Swiss chiropractors have just published a clinical trial to investigate outcomes of patients with radiculopathy due to cervical disk herniation (CDH). All patients had neck pain and dermatomal arm pain; sensory, motor, or reflex changes corresponding to the involved nerve root and at least one positive orthopaedic test for cervical radiculopathy were included. CDH was confirmed by magnetic resonance imaging. All patients received regular neck manipulations.
Baseline data included two pain numeric rating scales (NRSs), for neck and arm, and the Neck Disability Index (NDI). At two, four and twelve weeks after the initial consultation, patients were contacted by telephone, and the data for NDI, NRSs, and patient’s global impression of change were collected. High-velocity, low-amplitude thrusts were administered by experienced chiropractors. The proportion of patients reporting to feel “better” or “much better” on the patient’s global impression of change scale was calculated. Pre-treatment and post-treatment NRSs and NDIs were analysed.
Fifty patients were included. At two weeks, 55.3% were “improved,” 68.9% at four and 85.7% at twelve weeks. Statistically significant decreases in neck pain, arm pain, and NDI scores were noted at 1 and 3 months compared with baseline scores. 76.2% of all sub-acute/chronic patients were improved at 3 months.
The authors concluded that most patients in this study, including sub-acute/chronic patients, with symptomatic magnetic resonance imaging-confirmed CDH treated with spinal manipulative therapy, reported significant improvement with no adverse events.
In the presence of disc herniation, chiropractic manipulations have been described to cause serious complications. Some experts therefore believe that CDH is a contra-indication for spinal manipulation. The authors of this study imply, however, that it is not – on the contrary, they think it is an effective intervention for CDH.
One does not need to be a sceptic to notice that the basis for this assumption is less than solid. The study had no control group. This means that the observed effect could have been due to:
a placebo response,
the regression towards the mean,
the natural history of the condition,
or other factors which have nothing to do with the chiropractic intervention per se.
And what about the interesting finding that no adverse-effects were noted? Does that mean that the treatment is safe? Sorry, but it most certainly does not! In order to generate reliable results about possibly rare complications, the study would have needed to include not 50 but well over 50 000 patients.
So what does the study really tell us? I have pondered over this question for some time and arrived at the following answer: NOTHING!
Is that a bit harsh? Well, perhaps yes. And I will revise my verdict slightly: the study does tell us something, after all – chiropractors tend to confuse research with the promotion of very doubtful concepts at the expense of their patients. I think, there is a name for this phenomenon: PSEUDO-SCIENCE.
The aim of this retrospective chart-review was to identify the percentage of non-musculoskeletal and musculoskeletal conditions treated by interns in the NUHS Student Clinic. The information was taken from the charts of patients treated in the fall trimester of 2011.
The results show that 52% of all patients were treated only for musculoskeletal conditions, and 48% were treated for non-musculoskeletal conditions, or musculoskeletal plus non-musculoskeletal conditions.
The authors draw the following conclusions: The NUHS Student Clinic interns are treating a greater percentage of non-musculoskeletal conditions and a lesser percentage of musculoskeletal conditions than practicing chiropractic physicians. The student interns also treat a lesser percentage of non-musculoskeletal and a greater percentage of musculoskeletal conditions than allopathic practitioners. This comparison would suggest that NUHS is nearing its institutional goal of training its student interns as primary care practitioners.
The very last sentence of the conclusions is particularly surprising, in my view. Do these findings really imply that the NUHS is training competent primary care practitioners? I fail to see that the data demonstrate this. On the contrary, I think they show that some US chiropractic schools want to promote the notion that chiropractors are, in fact, primary care physicians. More worryingly, I fear that this article demonstrates how, through the diligent work of chiropractic schools, the myth is being kept alive that chiropractic is effective for all sorts of non-musculoskeletal conditions. In other words, I think we might here have a fine example of unsubstantiated beliefs being handed from one to the next generation of chiropractors.
Evidence-based chiropractic my foot! They continue to “happily promote bogus claims”.
Chiropractors across the world tend to make false claims. This has been shown with such embarrassing regularity that there is no longer any question about it. Should someone have the courage to disclose and criticises this habit, chiropractors tend to attack their critic, rather than putting their house in order. One of their more devious strategies, in my view, is their insistence on claiming to effectively treat all sorts of childhood conditions.
