The aim of this RCT was to investigate the effects of an osteopathic manipulative treatment (OMT) which includes a diaphragm intervention compared to the same OMT with a sham diaphragm intervention in chronic non-specific low back pain (NS-CLBP).
Participants (N=66) with a diagnosis of NS-CLBP lasting at least 3 months were randomized to receive either an OMT protocol including specific diaphragm techniques (n=33) or the same OMT protocol with a sham diaphragm intervention (n=33), conducted in 5 sessions provided during 4 weeks.
The primary outcomes were pain (evaluated with the Short-Form McGill Pain Questionnaire [SF-MPQ] and the visual analog scale [VAS]) and disability (assessed with the Roland-Morris Questionnaire [RMQ] and the Oswestry Disability Index [ODI]). Secondary outcomes were fear-avoidance beliefs, level of anxiety and depression, and pain catastrophization. All outcome measures were evaluated at baseline, at week 4, and at week 12.
A statistically significant reduction was observed in the experimental group compared to the sham group in all variables assessed at week 4 and at week 12. Moreover, improvements in pain and disability were clinically relevant.
The authors concluded that an OMT protocol that includes diaphragm techniques produces significant and clinically relevant improvements in pain and disability in patients with NS-CLBP compared to the same OMT protocol using sham diaphragm techniques.
This seems to be a rigorous study. The authors describe in detail their well-standardised interventions in the full text of their paper. This, of course, will be essential, if someone wants to repeat the trial.
I have but a few points to add:
- What I fail to understand is this: why the authors call the interventions osteopathic? The therapist was a physiotherapist and the techniques employed are, if I am not mistaken, as much physiotherapeutic as osteopathic.
- The findings of this trial are encouraging but almost seem a little too good to be true. They need, of course, to be independently replicated in a larger study.
- If that is done, I would suggest to check whether the blinding of the patient was successful. If not, there is a suspicion that the diaphragm technique works partly or mostly via a placebo effect.
- I would also try to make sure that the therapist cannot influence the results in any way, for instance, by verbal or non-verbal suggestions.
- Finally, I suggest to employ more than one therapist to increase generalisability.
Once all these hurdles are taken, we might indeed have made some significant progress in the manual therapy of NS-CLBP.
Proof of Principle or Concept studies are investigations usually for an early stage of clinical drug development when a compound has shown potential in animal models and early safety testing. This step often links between Phase-I and dose ranging Phase-II studies. These small-scale studies are designed to detect a signal that the drug is active on a patho-physiologically relevant mechanism, as well as preliminary evidence of efficacy in a clinically relevant endpoint.
For therapies that have been in use for many years, proof of concept studies are unusual to say the least. A proof of concept study of osteopathy has never been heard of. This is why I was fascinated by this new paper. The objective of this ‘proof of concept’ study was to evaluate the effect of osteopathic manipulative therapy (OMTh) on chronic symptoms of multiple sclerosis (MS).
Patients (n=22) with MS received 5 forty-minute MS health education sessions (control group) or 5 OMTh sessions (OMTh group). All participants completed a questionnaire that assessed their level of clinical disability, fatigue, depression, anxiety, and quality of life before the first session, one week after the final session, and 6 months after the final session. The Extended Disability Status Scale, a modified Fatigue Impact Scale, the Beck Depression Inventory-II, the Beck Anxiety Inventory, and the 12-item Short Form Health Survey were used to assess clinical disability, fatigue, depression, anxiety, and quality of life, respectively. In the OMTh group, statistically significant improvements in fatigue and depression were found one week after the final session. A non-significant increase in quality of life was also found in the OMTh group one week after the final session.
The authors concluded that the results demonstrate that OMTh should be considered in the treatment of patients with chronic symptoms of MS.
Who said that reading alternative medicine research papers is not funny? I for one laughed heartily when I read this (no need at all to go into the many obvious flaws of the study). Calling a pilot study ‘proof of concept’ is certainly not without hilarity. Drawing definitive conclusions about the effectiveness of OMTh is outright laughable. But issuing a far-reaching recommendation for use of OMTh in MS is just better than the best comedy. This had me in stiches!
I congratulate the Journal of the American Osteopathic Association and the international team of authors for providing us with such fun.
