, I fail to see how this paper established causation.
most observations of AEs do not establish causation; they produce a signal which needs to be examined.
WHEN WILL CHIROS FINALLY ESTABLISH PROPER POST-MARKETING SURVEILLANCE?
Hang on, this study was on (and presumably, by) naprapaths – not chiropractors.
For sure they used ‘manual techniques’, but they profess different understandings of pathology, physiology and practice. They are different professions. Otherwise, what’s the point of naprapathy?
Quite why any person interested in practising in the field of healthcare would take up naprapathy rather than chiropractic, osteopathy, physiotherapy or indeed, medicine is for them to explain.
The only naprapath whose books I have read was Harlan Tarbell whose series of books have met with world wide acclaim. Their title?
Tarbell’s Course in Magic.
Says it all!
As I understand it, “Naprapathy” is in reality a variant of chiropractic, a remarketing term that originated in Chicago in the early twentieth century out of fear that the vitalistic philosophy upon which chiropractic is based, would increasingly cause chiropractic to be seen as a fringe practice.
In my country most chiropractors are brought up in the US and their services reflect this fact as far as I have seen.
From what (little) I know of Scandinavian (the paper professor Ernst discusses comes from Sweden) chiropractors and Naprapaths, they are mostly trying to be seen as spine specialists, a kind of subspecialised physiotherapists. What they designate themselves as depends more on the school than their services, I belieive. I guess they are what our chiro-friends might call “ultra-reformists”?
They seem to mix physiotherapy techniques and teachings with some classical chiropractic manipulation methods.
The ‘treatment’ I had from one physiotherapist for severe sciatica was to alter my posture whilst walking. The improvement was immediate. The Treatment I had from a second physiotherapist for severe upper neck and back pain was massage. The effect was immediate and lasted 6 months. The treatment I had from a third physiotherapist for an upper dorsal localised severe pain following rolling backward down a hill was an upper dorsal manipulation. There was the customary click and the pain vanished for three years. Anecdotal I agree but I was impressed.
SO …?
EE…but 178 AEs were rated as moderate to severe.
The paper didn’t use the word “severe”. It combined moderate and major based upon the NRS.
Regarding “major”:
“A low proportion of patients (3%) reached up to NRS > 7 (major AE), meaning that this group was to small to be analyzed separately.”
is that the answer to my question?
i didn’t respond to your question, mainly because I am focusing on the paper itself and your reporting of it.
I know you did not respond to my question
[oh my, one can have intelligent exchanges with chiros!]
Let’s see, you post a poorly written paper on AE from a student clinic in a Naprapathic college in Sweden.
I posted some additional points/concerns regarding the paper and your report of it.
Then your question was regarding the need of a AE reporting system from chiropractors.
Really? Can’t you stay on the paper that you posted? Apparently not.
so, what about a reporting system of chiro AEs
[my post also cited a review of AEs after chiro]
but don’t worry; I know you are merely perfecting your tolling technique.
i have given my views on AE reporting by chiropractors several times on this blog.
Since I fail to see how any skeptics in this group are willing or able to help in the endeavor, the only point of you bringing it up is to say it needs to be brought up.
and how would you call a profession that
1) has strong suspicion of AEs
2) knows about it for donkey’s years
3) cannot manage to establish this essential requirement?
RESPONSIBLE?
CARING FOR PATIENTS?
PROGRESSIVE?
INTERESTED IN EVIDENCE?
EE…and how would you call a profession that…
This has nothing to do with the paper on students adjusting patients in a Swedish naprapath college.
If you don’t want to discuss the paper that you posted, fine.
as I wrote in the post, the paper is a boring test of a bizarre hypothesis, in my mind.
the question of AEs, however, is acute and needs a solution.
[if you are hard of hearing, I could use capital letters]
with your kind permission, I will discuss here what I want to discuss.
@EE
You are well aware that there are NO AE reporting systems for Chiro’s AND osteo’s and PHYSIO’s, GP’s etc except the one in the UK but that is run by a chiro association who advocate for chiro’s and therefore . Yet you still harp on about it as if its purely a failing of the chiropractic profession.
As you know (I have pointed this out to you before) years ago we tried to have a standardized AE reporting system brought in here for ALL professions (chiro, physio, ostoe, GP etc) with the information gathered in emergency departments free from medical bias and assumptions. The report would then sent to the relevant registration board for investigation. It had the FULL support of the CHIROPRACTORS. It was killed off by doctors. A leading medical pain specialist who also supported it told us it went no further due to “sniveling” from doctors.
so you say…
with your permission, I will harp on about this until patients’ safety is taken care of adequately!!!
