MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

physiotherapists

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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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.

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.

GOOD GRIEF!

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:

  1. The study was underpowered, and thus an existing difference was not picked up.
  2. 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.

“Physiotherapy generally offers a highly science based approach to clinical practice.” This was a recent comment by someone (I presume a physiotherapist) on this blog. It got me thinking – is it true or false? I am in no position to review the entire field of physiotherapy in a blog post. What I will do instead, is list a few alternative therapies often used by physiotherapists.

  1. Acupuncture: many physiotherapists seem to love acupuncture. In the UK, for example, they have their own organisations. The AACP is the largest professional body for acupuncture in the UK with a membership of around 6000 chartered physiotherapists, practising medical acupuncture. They state that there is an increasing number of research publications in the UK and worldwide proving the treatment effectiveness of acupuncture when compared to (chemical) medication for example.
  2. Applied kinesiology: some physiotherapists offer applied kinesiology. This clinic, for instance, states that applied Kinesiology combines a system of muscle tests with acupuncture, reflex points emotion and nutrition to find any imbalances present in the whole person.
  3. Bowen technique: many physiotherapists use the Bowen technique. This practice advertises it as follows. If you’re looking for a way to treat tightness in your upper back, neck or shoulders or are suffering from respiratory pain or headaches, The Bowen Technique could be the answer you’re searching for. Achieving all these things as well as being a great way to treat sports injuries and enhance sporting performance, this therapy also promotes emotional wellbeing. A non-invasive therapy, it is equally suited for the treatment of acute (short-term) and chronic (long-term) conditions.
  4. Craniosacral therapy: some physios also employ craniosacral therapy. Here is an example. Craniosacral therapy as experienced by thousands of babies and people all around the country, has a proven track record at easing and relieving what makes babies upset. If your baby suffers from:
    • Colic
    • Wind
    • Digestive issues
    • Reflux
    • Unsettledness
    • Sleep problems
    • Ongoing crying
    • Difficulty with breast feeding/latch/suck
    • Other problems

    then call…

  5. Cupping: One physio writes this about cupping. It was good to see the public (Western cultures) exposed more to cupping therapy practice thanks to the recent Olympics in Rio 2016. Last Olympics in London 2012,  the Chinese and Japanese Athletes, amongst neighbouring nations, were readily seen to use and advocate the practice, along with the approval no doubt of their large team of Medical and Physiotherapy related support staff. This time however it has bridged to divide to Western World Athletes, such as Michael Phelps (he of 23 Olympic Golds fame). This advocacy of the practice and again the presumed support from his Medical and Sports science entourage with team USA, is a good barometer of the progress and acceptance within Western Medicine, for Cupping Therapy.
  6. Massage therapy: in many countries, massage and related techniques therapy always have been an integral part of physiotherapy.
  7. Feldenkrais method: The same applies to The Feldenkrais Method® is based on principles of physics, biomechanics, neuroscience, and the study of human motor development. Feldenkrais recognized the capability of the human brain to learn and relearn at any age – neuroplasticity. The method utilizes slow, gentle movements, and awareness of subtle differences to optimize learning, improve movement, and make changes in the brain.
  8. Kinesiology tape: If you have suffered an injury or illness that causes a problem with your functional mobility or normal activity, you may benefit from the skilled services of a physical therapist to help you return to your previous level of mobility.  Your physical therapist may use various exercises and modalities to help treat your specific problem.
  9. Reflexology: Here is what the UK Chartered Society of Physiotherapists writes about reflexology: Developed centuries ago in countries such as China, Egypt and India, reflexology is often referred to as a ‘gentle’ and ‘holistic’ therapy that benefits both mind and body. It centres on the feet because these are said by practitioners to be a mirror, or topographical map, for the rest of the body. Manipulation of certain pressure, or reflex, points is claimed to have an effect on corresponding zones in the body. The impact, say reflexologists, extends throughout – to bones, muscles, organs, glands, circulatory and neural pathways. The head and hands can also be massaged in some cases. The treatment is perhaps best known for use in connection with relaxation and relief from stress, anxiety, pain, sleep disorders, headaches, migraine, menstrual and digestive problems. But advocates say it can be used to great effect far more widely, often in conjunction with other treatments…
  10. Spinal manipulation: Physiotherapists learn spinal manipulation as part of continuing education courses in Canada. The Orthopaedic Division of the Canadian Physiotherapy Association is responsible for the standards of education and supervises exams required to meet the standards of the International Federation of Manipulative Physiotherapists (IFOMPT). In many other countries, the situation is similar.