Osteopathy is a form of manual therapy invented by the American Andrew Taylor Still (1828-1917). Today, US osteopaths (doctors of osteopathy or DOs) practise no or little manual therapy; they are fully recognised as medical doctors who can specialise in any medical field after their training which is almost identical with that of MDs. Outside the US, osteopaths practice almost exclusively manual treatments and are considered alternative practitioners. This post deals with the latter category of osteopaths.
Still defined his original osteopathy as a science which consists of such exact, exhaustive, and verifiable knowledge of the structure and function of the human mechanism, anatomical, physiological and psychological, including the chemistry and physics of its known elements, as has made discoverable certain organic laws and remedial resources, within the body itself, by which nature under the scientific treatment peculiar to osteopathic practice, apart from all ordinary methods of extraneous, artificial, or medicinal stimulation, and in harmonious accord with its own mechanical principles, molecular activities, and metabolic processes, may recover from displacements, disorganizations, derangements, and consequent disease, and regained its normal equilibrium of form and function in health and strength.
Based on such vague and largely nonsensical statements, traditional osteopaths feel entitled to offer treatments for most human diseases, conditions and symptoms. The studies they produce to back up their claims tend to be as poor as Still’s original assumptions were fantastic.
Here is an apt example:
The aim of this new study was to study the effect of osteopathic manipulation on pain relief and quality of life improvement in hospitalized oncology geriatric patients.
The researchers conducted a non-randomized controlled clinical trial with 23 cancer patients. They were allocated to two groups: the study group (OMT [osteopathic manipulative therapy] group, N = 12) underwent OMT in addition to physiotherapy (PT), while the control group (PT group, N = 12) underwent only PT. Included were postsurgical cancer patients, male and female, age ⩾65 years, with an oncology prognosis of 6 to 24 months and chronic pain for at least 3 months with an intensity score higher than 3, measured with the Numeric Rating Scale. Exclusion criteria were patients receiving chemotherapy or radiotherapy treatment at the time of the study, with mental disorders (Mini-Mental State Examination [MMSE] = 10-20), with infection, anticoagulation therapy, cardiopulmonary disease, or clinical instability post-surgery. Oncology patients were admitted for rehabilitation after cancer surgery. The main cancers were colorectal cancer, osteosarcoma, spinal metastasis from breast and prostatic cancer, and kidney cancer.
The OMT, based on osteopathic principles of body unit, structure-function relationship, and homeostasis, was designed for each patient on the basis of the results of the osteopathic examination. Diagnosis and treatment were founded on 5 models: biomechanics, neurologic, metabolic, respiratory-circulatory, and behaviour. The OMT protocol was administered by an osteopath with clinical experience of 10 years in one-on-one individual sessions. The techniques used were: dorsal and lumbar soft tissue, rib raising, back and abdominal myofascial release, cervical spine soft tissue, sub-occipital decompression, and sacroiliac myofascial release. Back and abdominal myofascial release techniques are used to improve back movement and internal abdominal pressure. Sub-occipital decompression involves traction at the base of the skull, which is considered to release restrictions around the vagus nerve, theoretically improving nerve function. Sacroiliac myofascial release is used to improve sacroiliac joint movement and to reduce ligament tension. Strain-counter-strain and muscle energy technique are used to diminish the presence of trigger points and their pain intensity. OMT was repeated once every week during 4 weeks for each group, for a total of 4 treatments. Each treatment lasted 45 minutes.
At enrolment (T0), the patients were evaluated for pain intensity and quality of life by an external examiner. All patients were re-evaluated every week (T1, T2, T3, and T4) for pain intensity, and at the end of the study treatment (T4) for quality of life.
The OMT added to physiotherapy produced a significant reduction in pain both at T2 and T4. The difference in quality of life improvements between T0 and T4 was not statistically significant. Pain improved in the PT group at T4. Between-group analysis of pain and quality of life did not show any significant difference between the two treatments.
The authors concluded that our study showed a significant improvement in pain relief and a nonsignificant improvement in quality of life in hospitalized geriatric oncology patients during osteopathic manipulative treatment.
Where to begin?
Even if there had been a difference in outcome between the two groups, such a finding would not have shown an effect of OMT per se. More likely, it would have been due to the extra attention and the expectation in the OMT group (or caused by the lack of randomisation). The A+B vs B design used for this study does not control for non-specific effects. Therefore it is incapable of establishing a causal relationship between the therapy and the outcome.
