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

physiotherapists

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An impressive 17% of US chiropractic patients are 17 years of age or younger. This figure increases to 39% among US chiropractors who have specialized in paediatrics. Data for other countries can be assumed to be similar. But is chiropractic effective for children? All previous reviews concluded that there is a paucity of evidence for the effectiveness of manual therapy for conditions within paediatric populations.

This systematic review is an attempt to shed more light on the issue by evaluating the use of manual therapy for clinical conditions in the paediatric population, assessing the methodological quality of the studies found, and synthesizing findings based on health condition.

Of the 3563 articles identified through various literature searches, 165 full articles were screened, and 50 studies (32 RCTs and 18 observational studies) met the inclusion criteria. Only 18 studies were judged to be of high quality. Conditions evaluated were:

  • attention deficit hyperactivity disorder (ADHD),
  • autism,
  • asthma,
  • cerebral palsy,
  • clubfoot,
  • constipation,
  • cranial asymmetry,
  • cuboid syndrome,
  • headache,
  • infantile colic,
  • low back pain,
  • obstructive apnoea,
  • otitis media,
  • paediatric dysfunctional voiding,
  • paediatric nocturnal enuresis,
  • postural asymmetry,
  • preterm infants,
  • pulled elbow,
  • suboptimal infant breastfeeding,
  • scoliosis,
  • suboptimal infant breastfeeding,
  • temporomandibular dysfunction,
  • torticollis,
  • upper cervical dysfunction.

Musculoskeletal conditions, including low back pain and headache, were evaluated in seven studies. Only 20 studies reported adverse events.

The authors concluded that fifty studies investigated the clinical effects of manual therapies for a wide variety of pediatric conditions. Moderate-positive overall assessment was found for 3 conditions: low back pain, pulled elbow, and premature infants. Inconclusive unfavorable outcomes were found for 2 conditions: scoliosis (OMT) and torticollis (MT). All other condition’s overall assessments were either inconclusive favorable or unclear. Adverse events were uncommonly reported. More robust clinical trials in this area of healthcare are needed.

There are many things that I find remarkable about this review:

  • The list of indications for which studies have been published confirms the notion that manual therapists – especially chiropractors – regard their approach as a panacea.
  • A systematic review evaluating the effectiveness of a therapy that includes observational studies without a control group is, in my view, highly suspect.
  • Many of the RCTs included in the review are meaningless; for instance, if a trial compares the effectiveness of two different manual therapies none of which has been shown to work, it cannot generate a meaningful result.
  • Again, we find that the majority of trialists fail to report adverse effects. This is unethical to a degree that I lose faith in such studies altogether.
  • Only three conditions are, according to the authors, based on evidence. This is hardly enough to sustain an entire speciality of paediatric chiropractors.

Allow me to have a closer look at these three conditions.

  1. Low back pain: the verdict ‘moderate positive’ is based on two RCTs and two observational studies. The latter are irrelevant for evaluating the effectiveness of a therapy. One of the two RCTs should have been excluded because the age of the patients exceeded the age range named by the authors as an inclusion criterion. This leaves us with one single ‘medium quality’ RCT that included a mere 35 patients. In my view, it would be foolish to base a positive verdict on such evidence.
  2. Pulled elbow: here the verdict is based on one RCT that compared two different approaches of unknown value. In my view, it would be foolish to base a positive verdict on such evidence.
  3. Preterm: Here we have 4 RCTs; one was a mere pilot study of craniosacral therapy following the infamous A+B vs B design. The other three RCTs were all from the same Italian research group; their findings have never been independently replicated. In my view, it would be foolish to base a positive verdict on such evidence.

So, what can be concluded from this?

I would say that there is no good evidence for chiropractic, osteopathic or other manual treatments for children suffering from any condition.

And why do the authors of this new review arrive at such dramatically different conclusion? I am not sure. Could it perhaps have something to do with their affiliations?

  • Palmer College of Chiropractic,
  • Canadian Memorial Chiropractic College,
  • Performance Chiropractic.

