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:
- Chiropractor caused a Vertebral Artery Dissection from a completely unnecessary neck adjustment
- Associations between cervical artery dissection and spinal manipulation
- Chiropractic spinal manipulation is a risk factor for cranio-cervical artery dissection
- Double-sided vertebral artery dissection in a 33-year-old man. The chiropractor is not guilty?
- Vertebral artery dissection in a pregnant woman after cervical spine manipulation
- Chiropractic manipulations are a risk factor for vertebral artery dissections
- Cervical artery dissection and stroke related to chiropractic manipulation
- Vertebral artery dissection after chiropractic manipulation: yet another case
- Pseudoaneurysm of Neck External Carotid Artery Related to Chiropractic Manipulation
- Cervical Arterial Dissections and Association With Cervical Manipulative Therapy
- Chiropractic adjustments are causing more and more strokes in younger adults
- Another case of stroke due to chiropractic
- More about the dangers of chiropractic
- The incidence of severe adverse events after chiropractic spinal manipulative therapy
- Catastrophic injuries after chiropractic treatment
- “As soon as the chiropractor manipulated my neck, everything went black”
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:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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!
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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.
The purpose of this systematic review was to assess the effectiveness and safety of conservative interventions compared with other interventions, placebo/sham interventions, or no intervention on disability, pain, function, quality of life, and psychological impact in adults with cervical radiculopathy (CR), a painful condition caused by the compression or irritation of the nerves that supply the shoulders, arms and hands.
A multidisciplinary team autors searched MEDLINE, CENTRAL, CINAHL, Embase, and PsycINFO from inception to June 15, 2022 to identify studies that were:
- randomized trials,
- had at least one conservative treatment arm,
- diagnosed participants with CR through confirmatory clinical examination and/or diagnostic tests.
Studies were appraised using the Cochrane Risk of Bias 2 tool and the quality of the evidence was rated using the Grades of Recommendations, Assessment, Development, and Evaluation approach.
Of the 2561 records identified, 59 trials met the inclusion criteria (n = 4108 participants). Due to clinical and statistical heterogeneity, the findings were synthesized narratively.
There is very-low certainty evidence supporting the use of:
- cervical manipulation,
- low-level laser therapy
for pain and disability in the immediate to short-term, and
- thoracic manipulation,
- low-level laser therapy
for improvements in cervical range of motion in the immediate term.
There is low to very-low certainty evidence for multimodal interventions, providing inconclusive evidence for pain, disability, and range of motion.
There is inconclusive evidence for pain reduction after conservative management compared with surgery, rated as very-low certainty.
The authors concluded that there is a lack of high-quality evidence, limiting our ability to make any meaningful conclusions. As the number of people with CR is expected to increase, there is an urgent need for future research to help address these gaps.
Yet, to patients suffering from CR, this is hardly constructive advice. What should they do vis a vis such disappointing evidence?
They might speak to a orthopedic surgeon; but often there is no indication for an operation. What then?
Patients are bound to try some of the conservative options – but which one?
- Cervical manipulation,?
- Low-level laser therapy?
My advice is this: be patient – the vast majority of cases resolves spontaneously regardless of therapy – and, if you are desperate, try any of them except cervical manipulation which is burdened with the risk of serious complications and often makes things worse.
The concept that the outcomes of spinal manipulation therapy (SMT) – the hallmark intervention of chiropractors which they use on practically every patient – are optimized when the treatment is aimed at a clinically relevant joint is commonly assumed and central to teaching and clinical use of chiropractic. But is the assumption true?
This systematic review investigated whether clinical effects are superior when this is the case compared to SMT applied elsewhere. Eligible study designs were randomized controlled trials that investigated the effect of SMT applied to candidate versus non-candidate sites for spinal pain.
The authors obtained studies from four different databases. Risk of bias was assessed using an adjusted Cochrane risk of bias tool, adding four items for study quality. Between-group differences were extracted for any reported outcome or, when not reported, calculated from the within-group changes. Outcomes were compared for SMT applied at a ‘relevant’ site to SMT applied elsewhere. The authors prioritized methodologically robust studies when interpreting results.
Ten studies were included. They reported 33 between-group differences; five compared treatments within the same spinal region and five at different spinal regions.