What could be more evil than treating sick children with ineffective and harmful spinal manipulations? The answer is surprisingly simple: PREVENTING CHILDREN FROM PROFITTING FROM ONE OF THE MOST BENEFICIAL INTERVENTIONS EVER DISCOVERED!
The National Vaccine Information Center (NVIC) is an organisation which seems to support anti-vaxers of various kinds. Officially they try hard to give the image of being neutral about vaccinations and state that they are dedicated to the prevention of vaccine injuries and deaths through public education and to defending the informed consent ethic in medicine. As an independent clearinghouse for information on diseases and vaccines, NVIC does not advocate for or against the use of vaccines. We support the availability of all preventive health care options, including vaccines, and the right of consumers to make educated, voluntary health care choices.
In my view, this is thinly disguised promotion of an anti-vaccination stance. The NVIC recently made the following announcement:
The International Chiropractic Pediatric Association (ICPA), which was founded by Dr. Larry Webster and represents doctors of chiropractic caring for children, has supported NVIC’s mission to prevent vaccine injuries and deaths through public education and to protect informed consent rights for more than two decades. ICPA’s 2013 issue of Pathways to Family Wellness magazine features an article written by Barbara Loe Fisher on “The Moral Right to Religious and Conscientious Belief Exemptions to Vaccination.”
Pathways to Family Wellness is a full-color, quarterly publication that offers parents timely, relevant information about health and wellness options that will help them make conscious health choices for their families. ICPA offers NVIC donor supporters and NVIC Newsletter subscribers a complimentary digital version or print version of Pathways to Family Wellness magazine at a significant discount. Visit the Pathways subscription page and, when checking out in the shopping cart, add the exclusive code: NVIC.
ICPA also has initiated parenting support groups that meet monthly to discuss health and parenting topics. Meetings are hosted by local doctors of chiropractic and the Pathways website features a directory of local groups. ICPA Executive Director Dr. Jeanne Ohm said “We look forward to many more years of collaborating with NVIC to forward our shared goal of enhancing and protecting the ability of parents to make fully informed health and wellness choices for their children.”
Why, we may well ask, are so many chiropractors against immunisations? The answer might be found in the history of chiropractic. Their founding fathers believed and taught that “subluxations” are the cause of all human diseases. To uphold this ridiculous creed, it was necessary to deny that infections play an important role in many illnesses. In other words, early chiropractors negated the germ theory of disease. Today, of course, they claim that all of this is ancient history – but the stance of many chiropractors against immunisations discloses fairly clearly, I think, that this is not true. Many chiropractic institutions still teach obsolete pseudo-knowledge and many chiropractors seem unable to totally free themselves from such obvious nonsense.
But back to the ICPA: they profess to be a non-profit organization whose mission is to engage and serve family chiropractors worldwide through education, training, and research, establishing evidenced informed practice, excellence in professional skills and unity in a global community which cooperatively and enthusiastically participates in advancing chiropractic for both the profession and the public.
What does “evidence informed practice” mean? This bizarre creation is alarmingly popular with quacks of all kinds and seems to aim at misleading the unsuspecting public. It clearly has little to do with EVIDENCE-BASED PRACTICE as globally adopted by responsible clinicians. If not, the ICPA would inform its members and the public at large that immunisations are amongst the most successful preventive measures in the history of medicine. It is hard to think of another medical intervention where the benefits so clearly and hugely outweigh the risks. Immunisations have saved more lives than most other medical treatments. To not make this crystal clear to concerned parents is, in my view, wholly irresponsible.
In a recent comment, US chiropractors stated that there is a growing recognition within the profession that the practicing chiropractor must be able to do the following: formulate a searchable clinical question, rapidly access the best evidence available, assess the quality of that evidence, determine if it is applicable to a particular patient or group of patients, and decide if and how to incorporate the evidence into the care being offered. In a word, they believe, that evidence-based chiropractic is possible, perhaps even (almost) a reality. For evidence-based practice to penetrate and transform a profession, the penetration must occur at two levels, they explain. One level is the degree to which individual practitioners possess the willingness and basic skills to search and assess the literature.