What do you think?

A new update of the current Cochrane review assessed the benefits and harms of spinal manipulative therapy (SMT) for the treatment of chronic low back pain. The authors included all randomised controlled trials (RCTs) examining the effect of spinal manipulation or mobilisation in adults (≥18 years) with chronic low back pain with or without referred pain. Studies that exclusively examined sciatica were excluded.

The effect of SMT was compared with recommended therapies, non-recommended therapies, sham (placebo) SMT, and SMT as an adjuvant therapy. Main outcomes were pain and back specific functional status, examined as mean differences and standardised mean differences (SMD), respectively. Outcomes were examined at 1, 6, and 12 months.

Forty-seven RCTs including a total of 9211 participants were identified. Most trials compared SMT with recommended therapies. In 16 RCTs, the therapists were chiropractors, in 14 they were physiotherapists, and in 5 they were osteopaths. They used high velocity manipulations in 18 RCTs, low velocity manipulations in 12 studies and a combination of the two in 20 trials.

Moderate quality evidence suggested that SMT has similar effects to other recommended therapies for short term pain relief and a small, clinically better improvement in function. High quality evidence suggested that, compared with non-recommended therapies, SMT results in small, not clinically better effects for short term pain relief and small to moderate clinically better improvement in function.

In general, these results were similar for the intermediate and long term outcomes as were the effects of SMT as an adjuvant therapy.

Low quality evidence suggested that SMT does not result in a statistically better effect than sham SMT at one month. Additionally, very low quality evidence suggested that SMT does not result in a statistically better effect than sham SMT at six and 12 months. Low quality evidence suggested that SMT results in a moderate to strong statistically significant and clinically better effect than sham SMT at one month. Additionally, very low quality evidence suggested that SMT does not result in a statistically significant better effect than sham SMT at six and 12 months.

(Mean difference in reduction of pain at 1, 3, 6, and 12 months (0-100; 0=no pain, 100 maximum pain) for spinal manipulative therapy (SMT) versus recommended therapies in review of the effects of SMT for chronic low back pain. Pooled mean differences calculated by DerSimonian-Laird random effects model.)

About half of the studies examined adverse and serious adverse events, but in most of these it was unclear how and whether these events were registered systematically. Most of the observed adverse events were musculoskeletal related, transient in nature, and of mild to moderate severity. One study with a low risk of selection bias and powered to examine risk (n=183) found no increased risk of an adverse event or duration of the event compared with sham SMT. In one study, the Data Safety Monitoring Board judged one serious adverse event to be possibly related to SMT.

The authors concluded that SMT produces similar effects to recommended therapies for chronic low back pain, whereas SMT seems to be better than non-recommended interventions for improvement in function in the short term. Clinicians should inform their patients of the potential risks of adverse events associated with SMT.

This paper is currently being celebrated (mostly) by chiropractors who think that it vindicates their treatments as being both effective and safe. However, I am not sure that this is entirely true. Here are a few reasons for my scepticism:

  • SMT is as good as other recommended treatments for back problems – this may be so but, as no good treatment for back pain has yet been found, this really means is that SMT is as BAD as other recommended therapies.
  • If we have a handful of equally good/bad treatments, it stand to reason that we must use other criteria to identify the one that is best suited – criteria like safety and cost. If we do that, it becomes very clear that SMT cannot be named as the treatment of choice.
  • Less than half the RCTs reported adverse effects. This means that these studies were violating ethical standards of publication. I do not see how we can trust such deeply flawed trials.
  • Any adverse effects of SMT were minor, restricted to the short term and mainly centred on musculoskeletal effects such as soreness and stiffness – this is how some naïve chiro-promoters already comment on the findings of this review. In view of the fact that more than half the studies ‘forgot’ to report adverse events and that two serious adverse events did occur, this is a misleading and potentially dangerous statement and a good example how, in the world of chiropractic, research is often mistaken for marketing.
  • Less than half of the studies (45% (n=21/47)) used both an adequate sequence generation and an adequate allocation procedure.
  • Only 5 studies (10% (n=5/47)) attempted to blind patients to the assigned intervention by providing a sham treatment, while in one study it was unclear.
  • Only about half of the studies (57% (n=27/47)) provided an adequate overview of withdrawals or drop-outs and kept these to a minimum.
  • Crucially, this review produced no good evidence to show that SMT has effects beyond placebo. This means the modest effects emerging from some trials can be explained by being due to placebo.
  • The lead author of this review (SMR), a chiropractor, does not seem to be free of important conflicts of interest: SMR received personal grants from the European Chiropractors’ Union (ECU), the European Centre for Chiropractic Research Excellence (ECCRE), the Belgian Chiropractic Association (BVC) and the Netherlands Chiropractic Association (NCA) for his position at the Vrije Universiteit Amsterdam. He also received funding for a research project on chiropractic care for the elderly from the European Centre for Chiropractic Research and Excellence (ECCRE).
  • The second author (AdeZ) who also is a chiropractor received a grant from the European Chiropractors’ Union (ECU), for an independent study on the effects of SMT.

After carefully considering the new review, my conclusion is the same as stated often before: SMT is not supported by convincing evidence for back (or other) problems and does not qualify as the treatment of choice.

Crohn’s disease (CD) is an inflammatory bowel disease characterized by recurring flares altered by periods of inactive disease and remission, affecting physical and psychological aspects and quality of life (QoL). The aim of this study was to determine the therapeutic benefits of soft non-manipulative osteopathic techniques in patients with CD.

A randomized controlled trial was performed. It included 30 individuals with CD who were divided into 2 groups: 16 in the experimental group (EG) and 14 in the control group (CG). The EG was treated with the 6 manual techniques depicted below. All patients were advised to continue their prescribed medications and diets. The intervention period lasted 30 days (1 session every 10 days). Pain, global quality of life (GQoL) and QoL specific for CD (QoLCD) were assessed before and after the intervention. Anxiety and depression levels were measured at the beginning of the study.

A significant effect was observed of the treatment in both the physical and task subscales of the GQoL and also in the QoLCD but not in pain score. When the intensity of pain was taken into consideration in the analysis of the EG, there was a significantly greater increment in the QoLCD after treatment in people without pain than in those with pain. The improvements in GQoL were independent from the disease status.

The authors concluded that soft, non-manipulative osteopathic treatment is effective in improving overall and physical-related QoL in CD patients, regardless of the phase of the disease. Pain is an important factor that inversely correlates with the improvements in QoL.

Where to begin?

Here are some of the most obvious flaws of this study:

  1. It was far too small for drawing any far-reaching conclusions.
  2. Because the sample size was so small, randomisation failed to create two comparable groups.
  3. Sub-group analyses are based on even smaller samples and thus even less meaningful.
  4. The authors call their trial a ‘single-blind’ study but, in fact, neither the patients nor the therapists (physiotherapists) were blind.
  5. The researchers were physiotherapists, their treatments were mostly physiotherapy. It is therefore puzzling why they repeatedly call them ‘osteopathic’.
  6. It also seems unclear why these and not some other soft tissue techniques were employed.
  7. The CG did not receive additional treatment at all; no attempt was thus made to control for placebo effects.
  8. The stated aim to determine the therapeutic benefits… seems to be a clue that this study was never aimed at rigorously testing the effectiveness of the treatments.

My conclusion therefore is (yet again) that poor science has the potential to mislead and thus harm us all.

Spinal epidural haematoma (SEH) is an uncommon but serious emergency condition. A team of emergency physicians reported the case of a SEH associated with traditional massage initially presenting with delayed lower paraplegia.

