In 2005, I published a systematic review of ophthalmic adverse effects after spinal manipulations. At the time, I found 14 case reports. Clinical symptoms and signs were diverse and included loss of vision, ophthalmoplegia, diplopia and Horner’s syndrome. The underlying mechanism was arterial wall dissection in most cases. The eventual outcome varied and often included permanent deficits. Causality was frequently deemed likely or certain.
I concluded that upper spinal manipulation is associated with ophthalmological adverse effects of unknown frequency. Ophthalmologists should be aware of its risks. Rigorous investigations must be conducted to establish reliable incidence figures.
Now a new article has emerged that throws more light on this issue:
A 46-year-old healthy male with a history of chronic musculoskeletal neck pain presented to the emergency department with left sided weakness after a syncopal episode. The patient had been treated with frequent chiropractic neck manipulations over the past seven years, with his last session one month prior to presentation. One week prior to presentation, the patient developed a new headache, anisocoria, and ptosis of his right upper eyelid. Computed tomography angiography (CTA) of the head and neck showed an internal carotid occlusion with right middle cerebral artery zone of ischemia, and tissue plasminogen activator (tPA) was administered. Subsequently, the patient experienced vision loss in his right eye. MRI and CTA were repeated, revealing a right ICA dissection from below the ophthalmic artery to the posterior communicating artery. On examination, vision in the right eye was no light perception (NLP) and the pupil was amaurotic. Fundus exam showed vascular attenuation, severe pallor of the optic nerve and retina, without a cherry red spot. A diagnosis of ophthalmic artery occlusion was made.
Inpatient workup revealed no stroke risk factors, and he was discharged on aspirin and clopidogrel therapy. Follow up imaging showed re-cannulation of the ICA, although vision remained NLP at outpatient evaluation the following month. Macular spectral domain optical coherence tomography (SDOCT) showed hyperreflectivity of the inner retina diffusely and of the outer retina and retinal pigment epithelium (RPE) centrally. Fluorescein angiography revealed patchy choroidal filling, delayed arterial filling, and macular nonperfusion. Three months after presentation, vision had improved to light perception, and remains stable at one year after the dissection.
Central retinal artery occlusion (CRAO) has been previously described after neck manipulation; however, these cases have been attributed to a dislodged embolic plaque rather than arterial dissection as in this case. Carotid artery dissection after neck manipulation is rare, although the exact incidence is unknown, and may be fatal.
The authors of this case report concluded that internal carotid artery dissection in this case was permanently devastating to the vision of a previously healthy young patient.
What follows is simple:
- upper spinal manipulations have no or very little proven benefit;
- they are associated with a finite risk;
- thus, their risk/benefit balance fails to be positive;
- consequently, upper spinal manipulations cannot be recommended as a treatment of any condition.
Systematic research on complaints about chiropractors, osteopaths, and physiotherapists is rare. We have often heard chiropractors claim that complaints against them are extremely rare events.
But is this true?
Two recent investigations might go some way towards answering this question.
The aim of the first investigation was to understand differences in the frequency and nature of formal complaints about Australian practitioners in these professions in order to inform improvements in professional regulation and education.
This retrospective cohort study analysed all formal complaints about all registered chiropractors, osteopaths, and physiotherapists in Australia lodged with health regulators between 2011 and 2016. Based on initial assessments by regulators, complaints were classified into 11 issues across three domains: performance, professional conduct, and health. Differences in complaint rate were assessed using incidence rate ratios. A multivariate negative binomial regression model was used to identify predictors of complaints among practitioners in these professions.
Patients and their relatives were the most common source of complaints about chiropractors, osteopaths and physiotherapists. Concerns about professional conduct accounted for more than half of the complaints about practitioners in these three professions. Regulatory outcome of complaints differed by profession. Male practitioners, those who were older than 65 years, and those who practised in metropolitan areas were at higher risk of complaint. The overall rate of complaints was higher for chiropractors than osteopaths and physiotherapists (29 vs. 10 vs. 5 complaints per 1000 practice years respectively, p < 0.001). Among chiropractors, 1% of practitioners received more than one complaint – they accounted for 36% of the complaints within their profession. Overall, nearly half of the complaints (47.7%) involved chiropractors, even though chiropractors make up less than one-sixth (13.9%) of the workforce across these three professions.
The authors concluded that their study demonstrates differences in the frequency of complaints by source, issue and outcome across the chiropractic, osteopathic and physiotherapy professions. Independent of profession, male sex and older age were significant risk factors for complaint in these professions. Chiropractors were at higher risk of being the subject of a complaint to their practitioner board compared with osteopaths and physiotherapists. These findings may assist regulatory boards, professional associations and universities in developing programs that avert patient dissatisfaction and harm and reduce the burden of complaints on practitioners.
The aim of the second study was to describe claims reported to the Danish Patient Compensation Association and the Norwegian System of Compensation to Patients related to chiropractic from 2004 to 2012.
