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

physiotherapists

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On 8 March 2019, the Council of Australian Governments (COAG) Health Council (CHC) noted community concerns about spinal manipulation on children performed by chiropractors and agreed that there was a need to consider whether public safety was at risk.

On behalf of the CHC, the Victorian Minister for Health, the Hon. Jenny Mikakos MP, instructed Safer Care Victoria (SCV) to undertake an independent review of the practice of chiropractic spinal manipulation on children under 12 years. The findings of this review are to be provided to the Minister for reporting to the CHC. To provide expert guidance and advice to inform the review, SCV established an independent advisory panel. The panel included expertise in chiropractic care, academic allied health, health practitioner regulation, healthcare evidence, governance, paediatrics and paediatric surgery, and musculoskeletal care, and had consumer representation.

The main conclusions were as follows:

  • … spinal manipulation in children is not wholly without risk. Any risk associated
    with care, no matter how uncommon or minor, must be considered in light of any potential or likely
    benefits. This is particularly important in younger children, especially those under the age of 2 years in
    whom minor adverse events may be more common.
  • … the evidence base for spinal manipulation in children is very poor. In particular, no studies have been performed in Australia … The possible, but unlikely, benefits of spinal manipulation in the management of colic or enuresis should be balanced by the possibility, albeit rare, of minor harm.

The main recommendation was straight forward: “Spinal manipulation, as defined in Section 123 of National Law, should not be provided to children under 12 years of age, by any practitioner, for general wellness or for the management of the following conditions: developmental and behavioural disorders, hyperactivity disorders, autism spectrum disorders, asthma, infantile colic, bedwetting, ear infections, digestive problems, headache, cerebral palsy and torticollis.”

The Chiropractic Board of Australia nevertheless decided they would re-start manipulationg babies. On 11/6/2024 The Sydney Morning Harald reported:

Chiropractors have given themselves the green light to resume manipulating the spines of babies following a four-year interim ban supported by the country’s health ministers. In a move slammed by doctors as irresponsible, the Chiropractic Board of Australia has quietly released new guidelines permitting the controversial treatment for children under two. The Royal Australian College of General Practitioners (RACGP) hit out at the decision, saying there was no evidence supporting the spinal manipulation of babies and children and that the practice should be outlawed. ‘‘There is no way in the world I would let anyone manipulate a child’s spine,’’ said Dr James Best, the college’s Specific Interests Child and Young Person’s Health chair. ‘‘The fact that it hasn’t been ruled out by this organisation is very disappointing and concerning. It’s irresponsible.’’ …

Subsequently, it was reported that the federal health minister has intervened in the Chiropractic Board of Australia’s controversial decision to allow practitioners to resume spinal manipulation of children under two and is seeking an urgent explanation.

As pressure mounts on chiropractors to ditch the treatment, federal Health Minister Mark Butler confirmed on Thursday that he would also raise the issue with his state and territory colleagues at a meeting of health ministers in South Australia on Friday.

“The Health Minister is writing to the Chiropractic Board seeking an urgent explanation on its decision to allow a resumption of spinal manipulation of infants under two, in spite of two reviews concluding there was no evidence to support that practice,” a spokeswoman said.

___________________________

This course of events can only be surprising to those who are not familiar with the chiropractors’ general attitude. Chiropractors have always put income before ethics and safety. This, I fear, is not a phenomenon confined to Australia or to the care of children but one that beleagues this profession worldwide from the days of DD Palmer to the present.

Due to the unclear risk level of adverse events (AEs) associated with high-velocity, low-amplitude (HVLA) cervical manipulation, the aim of this study was to extract available information from randomized clinical trials (RCTs) and thereby synthesize the comparative risk of AEs following cervical manipulation to that of various control interventions.

 A systematic literature search was conducted in the PubMed and Cochrane databases. This search included RCTs in which cervical HVLA manipulations were applied and AEs were reported. Two independent reviewers performed the study selection, the methodological quality assessment, and the GRADE approach. Incidence rate ratios (IRR) were calculated. The study quality was assessed by using the risk of bias 2 (RoB-2) tool, and the certainty of evidence was determined by using the GRADE approach.

Fourteen articles were included in the systematic review and meta-analysis. The pooled IRR indicates no statistically significant differences between the manipulation and control groups. All the reported AEs were classified as mild, and none of the AEs reported were serious or moderate.

