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

back pain

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Charles III is about to pay his first visit to France, his second visit to any state. Earlier this year, he has already visited Germany. Originally, France had been first on his list but the event was cancelled in view of the violent protests that rocked the country at the time. Now he is definitely expected and the French are exited. I am currently in France and have been asked to give several interviews on the king’s love affair with so-called alternative medicine (SCAM).

The French have long been fascinated by our royal family which seems a bit odd considering what they did to their own. Now that Charles and Camilla are about to appear with an entourage of about 50 servants between them, the press is full with slightly bemused reports and comments:

Since childhood, Charles has been accustomed to a luxurious, gilded life, which is reproduced on every trip outside the royal palaces, to ensure maximum service, comfort and security… The new king always travels with his private secretary, Sir Clive Alderton, his press advisor, his steward, his doctor, his personal valets, his security guards, and his private chauffeur, Tim Williams… And, of course, his regular osteopath to relieve his lower back. Since he’s had a lot of falls playing polo, Charles regularly suffers from back pain…”.

Really, just an osteopath?

What about all the other SCAM-practitioners whose businesses Charles so regularly supported in the past:

  • · Acupuncture
  • · Aromatherapy
  • · Ayurveda
  • · Chiropractic
  • · Detox
  • · Gerson therapy
  • · Herbal medicine
  • · Homeopathy
  • · Iridology
  • · Marma massage
  • · Massage therapy
  • · Pulse diagnosis
  • · Reflexology
  • · Tongue diagnosis
  • · Traditional Chinese Medicine
  • · Yoga

Will they not be disappointed?

I do wonder who Charles’ osteopath and doctor are. Are they competent? I am sure they both must be well-informed and evidence-based experts. If that is the case, they will have, of course, told Charles that osteopathy is hardly an optimal solution for an injured back.

In any case, now I am concerned about the royal back and therefore urgently recommend that HIS MAJESTY reads some of my previous posts on the subject, e.g.:

Let’s hope all goes well here in France, and please let’s not be so akward as to ask about the environmental aspects – we all know how worried Charles truly is about not just his health but also the health of the planet – of moving such an entourage for a two-day visit.

PS

Charles flew in a private jet from London to Paris and took his Bentley with him.

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 [1] rotation, [2] extension, [3] flexion, [4] rotation with extension, and [5] rotation with flexion. Finally, Patients treated using the standardized MSI protocol as follows: [1] education regarding normal postures and movements such as sitting, walking, bending, standing, and lying down; [2] education regarding exercises to perform trunk movements as painlessly as possible; and [3] prescription of functional exercises to improve trunk movement [32].

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: [1] 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 [2] 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 [3] 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.

My conclusion:

we need not just more but better evidence.

This study aimed to compare the effectiveness of three distinct interventions – Yoga, Naturopathy, and Conventional medical management – in alleviating pain, reducing disability, enhancing spinal mobility, and improving the quality of life in individuals with low back pain. Ninety participants were recruited and randomly divided into three groups.

  • The first group (group 1) received Yoga,
  • the second group (group 2) received Naturopathy treatments,
  • the third group served as the control and received conventional medications.

Visual Analogue Scale (VAS) scores, Oswestry Disability Index (ODI), Flexion Test-Finger to Floor Test (FTFT) results, and Quality of Life (QOL) were assessed at baseline and after a 10-day intervention period for all groups.

Overall comparisons between the groups, utilizing ANOVA, revealed marked differences in pain severity, disability index, daily functional capacity, and Quality of Life (QoL) improvements following respective interventions. Substantial improvements were also noted within the yoga and naturopathic medicine groups across multiple variables.

The authors concluded that the results of this comparative analysis emphasize the effectiveness of Yoga, Naturopathy, and Conventional Medical Treatment in managing low back pain. All three interventions demonstrated significant improvements in pain intensity, disability, spinal mobility, and quality of life. This study contributes valuable insights into the diverse therapeutic approaches for low back pain management, highlighting the potential of holistic and alternative treatments to enhance patients’ well-being.

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This is a remarkably poor study. Its flaws are too numerous to account for them all here. Let me focus on just a three that stand out.

  1. All we learn about the 3 treatment regimen is this (and it clearly not enough to do an independent replication of this trial):

Yoga Group:

Participants in the Yoga Group underwent a specifically designed integrated approach of Yoga therapy (IAYT) for back pain, incorporating relaxation techniques, spinal movements, breathing exercises, pranayama, and deep relaxation techniques. The intervention was conducted by qualified yoga instructors at SDM College of Naturopathy and Yogic Sciences.

Naturopathy Group:

Participants in the Naturopathy Group received neutral spinal baths and partial massages. The spinal bath was administered at Government Yoga & Nature Cure Out Patient Center, Puttur, and massages were performed by trained naturopathy therapists.

Conventional Medicine Group:

Participants in the Conventional Medicine Group received standard medical treatments for low back pain as recommended by orthopedic physicians from S.D.M Medical College, Dharward

  1. As an equivalence trial, the sample size of this study is far too small. This means that its findings are most likely caused by coincidence and not by the interventions applied.
  2. There was no attempt of blinding the patients. Therefore, the results – if they were otherwise trustworthy – would be dominated by expectations and not by the effects of the treatments.