All finalized compensation claims involving chiropractors reported to one of the two associations between 2004 and 2012 were assessed for age, gender, type of complaint, decisions and appeals. Descriptive statistics were used to describe the study population. The results show that 338 claims were registered in Denmark and Norway between 2004 and 2012 of which 300 were included in the analysis. 41 (13.7%) were approved for financial compensation. The most frequent complaints were worsening of symptoms following treatment (n = 91, 30.3%), alleged disk herniations (n = 57, 19%) and cases with delayed referral (n = 46, 15.3%). A total financial payment of €2,305,757 (median payment €7,730) were distributed among the forty-one cases with complaints relating to a few cases of cervical artery dissection (n = 11, 5.7%) accounting for 88.7% of the total amount.
The authors concluded that chiropractors in Denmark and Norway received approximately one compensation claim per 100.000 consultations. The approval rate was low across the majority of complaint categories and lower than the approval rates for general practioners and physiotherapists. Many claims can probably be prevented if chiropractors would prioritize informing patients about the normal course of their complaint and normal benign reactions to treatment.
In their discussion section the authors make the following comments: A particular concern after cervical SMT is dissection of the vertebral and carotid arteries. Seventeen claims concerning CAD were reported in this data, 14 in Denmark and three in Norway, and 11 of these were approved for financial compensation (64.7% approval rate) representing by far the highest approval rate across all complaint categories… chiropractors generally seem to receive more claims per consultation than GPs and physiotherapists, the approval rate is substantially lower and a similar trend is observed in Norway. However, it is also evident that approved claims within chiropractic bear a higher financial burden than their peers. These numbers are clearly highly influenced by the cases related to CAD. Several reasons might explain a higher complaint rate within chiropractic but this remains speculation and we do not have hard evidence supporting any of the following suggestions: (1) chiropractic treatment might be perceived as more aggressive than that of GPs and physiotherapists (2) maybe scepticism towards chiropractic among medical physicians and physiotherapists could encourage more patient complaints (3) a higher out-of-pocket expense for chiropractic services compared with GP and physiotherapist services might influence the higher number of complaints (4) chiropractors do not adequately inform patients about normal side effects and reactions and patients regard these as serious and relevant for compensation claims (5) chiropractors encourage patients to report AE more frequently than GPs and physiotherapists.
So, are complaints against chiropractors rarities?
I don’t think so.
THE CONVERSATION recently carried an article shamelessly promoting osteopathy. It seems to originate from the University of Swansea, UK, and is full of bizarre notions. Here is an excerpt:
To find out more about how osteopathy could potentially affect mental health, at our university health and well-being academy, we have recently conducted one of the first studies on the psychological impact of OMT – with positive results.
For the last five years, therapists at the academy have been using OMT to treat members of the public who suffer from a variety of musculoskeletal disorders which have led to chronic pain. To find out more about the mental health impacts of the treatment, we looked at three points in time – before OMT treatment, after the first week of treatment, and after the second week of treatment – and asked patients how they felt using mental health questionnaires.
This data has shown that OMT is effective for reducing anxiety and psychological distress, as well as improving patient self-care. But it may not be suitable for all mental illnesses associated with chronic pain. For instance, we found that OMT was less effective for depression and fear avoidance.
All is not lost, though. Our results also suggested that the positive psychological effects of OMT could be further optimised by combining it with therapy approaches like acceptance and commitment therapy (ACT). Some research indicates that psychological problems such as anxiety and depression are associated with inflexibility, and lead to experiential avoidance. ACT has a positive effect at reducing experiential avoidance, so may be useful with reducing the fear avoidance and depression (which OMT did not significantly reduce).
Other researchers have also suggested that this combined approach may be useful for some subgroups receiving OMT where they may accept this treatment. And, further backing this idea up, there has already been at least one pilot clinical trial and a feasibility study which have used ACT and OMT with some success.
Looking to build on our positive results, we have now begun to develop our ACT treatment in the academy, to be combined with the osteopathic therapy already on offer. Though there will be a different range of options, one of these ACT therapies is psychoeducational in nature. It does not require an active therapist to work with the patient, and can be delivered through internet instruction videos and homework exercises, for example.
Looking to the future, this kind of low cost, broad healthcare could not only save the health service money if rolled out nationwide but would also mean that patients only have to undergo one treatment.
END OF QUOTE
So, they recruited a few patients who had come to receive osteopathic treatments (a self-selected population full of expectation and in favour of osteopathy), let them fill a few questionnaires and found some positive changes. From that, they conclude that OMT (osteopathic manipulative therapy) is effective. Not only that, they advocate that OMT is rolled out nationwide to save NHS funds.
Vis a vis so much nonsense, I am (almost) speechless!
As this comes not from some commercial enterprise but from a UK university, the nonsense is intolerable, I find.
Do I even need to point out what is wrong with it?
Not really, it’s too obvious.
But, just in case some readers struggle to find the fatal flaws of this ‘study’, let me mention just the most obvious one. There was no control group! That means the observed outcome could be due to many factors that are totally unrelated to OMT – such as placebo-effect, regression towards the mean, natural history of the condition, concomitant treatments, etc. In turn, this also means that the nationwide rolling out of their approach would most likely be a costly mistake.
