systematic review
Manual therapy is considered a safe and less painful method and has been increasingly used to alleviate chronic neck pain. However, there is controversy about the effectiveness of manipulation therapy on chronic neck pain. Therefore, this systematic review and meta-analysis of randomized controlled trials (RCTs) aimed to determine the effectiveness of manipulative therapy for chronic neck pain.
A search of the literature was conducted on seven databases (PubMed, Cochrane Center Register of Controlled Trials, Embase, Medline, CNKI, WanFang, and SinoMed) from the establishment of the databases to May 2022. The review included RCTs on chronic neck pain managed with manipulative therapy compared with sham, exercise, and other physical therapies. The retrieved records were independently reviewed by two researchers. Further, the methodological quality was evaluated using the PEDro scale. All statistical analyses were performed using RevMan V.5.3 software. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) assessment was used to evaluate the quality of the study results.
Seventeen RCTs, including 1190 participants, were included in this meta-analysis. Manipulative therapy showed better results regarding pain intensity and neck disability than the control group. Manipulative therapy was shown to relieve pain intensity (SMD = -0.83; 95% confidence interval [CI] = [-1.04 to -0.62]; p < 0.0001) and neck disability (MD = -3.65; 95% CI = [-5.67 to – 1.62]; p = 0.004). However, the studies had high heterogeneity, which could be explained by the type and control interventions. In addition, there were no significant differences in adverse events between the intervention and the control groups.
The authors concluded that manipulative therapy reduces the degree of chronic neck pain and neck disabilities.
Only a few days ago, we discussed another systematic review that drew quite a different conclusion: there was very low certainty evidence supporting cervical SMT as an intervention to reduce pain and improve disability in people with neck pain.
How can this be?
Systematic reviews are supposed to generate reliable evidence!
How can we explain the contradiction?
There are several differences between the two papers:
- One was published in a SCAM journal and the other one in a mainstream medical journal.
- One was authored by Chinese researchers, the other one by an international team.
- One included 17, the other one 23 RCTs.
- One assessed ‘manual/manipulative therapies’, the other one spinal manipulation/mobilization.
The most profound difference is that the review by the Chinese authors is mostly on Chimese massage [tuina], while the other paper is on chiropractic or osteopathic spinal manipulation/mobilization. A look at the Chinese authors’ affiliation is revealing:
- Department of Tuina and Spinal Diseases Research, The Third School of Clinical Medicine (School of Rehabilitation Medicine), Zhejiang Chinese Medical University, Hangzhou, China.
- Department of Tuina and Spinal Diseases Research, The Third School of Clinical Medicine (School of Rehabilitation Medicine), Zhejiang Chinese Medical University, Hangzhou, China; Department of Tuina, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China. Electronic address: [email protected].
- Department of Tuina and Spinal Diseases Research, The Third School of Clinical Medicine (School of Rehabilitation Medicine), Zhejiang Chinese Medical University, Hangzhou, China; Department of Tuina, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China. Electronic address: [email protected].
What lesson can we learn from this confusion?
Perhaps that Tuina is effective for neck pain?
No!
What the abstract does not tell us is that the Tuina studies are of such poor quality that the conclusions drawn by the Chinese authors are not justified.
What we do learn – yet again – is that
- Chinese papers need to be taken with a large pintch of salt. In the present case, the searches underpinning the review and the evaluations of the included primary studies were clearly poorly conducted.
- Rubbish journals publish rubbish papers. How could the reviewers and the editors have missed the many flaws of this paper? The answer seems to be that they did not care. SCAM journals tend to publish any nonsense as long as the conclusion is positive.
This systematic review with meta-analysis of randomized clinical trials (RCTs) estimated the benefits and harms of cervical spinal manipulative therapy (SMT) for treating neck pain. The authors searched the MEDLINE, Cochrane CENTRAL, EMBASE, CINAHL, PEDro, Chiropractic Literature Index bibliographic databases, and grey literature sources, up to June 6, 2022.
RCTs evaluating SMT compared to guideline-recommended and non-recommended interventions, sham SMT, and no intervention for adults with neck pain were eligible. Pre-specified outcomes included pain, range of motion, disability, health-related quality of life.
A total of 28 RCTs could be included. There was very low to low certainty evidence that SMT was more effective than recommended interventions for improving pain at short-term (standardized mean difference [SMD] 0.66; confidence interval [CI] 0.35 to 0.97) and long-term (SMD 0.73; CI 0.31 to 1.16), and for reducing disability at short-term (SMD 0.95; CI 0.48 to 1.42) and long-term (SMD 0.65; CI 0.23 to 1.06). Only transient side effects were found (e.g., muscle soreness).
The authors concluded that there was very low certainty evidence supporting cervical SMT as an intervention to reduce pain and improve disability in people with neck pain.