None of the nine studies with low or moderate risk of bias reported statistically significant between-group differences for any outcome. The tenth study reported a small effect on pain (1.2/10, 95%CI – 1.9 to – 0.5) but had a high risk of bias. None of the nine articles of low or moderate risk of bias and acceptable quality reported that “clinically-relevant” SMT has a superior outcome on any outcome compared to “not clinically-relevant” SMT. This finding contrasts with ideas held in educational programs and clinical practice that emphasize the importance of joint-specific application of SMT.
The authors concluded that the current evidence does not support that SMT applied at a supposedly “clinically relevant” candidate site is superior to SMT applied at a supposedly “not clinically relevant” site for individuals with spinal pain.
I came across this study when I searched for the published work of Prof Stephen Perle, a chiropractor and professor at the School of Chiropractic, College of Health Sciences, University of Bridgeport, US, who recently started trolling me on this blog. Against my expectation, I find his study interesting and worthwhile.
His data quite clearly show that the effects of SMT are non-specific and mainly due to a placebo response. That in itself is not hugely remarkable and has been suspected to some time, e.g.:
- Chiropractic manipulation for migraine is a placebo therapy
- Chiropractic treatments are placebos
- Chiropractic spinal manipulation = placebo!
- Manual therapy (mainly chiropractic and osteopathy) does not have clinically relevant effects on back pain compared with sham treatment
- Manual therapies for back pain: not better than a placebo
- Is spinal manipulation a placebo therapy?
What is remarkable, however, is the fact that Perle and his co-authors offer all sorts of other explanation for their findings without even seriously considering what is stareing in their faces:
SPINAL MANIPULATIONS ARE PLACEBOS
CHIROPRACTIC IS A PLACEBO THERAPY
This might be almost acceptable, if chiropractic would not also be burdened with significant risks (as we have discussed ad nauseam on this blog) – another fact of which chiros like Perle are in denial.
What does all that mean for patients?
The practical implication is fairly straight forward: the risk/benefit balance of chiropractic is negative. And this surely means the only responsible advice to patients is this:
NEVER CONSULT A CHIRO!
The ‘University College of Osteopathy’ announced a proposal to merge with the AECC University College (AECC UC). Both institutions will seek to bring together the two specialist providers to offer a “unique inter-disciplinary environment for education, clinical practice and research in osteopathy, chiropractic, and across a wide range of allied health and related disciplines”.
The partnership is allegedly set to unlock significant opportunities for growth and development by bringing together the two specialist institutions’ expertise and resources across two locations – in Dorset and central London.
As a joint statement, Chair of the Board of Governors at AECC UC, Jeni Bremner and Chair of the Board of Governors at UCO, Professor Jo Price commented:
“We believe the proposed merger would further the institutional ambitions for both of our organisations and the related professional groups, by allowing us to expand our educational offering, grow student numbers and provide a unique inter-disciplinary training environment, providing students the opportunity to be immersed in multi-professional practice and research, with exposure to and participation in multi-disciplinary teams.
“There is also an exciting and compelling opportunity to expedite the development of a nationally unique, and internationally-leading MSK Centre of Excellence for Education and Research, developed and delivered across our two sites.”
The announcement is accompanied by further uncritical and promotional language:
Established as the first chiropractic training provider in Europe, AECC UC has been at the forefront of evidence-based chiropractic education, practice and research for more than 50 years. The institution is on an exciting journey of growth and development, having expanded and diversified its academic portfolio and activity beyond its traditional core offering of chiropractic across a broad range of allied health courses and apprenticeships, working closely with NHS, local authority and other system partners across Dorset and the south-west. The proposed merger with UCO would allow AECC UC to enhance the breadth and depth of its offer to support the expansion and development of the health and care workforce across a wider range of partners.
Now in its 106th year, UCO is one of the UK’s leading providers of osteopathic education and research with an established reputation for creating highly-skilled, evidence-informed graduates. UCO research is recognised as world-leading, delivering value to the osteopathic and wider health care community.
Sharon Potter, Acting Vice-Chancellor of UCO, said:
“As an institution that has long been at the forefront of osteopathic education and research, we are committed to ensuring further growth and development of the osteopathic profession.