The general adoption of OMT would of course please osteopaths a lot; it could even reduce anxiety – but only that of the osteopaths and their bank-managers, I am afraid.
We recently discussed the deplorable case of Larry Nassar and the fact that the ‘American Osteopathic Association’ stated that intravaginal manipulations are indeed an approved osteopathic treatment. At the time, I thought this was a shocking claim. So, imagine my surprise when I was alerted to a German trial of osteopathic intravaginal manipulations.
Here is the full and unaltered abstract of the study:
Introduction: 50 to 80% of pregnant women suffer from low back pain (LBP) or pelvic pain (Sabino und Grauer, 2008). There is evidence for the effectiveness of manual therapy like osteopathy, chiropractic and physiotherapy in pregnant women with LBP or pelvic pain (Liccardione et al., 2010). Anatomical, functional and neural connections support the relationship between intrapelvic dysfunctions and lumbar and pelvic pain (Kanakaris et al., 2011). Strain, pressure and stretch of visceral and parietal peritoneum, bladder, urethra, rectum and fascial tissue can result in pain and secondary in muscle spasm. Visceral mobility, especially of the uterus and rectum, can induce tension on the inferior hypogastric plexus, which may influence its function. Thus, stretching the broad ligament of the uterus and the intrapelvic fascia tissue during pregnancy can reinforce the influence of the inferior hypogastric plexus. Based on above facts an additional intravaginal treatment seems to be a considerable approach in the treatment of low back pain in pregnant women.
Objective: The purpose of this study was to compare the effect of osteopathic treatment including intravaginal techniques versus osteopathic treatment only in females with pregnancy-related low back pain.
Methods: Design: The study was performed as a randomized controlled trial. The participants were randomized by drawing lots, either into the intervention group including osteopathic and additional intravaginal treatment (IV) or a control group with osteopathic treatment only (OI). Setting: Medical practice in south of Germany.
Participants 46 patients were recruited between the 30th and 36th week of pregnancy suffering from low back pain.
Intervention Both groups received three treatments within a period of three weeks. Both groups were treated with visceral, mobilization, and myofascial techniques in the cervical, thoracic and lumbar spine, the pelvic and the abdominal region (American Osteopathic Association Guidelines, 2010). The IV group received an additional treatment with intravaginal techniques in supine position. This included myofascial techniques of the M. levator ani and the internal obturator muscles, the vaginal tissue, the pubovesical and uterosacral ligaments as well as the inferior hypogastric plexus.
Main outcome measures As primary outcome the back pain intensity was measured by Visual Analogue Scale (VAS). Secondary outcome was the disability index assessed by Oswestry-Low-Back-Pain-Disability-Index (ODI), and Pregnancy-Mobility-Index (PMI).
Results: 46 participants were randomly assigned into the intervention group (IV; n = 23; age: 29.0 ±4.8 years; height: 170.1 ±5.8 cm; weight: 64.2 ±10.3 kg; BMI: 21.9 ±2.6 kg/m2) and the control group (OI; n = 23; age: 32.0 ±3.9 years; height: 168.1 ±3.5 cm; weight: 62.3 ±7.9 kg; BMI: 22.1 ±3.2 kg/m2). Data from 42 patients were included in the final analyses (IV: n=20; OI: n=22), whereas four patients dropped out due to general pregnancy complications. Back pain intensity (VAS) changed significantly in both groups: in the intervention group (IV) from 59.8 ±14.8 to 19.6 ±8.4 (p<0.05) and in the control group (OI) from 57.4 ±11.3 to 24.7 ±12.8. The difference between groups of 7.5 (95%CI: -16.3 to 1.3) failed to demonstrate statistical significance (p=0.93). Pregnancy-Mobility-Index (PMI) changed significantly in both groups, too. IV group: from 33.4 ±8.9 to 29.6 ±6.6 (p<0.05), control group (OI): from 36.3 ±5.2 to 29.7 ±6.8. The difference between groups of 2.6 (95%CI: -5.9 to 0.6) was not statistically significant (p=0.109). Oswestry-Low-Back-Pain-Disability-Index (ODI) changed significantly in the intervention group (IV) from 15.1 ±7.8 to 9.2 ±3.6 (p<0.05) and also significantly in the control group (OI) from 13.8 ±4.9 to 9.2 ±3.0. Between-groups difference of 1.3 (95%CI: -1.5 to 4.1) was not statistically significant (p=0.357).
Conclusions: In this sample a series of osteopathic treatments showed significant effects in reducing pain and increasing the lumbar range of motion in pregnant women with low back pain. Both groups attained clinically significant improvement in functional disability, activity and quality of life. Furthermore, no benefit of additional intravaginal treatment was observed.
END OF QUOTE
My first thoughts after reading this were: how on earth did the investigators get this past an ethics committee? It cannot be ethical, in my view, to allow osteopaths (in Germany, they have no relevant training to speak of) to manipulate women intravaginally. How deluded must an osteopath be to plan and conduct such a trial? What were the patients told before giving informed consent? Surely not the truth!