The authors concluded that HVLA manipulation does not impose an increased risk of mild or moderate AEs compared to various control interventions. However, these results must be interpreted with caution, since RCTs are not appropriate for detecting the rare serious AEs. In addition, future RCTs should follow a standardized protocol for reporting AEs in clinical trials.

I am more than a little puzzled by this paper. To explain why, I best show you our systematic review of a closely related subject:

Objective: To systematically review the reporting of adverse effects in clinical trials of chiropractic manipulation.

Data sources: Six databases were searched from 2000 to July 2011. Randomised clinical trials (RCTs) were considered, if they tested chiropractic manipulations against any control intervention in human patients suffering from any type of clinical condition. The selection of studies, data extraction, and validation were performed independently by two reviewers.

Results: Sixty RCTs had been published. Twenty-nine RCTs did not mention adverse effects at all. Sixteen RCTs reported that no adverse effects had occurred. Complete information on incidence, severity, duration, frequency and method of reporting of adverse effects was included in only one RCT. Conflicts of interests were not mentioned by the majority of authors.

Conclusions: Adverse effects are poorly reported in recent RCTs of chiropractic manipulations.

So, AEs are known to get seriously (and unethically) neglected in RCTs of chiropractic. Therefore, it must be expected that the new review finds only few of them in RCTs. No big deal! But why then conclude that HVLA manipulations do not impose an increased risk? Why do the authors claim that “case reports … do not imply causal relationships”? Why not be honest and simply state that RCTs are an inadequate tool for assessing the risks of spinal manipulation? And why ignore our review which, after all, is highly relevant and was published in a most visible journal? Did they perhaps read it and then decided to ignore it because it would have rendered their whole approach idiotic?

I don’t know the answer to any of these questions. What I do know, however, is that this new review arrives at a utterly misleading and possibly harmful conclusion. It thus is a significant disservice to our need to making progress in this important area.

Vertebral artery dissections (VAD) pose a significant risk for strokes, particularly in young adults. This case report details the presentation and management of a 48-year-old patient who was diagnosed with an extracranial VAD following cervical spine manipulation (CSM).

The patient’s symptoms included:

  • acute right-sided ataxia,
  • giddiness,
  • vertigo,
  • nausea,
  • vomiting,
  • persistent pain behind the right ear.

They prompted immediate evaluation. After ruling out acute intracerebral hemorrhages, a computed tomography angiogram (CTA) of the head and neck identified a severe narrowing of the right distal vertebral artery with a string sign at the level of the right C1 loop (V3 segment), indicating an extracranial VAD. This finding was further supported when ultrasound (US) imaging revealed a high resistance flow pattern in the right distal vertebral artery. Furthermore, T2 and diffusion-weighted magnetic resonance imaging (MRI) confirmed a 1.8 cm VAD/hematoma and a 1.4 cm acute/subacute infarct in the right posterior inferior cerebellar artery (PICA) territory.

The authors concluded by stressing the importance of recognizing and addressing that neck pain can be a symptom of musculoskeletal dysfunction or could have neurovascular origins. In this case, the patient’s neck pain may have been musculoskeletal or could have been due to a previous dissection. Thus, differentiation should be considered before cervical spine manipulation.

The link between CSM and arterial dissection is hard to deny. On this blog, we have discussed these issues with depressing regularity, e.g.:

Whether the CSM was the cause of the dissection of a previously intakt artery, or whether the CSM made a pre-existing problem worse, might often be difficult to decide in retrospect. What is crucial in both scenarios, is that CSM carries serious risks. This insight is all the more important, if we consider that the benefits of CSM are minimal or unproven. The inescapable conclusion, therefore, is that the risk/benefit balance of CSM is not positive. In other words, the only sensible advice here is this:

don’t allow chiropractors (who use CSM more often that any other profession), osteopaths, physiotherapists, etc. perform CSMs on your neck.

This systematic review and meta-analysis investigated the effectiveness and safety of manual therapy (MT) interventions compared to oral or topical pain medications in the management of neck pain.
The investigators searched from inception to March 2023, in Cochrane Central Register of Controller Trials (CENTRAL), MEDLINE, EMBASE, Allied and Complementary Medicine (AMED) and Cumulative Index to Nursing and Allied Health Literature (CINAHL; EBSCO) for randomized controlled trials that examined the effect of manual therapy interventions for neck pain when compared to oral or topical medication in adults with self-reported neck pain, irrespective of radicular findings, specific cause, and associated cervicogenic headaches. Trials with usual care arms were also included if they prescribed medication as part of the usual care and they did not include a manual therapy component. The authors used the Cochrane Risk of Bias 2 tool to assess the potential risk of bias in the included studies, and the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach to grade the quality of the evidence.