The second level, the authors explain, relates to whether the therapeutic interventions commonly employed by a particular health care discipline are supported by clinical research. The authors believe that a growing body of randomized controlled trials provides evidence of the effectiveness and safety of manual therapies. Is this really true, I wonder.
In support of these fairly bold statements, they cite a paper by Bronfort et al which, in their view, is currently the most comprehensive review of the evidence for the efficacy of manual therapies. According to these authors, the ‘Bronfort-report’ stated that evidence is inconclusive for pneumonia, stage 1 hypertension, pre-menstrual syndrome, nocturnal enuresis, and otitis media. The authors also believe that it is unlikely manipulation of the neck is causally related to stroke.
When I read this article, I could not stop myself from giggling. It seems to me that it provides pretty good evidence for the fact that the chiropractic profession is nowhere near reaching the stage where anyone could reasonably claim that chiropractors practice evidence-based medicine – not even the authors themselves seem to abide by the rules of evidence-based medicine! If they had truly been able to access the best evidence available and assess the quality of that evidence surely they would not have (mis-) quoted the ‘Bronfort-report’.
Bronfort’s overview was commissioned by the General Chiropractic Council, it was hastily compiled by ardent believers of chiropractic, published in a journal that non-chiropractors would not touch with a barge pole, and crucially it lacks some of the most important qualities of an unbiased systematic review. In my view, it is nothing short of a white-wash and not worth the paper it was printed on. Conclusions, such as the evidence regarding pneumonia, bed-wetting and otitis is inconclusive are just embarrassing; the correct conclusion is that the evidence fails to be positive for these and most other indications.
Similarly, if the authors had really studied and quoted the best evidence, how on earth could they have stated that manipulation of the neck cannot cause a stroke? The evidence for that is fairly overwhelming, and the only open question here is, how often do such complications occur? And even the biased ‘Bronfort-report’ states: Adverse events associated with manual treatment can be classified into two categories: 1) benign, minor or non-serious and 2) serious. Generally those that are benign are transient, mild to moderate in intensity, have little effect on activities, and are short lasting. Most commonly, these involve pain or discomfort to the musculoskeletal system. Less commonly, nausea, dizziness or tiredness are reported. Serious adverse events are disabling, require hospitalization and may be life-threatening. The most documented and discussed serious adverse event associated with spinal manipulation (specifically to the cervical spine) is vertebrobasilar artery (VBA) stroke. Less commonly reported are serious adverse events associated with lumbar spine manipulation, including lumbar disc herniation and cauda equina syndrome.
Evidence-based practice? Who are these chiropractors kidding? This article very neatly reflects the exact opposite. It ignores hundreds of peer-reviewed papers which are critical of chiropractic. The best one can do with this paper, I think, is to use it as a hilarious bit of involuntary humour or as a classic example of cherry-picking.
Come to think of it, chiropractic and evidence-based practice are contradictions in terms. Either a therapist claims to adjust mystical subluxations, in which case he/she does not practice evidence-based medicine. Or he/she practices evidence-based medicine, in which case adjusting mystical subluxations cannot be part of their therapeutic repertoire.
Towards the end of the article, we learn further fascinating things: the authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article – oh, really?!?! Furthermore, we are told that this ‘research’ was funded by the ‘National Center of Complementary and Alternative Medicine’ (NCCAM) of the National Institutes of Health.
Can it be true? Does the otherwise most respectable NIH really give its name for such overt nonsense? Yes, it is true, and it is by no means the first time. In fact, our analysis shows that, when it comes to chiropractic, this organisation has sponsored almost nothing but utter rubbish, and our conclusion was blunt: the criticism repeatedly aimed at NCCAM seems justified, as far as their RCTs of chiropractic is concerned. It seems questionable whether such research is worthwhile.
Upper spinal manipulation, the signature-treatment of many chiropractors is by no means free of serious risks. Most chiropractors negate this, but can any reasonable person deny it? Neurosurgeons from New York have just published an interesting case-report in this context:
A 45 year old male with presented to his internist with a two-week history of right sided neck pain and tenderness, accompanied by tingling in the hand. The internists’ neurological examination revealed nothing abnormal, except for a decreased range of motion of the right arm. He referred the patient to a chiropractor who performed plain X-rays which apparently showed “mild spasm” (how anyone can see spasm on an X-ray is beyond me!). No magnetic resonance imaging study was done.