My second thoughts were about the scientific validity of this study: the hypothesis which this trial claims to be testing is a far-fetched extrapolation, to put it mildly; in fact, it is not a hypothesis, it’s a very daft idea. The control-intervention is inadequate in that it cannot control for the (probably large) placebo effects of intravaginal manipulations. The observed outcomes are based on within-group comparisons and are therefore most likely unrelated to the treatments applied. The conclusion is as barmy as it gets; a proper conclusion should clearly and openly state that the results did not show any effects of the intravaginal manipulations.
In summary, this is a breathtakingly idiotic trial, and everyone involved in it (ethics committee, funding body, investigators, statistician, reviewers, journal editor) should be deeply ashamed and apologise to the poor women who were abused in a most deplorable fashion.
Gosh, we in the UK needed that boost of jingoism (at least, if you are white, non-Jewish and equipped with a British passport)! But it’s all very well to rejoice at the news that we have a new little Windsor. With all the joy and celebration, we must not forget that the blue-blooded infant might be in considerable danger!
I am sure that chiropractors know what I am talking about.
KISS (Kinematic Imbalance due to Suboccipital Strain) is a term being used to describe a possible causal relation between imbalance in the upper neck joints in infants and symptoms like postural asymmetry, development of asymmetric motion patterns, hip problems, sleeping and eating disorders. Chiropractors are particularly fond of KISS. It is a problem that chiropractors tend to diagnose in new-borns.
This website explains further:
The kinematic imbalances brought on by the suboccipital strain at birth give rise to a concept in which symptoms and signs associated with the cervical spine manifest themselves into two easily recognizable clinical presentations. The leading characteristic is a fixed lateroflexion [called KISS I] or fixed retroflexion [KISS II]. KISS I may be associated with torticollis, asymmetry of the skull, C–scoliosis of the neck and trunk, asymmetry of the gluteal area and of the limbs, and retardation of the motor development of one side. KISS II, on the other hand, displays hyperextension during sleep, occipital flattening that may be asymmetrical, hunching of the shoulders, fixed supination of the arms, orofacial muscular hypotonia, failure to lift the trunk from a ventral position, and difficulty in breast feeding on one side.  The leading trademarks of both KISS I and KISS II are illustrated in Figure 1. 
In essence, these birth experiences lay the groundwork for rationalizing the wisdom of providing chiropractic healthcare to the pediatric population…
END OF QUOTE
KISS must, of course, be treated with chiropractic spinal manipulation: the manual adjustment is the most common, followed by an instrument adjustment. This removes the neurological stress, re-balances the muscles and normal head position. Usually a dramatic change can be seen directly after the appropriate adjustment has been given…
Don’t frown! We all know that we can trust our chiropractors.
Do you have to insist on being a spoil-sport?
Alright, alright, the evidence tells a different story. A systematic review concluded that, given the absence of evidence of beneficial effects of spinal manipulation in infants and in view of its potential risks, manual therapy, chiropractic and osteopathy should not be used in infants with the KISS-syndrome, except within the context of randomised double-blind controlled trials.
And this means I now must worry for a slightly different reason: we all know that the new baby was born into a very special family – a family that seems to embrace every quackery available! I can just see the baby’s grandfather recruiting a whole range of anti-vaccinationists, tree-huggers, spoon-benders, homeopaths, faith healers and chiropractors to look after the new-born.
By Jove, one does worry about one’s Royals!
Osteopathy is an odd alternative therapy. In many parts of the world it is popular; the profession differs dramatically from country to country; and there is not a single condition for which we could say that osteopathy out-performs other options. No wonder then that osteopaths would be more than happy to find a new area where they could practice their skills.
Perhaps surgical care is such an area?
The aim of this systematic review was to present an overview of published research articles within the subject field of osteopathic manipulative treatment (OMT) in surgical care. The authors evaluated peer-reviewed research articles published in osteopathic journals during the period 1990 to 2017. In total, 10 articles were identified.
Previous research has been conducted within the areas of abdominal, thoracic, gynecological, and/or orthopedic surgery. The studies included outcomes such as pain, analgesia consumption, length of hospital stay, and range of motion. Heterogeneity was identified in usage of osteopathic techniques, treatment duration, and occurrence, as well as in the osteopath’s experience.
The authors concluded that despite the small number of research articles within this field, both positive effects as well as the absence of such effects were identified. Overall, there was a heterogeneity concerning surgical contexts, diagnoses, signs and symptoms, as well as surgical phases in current interprofessional osteopathic publications. In this era of multimodal surgical care, the authors concluded, there is an urgent need to evaluate OMT in this context of care and with a proper research approach.
This is an odd conclusion, if there ever was one!
The facts are fairly straight forward:
- Osteopaths would like to expand into the area of surgical care [mainly, I suspect, because it would be good for business]
- There is no plausible reason why OMT should be beneficial in this setting.
- Osteopaths are not well-trained for looking after surgical patients.