Nine trials  with a total of 779 participants were included in the meta-analysis.

  • low certainty of evidence was found that MT interventions may be more effective than oral pain medication in pain reduction in the short-term (Standardized Mean Difference: -0.39; 95% CI -0.66 to -0.11; 8 trials, 676 participants),
  • moderate certainty of evidence was found that MT interventions may be more effective than oral pain medication in pain reduction in the long-term (Standardized Mean Difference: −0.36; 95% CI −0.55 to −0.17; 6 trials, 567 participants),
  • low certainty evidence that the risk of adverse events may be lower for patients who received MT compared to the ones that received oral pain medication (Risk Ratio: 0.59; 95% CI 0.43 to 0.79; 5 trials, 426 participants).

The authors conluded that MT may be more effective for people with neck pain in both short and long-term with a better safety profile regarding adverse events when compared to patients receiving oral pain medications. However, we advise caution when interpreting our safety results due to the different level of reporting strategies in place for MT and medication-induced adverse events. Future MT trials should create and adhere to strict reporting strategies with regards to adverse events to help gain a better understanding on the nature of potential MT-induced adverse events and to ensure patient safety.

Let’s have a look at the primary studies. Here they are with their conclusions (and, where appropriate, my comments in capital letters):

  1. For participants with acute and subacute neck pain, spinal manipulative therapy (SMT) was more effective than medication in both the short and long term. However, a few instructional sessions of home exercise with (HEA) resulted in similar outcomes at most time points. EXERCISE WAS AS EFFECTIVE AS SMT
  2.  Oral ibuprofen (OI) pharmacologic treatment may reduce pain intensity and disability with respect to neural mobilization (MNNM and CLG) in patients with CP during six weeks. Nevertheless, the non-existence of between-groups ROM differences and possible OI adverse effects should be considered. MEDICATION WAS BETTER THAN MT
  3. It appears that both treatment strategies (usual care + MT vs usual care) can have equivalent positive influences on headache complaints. Additional studies with larger study populations are needed to draw firm conclusions. Recommendations to increase patient inflow in primary care trials, such as the use of an extended network of participating physicians and of clinical alert software applications, are discussed. MT DOES NOT IMPROVE OUTCOMES
  4. The consistency of the results provides, in spite of several discussed shortcomings of this pilot study, evidence that in patients with chronic spinal pain syndromes spinal manipulation, if not contraindicated, results in greater improvement than acupuncture and medicine. THIS IS A PILOT STUDY, A TRIAL TESTING FEASIBILITY, NOT EFFECTIVENESS
  5. The consistency of the results provides, despite some discussed shortcomings of this study, evidence that in patients with chronic spinal pain, manipulation, if not contraindicated, results in greater short-term improvement than acupuncture or medication. However, the data do not strongly support the use of only manipulation, only acupuncture, or only nonsteroidal antiinflammatory drugs for the treatment of chronic spinal pain. The results from this exploratory study need confirmation from future larger studies.
  6. In daily practice, manual therapy is a favorable treatment option for patients with neck pain compared with physical therapy or continued care by a general practitioner.
  7. Short-term results (at 7 weeks) have shown that MT speeded recovery compared with GP care and, to a lesser extent, also compared with PT. In the long-term, GP treatment and PT caught up with MT, and differences between the three treatment groups decreased and lost statistical significance at the 13-week and 52-week follow-up. MT IS NOT SUPERIOR [SAME TRIAL AS No 6]
  8. In this randomized clinical trial, for patients with chronic neck pain, Chuna manual therapy was more effective than usual care in terms of pain and functional recovery at 5 weeks and 1 year after randomization. These results support the need to consider recommending manual therapies as primary care treatments for chronic neck pain.
  9. In patients with chronic spinal pain syndromes, spinal manipulation, if not contraindicated, may be the only treatment modality of the assessed regimens that provides broad and significant long-term benefit. SAME TRIAL AS No 5
  10. An impairment-based manual physical therapy and exercise (MTE) program resulted in clinically and statistically significant short- and long-term improvements in pain, disability, and patient-perceived recovery in patients with mechanical neck pain when compared to a program comprising advice, a mobility exercise, and subtherapeutic ultrasound. THIS STUDY DID NOT TEST MT ALONE AND SHOULD NOT HAVE BEEN INCLUDED