Harms cannot be adequately investigated on the basis of RCT data. Firstly, because much larger sample sizes would be required for this purpose. Secondly, RCTs of spinal manipulation very often omit reporting adverse effects (as discussed repeatedly on this bolg). If we extend our searches beyond RCTs, we find many cases of serious harm caused by neck manipulations (also as discussed repeatedly on this bolg). Therefore, the conclusion of this review should be corrected:
Low certainty evidence exists supporting cervical SMT as an intervention to reduce pain and improve disability in people with neck pain. The evidence of harm is, however, substantial. It follows that the risk/benefit ratio is not positive. Cervical SMT should therefore be discouraged.
This systematic review and meta-analysis assessed the effectiveness of visceral osteopathy in improving pain intensity, disability and physical function in patients with low-back pain (LBP).
MEDLINE (Pubmed), PEDro, SCOPUS, Cochrane Library and Web of Science databases were searched from inception to February 2022. PICO search strategy was used to identify randomized clinical trials applying visceral techniques in patients with LBP. Eligible studies and data extraction were conducted independently by two reviewers. Quality of the studies was assessed with the Physiotherapy Evidence Database scale, and the risk of bias with Cochrane Collaboration tool. Meta-analyses were conducted using random effects models according to heterogeneity assessed with I2 coefficient. Data on outcomes of interest were extracted by a researcher using RevMan 5.4 software.
Five studies were included in the systematic review involving 268 patients with LBP. The methodological quality of the included ranged from high to low and the risk of bias was high. Visceral osteopathy techniques have shown no improvements in pain intensity (Standardized mean difference (SMD) = -0.53; 95% CI; -1.09, 0.03; I2: 78%), disability (SMD = -0.08; 95% CI; -0.44, 0.27; I2: 0%) and physical function (SMD = -0.26; 95% CI; -0.62, 0.10; I2: 0%) in patients with LBP.
The authors concluded that this systematic review and meta-analysis showed a lack of high-quality studies showing the effectiveness of visceral osteopathy in pain, disability, and physical function in patients with LBP.
Visceral osteopathy (or visceral manipulation) is an expansion of the general principles of osteopathy and involves the manual manipulation by a therapist of internal organs, blood vessels and nerves (the viscera) from outside the body.
Visceral osteopathy was developed by Jean-Piere Barral, a registered Osteopath and Physical Therapist who serves as Director (and faculty) of the Department of Osteopathic Manipulation in Paris, France. He stated that through his clinical work with thousands of patients, he created this modality based on organ-specific fascial mobilization. And through work in a dissection lab, he was able to experiment with visceral manipulation techniques and see the internal effects of the manipulations.[1] According to its proponents, visceral manipulation is based on the specific placement of soft manual forces looking to encourage the normal mobility, tone and motion of the viscera and their connective tissues. These gentle manipulations may potentially improve the functioning of individual organs, the systems the organs function within, and the structural integrity of the entire body.[2] Visceral osteopathy comprises of several different manual techniques firstly for diagnosing a health problem and secondly for treating it.
Several studies have assessed the diagnostic reliability of the techniques involved. The totality of this evidence fails to show that they are sufficiently reliable to be od practical use.[3] Other studies have tested whether the therapeutic techniques used in visceral osteopathy are effective in curing disease or alleviating symptoms. The totality of this evidence fails to show that visceral osteopathy works for any condition.[4]
The treatment itself seems to be safe, yet the risks of visceral osteopathy are nevertheless considerable: if a patient suffers from symptoms related to her inner organs, the therapist is likely to misdiagnose them and subsequently mistreat them. If the symptoms are due to a serious disease, this would amount to medical neglect and could, in extreme cases, cost the patient’s life.
My bottom line: if you see visceral osteopathy being employed anywhere, turn araound and seek proper healthcare whatever your illness might be.
References
[1] https://www.barralinstitute.com/about/jean-pierre-barral.php .
[2] http://www.barralinstitute.co.uk/ .
[3] Guillaud A, Darbois N, Monvoisin R, Pinsault N (2018) Reliability of diagnosis and clinical efficacy of visceral osteopathy: a systematic review. BMC Complement Altern Med 18:65
We discussed the 2015 Australian NHMRC report on homeopathy many times before, e.g.:
- Homeopathy: the 2015 NHMRC report and its criticism re-analysed
- HOMEOPATHY: the NHMRC report revisited
- Ombudsman investigates ‘flawed’ homeopathic study
- The final verdict on homeopathy: it’s a placebo
In a nutshell, the report was an hugely influential analysis of the effectiveness of homeopathy which came to squarely negative conclusions. Thus it was celebrated as a thorough and conclusive piece evidence demonstrating the madness of homeopathy. Unsurprisingly, homeopaths did not like it at all and produced various criticisms claiming that it was neither thorough nor conclusive.
Now the final evaluation of what has been going on was finally published (ISSUED BY THE COMMONWEALTH OMBUDSMAN, IAIN ANDERSON, ON 4 AUGUST 2023):
The Office of the Commonwealth Ombudsman (the Office) has finalised an investigation relating to the National Health and Medical Research Council’s (NHMRC) review of the evidence for the effectiveness of homeopathy, conducted between 2010 and 2015. We commenced this investigation in September 2017 in response to concerns raised with us about how the NHMRC review had proceeded.