- Physiotherapists, however, are and therefore there is no need for osteopaths on surgical wards.
- The evidence is extremely scarce.
- The available trials are of poor quality.
- Their results are contradictory.
- Therefore there is no reliable evidence to show that OMT is effective.
The correct conclusion of this review should thus be as follows:
THE AVAILABLE EVIDENCE FAILS TO SHOW EFFECTIVENESS OF OMT. THEREFORE THIS APPROACH CANNOT BE RECOMMENDED.
End of story.
We all know that there is a plethora of interventions for and specialists in low back pain (chiropractors, osteopaths, massage therapists, physiotherapists etc., etc.); and, depending whether you are an optimist or a pessimist, each of these therapies is as good or as useless as the next. Today, a widely-publicised series of articles in the Lancet confirms that none of the current options is optimal:
Almost everyone will have low back pain at some point in their lives. It can affect anyone at any age, and it is increasing—disability due to back pain has risen by more than 50% since 1990. Low back pain is becoming more prevalent in low-income and middle-income countries (LMICs) much more rapidly than in high-income countries. The cause is not always clear, apart from in people with, for example, malignant disease, spinal malformations, or spinal injury. Treatment varies widely around the world, from bed rest, mainly in LMICs, to surgery and the use of dangerous drugs such as opioids, usually in high-income countries.
The Lancet publishes three papers on low back pain, by an international group of authors led by Prof Rachelle Buchbinder, Monash University, Melbourne, Australia, which address the issues around the disorder and call for worldwide recognition of the disability associated with the disorder and the removal of harmful practices. In the first paper, Jan Hartvigsen, Mark Hancock, and colleagues draw our attention to the complexity of the condition and the contributors to it, such as psychological, social, and biophysical factors, and especially to the problems faced by LMICs. In the second paper, Nadine Foster, Christopher Maher, and their colleagues outline recommendations for treatment and the scarcity of research into prevention of low back pain. The last paper is a call for action by Rachelle Buchbinder and her colleagues. They say that persistence of disability associated with low back pain needs to be recognised and that it cannot be separated from social and economic factors and personal and cultural beliefs about back pain.
Overview of interventions endorsed for non-specific low back pain in evidence-based clinical practice guidelines (Danish, US, and UK guidelines)
In this situation, it makes sense, I think, to opt for a treatment (amongst similarly effective/ineffective therapies) that is at least safe, cheap and readily available. This automatically rules out chiropractic, osteopathy and many others. Exercise, however, does come to mind – but what type of exercise?
The aim of this meta-analysis of randomized controlled trials was to gain insight into the effectiveness of walking intervention on pain, disability, and quality of life in patients with chronic low back pain (LBP) at post intervention and follow ups.
Six electronic databases (PubMed, Science Direct, Web of Science, Scopus, PEDro and The Cochrane library) were searched from 1980 to October 2017. Randomized controlled trials (RCTs) in patients with chronic LBP were included, if they compared the effects of walking intervention to non-pharmacological interventions. Pain, disability, and quality of life were the primary health outcomes.
Nine RCTs were suitable for meta-analysis. Data was analysed according to the duration of follow-up (short-term, < 3 months; intermediate-term, between 3 and 12 months; long-term, > 12 months). Low- to moderate-quality evidence suggests that walking intervention in patients with chronic LBP was as effective as other non-pharmacological interventions on pain and disability reduction in both short- and intermediate-term follow ups.
The authors concluded that, unless supplementary high-quality studies provide different evidence, walking, which is easy to perform and highly accessible, can be recommended in the management of chronic LBP to reduce pain and disability.
I know – this will hardly please the legions of therapists who earn their daily bread with pretending their therapy is the best for LBP. But healthcare is clearly not about the welfare of the therapists, it is/should be about patients. And patients should surely welcome this evidence. I know, walking is not always easy for people with severe LBP, but it seems effective and it is safe, free and available to everyone.
My advice to patients is therefore to walk (slowly and cautiously) to the office of their preferred therapist, have a little rest there (say hello to the staff perhaps) and then walk straight back home.
Lock 10 bright people into a room and tell them they will not be let out until they come up with the silliest idea in healthcare. It is not unlikely, I think, that they might come up with the concept of visceral osteopathy.
In case you wonder what visceral osteopathy (or visceral manipulation) is, one ‘expert’ explains it neatly: Visceral Osteopathy is an expansion of the general principles of osteopathy which includes a special understanding of the organs, blood vessels and nerves of the body (the viscera). Visceral Osteopathy relieves imbalances and restrictions in the interconnections between the motions of all the organs and structures of the body. Jean-Piere Barral RPT, DO built on the principles of Andrew Taylor Still DO and William Garner Sutherland DO, to create this method of detailed assessment and highly specific manipulation. Those who wish to practice Visceral Osteopathy train intensively through a series of post-graduate studies. The ability to address the specific visceral causes of somatic dysfunction allows the practitioner to address such conditions as gastroesophageal reflux disease (GERD), irritable bowel (IBS), and even infertility caused by mechanical restriction.