I cannot bring myself to characterising this as an overall positive result for MT; anyone who can is guilty of wishful thinking, in my view. The small differences in favor of MT that (some of) the trials report have little to do with the effectiveness of MT itself. They are almost certainly due to the fact that none of these studies were placebo-controlled and double blind (even though this would clearly be possible). In contrast to popping a pill, MT involves extra attention, physical touch, empathy, etc. These factors easily suffice to bring about the small differences that some studies report.

It follows that the main conclusion of the authors of the review should be modified:

There is no compelling evidence to show that MT is more effective for people with neck pain in both short and long-term when compared to patients receiving oral pain medications.

 

Spinal manipulation is usually performed by a therapist (chiropractor, osteopath, physiotherpist, doctor, etc.). But many people do it themselves. Self-manipulation is by no means safer than the treatment by a therapist, it seems. We have previously seen cases where the results were dramatic:

Now, a further case has been reported. In this paper, American pathologists present a tragic case of fatal vertebral artery dissection that occurred as the result of self-manipulation of the cervical spine.

The decedent was a 40-year-old man with no significant past medical history. He was observed to “crack his neck” while at work. Soon after, he began experiencing neck pain, then developed stroke-like symptoms and became unresponsive. He was transported to a local medical center, where imaging showed bilateral vertebral artery dissection. His neurological status continued to decline, and brain death was pronounced several days later.

An autopsy examination showed evidence of cerebellar and brainstem infarcts, herniation, and diffuse hypoxic-ischemic injury. A posterior neck dissection was performed to expose the vertebral arteries, which showed grossly visible hemorrhage and dilation. There was no evidence of traumatic injury to the bone or soft tissue of the head or neck. Bilateral dissection tracts were readily appreciated on microscopic examination. Death was attributed to self-manipulation of the neck, which in turn led to bilateral vertebral artery dissection, cerebellar and brainstem infarcts, herniation, hypoxic-ischemic injury, and ultimately brain death.

It seems clear to me that only few and spectacular cases of this nature are being published. In other words, the under-reporting of adverse effects of self-manipulation must be close to 100%. It follows that the risk of sel-manipulation is impossible to quantify. I suspect it is substancial. In any case, the precautionary principle compells me to re-issue my warning:

do not allow anybody to manipulate your neck, not even yourself!

The aim of this study was to establish an international consensus regarding the use of spinal manipulation and mobilisation among infants, children, and adolescents among expert international physiotherapists. Twenty-six international expert physiotherapists in manual therapy and paediatrics voluntarily participated in a 3-Round Delphi survey to reach a consensus via direct electronic mail solicitation using Qualtrics®. Consensus was defined a-priori as ≥75% agreement on all items with the same ranking of agreement or disagreement. Round 1 identified impairments and conditions where spinal mobilisation and manipulation might be utilised. In Rounds 2 and 3, panelists agreed or disagreed using a 4-point Likert scale.

Eleven physiotherapists from seven countries representing five continents completed all three Delphi rounds. Consensus regarding spinal mobilisation or manipulation included:

● Manipulation is not recommended: (1) for infants across all conditions, impairments, and
spinal levels; and (2) for children and adolescents across most conditions and spinal levels.
● Manipulation may be recommended for adolescents to treat spinal region-specific joint
hypomobility (thoracic, lumbar), and pain (thoracic).
● Mobilisation may be recommended for children and adolescents with hypomobility, joint
pain, muscle/myofascial pain, or stiffness at all spinal levels.

The authors of this paper concluded that consensus revealed spinal manipulation should not be performed on infants regardless of condition, impairment, or spinal level. Additionally, the panel agreed that manipulation may be recommended only for adolescents to treat joint pain and joint hypomobility (limited to thoracic and/or lumbar levels). Spinal mobilisation may be recommended for joint hypomobility, joint pain, muscle/myofascial pain, and muscle/myofascial stiffness at all spinal levels among children and adolescents.

Various forms of spinal manipulations are the hallmark therapy of chiropractors. Almost 100% of their patients recieve these interventions. So, what will our friends, the chiros, say about the consensus? Might it be this:

  • Physiotherapists are not the experts on spinal manipulation.
  • Only chiropractors can do them properly.
  • And when WE do them, they are very good*!