A 20-year-old man was seen with bilateral lower extremity weakness and numbness, symptoms that had started three hours prior to presentation. He had received a Thai massage by a friend three days before. Magnetic resonance imaging revealed a spinal epidural lesion suspicious for haematoma extending from C6 to T2 levels. Emergent surgical intervention for cord decompression was performed. An epidural haematoma with cord compression at C6-T2 levels was identified intra-operatively. No evidence of abnormal vascular flow or AV malformations was identified. The authors concluded that, similar to chiropractic manipulation, massage may be associated with spinal trauma. Emergency physicians must maintain a high index of suspicion for spinal epidural haematomas in patients with a history of massage or chiropractic manipulation with neurologic complaints, because delays in diagnosis may worsen clinical outcome.

Thai massage therapists typically use no lubricants. The patient remains clothed during a treatment. There is constant body contact between the therapist – who, in the above case, was a lay person – and the patient.

The authors of this case report rightly stress that such adverse events are rare – but they are by no means unknown. In 2003, I reviewed the risks and found 16 reports of adverse effects as well as 4 case series on the subject (like for all other manual therapies, there is no reporting system of adverse effects). The majority of adverse effects were – like the above case – associated with exotic types of manual massage or massage delivered by laymen. Professionally trained massage therapists were rarely implicated. The reported adverse events include cerebrovascular accidents, displacement of a ureteral stent, embolization of a kidney, haematoma, leg ulcers, nerve damage, posterior interosseous syndrome, pseudoaneurism, pulmonary embolism, ruptured uterus, strangulation of neck, thyrotoxicosis and various pain syndromes. In the majority of these instances, there was little doubt about a cause-effect relationship. Serious adverse effects were associated mostly with massage techniques other than ‘Swedish’ massage.

For patients, this means that massage is still amongst the safest form of manual therapy (best to employ qualified therapists and avoid the exotic versions of massage because they are not supported by evidence and carry the highest risks). For doctors, it means to be vigilant, if patients present with neurological problems after having enjoyed a massage.

Chiropractors believe that their spinal manipulations bring about a reduction in pain perception, and they often call this ‘manipulation-induced hypoalgesia’ (MIH). It is unknown, however, whether MIH following high-velocity low-amplitude spinal manipulative therapy is a specific and clinically relevant treatment effect.

This systematic review was an effort in finding out.

The authors investigated changes in quantitative sensory testing measures following high-velocity low-amplitude spinal manipulative therapy in musculoskeletal pain populations, in randomised controlled trials. Their objectives were to compare changes in quantitative sensory testing outcomes after spinal manipulative therapy vs. sham, control and active interventions, to estimate the magnitude of change over time, and to determine whether changes are systemic or not.

Fifteen studies were included. Thirteen measured pressure pain threshold, and 4 of these were sham-controlled. Change in pressure pain threshold after spinal manipulative therapy compared to sham revealed no significant difference. Pressure pain threshold increased significantly over time after spinal manipulative therapy (0.32 kg/cm2, CI 0.22–0.42), which occurred systemically. There were too few studies comparing to other interventions or for other types of quantitative sensory testing to make robust conclusions about these.

The authors concluded that they found that systemic MIH (for pressure pain threshold) does occur in musculoskeletal pain populations, though there was low quality evidence of no significant difference compared to sham manipulation. Future research should focus on the clinical relevance of MIH, and different types of quantitative sensory tests.

An odd conclusion, if there ever was one!

A more straight forward conclusion might be this:

MIH is yet another myth to add to the long list of bogus claims made by chiropractors.

Chronic back pain is often a difficult condition to treat. Which option is best suited?

A review by the US ‘Agency for Healthcare Research and Quality’ (AHRQ) focused on non-invasive nonpharmacological treatments for chronic pain. The following therapies were considered:

  • exercise,
  • mind-body practices,
  • psychological therapies,
  • multidisciplinary rehabilitation,
  • mindfulness practices,
  • manual therapies,
  • physical modalities,
  • acupuncture.