“UCO has been proactively considering options to future-proof the institution. Following a review of strategic options, UCO is delighted by the proposed merger, working closely with AECC UC to ensure that UCO and osteopathy thrives as part of the inter-professional health sciences landscape, both academically and clinically. There is significant congruence between UCO and AECC UC in our strong aligned values, commitment to and delivery of excellent osteopathic education, clinical care and research, and opinion leadership.
“AECC UC has a strong track record of respecting the differences in professions, evidenced by the autonomy across the 10 different professional groups supported by the institution. The merger will not only mean we are protecting UCO through preserving its osteopathic heritage and creating a sustainable future, but that our staff and students can collaborate with other professional groups such as physiotherapy, chiropractic, sport rehabilitation, podiatry and diagnostic imaging, in a multidisciplinary MSK and rehabilitation environment unlike anywhere else in the UK.”
Professor Lesley Haig, Vice-Chancellor of AECC UC, commented:
“Preserving the heritage of UCO and safeguarding its future status as the flagship osteopathy training provider in the UK will be critical, just as it has been to protect the chiropractic heritage of the AECC brand. UCO is seen as synonymous with, and reflective of, the success of the osteopathy profession and we fully recognise and respect the important role that UCO plays not only as a sector-leading provider of osteopathic education, research and clinical care, but as the UK’s flagship osteopathy educational provider.
“Overall it is clear that UCO and AECC UC already have a common values base, similar understanding of approaches to academic and clinical delivery, and positive relationships upon which a future organisational structure and opportunities can be developed. It’s an exciting time for both institutions as we move forward in partnership to create something unique and become recognised nationally and internationally as a centre of excellence.”
The proposed merger would continue the already founded positive relations between the institutions, where regular visits, sharing of good practice, and collaborative research work are already taking place. Heads of terms for the potential merger have now been agreed and both institutions are entering into the next phase of discussions, which will include wide consultation with staff, students and other stakeholders to produce a comprehensive implementation plan.
In case this bonanza of platitudes and half-truths has not yet overwhelmed you, I might be so bold as to ask 10 critical questions:
- What is an “evidence-based chiropractic education”? Does it include the messages that 1) subluxation is nonsense, 2) chiropractic manipulations can cause harm, 3) there is little evidence that they do more good than harm?
- How an an “expansion and development of the health and care workforce” be anticipated on the basis of the 3 points I just made?
- What does the term “evidence-informed graduates” mean? Does it mean they are informed that you teach them nonsense but instruct them to practice this nonsense anyway?
- Do “options to future-proof the institution” include the continuation of misleading the public about the value of chiropractic/osteopathy?
- Does the”delivery of excellent osteopathic education, clinical care and research, and opinion leadership” account for the fact that the evidence for osteopathy is weak at best and for most conditions negative?
- By “preserving its osteopathic heritage”, do you intend to preserve also the reputation of your founding father, Andrew Taylor Still, who did many dubious things. In 1874, for instance, he was excommunicated by the Methodist Church because of his “laying on of hands”; specifically, he was accused of trying to emulate Jesus Christ, labelled an agent of the Devil, and condemned as practicing voodoo. Or do you prefer to white-wash the osteopathic heritage?
- You also want “to protect the chiropractic heritage”; does that mean you aim at white-washing the juicy biography of the charlatan who created chiropractic, DD Palmer, as well?
- “UCO and AECC UC already have a common values base” – what are they? As far as I can see, they mainly consist in hiding the truth about the uselessness of your activities from the public.
- How do you want to “recognised nationally and internationally as a centre of excellence”? Might it be a good idea to begin by critically assessing your interventions and ask whether they do more good than harm?
- Crucially, what is really behing the merger that you are trying to sell us with such concentrated BS?
This systematic review and meta-analysis was aimed at analyzing the effectiveness of craniosacral therapy in improving pain and disability among patients with headache disorders.