These 10 therapies have all been discussed on this blog before. They lack

  • plausibility or
  • proof of efficacy or
  • proof of safety or
  • all of the above

In other words, they are NOT highly science-based.

QED

Kinesiology tape KT is fashionable, it seems. Gullible consumers proudly wear it as decorative ornaments to attract attention and show how very cool they are.

Am I too cynical?

Perhaps.

But does KT really do anything more?

A new trial might tell us.

The aim of this study was to investigate whether adding kinesiology tape (KT) to spinal manipulation (SM) can provide any extra effect in athletes with chronic non-specific low back pain (CNLBP).

Forty-two athletes (21males, 21females) with CNLBP were randomized into two groups of SM (n = 21) and SM plus KT (n = 21). Pain intensity, functional disability level and trunk flexor-extensor muscles endurance were assessed by Numerical Rating Scale (NRS), Oswestry pain and disability index (ODI), McQuade test, and unsupported trunk holding test, respectively. The tests were done before and immediately, one day, one week, and one month after the interventions and compared between the two groups.

After treatments, pain intensity and disability level decreased and endurance of trunk flexor-extensor muscles increased significantly in both groups. Repeated measures analysis, however, showed that there was no significant difference between the groups in any of the evaluations.

The authors, physiotherapists from Iran, concluded that the findings of the present study showed that adding KT to SM does not appear to have a significant extra effect on pain, disability and muscle endurance in athletes with CNLBP. However, more studies are needed to examine the therapeutic effects of KT in treating these patients.

Regular readers of my blog will be able to predict what I have to say about this study design: A+B versus B is not a meaningful test of anything. I used to claim that it cannot possibly produce a negative result – and yet, here it seems to have done exactly that!

How come?

The way I see it, there are two possibilities to explain this:

  • the KT has a mildly negative effect on CNLBP; thus the expected positive placebo-effect was neutralised to result in a null-effect overall;
  • the study was under-powered such that the true inter-group difference could not manifest itself.

I think the second possibility is more likely, but it does really not matter at all. Because the only lesson we can learn from this trial is this: inadequate study designs will  hardly ever generate anything worthwhile.

And this is, I think, a lesson that would be valuable for many researchers.

_______________________________________________________________________

Reference

2018 Apr;22(2):540-545. doi: 10.1016/j.jbmt.2017.07.008. Epub 2017 Jul 26.

Comparing spinal manipulation with and without Kinesio Taping® in the treatment of chronic low back pain.

 

It is no secret to regular readers of this blog that chiropractic’s effectiveness is unproven for every condition it is currently being promoted for – perhaps with two exceptions: neck pain and back pain. Here we have some encouraging data, but also lots of negative evidence. A new US study falls into the latter category; I am sure chiropractors will not like it, but it does deserve a mention.

This study evaluated the comparative effectiveness of usual care with or without chiropractic care for patients with chronic recurrent musculoskeletal back and neck pain. It was designed as a prospective cohort study using propensity score-matched controls.

Using retrospective electronic health record data, the researchers developed a propensity score model predicting likelihood of chiropractic referral. Eligible patients with back or neck pain were then contacted upon referral for chiropractic care and enrolled in a prospective study. For each referred patient, two propensity score-matched non-referred patients were contacted and enrolled. We followed the participants prospectively for 6 months. The main outcomes included pain severity, interference, and symptom bothersomeness. Secondary outcomes included expenditures for pain-related health care.