 

 

 

(* for our income)

As we have often discussed on this blog, chiropractic spinal manipulations can lead to several complications and can result in vascular injury, including traumatic dissection of the vertebral arteries with often dire consequences – see, for instance, here:

 

This recent paper is a most unusual addition to the list. It is a case report of a 43-year-old woman who was admitted to the emergency department after performing a self-chiropractic spinal manipulation. She experienced headache and vomiting and was unresponsive with severe hypertension at the time of hospital admission. Clinical computerized tomography angiography showed narrowing of the right vertebral artery but was inconclusive for dissection or thrombosis.

The patient died a short while later. At autopsy, subacute dissection of the right vertebral artery was identified along with cerebral edema and herniation. A small peripheral pulmonary thromboembolism in the right lung was also seen. Neuropathology consultation confirmed the presence of diffuse cerebral edema and acute hypoxic-ischemic changes, with multifocal acute subarachnoid and intraparenchymal hemorrhage of the brain and spinal cord.

The authors concluded that this case presents a unique circumstance of a fatal vertebral artery dissection after self-chiropractic manipulation that, to the best of our knowledge, has not been previously described in the medical literature.

The aim of this study was to investigate whether there is a difference in outcome between participants with high compared to low pain self-efficacy (PSE) receiving manual therapy, acupuncture, and electrotherapy.

Participants were stratified into high or low baseline (i) PSE, (ii) shoulder pain and disability index (SPADI), and (iii) did or did not receive the treatment. Whether the effect of treatment differs for people with high compared to low PSE was assessed using the 95% confidence interval of the difference of difference (DoD) at a 5% significance level (p < 0.05).

Treatment was labelled using 3 categories, 2 of which were subcategories of the first

  • “Any passive treatment” – any form of manual therapy and/or acupuncture and/or electrotherapy.
  • “Any manual therapy” – shoulder or spine joint mobilisations, deep transverse frictions, capsular stretches, trigger point therapy, muscle facilitation, or other techniques listed by the treating physiotherapist.
  • “Spinal/shoulder joint mobilisation” – for example, Maitland, Kaltenborn or Mulligan techniques.

To be categorised, treatment must have been delivered by the physiotherapist at least once and may have been delivered in conjunction with other treatments.

Six-month SPADI scores were consistently lower (less pain and disability) for those who did not receive passive treatments compared to those who did (statistically significant less pain and disability in 7 of 24 models). However, DoD was statistically insignificant.

The authors concluded that PSE did not moderate the relationship between treatment and outcome. However, participants who received passive treatment experienced equal or more pain and disability at 6 months compared to those who did not. Results are subject to confounding by indication but do indicate the need for further appropriately designed research.

This analysis suggests that manual therapy, electrotherapy, or acupuncture in addition to advice and exercise offered no improvement in pain or disability at six months, irrespective of PSE. Some patients who receive these treatments experienced more pain and disability at six months compared to those who do not.

I am not aware of compelling evidence that either of these treatments, all of which are often recommended, are effective for shoulder pain, and the results of this new study certainly do not suggest they are. However, as the design of the study was not primarily for this research question, these findings are, of course, merely tentative and need to be investigated further.

The risks of chiropractic spinal manipulations (CSMs) feature regularly on my blog, not least because most chiropractors are in denial of this important issue and insist that chiropractic spinal manipulations are safe!!!. I therefore thought it might be a good idea to try and summarize the arguments they often put forward in promoting their dangerously fallacious and quasi-religious belief that CSMs are safe:

  1. There is not evidence to suggest that CSMs do harm. Such a statement is based on wishful thinking and ignorance motivated by the need of making a living. The evidence shows a different picture.
  2. There are hundreds of clinical trials that demonstrate the safety of CSMs. This argument is utterly unconvincing for at least two reasons: firstly clinical trials are far too small for identifying rare (but serious) complications; secondly, we know that clinical trials of CSM very often fail to report adverse events.
  3. Case reports of adverse effects are mere anecdotes and thus not reliable evidence. As there is no post-marketing surveillance system of adverse events after CSMs, case reports are, in fact, the most important and informative source of information we currently have on this subject.
  4. Case reports of harm by CSMs are invariably incomplete and of poor quality. Case reports are usually published by doctors who often have to rely on incomplete information. It would be up to chiropractors to publish case reports with the full details; yet chiropractors hardly ever do this.
  5. Case reports cannot establish cause and effect. True, but they do provide important signals which then should be investigated further. It would be up to chiropractors to do this; sadly, this is not what is happening.
  6. Adverse effects such as arterial dissections or strokes occur spontaneaously. True, but many have an identifiable cause, and it is our duty to find it.
  7. The forces applied during CSM are small and cannot cause an injury. This might be true under ideal conditions, but in clinical practice the conditions are often not ideal.
  8. If an arterial dissection occurs nevertheless, it is because there was a pre-existing injury. This argument is largely based on wishful thinking. Even if it were true, it would be foolish to aggravate a pre-existing injury by CSMs.
  9. Injuries happen only if the contra-indications of CSMs are ignored. This obviously begs the question: what are the contra-indications and how well established are they? The answer is that they are largely based on guess-work and not on systematic research. Thus chiropractors are able to claim that, once an adverse effects has occurred, the incident was due to a disregard of contra-indication and not due to the inherent risks of CSM.
  10. Only poorly trained chiropractors cause harm. This is evidently untrue, yet the argument provides yet another welcome escape route for those defending CSMs: if something went wrong, it must have been due to the practitioner and not the intervention!
  11. Chiropractors are an easy target. In my fairly extensive experience in this field, the opposite is true. Chiropractors tend to have multiple excuses and escape routes. As a consequence, they are difficult to pin down.
  12. Other causes, e.g. car accidents, are much more common causes of vascular injuries. Even if this were true, it does certainly not mean that CSM can be ruled out as the cause of serious harm.
  13. Patients who experience harm had pre-existing issues. Again, this notion is mostly based on wishful thinking and not based on sound evidence. Yet, it clearly is another popular escape route for chiropractors. And again, it is irresponsible to administer CSM if there is the possibility that pre-existing issues are present.
  14. The alleged harms of CSMs are merely an obsession for people who don’t really understand chiropractic. That is an old trick of someone trying to defend the indefensible. Chiropractors like to pompously claim that opponents are ignorant and only chiropractors understand the subject area. They use arrogance in an attempt to intimidate or scilence experts who disagree with them.
  15. Chiropractors do so much more than just CSN. True. They have ‘borrowed’ many modalities from physiotherapy and, by pointing that out, they aim at distracting from the dangers of CSMs. Yet, it is also true that practically every patient who consults a chiropractor will receive a CSM.
  16. Doctors are just jealous of the success of chiropractors. This fallacy is used when chiropractors run out of proper arguments. Rather than addressing the problem, they try to distract from it by claiming the opponent has ulterior motives.
  17. Medical treatments cause much more harm than CSM. Chiropractors are keen to mislead us into believing that NSAIDs, for instance, are much more dangerous than CSMs. The notion is largely based on one lousy article and thus not convincing. Even if it were true, it would obviously be no reason to ignore the risks of CSNs.

I am sure my list is far from complete. If you can think of further (pseudo-) arguments, please use the comments section below to let us know.

The WHO has just released guidelines for non-surgical management of chronic primary low back pain (CPLBP). The guideline considers 37 types of interventions across five intervention classes. With the guidelines, WHO recommends non-surgical interventions to help people experiencing CPLBP. These interventions include:

  • education programs that support knowledge and self-care strategies;
  • exercise programs;
  • some physical therapies, such as spinal manipulative therapy (SMT) and massage;
  • psychological therapies, such as cognitive behavioural therapy; and
  • medicines, such as non-steroidal anti-inflammatory medicines.

The guidelines also outline 14 interventions that are not recommended for most people in most contexts. These interventions should not be routinely offered, as WHO evaluation of the available evidence indicate that potential harms likely outweigh the benefits. WHO advises against interventions such as:

  • lumbar braces, belts and/or supports;
  • some physical therapies, such as traction;
  • and some medicines, such as opioid pain killers, which can be associated with overdose and dependence.

As you probably guessed, I am particularly intrigued by the WHO’s positive recommendation for SMT. Here is what the guideline tells us about this specific topic:

Considering all adults, the guideline development group (GDG) judged overall net benefits [of spinal manipulation] across outcomes to range from trivial to moderate while, for older people the benefit was judged to be largely uncertain given the few trials and uncertainty of evidence in this group. Overall, harms were judged to be trivial to small for all adults and uncertain for older people due to lack of evidence.