EE…with your permission, I will harp on about this until patients’ safety is taken care of adequately!!!
“FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event.”
“Importantly, the FAERS data by themselves are not an indicator of the safety profile of the drug.”
https://www.fda.gov/drugs/surveillance/fda-adverse-event-reporting-system-faers
are you trying to convince me that you are an imbecile?
EE…with your kind permission, I will discuss here what I want to discuss.
Ditto.
not quite!
I decide what gets published on this blog, if you don’t mind.
That’s too funny. You want to twist the paper to discuss AE reporting in chiropractic. I point out a few of the limitations of such a system. But now you refer to me as an imbecile.
Apparently, you don’t even know what you want to discuss.
“you refer to me as an imbecile”
I DID NOT!
learn to read
I carried out my own study on this very subject a few years back.
There was one subject (me). He sustained neck stiffness following being rear-ended at a coffee-shop drive-through (true story). Following several sessions of massage therapy with Olga, a former drill sergeant in the Russian Army, he reported moderate discomfort that, over time became worse.
He’s fine now (finally). Olga still practices but she is being investigated by the College of Former Russian Drill Sergeants.
Solid science. End of discussion.
I guessed the end of your story wrongly, Ron. I thought your subject was going to end up marrying Olga because he found he was enjoying the discomfort.
As long as they do not tell, what exactly they did under which circumstances the term “manual therapy” is as precise as “surgery”…. so “is there evidence” for “surgery” is a worthless category like it is for “manual therapy” in general I guess…
It is necessary to install national reporting systems for AR or side effects of manual therapy like it is compulsatory in cases of AR of drugs, especially for AR of high velocity low amplitude spinal manipulations and visceral manipulations.
I guess that there is enough experience with ADR reporting systems. Therefore the reporting system for AMTR Adverse Manual Therapy Reactions must be open for patients too like it is in cases of Adverse Drug Reactions and like in the ADR reporting systems the patients need to be encouraged to report to this system by their own (e.g. like in VAERS / vaccination).
1) So the first step ist to organise the national reporting of data.
2) The nect step then is the scientific epidemiological exploration of the reported cases:
https://data.europa.eu/euodp/de/data/dataset/suspected-adverse-drug-reaction-reports
https://www.ncbi.nlm.nih.gov/m/pubmed/21685607/
VAERS tracks vaccine injuries like I track polar bears. Not very well.
bit.ly/SkepDoc_VAERS
What is their next report, ‘Bears really do poop in the woods’ or ‘We can confirm the Pope is a Catholic’?
There should be an investigation into why there are so many busy osteopaths and chiropractors? Why are patients so dissatisfied with evidence based treatments for back and neck injuries that so many end up goin to osteopaths and chiropractors?
I think there are already many studies of this question
From a layerson’s POV, I can tell you that to the uninformed, going to a chiro for back issues seems appropriate because chiros specifically promote that they can help with that issue.
While clearly, woo is attractive to some for reasons I will never understand, marketing plays a huge role. SCAMs promote. The regular health-care system doesn’t. Simple.
Why is that? Well, for one reason, as individual skeptics, we don’t have the kind of money it would take to make a dent. And health-care providers spend their money on health care, not marketing. Skeptic associations are also strapped for money so to launch a major campaign would be difficult, if not impossible.
Woo providers, on the other hand, are all about the money. They advertise to make more of it. It’s also simpler for them as they are usually selling one product or service. It’s far more complicated than that for the health-care system.
Also, woo doesn’t have to organize others to launch a campaign. Imagine trying to get health-care providers on board and then getting them agree to a marketing campaign.
As I think you can appreciate, woo has an advantage when it comes to marketing.
It’s surprising what you can sell with the right marketing. Especially when you play too people’s fear. (As a professional marketing writer for decades, I know how effective it can be.) Skeptics have blogs and Twitter accounts and such that reach small pockets of people here and there but no real marketing campaigns. At least none I’ve ever seen. Maybe if they did, things would be different.
“Given the limited available evidence, the decision to seek or to refer patients for chiropractic care should be based on patient preference and values.”
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0160037
I’d say “Given the limited available evidence, the decision to seek or to refer patients should be based on the best of this limited evidence; and that is not in favour of chiropractic.”
“However, we believe that additional pragmatic, practice-based studies will help clarify whether chiropractic care is truly equivalent to other types of care in terms of effectiveness and cost.”
What is a practice-based study and how is it different from a clinical study? Thanks in advance.