PubMed, Physiotherapy Evidence Database, Scopus, Cochrane Library, Web of Science, and Osteopathic Medicine Digital Library databases were searched in March 2023. Two independent reviewers searched the databases and extracted data from randomized clinical trials comparing craniosacral therapy with control or sham interventions. The same reviewers assessed the methodological quality and the risk of bias using the PEDro scale and the Cochrane Collaboration tool, respectively. Grading of recommendations, assessment, development, and evaluations was used to rate the certainty of the evidence. Meta-analyses were conducted using random effects models using RevMan 5.4 software.
The searches retrieved 735 papers, and 4 studies were finally included. The craniosacral therapy provided statistically significant but clinically unimportant change on pain intensity (Mean difference = –1.10; 95% CI: –1.85, –0.35; I2: 44%), and no change on disability or headache effect (Standardized Mean Difference = –0.34; 95% CI –0.70, 0.01; I2: 26%). The certainty of the evidence was downgraded to very low.
The authors concluded that very low certainty of evidence suggests that craniosacral therapy produces clinically unimportant effects on pain intensity, whereas no significant effects were observed in disability or headache effect.
I find it strange that researchers seem so frequently unable to formulate their conclusions clearly. Is it political correctness? Or are they somehow favorably inclined (i.e. biased) towards the treatment that they pretend to critically evaluate?
Let’s look at the facts related to this review:
- Craniosacral therapy (CST) is utterly implausible.
- Only 4 RCTs were found.
- They were of poor quality.
- They were published mostly by people who want to promote CST.
- Therefore the overall statistically significant effect is most likely a false-positive result.
- This means that the conclusion should be much more straight forward.
I suggest something along the following lines:
A critical evaluation of the existing RCTs failed to find convincing evidence that CST is an effective treatment for headache disorders.
The aim of this systematic review was to update the current level of evidence for spinal manipulation in influencing various biochemical markers in healthy and/or symptomatic population.
Various databases were searched (inception till May 2023) and fifteen trials (737 participants) that met the inclusion criteria were included in the review. Two authors independently screened, extracted and assessed the risk of bias in included studies. Outcome measure data were synthesized using standard mean differences and meta-analysis for the primary outcome (biochemical markers). The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) was used for assessing the quality of the body of evidence for each outcome of interest.
There was low-quality evidence that spinal manipulation influenced various biochemical markers (not pooled). There was low-quality evidence of significant difference that spinal manipulation is better (SMD -0.42, 95% CI – 0.74 to -0.1) than control in eliciting changes in cortisol levels immediately after intervention. Low-quality evidence further indicated (not pooled) that spinal manipulation can influence inflammatory markers such as interleukins levels post-intervention. There was also very low-quality evidence that spinal manipulation does not influence substance-P, neurotensin, oxytocin, orexin-A, testosterone and epinephrine/nor-epinephrine.
The authors concluded that spinal manipulation may influence inflammatory and cortisol post-intervention. However, the wider prediction intervals in most outcome measures point to the need for future research to clarify and establish the clinical relevance of these changes.
The majority of the studies were of low or very low quality. This means that the collective evidence is less than reliable. In turn, this means, I think, that the conclusions are misleading. A more honest conclusion would be this:
There is no reliable evidence that spinal manipulation influences inflammatory and cortisol levels.
As for the clinical relevance, I would like to point out that it would not be surprising if chiropractors could one day convincingly show that spinal manipulation do influence various biochemical markers. Many things do! If you fall down a staircase, for instance, plenty of biochemical markers will be affected. This, however, does not mean that throwing our patients down the stairs is of therapeutic value.
This study aimed to compare the effects of cognitive functional therapy (CFT) and movement system impairment (MSI)-based treatment on pain intensity, disability, Kinesiophobia, and gait kinetics in patients with chronic non-specific low back pain (CNSLBP).
In a single-blind randomized clinical trial, the researchers randomly assigned 91 patients with CNSLBP into CFT (n = 45) and MSI-based treatment (n = 46) groups. An 8-week training intervention was given to both groups. The researchers measured the primary outcome, which was pain intensity (Numeric rating scale), and the secondary outcomes, including disability (Oswestry disability index), Kinesiophobia (Tampa Kinesiophobia Scale), and vertical ground reaction force (VGRF) parameters at self-selected and faster speed (Force distributor treadmill). They evaluated patients at baseline, at the end of the 8-week intervention (post-treatment), and six months after the first treatment. Mixed-model ANOVA was used to evaluate the effects of the interaction between time (baseline vs. post-treatment vs. six-month follow-up) and group (CFT vs. MSI-based treatment) on each measure.