The chiropractor proceeded manipulating the patient’s neck on two successive days. By the morning of the third visit, the patient reported extreme pain and difficulty walking. Without performing a new neurological examination or obtaining a magnetic resonance study, the chiropractor manipulated the patient’s neck for a third time.
Thereafter, the patient immediately became quadriplegic. Despite undergoing an emergency C5 C6 anterior cervical diskectomy/fusion to address a massive disc found on the magnetic resonance scan, the patient remained quadriplegic. There seemed to be very little doubt that the quadriplegia was caused by the chiropractic spinal manipulation.
The authors of this report also argue that a major point of negligence in this case was the failure of both the referring internist and chiropractor to order a magnetic resonance study of the cervical spine prior to the chiropractic manipulations. In his defence, the internist claimed that there was no known report of permanent quadriplegia resulting from neck manipulation in any medical journal, article or book, or in any literature of any kind or on the internet. Even the quickest of literature searches discloses this assumption to be wrong. The first such case seems to have been published as early as 1957. Since then, numerous similar reports have been documented in the medical literature.
The internist furthermore claimed that the risk of this injury must be vanishingly small given the large numbers of manipulations performed annually. As we have pointed out repeatedly, this argument is pure speculation; under-reporting of such cases is huge, and therefore exact incidence figures are anybody’s guess.
The patient sued both the internist and the chiropractor, and the total amount of the verdict was $14,596,000.00 the internist’s liability was 5% ($759,181.65).
A recently published study by Danish researchers aimed at comparing the effectiveness of a patient education (PEP) programme with or without the added effect of chiropractic manual therapy (MT) to a minimal control intervention (MCI). Its results seem to indicate that chiropractic MT is effective. Is this the result chiropractors have been waiting for?
To answer this question, we need to look at the trial and its methodology in more detail.
A total of 118 patients with clinical and radiographic unilateral hip osteoarthritis (OA) were randomized into one of three groups: PEP, PEP+ MT or MCI. The PEP was taught by a physiotherapist in 5 sessions. The MT was delivered by a chiropractor in 12 sessions, and the MCI included a home stretching programme. The primary outcome measure was the self-reported pain severity on an 11-box numeric rating scale immediately following the 6-week intervention period. Patients were subsequently followed for one year.
The primary analyses included 111 patients. In the PEP+MT group, a statistically and clinically significant reduction in pain severity of 1.9 points was noted compared to the MCI of 1.90. The number needed to treat for PEP+MT was 3. No difference was found between the PEP and the MCI groups. At 12 months, the difference favouring PEP+MT was maintained.
The authors conclude that for primary care patients with osteoarthritis of the hip, a combined intervention of manual therapy and patient education was more effective than a minimal control intervention. Patient education alone was not superior to the minimal control intervention.
This is an interesting, pragmatic trial with a result suggesting that chiropractic MT in combination with PEP is effective in reducing the pain of hip OA. One could easily argue about the small sample size, the need for independent replication etc. However, my main concern is the fact that the findings can be interpreted in not just one but in at least two very different ways.
The obvious explanation would be that chiropractic MT is effective. I am sure that chiropractors would be delighted with this conclusion. But how sure can we be that it would reflect the truth?
I think an alternative explanation is just as (possibly more) plausible: the added time, attention and encouragement provided by the chiropractor (who must have been aware what was at stake and hence highly motivated) was the effective element in the MT-intervention, while the MT per se made little or no difference. The PEP+MT group had no less than 12 sessions with the chiropractor. We can assume that this additional care, compassion, empathy, time, encouragement etc. was a crucial factor in making these patients feel better and in convincing them to adhere more closely to the instructions of the PEP. I speculate that these factors were more important than the actual MT itself in determining the outcome.
In my view, such critical considerations regarding the trial methodology are much more than an exercise in splitting hair. They are important in at least two ways.