The Office conducts its investigations in private, and the Ombudsman generally does not make a public statement in the absence of a formal report. In the circumstances of this matter, including that the then-Ombudsman released a public statement on 4 June 2021 which acknowledged the Office was investigating, we believe it is important to share publicly the information we can, now that the investigation is complete.
Our investigation was finalised in July 2023. We acknowledge the length of time the investigation has taken. This is in part due to the extensive efforts the Office made to source independent scientific expertise to advise us on some detailed and specific questions of scientific methodology that were raised with our Office, including some that were only brought to our attention as our investigation progressed. Despite our best efforts, it was not possible to engage an expert (or experts) to provide independent advice to our Office on this subject. In the absence of independent, expert scientific expertise we have not been able to conclusively determine those matters of scientific methodology. This did not prevent our Office from forming a view on other aspects of the matter.
Our investigation did not result in any adverse findings about the review or the NHMRC. When finalising investigations, we may offer comments and suggestions to an agency about areas for future improvement. In this instance, we offered comments and suggestions to the NHMRC about how it records and publicly explains decisions about its activities. The NHMRC also independently made several improvements to its processes during the course of our investigation.
________________
In essence, this means that the conclusions of the report stand:
Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.
Thus the matter is closed – that is closed for rational thinkers. For irrationalists, the matter will no doubt continue to be a stone of contention. No, homeopath will be able to accept these conclusions simply because a member of a cult ceases to be a cultist once he/she accepts the criticism agaist the cult.
As we have recently discussed diet and its effects on health, it seems reasonable to ask whether there is a diet that is demonstrably healthy. A recent investigation attempted to answer this question.
This study was aimed at developing a healthy diet score that is associated with health outcomes and is globally applicable. It used data from the Prospective Urban Rural Epidemiology (PURE) study and tried to replicate it in five independent studies on a total of 245 000 people from 80 countries.
A healthy diet score was developed on the basis of the data from 147 642 people from the general population, from 21 countries in the PURE study. The consistency of the associations of the score with events was examined in five large independent studies from 70 countries.
The healthy diet score was developed based on six foods each of which has been associated with a significantly lower risk of mortality [i.e. fruit, vegetables, nuts, legumes, fish, and dairy (mainly whole-fat); range of scores, 0–6]. The main outcome measures were all-cause mortality and major cardiovascular events [cardiovascular disease (CVD)].
During a median follow-up of 9.3 years in PURE, compared with a diet score of ≤1 point, a diet score of ≥5 points was associated with a lower risk of:
- mortality [hazard ratio (HR) 0.70; 95% confidence interval (CI) 0.63–0.77)],
- CVD (HR 0.82; 0.75–0.91),
- myocardial infarction (HR 0.86; 0.75–0.99),
- stroke (HR 0.81; 0.71–0.93).
In three independent studies with vascular patients, similar results were found, with a higher diet score being associated with lower mortality (HR 0.73; 0.66–0.81), CVD (HR 0.79; 0.72–0.87), myocardial infarction (HR 0.85; 0.71–0.99), and a non-statistically significant lower risk of stroke (HR 0.87; 0.73–1.03). Additionally, in two case-control studies, a higher diet score was associated with lower first myocardial infarction [odds ratio (OR) 0.72; 0.65–0.80] and stroke (OR 0.57; 0.50–0.65). A higher diet score was associated with a significantly lower risk of death or CVD in regions with lower than with higher gross national incomes (P for heterogeneity <0.0001). The PURE score showed slightly stronger associations with death or CVD than several other common diet scores (P < 0.001 for each comparison).
The authors concluded that consumption of a diet comprised of higher amounts of fruits, vegetables, nuts, legumes, and a moderate amount of fish and whole-fat dairy is associated with a lower risk of CVD and mortality in all world regions, but especially in countries with lower income where consumption of these natural foods is low. Similar associations were found with the inclusion of meat or whole grain consumption in the diet score (in the ranges common in the six studies that we included). Our findings indicate that the risks of deaths and vascular events in adults globally are higher with inadequate intake of protective foods.
The authors rightly stress that their analyses have a number of limitations:
First, diet (as in most large epidemiologic studies) was self-reported and variations in reporting might lead to random errors that could dilute real associations between diet scores and clinical outcomes. Therefore, the beneficial effects of a healthier diet may be larger than estimated.
Second, the researchers did not examine the role of individual types of fruits and vegetables as components in the diet score, since the power to detect associations of the different types of fruits and vegetables vs. CVD or mortality is low (i.e. given that the number of events per type of fruit and vegetable was relatively low). Recent evidence suggests that bioactive compounds and, in particular, polyphenols which are found in certain fruit or vegetables (e.g. berries, spinach, and beans) may be especially protective against CVD.
Third, in observational studies, the possibility of residual confounding from unquantified or imprecise measurement of covariates cannot be ruled out—especially given that the differences in risk of clinical events are modest (∼10%–20% relative differences). Ideally, large randomized trials would be needed to clarify the clinical impact on events of a policy of proposing a dietary pattern in populations.