But, as I have pointed out many times before, the fact that a treatment is based on erroneous assumptions does not necessarily mean that it does not work. What we need to decide is evidence. And here we are lucky; a recent paper provides just that.
The purpose of this systematic review was to identify and critically appraise the scientific literature concerning the reliability of diagnosis and the clinical efficacy of techniques used in visceral osteopathy.
Only inter-rater reliability studies including at least two raters or the intra-rater reliability studies including at least two assessments by the same rater were included. For efficacy studies, only randomized-controlled-trials (RCT) or crossover studies on unhealthy subjects (any condition, duration and outcome) were included. Risk of bias was determined using a modified version of the quality appraisal tool for studies of diagnostic reliability (QAREL) in reliability studies. For the efficacy studies, the Cochrane risk of bias tool was used to assess their methodological design. Two authors performed data extraction and analysis.
Extensive searches located 8 reliability studies and 6 efficacy trials that could be included in this review. The analysis of reliability studies showed that the diagnostic techniques used in visceral osteopathy are unreliable. Regarding efficacy studies, the least biased study showed no significant difference for the main outcome. The main risks of bias found in the included studies were due to the absence of blinding of the examiners, an unsuitable statistical method or an absence of primary study outcome.
The authors (who by the way declared no conflicts of interest) concluded that the results of the systematic review lead us to conclude that well-conducted and sound evidence on the reliability and the efficacy of techniques in visceral osteopathy is absent.
It is hard not to appreciate the scientific rigor of this review or to agree with the conclusions drawn by the French authors.
But what consequences should we draw from all this?
The authors of this paper state that more and better research is needed. Somehow, I doubt this. Visceral osteopathy is not plausible and the best evidence available to date does not show it works. In my view, this means that we should declare it an obsolete aberration of medical history.
To this, the proponents of visceral osteopathy will probably say that they have tons of experience and have witnessed wonderful cures etc. This I do not doubt; however, the things they saw were not due to the effects of visceral osteopathy, they were due to chance, placebo, regression towards the mean, the natural history of the diseases treated etc., etc. And sometimes, experience is nothing more that the ability to repeat a mistake over and over again.
- If it looks like a placebo,
- if it behaves like a placebo,
- if it tests like a placebo,
IT MOST LIKELY IS A PLACEBO!!!
And what is wrong with a placebo, if it helps patients?
GIVE ME A BREAK!
WE HAVE ALREADY DISCUSSED THIS AD NAUSEAM. JUST READ SOME OF THE PREVIOUS POSTS ON THIS SUBJECT.
The chiropractor Oakley Smith had graduated under D D Palmer in 1899. Smith was a former Iowa medical student who also had investigated Andrew Still’s osteopathy in Kirksville, before going to Palmer in Davenport. Eventually, Smith came to reject the Palmer concept of vertebral subluxation and developed his own concept of “the connective tissue doctrine” or naprapathy. Today, naprapathy is a popular form of manual therapy, particularly in Scandinavia and the US.
But what exactly is naprapathy? This website explains it quite well: Naprapathy is defined as a system of specific examination, diagnostics, manual treatment and rehabilitation of pain and dysfunction in the neuromusculoskeletal system. The therapy is aimed at restoring function through treatment of the connective tissue, muscle- and neural tissues within or surrounding the spine and other joints. Naprapathic treatment consists of combinations of manual techniques for instance spinal manipulation and mobilization, neural mobilization and Naprapathic soft tissue techniques, in additional to the manual techniques Naprapaths uses different types of electrotherapy, such as ultrasound, radial shockwave therapy and TENS. The manual techniques are often combined with advice regarding physical activity and ergonomics as well as medical rehabilitation training in order to decrease pain and disability and increase work ability and quality of life. A Dr. of Naprapathy is specialized in the diagnosis of structural and functional neuromusculoskeletal disorders, treatment and rehabilitation of patients with problems of such origin as well as to differentiate pain of other origin.
DOCTOR OF NAPRAPATHY? I hear you shout.
Yes, in the US, the title exists: The National College of Naprapathic Medicine is chartered by the State of Illinois and recognized by the State Board of Higher Education to grant the degree, Doctor of Naprapathy (D.N.). Graduates of the College are eligible to take the Naprapathic Medicine examination for licensure in the State of Illinois. The D.N. Degree requires:
- 66 hours – Basic Sciences
- 64 hours – Naprapathic Sciences
- 60 hours – Clinical Internship
Things become even stranger when we ask, what does the evidence show?
I found all of three clinical trials on Medline.
A 2016 clinical trial was designed to compare the treatment effect on pain intensity, pain related disability and perceived recovery from a) naprapathic manual therapy (spinal manipulation, spinal mobilization, stretching and massage) to b) naprapathic manual therapy without spinal manipulation and to c) naprapathic manual therapy without stretching for male and female patients seeking care for back and/or neck pain.