Both groups’ (N = 70 referred, 139 non-referred) pain scores improved significantly over the first 3 months, with less change between months 3 and 6. No significant between-group difference was observed. After controlling for variances in baseline costs, total costs during the 6-month post-enrollment follow-up were significantly higher on average in the non-referred versus referred group. Adjusting for differences in age, gender, and Charlson comorbidity index attenuated this finding, which was no longer statistically significant (p = .072).

The authors concluded by stating this: we found no statistically significant difference between the two groups in either patient-reported or economic outcomes. As clinical outcomes were similar, and the provision of chiropractic care did not increase costs, making chiropractic services available provided an additional viable option for patients who prefer this type of care, at no additional expense.

This comes from some of the most-renowned experts in back pain research, and it is certainly an elaborate piece of investigation. Yet, I find the conclusions unreasonable.

Essentially, the authors found that chiropractic has no clinical or economical advantage over other approaches currently used for neck and back pain. So, they say that it a ‘viable option’.

I find this odd and cannot quite follow the logic. In my view, it lacks critical thinking and an attempt to produce progress. If it is true that all treatments were similarly (in)effective – which I can well believe – we still should identify those that have the least potential for harm. That could be exercise, massage therapy or some other modality – but I don’t think it would be chiropractic care.


References

Comparative Effectiveness of Usual Care With or Without Chiropractic Care in Patients with Recurrent Musculoskeletal Back and Neck Pain.

Elder C, DeBar L, Ritenbaugh C, Dickerson J, Vollmer WM, Deyo RA, Johnson ES, Haas M.

J Gen Intern Med. 2018 Jun 25. doi: 10.1007/s11606-018-4539-y. [Epub ahead of print]

PMID: 29943109

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?

Nothing!

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:

  1. 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!
  2. 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.
  3. 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.
  4. 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!)

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:

  1. upper spinal manipulations have no or very little proven benefit;
  2. they are associated with a finite risk;
  3. thus, their risk/benefit balance fails to be positive;
  4. 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.

Reiki is a Japanese technique administered by “laying on hands” and is based on the idea that an unseen “life force energy” flows through us and is what causes us to be alive. If one’s “life force energy” is low, then we are more likely to get sick or feel stress, and if it is high, we are more capable of being happy and healthy (because it is such a clear-cut case of nonsense, we have discussed Reiki regularly; see for instance here, here, here, here, here, here, and here).

But nonsense does not stop researchers from conducting trials. In this new clinical trial, conducted in Physiotherapy Clinic of Khatam Al-Anbia Hospital in Iran, 60 patients with pain due to inter-vertebral disc herniation (IVDH) were randomly assigned to one of three groups.

  1. The Reiki group received three 15-minute Reiki sessions on consecutive days by a master of Reiki plus Indomethacin and Methocarbamol (as in group 3).
  2. The physiotherapy group underwent 7 to 10 sessions of physiotherapy of 60 to 90 minutes (heat therapy, TENS, pelvic traction, and physical exercises) plus Indomethacin and Methocarbamol (as in group 3).
  3. The drug group received Indomethacin capsules 75 mg and Methocarbamol tablets 500 mg every 8 hours daily for one week.

The severity of pain and the activities of daily living (ADL) were measured using visual analogue scales (VAS) and ADL-Instrumental ADL questionnaire before and after the intervention. A significant difference was found in pain intensity and ADL improvement between Reiki and the drug therapy. No significant difference between the Reiki and physiotherapy groups were noted.

The authors concluded that Reiki and physiotherapy are effective methods in managing pain and improving ADL in patients with IVDH; however, Reiki is more cost-effective and faster treatment method than physiotherapy.

This RCT seems fairly well-panned and conducted, and its results are straight forward. My only problem with it is how the findings are interpreted.