Fourth, the use of the median intake of each food component as a cut-off in the scoring scheme for each diet may not reflect the full range of consumption or provide a meaningful indicator of consumption associated with the disease. However, the use of quintiles instead of medians within each study or within each region yielded the same results indicating the robustness of our findings.
Fifth, the level of intake to meet the cut-off threshold for each food group in the diet score may differ between countries. However, in sensitivity analyses where region-specific median cut-offs were used to classify participants on each component of the diet score, the results were similar to using the overall cohort median of each food component. Further, with unprocessed red meat and whole grains included or excluded from the diet score in these sensitivity analyses, the results were again similar.
Sixth, misclassification of exposures cannot be ruled out as repeat measures of diet were not available in all studies. However, the ORIGIN study, in which repeat diet assessments at 2 years were conducted, showed similar results based on the first vs. second diet assessments. This indicates that misclassification of dietary intake during follow-up was not undermining the findings.
Seventh, one unique aspect of the study is the focus on only protective foods, i.e. a dietary pattern score that highlights what is missing from the food supply, especially in poorer world regions, but this does not negate the importance of limiting the consumption of harmful foods such as highly processed foods. While the PURE diet score had significantly stronger associations with events than other diet scores, the HRs were only slightly larger for PURE than for most other diet scores. However, the Planetary score was the least predictive of events. The analyses provide empirical evidence that all diet scores (other than the Planetary diet score) are of value to predicting death or CVD globally and in all regions of the world.
So, what should we, according to these findings, be looking for and how much of it should we consume? Here is the table that should answer these questions:
| Fruits and vegetables | 4 to 5 servings daily | 1 medium apple, banana, pear; 1 cup leafy vegs; 1/2 cup other vegs |
| Legumes | 3 to 4 servings weekly | 1/2 cup beans or lentils |
| Nuts | 7 servings weekly | 1 oz., tree nuts or peanuts |
| Fish | 2 to 3 servings weekly | 3 oz. cooked (pack of cards size) |
| Dairy | 14 servings weekly | 1 cup milk or yogurt; 1 ½ oz cheese |
| Whole grainsc | Moderate amounts (e.g. 1 serving daily) can be part of a healthy diet | 1 slice (40 g) bread; ½ medium (40 g) flatbread; ½ cup (75–120 g) cooked rice, barley, buckwheat, semolina, polenta, bulgur, or quinoa |
| Unprocessed meatsc | Moderate amounts (e.g. 1 serving daily) can be part of a healthy diet | 3 oz. cooked red meat or poultry |
Charles has a well-documented weakness for so-called alternative medicine (SCAM) – not just any SCAM but predominantly the type of SCAM that is both implausible and ineffective. Therefore, nobody can be all that surprised to read in THE TIMES that he has decided to use SCAM for helping women who have difficulties getting pregnant.
If one really wanted to employ SCAM for this aim one is spoilt for choice. In fact, there are only few SCAMs that don’t claim to be useful for this purpose.
A recent review, for instance, suggested that some supplements might be helpful. Other authors advocate SCAMs such as acupuncture, moxibustion, Chinese herbal medicine, psychological intervention, biosimilar electrical stimulation, homeopathy, or hyperbaric oxygen therapy.
Yes, I know! The evidence for these treatments is lousy, and I would never issue a recommendation based on such flimsy evidence.
Yet, the SCAM project at Dumfries House, the Scottish stately home Charles restored in 2007, offers acupuncture, reflexology, massage, yoga, and hypnotherapy for infertile women.
REFLEXOLOGY for female infertility?
Reflexology, also called zone therapy, is a manual treatment where pressure is applied usually to the sole of the patient’s foot and sometimes also to other areas such as the hands or ears. According to its proponents, foot reflexology is more than a simple foot massage that makes no therapeutic claims beyond relaxation. It is based on the idea that the human body is divided into 10 zones each of which is represented on the sole of the foot. Reflexologists employ maps of the sole of the foot where the body’s organs are depicted. By massaging specific zones which are assumed to be connected to specific organs, reflexologists believe to positively influence the function of these organs. While reflexology is mostly used as a therapy, some therapists also claim they can diagnose health problems through feeling tender or gritty areas on the sole of the foot which, they claim, correspond to specific organs.
Reflexology is not merely implausible as a treatment for infertility, it also boasts of some fairly rigorous trial evidence. A clinical trial (perhaps even the most rigorous of all the trials of SCAM for female fertility problems) testing whether foot reflexology might have a positive effect on the induction of ovulation stated that “the results suggest that any effect on ovulation would not be clinically relevant”.
So, as so often before in the realm of SCAM, Charles has demonstrated that his lack of critical thinking leads him to the least promising options.
Well done, Your Majesty!
Diabetic peripheral neuropathy (DPN) is a common complication of diabetes mellitus (DM) that can cause annoying symptoms. To address this condition, several treatment approaches have been proposed, including static magnetic field (SMF) therapy, which has shown promise in treating neurological conditions. Therefore, this study aimed to investigate the effects of SMF therapy on symptomatic DPN and the quality of life (QoL) in patients with type 2 diabetes.