Participants were recruited among patients, ages 18-65, seeking care at the educational clinic of Naprapathögskolan – the Scandinavian College of Naprapathic Manual Medicine in Stockholm. The patients (n = 1057) were randomized to one of three treatment arms a) manual therapy (i.e. spinal manipulation, spinal mobilization, stretching and massage), b) manual therapy excluding spinal manipulation and c) manual therapy excluding stretching. The primary outcomes were minimal clinically important improvement in pain intensity and pain related disability. Treatments were provided by naprapath students in the seventh semester of eight total semesters. Generalized estimating equations and logistic regression were used to examine the association between the treatments and the outcomes.
At 12 weeks follow-up, 64% had a minimal clinically important improvement in pain intensity and 42% in pain related disability. The corresponding chances to be improved at the 52 weeks follow-up were 58% and 40% respectively. No systematic differences in effect when excluding spinal manipulation and stretching respectively from the treatment were found over 1 year follow-up, concerning minimal clinically important improvement in pain intensity (p = 0.41) and pain related disability (p = 0.85) and perceived recovery (p = 0.98). Neither were there disparities in effect when male and female patients were analyzed separately.
The authors concluded that the effect of manual therapy for male and female patients seeking care for neck and/or back pain at an educational clinic is similar regardless if spinal manipulation or if stretching is excluded from the treatment option.
Even though this study is touted as showing that naprapathy works by advocates, in all honesty, it tells us as good as nothing about the effect of naprapathy. The data are completely consistent with the interpretation that all of the outcomes were to the natural history of the conditions, regression towards the mean, placebo, etc. and entirely unrelated to any specific effects of naprapathy.
A 2010 study by the same group was to compare the long-term effects (up to one year) of naprapathic manual therapy and evidence-based advice on staying active regarding non-specific back and/or neck pain.
Subjects with non-specific pain/disability in the back and/or neck lasting for at least two weeks (n = 409), recruited at public companies in Sweden, were included in this pragmatic randomized controlled trial. The two interventions compared were naprapathic manual therapy such as spinal manipulation/mobilization, massage and stretching, (Index Group), and advice to stay active and on how to cope with pain, provided by a physician (Control Group). Pain intensity, disability and health status were measured by questionnaires.
89% completed the 26-week follow-up and 85% the 52-week follow-up. A higher proportion in the Index Group had a clinically important decrease in pain (risk difference (RD) = 21%, 95% CI: 10-30) and disability (RD = 11%, 95% CI: 4-22) at 26-week, as well as at 52-week follow-ups (pain: RD = 17%, 95% CI: 7-27 and disability: RD = 17%, 95% CI: 5-28). The differences between the groups in pain and disability considered over one year were statistically significant favoring naprapathy (p < or = 0.005). There were also significant differences in improvement in bodily pain and social function (subscales of SF-36 health status) favoring the Index Group.
The authors concluded that combined manual therapy, like naprapathy, is effective in the short and in the long term, and might be considered for patients with non-specific back and/or neck pain.
This study is hardly impressive either. The results are consistent with the interpretation that the extra attention and care given to the index group was the cause of the observed outcomes, unrelated to ant specific effects of naprapathy.
The last study was published in 2017 again by the same group. It was designed to compare naprapathic manual therapy with evidence-based care for back or neck pain regarding pain, disability, and perceived recovery.
Four hundred and nine patients with pain and disability in the back or neck lasting for at least 2 weeks, recruited at 2 large public companies in Sweden in 2005, were included in this randomized controlled trial. The 2 interventions were naprapathy, including spinal manipulation/mobilization, massage, and stretching (Index Group) and support and advice to stay active and how to cope with pain, according to the best scientific evidence available, provided by a physician (Control Group). Pain, disability, and perceived recovery were measured by questionnaires at baseline and after 3, 7, and 12 weeks.
At 7-week and 12-week follow-ups, statistically significant differences between the groups were found in all outcomes favoring the Index Group. At 12-week follow-up, a higher proportion in the naprapathy group had improved regarding pain [risk difference (RD)=27%, 95% confidence interval (CI): 17-37], disability (RD=18%, 95% CI: 7-28), and perceived recovery (RD=44%, 95% CI: 35-53). Separate analysis of neck pain and back pain patients showed similar results.
The authors thought that this trial suggests that combined manual therapy, like naprapathy, might be an alternative to consider for back and neck pain patients.
As the study suffers from the same limitations as the one above (in fact, it might be a different analysis of the same trial), they might be mistaken. I see no good reason to assume that any of the three studies provide good evidence for the effectiveness of naprapathy.
So, what should we conclude from all this?
If you ask me, naprapathy is something between chiropractic (without some of the woo) and physiotherapy (without its expertise). There is no good evidence that it works. Crucially, there is no evidence that it is superior to other therapeutic options.
I was going to finish on a positive note stating that ‘at least the ‘naprapathologists’ (I refuse to even consider the title of ‘doctor of naprapathy’) do not claim to treat conditions other than musculoskeletal problems’. But then I found this advertisement of a ‘naprapathologist’ on Twitter:
And now, I am going to finish by stating that A LOT OF NAPRAPATHY LOOKS VERY MUCH LIKE QUACKERY TO ME.