Firstly, they remind us that clinical trials, whenever possible, should be designed such that they allow only one interpretation of their results. This can sometimes be a problem with pragmatic trials of this nature. It would be wise, I think, to conduct pragmatic trials only of interventions which have previously been proven to work. To the best of my knowledge, chiropractic MT as a treatment for hip OA does not belong to this category.
Secondly, it seems crucial to be aware of such methodological issues and to consider them carefully before research findings are translated into clinical practice. If not, we might end up with therapeutic decisions (or guidelines) which are quite simply not warranted.
I would not be in the least surprised, if chiropractic interest groups were to use the current findings for promoting chiropractic in hip-OA. But what, if the MT per se was ineffective, while the additional care, compassion and encouragement was? In this case, we would not need to recruit (and pay for) chiropractors and put up with the considerable risks chiropractic treatments can entail; we would merely need to modify the PE programme such that patients are better motivated to adhere to it.
As it stands, the new study does not tell us much that is of any practical use. In my view, it is a pragmatic trial which cannot readily be translated into evidence-based practice. It might get interpreted as good news for chiropractic but, in fact, it is not.
Some people will probably think that I am obsessed with writing about the risk of chiropractic. True, I have published quite a bit on this subject, both in the peer-reviewed literature as well as on this blog – but not because I am obsessed; on this blog, I will re-visit the topic every time a relevant new piece of evidence becomes available because it is indisputably such an important subject. Writing about it might prevent harm.
So far, we know for sure that mild to moderate as well as serious complications, including deaths, do occur after chiropractic spinal manipulations, particularly those of the upper spine. What we cannot say with absolute certainty is whether they are caused by the treatment or whether they happened coincidentally. Our knowledge in this area relies mostly on case-reports and surveys which, by their very nature, do not allow causal inferences. Therefore chiropractors have, in the past, been able to argue that a causal link remains unproven.
A brand-new blinded parallel group RCT might fill this gap in our knowledge and might reject or establish the notion of causality once and for all. The authors’ objective was to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. They thus conducted the first ever RCT with the specific aim to examine the occurrence of adverse events resulting from chiropractic treatment. It was conducted across 12 chiropractic clinics in Perth, Western Australia. The participants comprised 183 adults, aged 20-85, with spinal pain. Ninety two participants received individualized care consistent with the chiropractors’ usual treatment approach; 91 participants received a sham intervention. Each participant received two treatment sessions.
Completed adverse questionnaires were returned by 94.5% of the participants after the first appointment and 91.3% after the second appointment. Thirty three per cent of the sham group and 42% of the usual care group reported at least one adverse event. Common adverse events were increased pain (sham 29%; usual care 36%), muscle stiffness (sham 29%; usual care 37%), headache (sham 17%; usual care 9%). The relative risk was not significant for either adverse event occurrence (RR = 1.24 95% CI 0.85 to 1.81); occurrence of severe adverse events (RR = 1.9; 95% CI 0.98 to 3.99); adverse event onset (RR = 0.16; 95% CI 0.02 to 1.34); or adverse event duration (RR = 1.13; 95% CI 0.59 to 2.18). No serious adverse events were reported.
The authors concluded that a substantial proportion of adverse events following chiropractic treatment may result from natural history variation and non-specific effects.
If we want to assess causality of effects, we have no better option than to conduct an RCT. It is the study design that can give us certainty, or at least near certainty – that is, if the RCT is rigorous and well-made. So, does this study reject or confirm causality? The disappointing truth is that it does neither.
Adverse events were clearly more frequent with real as compared to sham-treatment. Yet the difference failed to be statistically significant. Why? There are at least two possibilities: either there was no true difference and the numerically different percentages are a mere fluke; or there was a true difference but the sample size was too small to prove it.
My money is on the second option. The number of patients was, in my view, way too small for demonstrating differences in frequencies of adverse effects. This applies to the adverse effects noted, but also, and more importantly, to the ones not noted.
The authors state that no serious adverse effects were observed. With less that 200 patients participating, it would have been most amazing to see a case of arterial dissection or stroke. From all we currently know, such events are quite rare and occur perhaps in one of 10 000 patients or even less often. This means that one would require a trial of several hundred thousand patients to note just a few of such events, and an RCT with several million patients to see a difference between real and sham treatment. It seems likely that such an undertaking will never be affordable.