A double-blind, randomized, placebo-controlled trial was conducted from April to October 2021. Sixty-four DPN patients (20 males, 44 females) were recruited for the study via invitation. The participants were divided into two groups: the magnet group, which used magnetic ankle bracelets (155 mT) for 12 weeks, and the sham group, which used non-magnetic ankle bracelets for the same duration. Neuropathy Symptom Score (NSS), Neuropathic Disability Score (NDS), and Visual Analogue Scale (VAS) were used to assess neuropathy symptoms and pain. In addition, the Neuropathy Specific Quality of Life Questionnaire (Neuro-QoL) tool was used to measure the patients’ quality of life.
Before treatment, there were no significant differences between the magnet and sham groups in terms of the NSS scores (P = 0.50), NDS scores (P = 0.74), VAS scores (P = 0.17), and Neuro-QoL scores (P = 0.82). However, after 12 weeks of treatment, the SMF exposure group showed a significant reduction in NSS scores (P < 0.001), NDS scores (P < 0.001), VAS scores (P < 0.001), and Neuro-QoL scores (P < 0.001) compared to the baseline. The changes in the sham group, on the other hand, were not significant.
The authors concluded that according to obtained data, SMF therapy is recommended as an easy-to-use and drug-free method for reducing DPN symptoms and improving QoL in diabetic type-2 patients.
Our own study and systematic review of the effects of magnetic bracelets and similar devices suggested that the effects of such treatments are due to placebo responses. Therefore, I find the findings of this new study most surprising. Not only that, to be honest, I also find them suspect. Apart from the fact that the treatment has no biological plausibility, I have three main reasons for my skepticism.
- The authors stated that there was no distinguishable difference between the sham and SMF devices in terms of their appearance, weight, or texture, which helped to ensure that the study was double-blinded. This is nonsense, I am afraid! The verum device is magnetic and the sham device is not. It is hardly conceivable that patients who handle such devices for any length of time do not discover this simple fact and thus de-blind themselves. In turn, this means that a placebo effect can easily explain the outcomes.
- Authors who feel that their tiny study of a highly implausible therapy lends itself to concluding that their therapy ‘is recommended as an easy-to-use and drug-free method for reducing DPN symptoms and improving QoL’ can, in my view, not be taken seriously.
- Something that always makes me suspicious of clinical trials is a lack of a placebo response where one would normally expect one. In this study, the control group exhibits hardly any placebo response. Wearing a strap around your ankle that allegedly emits therapeutic radiation would result in quite a strong placebo effect, according to our own findings.
So, forgive me if I do not trust this study any further than I can throw it! And pardon me if I still think that our previous conclusion is correct: The evidence does not support the use of static magnets for pain relief, and therefore magnets cannot be recommended as an effective treatment.
This systematic review evaluated all available randomized controlled trials (RCTs) investigating the clinical effects of hydrotherapy according to Kneipp which is characterized by cold water applications. All RCTs on therapy and prevention with Kneipp hydrotherapy were included. Study participants were patients and healthy volunteers of all age groups. MEDLINE (via PubMed), Scopus, Central, CAMbase, and opengrey.eu were systematically searched through April 2021 without language restrictions and updated by searching PubMed until April 6th 2023. The risk of bias was assessed using the Cochrane tool version 1.
Twenty RCTs (N=4247) were included. Due to the high heterogeneity of the RCTs, no meta-analysis was performed. The risk of bias was rated as unclear in most of the domains. Of 132 comparisons, 46 showed significant positive effects in favor of hydrotherapy on chronic venous insufficiency, menopausal symptoms, fever, cognition, emotional function, and sickness absenteeism. However, 81 comparisons showed no differences between groups, and 5 were in favor of the respective control group. Only half of the studies reported safety issues.
The authors concluded that although RCTs on Kneipp hydrotherapy seem to show positive effects in some conditions and outcomes, it remains difficult to ascertain treatment effects due to the high risk of bias and heterogeneity of most of the considered studies. Further high-quality RCTs on Kneipp hydrotherapy are urgently warranted.
This is certainly the best review of the subject so far. It makes it very clear that the evidence for Kneipp hydrotherapy is weak, mostly because of the many flaws in the primary studies. One needs to add, I think, that 20 RCTs are an absurdly small amount considering that many indications this type of therapy is advocated for – many enthusiasts even consider it a panacea.
It follows, I fear, that Kneipp hydrotherapy is almost entirely not evidence-based. This should be bad news for the numerous institutions and Spa towns (mostly in Germany) that live on employing this treatment and telling patients that it is effective. They usually claim that experience shows this to be true. But this was the mantra of medicine ~100 years ago. Since then, we have learned that experience is a very poor guide that regularly leads us up the garden path.
Kneippians will counter that clinical trials are difficult to conduct and expensive to finance. Both arguments are of course true but, considering that an entire industry lives on telling patients something that essentially amounts to a lie (i.e. the claim that it works), it surely is obligatory to overcome these obstacles.