As it turns out, there were no inter-group differences. How can this be? I have often stated that A+B is always more than B alone. And this is surely true!
So, how can I explain this?
As far as I can see, there are two possibilities:
- The study was underpowered, and thus an existing difference was not picked up.
- The OMT had a detrimental effect on the outcome measures thus neutralising the positive effects of the extra attention and expectation.
And which possibility does apply in this case?
Nobody can know from these data.
Integrative Cancer Therapies, the journal that published this paper, states that it focuses on a new and growing movement in cancer treatment. The journal emphasizes scientific understanding of alternative and traditional medicine therapies, and the responsible integration of both with conventional health care. Integrative care includes therapeutic interventions in diet, lifestyle, exercise, stress care, and nutritional supplements, as well as experimental vaccines, chrono-chemotherapy, and other advanced treatments. I feel that the editors should rather focus more on the quality of the science they publish.
My conclusion from all this is the one I draw so depressingly often: fatally flawed science is not just useless, it is unethical, gives clinical research a bad name, hinders progress, and can be harmful to patients.
The Royal College of Chiropractors (RCC), a Company Limited by guarantee, was given a royal charter in 2013. It has following objectives:
- to promote the art, science and practice of chiropractic;
- to improve and maintain standards in the practice of chiropractic for the benefit of the public;
- to promote awareness and understanding of chiropractic amongst medical practitioners and other healthcare professionals and the public;
- to educate and train practitioners in the art, science and practice of chiropractic;
- to advance the study of and research in chiropractic.
In a previous post, I pointed out that the RCC may not currently have the expertise and know-how to meet all these aims. To support the RCC in their praiseworthy endeavours, I therefore offered to give one or more evidence-based lectures on these subjects free of charge.
And what was the reaction?
This might be disappointing, but it is not really surprising. Following the loss of almost all chiropractic credibility after the BCA/Simon Singh libel case, the RCC must now be busy focussing on re-inventing the chiropractic profession. A recent article published by RCC seems to confirm this suspicion. It starts by defining chiropractic:
“Chiropractic, as practised in the UK, is not a treatment but a statutorily-regulated healthcare profession.”
Obviously, this definition reflects the wish of this profession to re-invent themselves. D. D. Palmer, who invented chiropractic 120 years ago, would probably not agree with this definition. He wrote in 1897 “CHIROPRACTIC IS A SCIENCE OF HEALING WITHOUT DRUGS”. This is woolly to the extreme, but it makes one thing fairly clear: chiropractic is a therapy and not a profession.
So, why do chiropractors wish to alter this dictum by their founding father? The answer is, I think, clear from the rest of the above RCC-quote: “Chiropractors offer a wide range of interventions including, but not limited to, manual therapy (soft-tissue techniques, mobilisation and spinal manipulation), exercise rehabilitation and self-management advice, and utilise psychologically-informed programmes of care. Chiropractic, like other healthcare professions, is informed by the evidence base and develops accordingly.”
Many chiropractors have finally understood that spinal manipulation, the undisputed hallmark intervention of chiropractors, is not quite what Palmer made it out to be. Thus, they try their utmost to style themselves as back specialists who use all sorts of (mostly physiotherapeutic) therapies in addition to spinal manipulation. This strategy has obvious advantages: as soon as someone points out that spinal manipulations might not do more good than harm, they can claim that manipulations are by no means their only tool. This clever trick renders them immune to such criticism, they hope.
The RCC-document has another section that I find revealing, as it harps back to what we just discussed. It is entitled ‘The evidence base for musculoskeletal care‘. Let me quote it in its entirety:
The evidence base for the care chiropractors provide (Clar et al, 2014) is common to that for physiotherapists and osteopaths in respect of musculoskeletal (MSK) conditions. Thus, like physiotherapists and osteopaths, chiropractors provide care for a wide range of MSK problems, and may advertise that they do so [as determined by the UK Advertising Standards Authority (ASA)].