So, what does this new study tell us? In my view, it is strong evidence to suggest a causal kink between chiropractic treatment and mild to moderate adverse effects. I dose not prove it, but merely suggests it – yet I am fairly sure that chiropractors, once again, will not agree with me.
On this blog, we have repeatedly discussed the serious adverse effects of Spinal Manipulative Therapies (SMT) as frequently administered by chiropractors, osteopaths and physiotherapists. These events mostly relate to vascular accidents involving vertebral or carotid arterial dissections after SMT of the upper spine. Lower down, the spine is anatomically far less vulnerable which, however, does not mean that injuries in this region after SMT are impossible. They have been reported repeatedly but, to the best of my knowledge, there is no up-to-date review of such events – that is until recently.
Australian researchers have just filled this gap by publishing a systematic review aimed at systematically reviewing all reports of serious adverse events following lumbo-pelvic SMT. They conducted electronic searches in MEDLINE, EMBASE, CINAHL, and The Cochrane Library up to January 12, 2012. Article-selection was performed by two independent reviewers using predefined criteria. Cases were included involving individuals 18 years or older who experienced a serious adverse event following SMT applied to the lumbar spine or pelvis by any type of provider (chiropractic, medical, physical therapy, osteopathic, layperson). A serious adverse event was defined as an untoward occurrence that resulted in death or was life threatening, required hospital admission, or resulted in significant or permanent disability. Reports published in English, German, Dutch, and Swedish were included.
The searches identified a total of 2046 papers, and 41 articles reporting a total of 77 cases were included in the review. Important case details were frequently missing in these reports, such as descriptions of SMT technique, the pre-SMT presentation of the patient, the specific details of the adverse event, time from SMT to the adverse event, factors contributing to the adverse event, and clinical outcome.
The 77 adverse events consisted of cauda equina syndrome (29 cases); lumbar disk herniation (23 cases); fracture (7 cases); haematoma or haemorrhagic cyst (6 cases); and12 cases of neurologic or vascular compromise, soft tissue trauma, muscle abscess formation, disrupted fracture healing, and oesophageal rupture.
The authors’ conclusion was that this systematic review describes case details from published articles that describe serious adverse events that have been reported to occur following SMT of the lumbo-pelvic region. The anecdotal nature of these cases does not allow for causal inferences between SMT and the events identified in this review.
This review is timely and sound. Yet several factors need consideration:
1) The search strategy was thorough but it is unlikely that all relevant articles were retrieved because these papers are often well-hidden in obscure and not electronically listed journals.
2) It is laudable that the authors included languages other than English but it would have been preferable to impose no language restrictions at all.
3) Under-reporting of adverse events is a huge problem, and it is anyone’s guess how large it really is [we have shown that, in our research it was precisely 100%]
4) This means that the 77 cases, which seem like a minute number, could in reality be 770 or 7700 or 77000; nobody can tell.
Cauda equina (horse tail) syndrome was the most frequent and most serious adverse event reported. This condition is caused by nerve injury at the lower end of the spinal canal. Symptoms can include leg pain along the sciatic nerve, severe back pain, altered or loss of sensation over the area around the genitals, anus and inner thighs as well as urine retention or incontinence and faecal incontinence. The condition must be treated as an emergency and usually requires surgical decompression of the injured nerves.
Disk herniation, the second most frequent adverse event, is an interesting complication of SMT. Most therapists using SMT would probably claim (no, I have no reference for that speculation!) that they can effectively treat herniated disks with SMT. The evidence for this claim is, as far as I know, non-existent. In view of the fact that SMT can actually cause a disk to herniate, I wonder whether SMT should not be contra-indicated for this condition. I am sure there will be some discussion about this question following this post.
The authors make a strong point about the fact that case reports never allow causal inference. One can only agree with this notion. However, the precautionary principle in medicine also means that, if case reports provide reasonable suspicion that an intervention might led to adverse-effects, we need to be careful and should warn patients of this possibility. It also means that it is up to the users of SMT to demonstrate beyond reasonable doubt that SMT is safe.