There is widespread agreement amongst clinicians that people with non-specific low back pain (NSLBP) comprise a heterogeneous group and that their management should be individually tailored. One treatment known by its tailored design is the McKenzie method (e.g. an individualized program of exercises based on clinical clues observed during assessment) used mostly but not exclusively by physiotherapists.
A recent Cochrane review evaluated the effectiveness of the McKenzie method in people with (sub)acute non-specific low back pain. Randomized clinical trials (RCTs) investigating the effectiveness of the McKenzie method in adults with (sub)acute (less than 12 weeks) NSLBP.
Five RCTs were included with a total of 563 participants recruited from primary or tertiary care. Three trials were conducted in the USA, one in Australia, and one in Scotland. Three trials received financial support from non-commercial funders and two did not provide information on funding sources. All trials were at high risk of performance and detection bias. None of the included trials measured adverse events.
McKenzie method versus minimal intervention (educational booklet; McKenzie method as a supplement to other intervention – main comparison) There is low-certainty evidence that the McKenzie method may result in a slight reduction in pain in the short term (MD -7.3, 95% CI -12.0 to -2.56; 2 trials, 377 participants) but not in the intermediate term (MD -5.0, 95% CI -14.3 to 4.3; 1 trial, 180 participants). There is low-certainty evidence that the McKenzie method may not reduce disability in the short term (MD -2.5, 95% CI -7.5 to 2.0; 2 trials, 328 participants) nor in the intermediate term (MD -0.9, 95% CI -7.3 to 5.6; 1 trial, 180 participants).
McKenzie method versus manual therapy There is low-certainty evidence that the McKenzie method may not reduce pain in the short term (MD -8.7, 95% CI -27.4 to 10.0; 3 trials, 298 participants) and may result in a slight increase in pain in the intermediate term (MD 7.0, 95% CI 0.7 to 13.3; 1 trial, 235 participants). There is low-certainty evidence that the McKenzie method may not reduce disability in the short term (MD -5.0, 95% CI -15.0 to 5.0; 3 trials, 298 participants) nor in the intermediate term (MD 4.3, 95% CI -0.7 to 9.3; 1 trial, 235 participants).
McKenzie method versus other interventions (massage and advice) There is very low-certainty evidence that the McKenzie method may not reduce disability in the short term (MD 4.0, 95% CI -15.4 to 23.4; 1 trial, 30 participants) nor in the intermediate term (MD 10.0, 95% CI -8.9 to 28.9; 1 trial, 30 participants).
The authors concluded that, based on low- to very low-certainty evidence, the treatment effects for pain and disability found in our review were not clinically important. Thus, we can conclude that the McKenzie method is not an effective treatment for (sub)acute NSLBP.
The hallmark of the McKenzie method for back pain involves the identification and classification of nonspecific spinal pain into homogenous subgroups. These subgroups are based on the similar responses of a patient’s symptoms when subjected to mechanical forces. The subgroups include postural syndrome, dysfunction syndrome, derangement syndrome, or “other,” with treatment plans directed to each subgroup. The McKenzie method emphasizes the centralization phenomenon in the assessment and treatment of spinal pain, in which pain originating from the spine refers distally, and through targeted repetitive movements the pain migrates back toward the spine. The clinician will then use the information obtained from this assessment to prescribe specific exercises and advise on which postures to adopt or avoid. Through an individualized treatment program, the patient will perform specific exercises at home approximately ten times per day, as opposed to 1 or 2 physical therapy visits per week. According to the McKenzie method, if there is no restoration of normal function, tissue healing will not occur, and the problem will persist.
Classification:
The postural syndrome is pain caused by mechanical deformation of soft tissue or vasculature arising from prolonged postural stresses. These may affect the joint surfaces, muscles, or tendons, and can occur in sitting, standing, or lying. Pain may be reproducible when such individuals maintain positions or postures for sustained periods. Repeated movements should not affect symptoms, and relief of pain typically occurs immediately following the correction of abnormal posture.
The dysfunction syndrome is pain caused by the mechanical deformation of structurally impaired soft tissue; this may be due to traumatic, inflammatory, or degenerative processes, causing tissue contraction, scarring, adhesion, or adaptive shortening. The hallmark is a loss of movement and pain at the end range of motion. Dysfunction has subsyndromes based upon the end-range direction that elicits this pain: flexion, extension, side-glide, multidirectional, adherent nerve root, and nerve root entrapment subsyndromes. Successful treatment focuses on patient education and mobilization exercises that focus on the direction of the dysfunction/direction of pain. The goal is on tissue remodeling which can be a prolonged process.