Here, I want to share with you the essence of the assessment of spinal manipulation:

  • Spinal manipulation was associated with slightly greater effects than sham manipulation, usual care, an attention control, or a placebo intervention in short-term function (3 trials, pooled SMD -0.34, 95% CI -0.63 to -0.05, I2=61%) and intermediate-term function (3 trials, pooled SMD -0.40, 95% CI -0.69 to -0.11, I2=76%) (strength of evidence was low)
  • There was no evidence of differences between spinal manipulation versus sham manipulation, usual care, an attention control or a placebo intervention in short-term pain (3 trials, pooled difference -0.20 on a 0 to 10 scale, 95% CI -0.66 to 0.26, I2=58%), but manipulation was associated with slightly greater effects than controls on intermediate-term pain (3 trials, pooled difference -0.64, 95% CI -0.92 to -0.36, I2=0%) (strength of evidence was low for short term, moderate for intermediate term).

This seems to confirm what I have been saying for a long time: the benefit of spinal manipulation for chronic back pain is close to zero. This means that the hallmark therapy of chiropractors for the one condition they treat more often than any other is next to useless.

But which other treatments should patients suffering from this frequent and often agonising problem employ? Perhaps the most interesting point of the AHRQ review is that none of the assessed nonpharmacological treatments are supported by much better evidence for efficacy than spinal manipulation. The only two therapies that seem to be even worse are traction and ultrasound (both are often used by chiropractors). It follows, I think, that for chronic low back pain, we simply do not have a truly effective nonpharmacological therapy and consulting a chiropractor for it does make little sense.

What else can we conclude from these depressing data? I believe, the most rational, ethical and progressive conclusion is to go for those treatments that are associated with the least risks and the lowest costs. This would make exercise the prime contender. But it would definitely exclude spinal manipulation, I am afraid.

And this beautifully concurs with the advice I recently derived from the recent Lancet papers: walk (slowly and cautiously) to the office of your preferred therapist, have a little rest there (say hello to the staff perhaps) and then walk straight back home.

 

I would warn every parent who thinks that taking their child to a chiropractor is a good idea. For this, I have three main reasons:

  1. Chiropractic has not been shown to be effective for any paediatric condition.
  2. Chiropractors often advise parents against vaccinating their children.
  3. Chiropractic spinal manipulations can cause harm to kids.

The latter point seems to be confirmed by a recent PhD thesis of which so far only one short report is available. Here are the relevant bits of information from it:

Katie Pohlman has successfully defended her PhD thesis, which focused on the assessment of safety in pediatric manual therapy. As a clinical research scientist at Parker University, Dallas, Texas, she identified a lack of prospective patient safety research within the chiropractic population in general and investigated this deficit in the paediatric population in particular.

Pohlman used a cross-sectional survey to assess the barriers and facilitators for participation in a patient safety reporting system. At the same time, she also conducted a randomized controlled trial comparing the quantity and quality of adverse event reports in children under 14 years receiving chiropractic care.

The RCT recruited 69 chiropractors and found adverse events reported in 8.8% and 0.1% of active and passive surveillance groups respectively. Of the adverse events reported, 56% were considered mild, 26% were moderate and 18% were severe. The frequency of adverse events was more common than previously thought.

This last sentence from the report is somewhat puzzling. Our systematic review of the risks of spinal manipulation showed that data from prospective studies suggest that minor, transient adverse events occur in approximately half of all patients receiving spinal manipulation. The most common serious adverse events are vertebrobasilar accidents, disk herniation, and cauda equina syndrome. Estimates of the incidence of serious complications range from 1 per 2 million manipulations to 1 per 400,000. Given the popularity of spinal manipulation, its safety requires rigorous investigation.

The 8.8% reported by Pohlman are therefore not even one fifth of the average incidence figure reported previously in all age groups.

What could be the explanation for this discrepancy?

There are, of course, several possibilities, including the fact that infants cannot tell the clinician when their pain has increased. However, the most likely one, in my view, lies in the fact that RCTs are wholly inadequate for investigating risks because they typically include far too few patients to generate reliable incidence figures about adverse events. More importantly, clinicians included in such studies are self-selected (and thus particularly responsible/cautious) and are bound to behave most carefully while being part of a clinical trial. Therefore it seems possible – I would speculate even likely – that the 8.8% reported by Pohlman is unrealistically low.