A team of Swiss and UK chiropractors just published a survey to determine which management options their colleagues would choose in response to several clinical case scenarios. In order to avoid the accusations of citing out of context, or misreporting the findings in other ways, the wording of the following post is close to the original text of the article.
The clinical scenarios refer to treatments which appear not to be successful, not indicated, possibly harmful or where a patient might be suffering from a treatment-induced complication:
Scenario 1. A patient with non-specific low back pain has not improved at all after 4–6 treatments.
Scenario 2. A patient, who has a simple neck problem with no previous long-term problems, has now improved at least 80% and stayed at this level for a couple of weeks.
Scenario 3. A patient returns from the last treatment with a new distal pain (e.g. sciatica when treated only for localized LBP, or brachialgia when treated only for local neck pain).
Scenario 4. An elderly woman complains about immediate chest pain on inspiration after manual treatment directed to her thoracic spine.
It is worth noting that scenario 4 is the most dramatic but it is by far not the worst case scenario; this would have been the case of a patient who develops signs of a stroke after neck manipulation. It is telling, I think, that this possibility has been excluded in the survey.
The following 9 management options were provided:
• I would re-evaluate the patient with a view to establishing a better diagnosis
• I would send the patient for diagnostic imaging
• I would change my treatment approach and use another technique
• I would send the patient for a second opinion to another healthcare professional but keep on monitoring their condition
• I would try a few times more
• I would encourage the patient to continue the treatment until their spine is subluxation-free
• I would stop treatment and monitor the patient regularly
• I would stop the treatment, apologise and report the event to the chiropractic reporting and learning system
• I would stop the treatment, but tell the patient that s/he is welcome to return if they feel the need
To each of these options, the chiropractors could answer by ticking: ‘never’, ‘unlikely’, ‘likely’ and ‘most likely’.
In a second part of the questionnaire the researchers assessed the chiropractors’ general attitude towards safety issues by seeking the level of agreement on a five-point scale, with the responses ‘strongly disagree’, ‘disagree’, ‘neither agree nor disagree’, ‘agree’ and ‘strongly agree’, with 23 statements relating to six different safety dimensions, as follows:
• Teamwork – helping out, relationships, respect, teamwork-emphasis
• Work pressure – rushing, overwork, staff contingent, patient numbers
• Staff training – in response to new processes, on-the-job, appropriateness of tasks
• Process and standardisation – organisation, procedures, workflow, processes
• Communication openness – ideas for improvement, alternative views, asking questions, voicing disagreement
• Patient tracking/follow-up – reminders, documentation, reports, monitoring
260 Swiss and 1258 UK chiropractors were invited to complete the questionnaire. Responses were received from 76% of the Swiss and from 31% of the UK chiropractors. The dismal response rate for UK chiropractors seems to speak volumes.
The results of this survey indicate that both Swiss and UK chiropractors tend to manage clinical scenarios where treatment appears not to be successful, not indicated, possibly harmful or where a serious complication might have occurred, by re-evaluating their care. Stopping treatment and/or incident reporting to a safety incident reporting and learning system were generally found to be unlikely courses of action. The authors believe that this unlikeliness of safety incident reporting is due to a range of recognised barriers, although Swiss and UK chiropractors are positive about local communication and openness which are important tenets for safety incident reporting. The observed positivity towards key aspects of clinic safety indicates a developing safety culture within the Swiss and UK chiropractic professions.
In this context, scenario 4 is the most dramatic and therefore the most relevant scenario -but, as noted above, not a worst case scenario. It suggested a rib fracture as a result of chiropractic manipulation, with osteoporosis as a possible risk factor. The authors state that there is a strong argument for such an incident to be reported because patient injury occurred and because reflection on the detailed circumstances of the case, shared with colleagues, might serve to minimise the risk of such an occurrence happening elsewhere. However, incident reporting was found to be an unlikely option and comments revealed that this may be due to a perceived connection of reporting with guilt and error, as has been identified with other healthcare reporting initiatives, or only warranted in extreme cases.
The survey also showed that 33% of UK and 48% of Swiss chiropractors seem to work alone. In the eyes of the authors, this is limiting opportunities for fostering a safety culture through activities such as teamwork.
The authors draw the following conclusions:
• This study prompted chiropractors to reflect on aspects of clinical risk.