The derangement syndrome is the most commonly encountered pain syndrome, reported in one study to have a prevalence as high as 78% of patients classified by the McKenzie method. It is caused by an internal dislocation of articular tissue, causing a disturbance in the normal position of affected joint surfaces, deforming the capsule, and periarticular supportive ligaments. This derangement will both generate pain and obstruct movement in the direction of the displacement. There are seven different subsyndromes which are classified by the location of pain and the presence, or absence, of deformities. Pain is typically elicited by provocative assessment movements, such as flexion or extension of the spine. The centralization and peripheralization of symptoms can only occur in the derangement syndrome. Thus the treatment for derangement syndrome focuses on repeated movement in a single direction that causes a gradual reduction in pain. Studies have shown approximately anywhere between 58% to 91% prevalence of centralization of lower back pain. Studies have also shown that between 67% to 85% of centralizers displayed the directional preference for a spinal extension. This preference may partially explain why the McKenzie method has become synonymous with spinal extension exercises. However, care must be taken to accurately diagnose the direction of pain, as one randomized controlled study has shown that giving the ‘wrong’ direction of exercises can actually lead to poorer outcomes.
Other or Nonmechanical syndrome refers to any symptom that does not fit in with the other mechanical syndromes, but exhibits signs and symptoms of other known pathology; Some of these examples include spinal stenosis, sacroiliac disorders, hip disorders, zygapophyseal disorders, post-surgical complications, low back pain secondary to pregnancy, spondylolysis, and spondylolisthesis.
CONCLUSION:
“Internationally researched” and found to be ineffective!
I have seen some daft meta-analyses in my time – this one, however, takes the biscuit. Here is its unaltered abstract:
Although mindfulness-based mind-body therapy (MBMBT) is an effective non-surgical treatment for patients with non-specific low back pain (NLBP), the best MBMBT mode of treatment for NLBP patients has not been identified. Therefore, a network meta-analysis (NMA) was conducted to compare the effects of different MBMBTs in the treatment of NLBP patients.
Methods: PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and Web of Science databases were searched for randomized controlled trials (RCTs) applying MBMBT for the treatment of NLBP patients, with all of the searches ranging from the time of database creation to January 2023. After 2 researchers independently screened the literature, extracted information, and evaluated the risks of biases in the included studies, the data were analyzed by using Stata 16.0 software.
Results: A total of 46 RCTs were included, including 3,886 NLBP patients and 9 MBMBT (Yoga, Ayurvedic Massage, Pilates, Craniosacral Therapy, Meditation, Meditation + Yoga, Qigong, Tai Chi, and Dance). The results of the NMA showed that Craniosacral Therapy [surface under the cumulative ranking (SUCRA): 99.2 and 99.5%] ranked the highest in terms of improving pain and disability, followed by Other Manipulations (SUCRA: 80.6 and 90.8%) and Pilates (SUCRA: 54.5 and 71.2%). In terms of improving physical health, Craniosacral Therapy (SUCRA: 100%) ranked the highest, followed by Pilates (SUCRA: 72.3%) and Meditation (SUCRA: 55.9%). In terms of improving mental health, Craniosacral Therapy (SUCRA: 100%) ranked the highest, followed by Meditation (SUCRA: 70.7%) and Pilates (SUCRA: 63.2%). However, in terms of improving pain, physical health, and mental health, Usual Care (SUCRA: 7.0, 14.2, and 11.8%, respectively) ranked lowest. Moreover, in terms of improving disability, Dance (SUCRA: 11.3%) ranked lowest.
Conclusion: This NMA shows that Craniosacral Therapy may be the most effective MBMBT in treating NLBP patients and deserves to be promoted for clinical use.
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This meta-analysis has too many serious flaws to mention. Let me therefore just focus on the main two:
- Craniosacral Therapy is not an MBMBT.
- Craniosacral Therapy is not effective for NLBP. The false positive result was generated on the basis of 4 studies. All of them have serious methodological problems that prevent an overall positive conclusion about the effectiveness of this treatment. In case you don’t believe me, here are the 4 abstracts:
1) Background and objectives: The study aimed to compare the effectiveness of craniosacral therapy (CST), muscle energy technique (MET), and sensorimotor training (SMT) on pain, disability, depression, and quality of life of patients with non-specific chronic low back pain (NCLBP).
Methodology: In this randomized clinical trial study 45 patients with NCLBP were randomly divided in three groups including CST, SMT, and MET. All groups received 10 sessions CST, SMT, and MET training in 5 weeks. Visual analogue scale (VAS), Oswestry functional disability questionnaire (ODQ), Beck depression inventory-II (BDI-II), and 36-item short form health survey (SF-36) were used to evaluate the pain, disability, depression, and quality of life, respectively, in three times, before treatment, after the last session of treatment, and after 2 months follow up.
Results: The Results showed that VAS, ODI, BDI, and SF-36 changes were significant in the groups SMT, CST and MET (p < 0.001, p < 0.001, p < 0.001). The VAS, ODI, BDI, and SF-36 changes in post-treatment and follow-up times in the CST group were significantly different in comparison to SMT group, and the changes in VAS, ODI, BDI, and SF-36 at after treatment and follow-up times in the MET group compared with the CST group had a significant difference (p < 0.001).