Cranio-sacral therapy is firstly implausible, and secondly it lacks evidence of effectiveness (see for instance here, here, here and here). Yet, some researchers are nevertheless not deterred to test it in clinical trials. While this fact alone might be seen as embarrassing, the study below is a particular and personal embarrassment to me, in fact, I am shocked by it and write these lines with considerable regret.
Why? Bear with me, I will explain later.
The purpose of this trial was to evaluate the effectiveness of osteopathic manipulative treatment and osteopathy in the cranial field in temporomandibular disorders. Forty female subjects with temporomandibular disorders lasting at least three months were included. At enrollment, subjects were randomly assigned into two groups: (1) osteopathic manipulative treatment group (n=20) and (2) osteopathy in the cranial field [craniosacral therapy for you and me] group (n=20). Examinations were performed at baseline (E0) and at the end of the last treatment (E1), and consisted of subjective pain intensity with the Visual Analog Scale, Helkimo Index and SF-36 Health Survey. Subjects had five treatments, once a week. 36 subjects completed the study.
Patients in both groups showed significant reduction in Visual Analog Scale score (osteopathic manipulative treatment group: p = 0.001; osteopathy in the cranial field group: p< 0.001), Helkimo Index (osteopathic manipulative treatment group: p = 0.02; osteopathy in the cranial field group: p = 0.003) and a significant improvement in the SF-36 Health Survey – subscale “Bodily Pain” (osteopathic manipulative treatment group: p = 0.04; osteopathy in the cranial field group: p = 0.007) after five treatments (E1). All subjects (n = 36) also showed significant improvements in the above named parameters after five treatments (E1): Visual Analog Scale score (p< 0.001), Helkimo Index (p< 0.001), SF-36 Health Survey – subscale “Bodily Pain” (p = 0.001). The differences between the two groups were not statistically significant for any of the three endpoints.
The authors concluded that both therapeutic modalities had similar clinical results. The findings of this pilot trial support the use of osteopathic manipulative treatment and osteopathy in the cranial field as an effective treatment modality in patients with temporomandibular disorders. The positive results in both treatment groups should encourage further research on osteopathic manipulative treatment and osteopathy in the cranial field and support the importance of an interdisciplinary collaboration in patients with temporomandibular disorders. Implications for rehabilitation Temporomandibular disorders are the second most prevalent musculoskeletal condition with a negative impact on physical and psychological factors. There are a variety of options to treat temporomandibular disorders. This pilot study demonstrates the reduction of pain, the improvement of temporomandibular joint dysfunction and the positive impact on quality of life after osteopathic manipulative treatment and osteopathy in the cranial field. Our findings support the use of osteopathic manipulative treatment and osteopathy in the cranial field and should encourage further research on osteopathic manipulative treatment and osteopathy in the cranial field in patients with temporomandibular disorders. Rehabilitation experts should consider osteopathic manipulative treatment and osteopathy in the cranial field as a beneficial treatment option for temporomandibular disorders.
This study has so many flaws that I don’t know where to begin. Here are some of the more obvious ones:
- There is, as already mentioned, no rationale for this study. I can see no reason why craniosacral therapy should work for the condition. Without such a rationale, the study should never even have been conceived.
- Technically, this RCTs an equivalence study comparing one therapy against another. As such it needs to be much larger to generate a meaningful result and it also would require a different statistical approach.
- The authors mislabelled their trial a ‘pilot study’. However, a pilot study “is a preliminary small-scale study that researchers conduct in order to help them decide how best to conduct a large-scale research project. Using a pilot study, a researcher can identify or refine a research question, figure out what methods are best for pursuing it, and estimate how much time and resources will be necessary to complete the larger version, among other things.” It is not normally a study suited for evaluating the effectiveness of a therapy.
- Any trial that compares one therapy of unknown effectiveness to another of unknown effectiveness is a complete and utter nonsense. Equivalent studies can only ever make sense, if one of the two treatments is of proven effectiveness – think of it as a mathematical equation: one equation with two unknowns is unsolvable.
- Controlled studies such as RCTs are for comparing the outcomes of two or more groups, and only between-group differences are meaningful results of such trials.
- The ‘positive results’ which the authors mention in their conclusions are meaningless because they are based on such within-group changes and nobody can know what caused them: the natural history of the condition, regression towards the mean, placebo-effects, or other non-specific effects – take your pick.
- The conclusions are a bonanza of nonsensical platitudes and misleading claims which do not follow from the data.
As regular readers of this blog will doubtlessly have noticed, I have seen plenty of similarly flawed pseudo-research before – so, why does this paper upset me so much? The reason is personal, I am afraid: even though I do not know any of the authors in person, I know their institution more than well. The study comes from the Department of Physical Medicine and Rehabilitation, Medical University of Vienna, Austria. I was head of this department before I left in 1993 to take up the Exeter post. And I had hoped that, even after 25 years, a bit of the spirit, attitude, knowhow, critical thinking and scientific rigor – all of which I tried so hard to implant in my Viennese department at the time – would have survived.
Perhaps I was wrong.