• Swiss and UK chiropractors tend to manage potentially risky clinical scenarios by reevaluating their care and changing their approach
• Safety incident reporting to an online system is currently an unlikely course of action, probably due to previously recognised barriers, although Swiss and UK chiropractors are positive about local communication and openness which are important tenets for safety incident reporting.
• Barriers to the use of safety incident reporting systems need to be addressed in order to encourage wider use of the existing systems.
• A significant proportion of Swiss and UK chiropractors practice in a single-handed environment. We suggest that single-handed practitioners have most to gain from participation in a national safety incident reporting and learning system.
• Female chiropractors appear to be more risk-averse than male chiropractors.
• Positivity towards key aspects of clinic safety indicate a developing safety culture within the Swiss and UK chiropractic professions.
In my view, the findings of this survey are deeply worrying and the interpretation of the authors is not far from an attempt to ‘white-wash’ the results. Like with most investigations of this nature, the results are wide open to selection bias; particularly the dismal UK response rate begs many questions. In all likelihood, reality is much worse than implied by the results of this investigation. And these results clearly show that, even with a fairly dramatic safety incident, chiropractors fail to respond adequately. There is no doubt in my mind: chiropractors put patients at risk.
Some national and international guidelines advise physicians to use spinal manipulation for patients suffering from acute (and chronic) low back pain. Many experts have been concerned about the validity of this advice. Now an up-date of the Cochrane review on this subject seems to provide clarity on this rather important matter.
Its aim was to assess the effectiveness of spinal manipulative therapy (SMT) as a treatment of acute low back pain. Randomized controlled trials (RCTs) testing manipulation/mobilization in adults with low back pain of less than 6-weeks duration were included. The primary outcome measures were pain, functional status and perceived recovery. Secondary endpoints were return-to-work and quality of life. Two authors independently conducted the study selection, risk of bias assessment and data extraction. The effects were examined for SMT versus inert interventions, sham SMT, other interventions, and for SMT as an adjunct to other forms of treatment.
The researchers identified 20 RCTs with a total number of 2674 participants, 12 (60%) RCTs had not been included in the previous version of this review. Only 6 of the 20 studies had a low risk of bias. For pain and functional status, there was low- to very low-quality evidence suggesting no difference in effectiveness of SMT compared with inert interventions, sham SMT or as adjunct therapy. There was varying quality of evidence suggesting no difference in effectiveness of SMT compared with other interventions. Data were sparse for recovery, return-to-work, quality of life, and costs of care.
The authors draw the following conclusion: “SMT is no more effective for acute low back pain than inert interventions, sham SMT or as adjunct therapy. SMT also seems to be no better than other recommended therapies. Our evaluation is limited by the few numbers of studies; therefore, future research is likely to have an important impact on these estimates. Future RCTs should examine specific subgroups and include an economic evaluation.”
In other words, guidelines that recommend SMT for acute low back pain are not based on the current best evidence. But perhaps the situation is different for chronic low back pain? The current Cochrane review of 26 RCTs is equally negative: “High quality evidence suggests that there is no clinically relevant difference between SMT and other interventions for reducing pain and improving function in patients with chronic low-back pain. Determining cost-effectiveness of care has high priority. Further research is likely to have an important impact on our confidence in the estimate of effect in relation to inert interventions and sham SMT, and data related to recovery.”
This clearly begs the question why many of the current guidelines seem to mislead us. I am not sure I know the answer to this one; however I suspect that the panels writing the guidelines might have been dominated by chiropractors and osteopaths or their supporters who have not exactly made a name for themselves for being impartial. Whatever the reason, I think it is time for a re-think and for up-dating guidelines which are out of date and misleading.
Similarly, it might be time to question for what conditions chiropractors and osteopaths, the two professions who use spinal manipulation/mobilisation most, do actually offer anything of real value at all. Back pain and SMT are clearly their domains; if it turns out that SMT is not evidence-based for back pain, what is left? There is no good evidence for anything else, as far as I can see. To make matters worse, there are quite undeniable risks associated with SMT. The conclusion of such considerations is, I fear, obvious: the value of and need for these two professions should be re-assessed.