Conclusion: Craniosacral therapy, muscle energy technique, and sensorimotor training were all effective in improvement of pain, depression, functional disability, and quality of life of patients with non-specific chronic low back pain. Craniosacral therapy is more effective than muscle energy technique, and sensorimotor training in post-treatment and follow up. The effect of craniosacral therapy was continuous after two months follow up.
2) Background: Craniosacral therapy (CST) and sensorimotor training (SMT) are two recommended interventions for nonspecific chronic low back pain (NCLBP). This study compares the effects of CST and SMT on pain, functional disability, depression and quality of life in patients with NCLBP.
Methodology: A total of 31 patients with NCLBP were randomly assigned to the CST group (n=16) and SMT (n=15). The study patients received 10 sessions of interventions during 5 weeks. Visual analogue scale (VAS), Oswestry disability index (ODI), Beck depression inventory-II (BDI-II), and Short Form-36 (SF-36) questionnaires were used at baseline (before the treatment), after the treatment, and 2 months after the last intervention session. Results were compared and analyzed statistically.
Results: Both groups showed significant improvement from baseline to after treatment (p < 0.05). In the CST group, this improvement continued during the follow-up period in all outcomes (p < 0.05), except role emotional domain of SF-36. In the SMT group, VAS, ODI and BDI-II increased during follow-up. Also, all domains of SF-36 decreased over this period. Results of group analysis indicate a significant difference between groups at the end of treatment phase (p < 0.05), except social functioning.
Conclusions: Results of our research confirm that 10 sessions of craniosacral therapy (CST) or sensorimotor training (SMT) can significantly control pain, disability, depression, and quality of life in patients with NCLBP; but the efficacy of CST is significantly better than SMT.
3) Background: Non-specific low back pain is an increasingly common musculoskeletal ailment. The aim of this study was to examine the utility of craniosacral therapy techniques in the treatment of patients with lumbosacral spine overload and to compare its effectiveness to that of trigger point therapy, which is a recognised therapeutic approach.
Material and methods: The study enrolled 55 randomly selected patients (aged 24-47 years) with low back pain due to overload. Other causes of this condition in the patients were ruled out. The participants were again randomly assigned to two groups: patients treated with craniosacral therapy (G-CST) and patients treated with trigger point therapy (G-TPT). Multiple aspects of the effectiveness of both therapies were evaluated with the use of: an analogue scale for pain (VAS) and a modified Laitinen questionnaire, the Schober test and surface electromyography of the multifidus muscle. The statistical analysis of the outcomes was based on the basic statistics, the Mann-Whitney U test and Wilcoxon’s signed rank test. The statistical significance level was set at p≤0.05.
Results: Both groups demonstrated a significant reduction of pain measured with the VAS scale and the Laitinen questionnaire. Moreover, the resting bioelectric activity of the multifidus muscle decreased significantly in the G-CST group. The groups did not differ significantly with regard to the study parameters.
Conclusions: 1. Craniosacral therapy and trigger point therapy may effectively reduce the intensity and frequency of pain in patients with non-specific low back pain. 2. Craniosacral therapy, unlike trigger point therapy, reduces the resting tension of the multifidus muscle in patients with non-specific lumbosacral pain. The mechanism of these changes requires further research. 3. Craniosacral therapy and trigger point therapy may be clinically effective in the treatment of patients with non-specific lumbosacral spine pain. 4. The present findings represent a basis for conducting further and prospective studies of larger and randomized samples.
4) Background: Non-specific low back pain is an increasingly common musculoskeletal ailment. The aim of this study was to examine the utility of craniosacral therapy techniques in the treatment of patients with lumbosacral spine overload and to compare its effectiveness to that of trigger point therapy, which is a recognised therapeutic approach.
Material and methods: The study enrolled 55 randomly selected patients (aged 24-47 years) with low back pain due to overload. Other causes of this condition in the patients were ruled out. The participants were again randomly assigned to two groups: patients treated with craniosacral therapy (G-CST) and patients treated with trigger point therapy (G-TPT). Multiple aspects of the effectiveness of both therapies were evaluated with the use of: an analogue scale for pain (VAS) and a modified Laitinen questionnaire, the Schober test and surface electromyography of the multifidus muscle. The statistical analysis of the outcomes was based on the basic statistics, the Mann-Whitney U test and Wilcoxon’s signed rank test. The statistical significance level was set at p≤0.05.
Results: Both groups demonstrated a significant reduction of pain measured with the VAS scale and the Laitinen questionnaire. Moreover, the resting bioelectric activity of the multifidus muscle decreased significantly in the G-CST group. The groups did not differ significantly with regard to the study parameters.
Conclusions: 1. Craniosacral therapy and trigger point therapy may effectively reduce the intensity and frequency of pain in patients with non-specific low back pain. 2. Craniosacral therapy, unlike trigger point therapy, reduces the resting tension of the multifidus muscle in patients with non-specific lumbosacral pain. The mechanism of these changes requires further research. 3. Craniosacral therapy and trigger point therapy may be clinically effective in the treatment of patients with non-specific lumbosacral spine pain. 4. The present findings represent a basis for conducting further and prospective studies of larger and randomized samples.
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I REST MY CASE