The study design was such that there was no blinding or control for placebo effects. Therefore, the observed outcomes can be interpreted in more than one way. In my view, by far the most plausible explanation is that Reiki (being an exotic, impressive intervention that generates plenty of expectation) produced a powerful placebo effect. Physiotherapy (being entirely normal and routine), on the other hand, was only marginally successful. It is regrettable that the authors do not even consider this interpretation of their results. They should have remembered that a clinical trial test the null-hypothesis (the experimental treatment is not better that the comparator) which can be rejected only, if there is no other reasonable explanation for the results produced.

If I am correct, the conclusions should be re-written as follows:

The addition of Reiki to drug treatment generated better outcomes than drug therapy alone. Physiotherapy was only marginally effective. The effects of Reiki are most likely not due to the treatment per se but to a classical placebo response.

The media have (rightly) paid much attention to the three Lancet-articles on low back pain (LBP) which were published this week. LBP is such a common condition that its prevalence alone renders it an important subject for us all. One of the three papers covers the treatment and prevention of LBP. Specifically, it lists various therapies according to their effectiveness for both acute and persistent LBP. The authors of the article base their judgements mainly on published guidelines from Denmark, UK and the US; as these guidelines differ, they attempt a synthesis of the three.

Several alternative therapist organisations and individuals have consequently jumped on the LBP  bandwagon and seem to feel encouraged by the attention given to the Lancet-papers to promote their treatments. Others have claimed that my often critical verdicts of alternative therapies for LBP are out of line with this evidence and asked ‘who should we believe the international team of experts writing in one of the best medical journals, or Edzard Ernst writing on his blog?’ They are trying to create a division where none exists,

The thing is that I am broadly in agreement with the evidence presented in Lancet-paper! But I also know that things are a bit more complex.

Below, I have copied the non-pharmacological, non-operative treatments listed in the Lancet-paper together with the authors’ verdicts regarding their effectiveness for both acute and persistent LBP. I find no glaring contradictions with what I regard as the best current evidence and with my posts on the subject. But I feel compelled to point out that the Lancet-paper merely lists the effectiveness of several therapeutic options, and that the value of a treatment is not only determined by its effectiveness. Crucial further elements are a therapy’s cost and its risks, the latter of which also determines the most important criterion: the risk/benefit balance. In my version of the Lancet table, I have therefore added these three variables for non-pharmacological and non-surgical options:

EFFECTIVENESS ACUTE LBP EFFECTIVENESS PERSISTENT LBP RISKS COSTS RISK/BENEFIT BALANCE
Advice to stay active +, routine +, routine None Low Positive
Education +, routine +, routine None Low Positive
Superficial heat +/- Ie Very minor Low to medium Positive (aLBP)
Exercise Limited +/-, routine Very minor Low Positive (pLBP)
CBT Limited +/-, routine None Low to medium Positive (pLBP)
Spinal manipulation +/- +/- vfbmae
sae
High Negative
Massage +/- +/- Very minor High Positive
Acupuncture +/- +/- sae High Questionable
Yoga Ie +/- Minor Medium Questionable
Mindfulness Ie +/- Minor Medium Questionable
Rehab Ie +/- Minor Medium to high Questionable

Routine = consider for routine use

+/- = second line or adjunctive treatment

Ie = insufficient evidence

Limited = limited use in selected patients

vfbmae = very frequent, minor adverse effects

sae = serious adverse effects, including deaths, are on record

aLBP = acute low back pain

The reason why my stance, as expressed on this blog and elsewhere, is often critical about certain alternative therapies is thus obvious and transparent. For none of them (except for massage) is the risk/benefit balance positive. And for spinal manipulation, it even turns out to be negative. It goes almost without saying that responsible advice must be to avoid treatments for which the benefits do not demonstrably outweigh the risks.

I imagine that chiropractors, osteopaths and acupuncturists will strongly disagree with my interpretation of the evidence (they might even feel that their cash-flow is endangered) – and I am looking forward to the discussions around their objections.

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