Chiropractors are most closely associated with management of low back pain, and the NICE Low Back Pain and Sciatica Guideline ‘NG59’ provides clear recommendations for managing low back pain with or without sciatica, which always includes exercise and may include manual therapy (spinal manipulation, mobilisation or soft tissue techniques such as massage) as part of a treatment package, with or without psychological therapy. Note that NG59 does not specify chiropractic care, physiotherapy care nor osteopathy care for the non-invasive management of low back pain, but explains that: ‘mobilisation and soft tissue techniques are performed by a wide variety of practitioners; whereas spinal manipulation is usually performed by chiropractors or osteopaths, and by doctors or physiotherapists who have undergone additional training in manipulation’ (See NICE NG59, p806).
The Manipulative Association of Chartered Physiotherapists (MACP), recently renamed the Musculoskeletal Association of Chartered Physiotherapists, is recognised as the UK’s specialist manipulative therapy group by the International Federation of Orthopaedic Manipulative Physical Therapists, and has approximately 1100 members. The UK statutory Osteopathic Register lists approximately 5300 osteopaths. Thus, collectively, there are approximately twice as many osteopaths and manipulating physiotherapists as there are chiropractors currently practising spinal manipulation in the UK.
END OF QUOTE
To me this sounds almost as though the RCC is saying something like this:
- We are very much like physiotherapists and therefore all the positive evidence for physiotherapy is really also our evidence. So, critics of chiropractic’s lack of sound evidence-base, get lost!
- The new NICE guidelines were a real blow to us, but we now try to spin them such that consumers don’t realise that chiropractic is no longer recommended as a first-line therapy.
- In any case, other professions also occasionally use those questionable spinal manipulations (and they are even more numerous). So, any criticism of spinal manipulation should not be directed at us but at physios and osteopaths.
- We know, of course, that chiropractors treat lots of non-spinal conditions (asthma, bed-wetting, infant colic etc.). Yet we try our very best to hide this fact and pretend that we are all focussed on back pain. This avoids admitting that, for all such conditions, the evidence suggests our manipulations to be worst than useless.
Personally, I find the RCC-strategy very understandable; after all, the RCC has to try to save the bacon for UK chiropractors. Yet, it is nevertheless an attempt at misleading the public about what is really going on. And even, if someone is sufficiently naïve to swallow this spin, one question emerges loud and clear: if chiropractic is just a limited version of physiotherapy, why don’t we simply use physiotherapists for back problems and forget about chiropractors?
(In case the RCC change their mind and want to listen to me elaborating on these themes, my offer for a free lecture still stands!)
Alternative practitioners practise highly diverse therapies. They seem to have nothing in common – except perhaps that ALL of them are allegedly stimulating our self-healing powers (and except that most proponents are latently or openly against vaccinations). And it is through these self-healing powers that the treatments in question cure anything and become a true panacea. When questioned what these incredible powers really are, most practitioners would (somewhat vaguely) name the immune system as the responsible mechanism. With this post, I intend to provide a short summary of the evidence on this issue:
Acupuncture: no good evidence to show stimulation of self-healing powers.
Aromatherapy: no good evidence to show stimulation of self-healing powers.
Bioresonance: no good evidence to show stimulation of self-healing powers.
Chiropractic: no good evidence to show stimulation of self-healing powers.
Detox: no good evidence to show stimulation of self-healing powers.
Energy healing: no good evidence to show stimulation of self-healing powers.
Feldenkrais: no good evidence to show stimulation of self-healing powers.
Gua sha: no good evidence to show stimulation of self-healing powers.
Herbal medicine: no good evidence to show stimulation of self-healing powers.
Homeopathy: no good evidence to show stimulation of self-healing powers.
Macrobiotics: no good evidence to show stimulation of self-healing powers.
Naturopathy: no good evidence to show stimulation of self-healing powers.
Osteopathy: no good evidence to show stimulation of self-healing powers.
Power bands: no good evidence to show stimulation of self-healing powers.
Reiki: no good evidence to show stimulation of self-healing powers.
Reflexology: no good evidence to show stimulation of self-healing powers.
Shiatsu: no good evidence to show stimulation of self-healing powers.
Tai chi: no good evidence to show stimulation of self-healing powers.
TCM: no good evidence to show stimulation of self-healing powers.
Vibrational therapy: no good evidence to show stimulation of self-healing powers.
Vaccinations: very good evidence to show stimulation of self-healing powers.
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.
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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…
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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!