Having said that, I do feel that the research by Kathie Pohlman is a step in the right direction and I do applaud her initiative.

Lumbar spinal stenosis (LSS) is a common reason for spine surgery. Several non-surgical LSS treatment options are also available, but their effectiveness remains unproven. The objective of this study was to explore the comparative clinical effectiveness of three non-surgical interventions for patients with LSS:

  • medical care,
  • group exercise,
  • individualised exercise plus manual therapy.

All interventions were delivered during 6 weeks with follow-up at 2 months and 6 months at an outpatient research clinic. Patients older than 60 years with LSS were recruited from the general public. Eligibility required anatomical evidence of central canal and/or lateral recess stenosis (magnetic resonance imaging/computed tomography) and clinical symptoms associated with LSS (neurogenic claudication; less symptoms with flexion). Analysis was intention to treat.

Medical care consisted of medications and/or epidural injections provided by a physiatrist. Group exercise classes were supervised by fitness instructors. Manual therapy/individualized exercise consisted of spinal mobilization, stretches, and strength training provided by chiropractors and physical therapists. The primary outcomes were between-group differences at 2 months in self-reported symptoms and physical function measured by the Swiss Spinal Stenosis questionnaire (score range, 12-55) and a measure of walking capacity using the self-paced walking test (meters walked for 0 to 30 minutes).

A total of 259 participants were allocated to medical care (n = 88), group exercise (n = 84), or manual therapy/individualized exercise (n = 87). Adjusted between-group analyses at 2 months showed manual therapy/individualized exercise had greater improvement of symptoms and physical function compared with medical care or group exercise. Manual therapy/individualized exercise had a greater proportion of responders (≥30% improvement) in symptoms and physical function (20%) and walking capacity (65.3%) at 2 months compared with medical care (7.6% and 48.7%, respectively) or group exercise (3.0% and 46.2%, respectively). At 6 months, there were no between-group differences in mean outcome scores or responder rates.

The authors concluded that a combination of manual therapy/individualized exercise provides greater short-term improvement in symptoms and physical function and walking capacity than medical care or group exercises, although all 3 interventions were associated with improvements in long-term walking capacity.

In many ways, this is a fairly rigorous study; in one important way, however, it is odd. One can easily see why one group received the usual standard care (except perhaps for the fact that standard medical care should also include exercise). I also understand why one group attended group exercise. Yet, I fail to see the logic in the third intervention, individualised exercise plus manual therapy.

Individualised exercise is likely to be superior to group exercise. If the researchers wanted to test this hypothesis, they should not have added the manual therapy. If they wanted to find out whether manual therapy is better that the other two treatments, they should not have added individualised exercise. As it stands, they cannot claim that either manual therapy or individualised exercise are effective (yet, I am sure that the chiropractic fraternity will claim that this study shows their treatment to be indicated for LSS [three of the authors are chiropractors and the 1st author seems to have a commercial interest in the matter!]).

Manual therapy procedures used in this trial included:

  • lumbar distraction mobilization,
  • hip joint mobilization,
  • side posture lumbar/sacroiliac joint mobilization,
  • and neural mobilization.

Is there any good reason to assume that these interventions work for LSS? I doubt it!

And this is what makes the new study odd, in my view. Assuming I am correct in speculating that individualised exercise is better than group exercise, the trial would have yielded a similarly positive result, if the researchers had offered, instead of the manual therapy, a packet of cigarettes, a cup of tea, a chocolate bar, or swinging a dead cat. In other words, if someone had wanted to make a useless therapy appear to be effective, they could not have chosen a better trial design.

And why do I find such studies objectionable?

Mainly because they deliberately mislead many of us. In the present case, many non-critical observers might conclude that manual therapy is effective for LSS. Yet, the truth could well be that it is useless or even harmful (assuming that the effect size of individualised exercise is large, adding a harmful therapy would still render the combination effective). To put it bluntly, such trials

  • could harm patients,
  • might waste money,
  • and hinder progress.

 

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.

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