CFT showed superiority over MSI-based treatment in reducing pain intensity (P < 0.001, Effect size (ES) = 2.41), ODI (P < 0.001, ES = 2.15), and Kinesiophobia (P < 0.001, ES = 2.47) at eight weeks. The CFT also produced greater improvement in VGRF parameters, at both self-selected (FPF[P < 0.001, ES = 3], SPF[P < 0.001, ES = 0.5], MSF[P < 0.001, ES = 0.67], WAR[P < 0.001, ES = 1.53], POR[P < 0.001, ES = 0.8]), and faster speed, FPF(P < 0.001, ES = 1.33, MSF(P < 0.001, ES = 0.57), WAR(P < 0.001, ES = 0.67), POR(P < 0.001, ES = 2.91)] than the MSI, except SPF(P < 0.001, ES = 0.0) at eight weeks.
The authors concluded that this study suggests that the CFT is associated with better results in clinical and cognitive characteristics than the MSI-based treatment for CNSLBP, and the researchers maintained the treatment effects at six-month follow-up. Also, This study achieved better improvements in gait kinetics in CFT. CTF seems to be an appropriate and applicable treatment in clinical setting.
To understand this study, we need to know what CFT and MSI exactly entailed. Here is the information that the authors provide:
Movement system impairment-based treatment
The movement system impairment-based treatment group received 11 sessions of MSI-based treatment over the 8 weeks for 60 min per session with a supervision of a native speaker experienced (above 5 years) physical therapist with the knowledge of MSI-based treatment. The researchers designed the MSI-based treatment uniquely for each patient based on the interview, clinical examination, and questionnaires, just like they did with the CFT intervention. First, they administered standardized tests to characterize changes in the patient’s low back pain symptoms, and then they modified the treatment to make it more specific based on the participant’s individual symptoms. Depending on the participant’s direction-specific low back pain classification, they performed the intervention following one of the five MSI subgroups namely  rotation,  extension,  flexion,  rotation with extension, and  rotation with flexion. Finally, Patients treated using the standardized MSI protocol as follows:  education regarding normal postures and movements such as sitting, walking, bending, standing, and lying down;  education regarding exercises to perform trunk movements as painlessly as possible; and  prescription of functional exercises to improve trunk movement .
Cognitive functional therapy
Cognitive functional therapy was prescribed for each patient in CFT group based the CFT protocol conducted by O’Sullivan et al. (2015). Patients received supervised 12 sessions of training over the 8-week period with 60 min per session provided with another physical therapist who had been trained in CFT treatment. In this protocol, a physical therapist with more than 5 years of experience conducted an interview and physical examination of the patients to determine their own unique training programs, considering modifiable cognitive, biopsychosocial, functional, and lifestyle behavior factors. The intervention consists of the following 3 main stages:  making sense of pain that is completely reflective, where physical therapist could use the context of the patient’s own story to provide a new understanding of their condition and question their old beliefs  exposure with control which is designed to normalize maladaptive or provocative movement and posture related to activities of daily living that is integrated into each patient’s functional impairments, including teaching how to relax trunk muscles, how to have normal body posture while sitting, lying, bending, lifting, moving, and standing, and how to avoid pain behaviors, which aims to break poor postural habits; and  lifestyle change which is investigating the influence of unhealthy lifestyles in the patient’s pain context. Assessing the individual’s body mass, nutrition, quality of sleep, levels of physical activity or sedentary lifestyle, smoking, and other factors via video calls. Identifying such lifestyle factors helped us to individually advise and design exercise programs, rebuild self-confidence and self-efficacy, promote changes in lifestyle, and design coping strategies.
I must admit that I am not fully convinced.
Firstly, the study was not large and we need – as the authors state – more evidence. Secondly, I am not sure that the results show CFT to be more effective that MSI. They might merely indicate 1) that the bulk of the improvement is due to non-specific effects (e.g. reression towards the mean, natural history of the condition, placebo) and 2) that CFT is less harmful than MSI.
we need not just more but better evidence.