The GDG commented that while rare, serious adverse events might occur with SMT, particularly in older people (e.g. fragility fracture in people with bone loss), and highlighted that appropriate training and clinical vigilance concerning potential harms are important. The GDG also acknowledged that rare serious adverse events were unlikely to be detected in trials. Some GDG members considered that the balance of benefits to harms favoured SMT due to small to moderate benefits while others felt the balance did not favour SMT, mainly due to the very low certainty evidence for some of the observed benefits.

The GDG judged the overall certainty of evidence to be very low for all adults, and very low for older people, consistent with the systematic review team’s assessment. The GDG judged that there was likely to be important uncertainty or variability among people with CPLBP with respect to their values and preferences, with GDG members noting that some people might prefer manual
therapies such as SMT, due to its “hands-on” nature, while others might not prefer such an approach.

Based on their experience and the evidence presented from the included trials which offered an average of eight treatment sessions, the GDG judged that SMT was likely to be associated with moderate costs, while acknowledging that such costs and the equity impacts from out-of-pocket costs would vary by setting.

The GDG noted that the cost-effectiveness of SMT might not be favourable when patients do not experience symptom improvements early in the treatment course. The GDG judged that in most settings, delivery of SMT would be feasible, although its acceptability was likely to vary across
health workers and people with CPLBP.

The GDG reached a consensus conditional recommendation in favour of SMT on the basis of small to moderate benefits for critical outcomes, predominantly pain and function, and the likelihood of rare adverse events.

The GDG concluded by consensus that the likely short-term benefits outweighed potential harms, and that delivery was feasible in most settings. The conditional nature of the recommendation was informed by variability in acceptability, possible moderate costs, and concerns that equity might be negatively impacted in a user-pays model of financing.

___________________________

This clearly is not a glowing endorsement or recommendation of SMT. Yet, in my view, it is still too positive. In particular, the assessment of harm is woefully deficient. Looking into the finer details, we find how the GDG assessed harms:

WHO commissioned quantitative systematic evidence syntheses of randomized controlled
trials (RCTs) to evaluate the benefits and harms (as reported in included trials) of each of the
prioritized interventions compared with no care (including trials where the effect of an
intervention could be isolated), placebo or usual care for each of the critical outcomes (refer to Table 2 for the PICO criteria for selecting evidence). Research designs other than RCTs
were not considered.

That explains a lot!

It is not possible to establish the harms of SMT (or any other therapy) on the basis of just a few RCTs, particularly because the RCTs in question often fail to report adverse events. I can be sure of this phenomenon because we investigated it via a systematic review:

Objective: To systematically review the reporting of adverse effects in clinical trials of chiropractic manipulation.

Data sources: Six databases were searched from 2000 to July 2011. Randomised clinical trials (RCTs) were considered, if they tested chiropractic manipulations against any control intervention in human patients suffering from any type of clinical condition. The selection of studies, data extraction, and validation were performed independently by two reviewers.

Results: Sixty RCTs had been published. Twenty-nine RCTs did not mention adverse effects at all. Sixteen RCTs reported that no adverse effects had occurred. Complete information on incidence, severity, duration, frequency and method of reporting of adverse effects was included in only one RCT. Conflicts of interests were not mentioned by the majority of authors.

Conclusions: Adverse effects are poorly reported in recent RCTs of chiropractic manipulations.

The GDG did not cite our review (or any other of our articles on the subject) but, as it was published in a very well-known journal, they must have been aware of it. I am afraid that this wilfull ignorance caused the WHO guideline to underestimate the level of harm of SMT. As there is no post-marketing surveillance system for SMT, a realistic assessment of the harm is far from easy and needs to include a carefully weighted summary of all the published reports (such as this one).

The GDG seems to have been aware of (some of) these problems, yet they ignored them and simply assumed (based on wishful thinking?) that the harms were small or trivial.

Why?

Even the most cursory look at the composition of the GDG, begs the question: could it be that the GDG was highjacked by chiropractors and other experts biased towards SMT?

The more I think of it, the more I feel that this might actually be the case. One committee even listed an expert, Scott Haldeman, as a ‘neurologist’ without disclosing that he foremost is a chiropractor who, for most of his professional life, has promoted SMT in one form or another.

Altogether, the WHO guideline is, in my view, a shameful example of pro-chiropractic bias and an unethical disservice to evidence-based medicine.

 

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