Altogether, this study is, I think, a good example for the fact that

poor research often is worse than no research at all.

An impressive article by John Mac Ghlionn caught my attention. Allow me to quote a few passages from it:

The U.S. House of Representatives and the U.S. Senate recently reintroduced legislation to increase access to Medicare-covered services provided by chiropractors. Last year, the US chiropractic market size was worth $13.13 Billion. By the end of the decade, it will be worth over $18 billion. Each year, a whopping 35 million Americans seek chiropractic care.

But why? It’s a questionable science full of questionable characters.

Last year, a Georgia woman was left paralyzed and unable to speak after receiving a neck adjustment from a chiropractor. She’s not the first person to have had her life utterly ruined by a chiropractor, and chances are she won’t be the last. Many patients who visit chiropractors suffer severe side effects; some lose their lives

As Dr. Steven Novella has noted, what used to be fraud is now known as holistic medicine. Dr. Edzard Ernst, a retired British-German physician and researcher, has expertly demonstrated the many ways in which chiropractic treatments are rooted not in science, but in mystical concepts…

Spinal adjustments, also known as “subluxations,” are also common. A dangerous practice that has been heavily criticized, spinal manipulations are associated with a number of adverse effects, including the risk of stroke. As Dr. Ernst has noted, the cost-effectiveness of this particular treatment “has not been demonstrated beyond reasonable doubt.”

Not content with spinal and neck manipulations, some chiropractors offer to treat other conditions — like diabetes, for example. They are not trained to treat diabetes. Other chiropractors appear to take joy in torturing infants. In August of 2018, a chiropractor made headlines for all the wrong reasons when a video emerged showing him hanging a two-week-old newborn upside down by the ankles

Finally, as I alluded to earlier, the chiropractic community is full of fraudsters. In 2019, in the US, 15 chiropractors were charged in an insurance fraud and illegal kickback operation. More recently, in February of this year, a New York federal judge sentenced Patrick Khaziran to 30 months in prison after he pleaded guilty to being part of a widespread scheme that defrauded the NBA out of at least $5 million. In recent times, the chiropractic community has come under scrutiny for abusive care and illegal billing practices. When it comes to instances of healthcare fraud, chiropractic medicine is unrivaled.

None of this should come as a surprise. After all, the entire chiropractic community was constructed on a foundation of lies. As the aforementioned Dr. Ernst told me, we should be skeptical of what chiropractors are offering, largely because the whole practice was founded “by a deluded charlatan, who insisted that all human diseases are due to subluxations of the spine. Today, we know that chiropractic subluxations are mere figments of Palmer’s imagination. Yet, the chiropractic profession is unable to separate itself from the myth. It is easy to see why: without it, they would at best become poorly trained physiotherapists without any raison d’etre.”

… Dr. William T. Jarvis famously referred to chiropractic as “the most significant nonscientific health-care delivery system in the United States.” Comparing the chiropractic community to a cult, Dr. Jarvis wondered, somewhat incredulously, why chiropractors are licensed to practice in all 50 US states. The entire profession, he warned, “should be viewed as a societal problem, not simply as a competitor of regular health-care.”

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In my view, this is an impressive article, not least because it is refreshingly devoid of the phenomenon known as ‘false balance, e.g. a chiropractor being invited to add his self-interested views at the end of the paper claiming, for instance, “we have years of experience and cause far less harm than real doctors”.

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:

  1. Craniosacral Therapy is not an MBMBT.
  2. 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

 

This study allegedly evaluated the efficacy of osteopathic manipulative therapy (OMT) compared to that of the Kaltenborn-Evjenth Orthopedic Manipulative Therapy (KEOMT) for patients with chronic LBP.

It included 68 participants of both genders, aged 30 to 60, with chronic LBP. Participants were randomly assigned to one of two parallel groups, each with 34 members. The OMT group received, as a direct technique, a high-velocity/low-amplitude (HVLA) impulse, and as indirect techniques, strain counterstrain (SCS), myofascial release (MFR), and visceral mobilization therapy (VMT). The KEOMT group received lumbar segmental traction and lumbar segmental mobilization-flexion and gliding therapy grade 3. The participants in both groups received 10 treatments, two per week for five weeks. The primary outcome was pain severity, using a numeric pain rating scale (NPRS). The secondary outcome was the measurement of functional disability, using the Oswestry Disability Index (ODI).

The OMT and KEOMT both decreased pain and disability; however, the changes on the NPRS and ODI postintervention were statistically greater for the OMT group compared to the KEOMT group (P < .05).

The authors concluded that the OMT was better at reducing pain and improving quality of life. It reduced functional disability more than KEOMT in patients with chronic LBP.

The Kaltenborn-Evjenth Orthopedic Manipulative Therapy (KEOMT) concept is a treatment and training system based upon a comprehensive biomechanical evaluation of the arthro-neuro-muscular system and an individual’s functional abilities. This system of diagnosis and patient management applies to both patients with acute, subacute and chronic conditions of the spine and extremities and to athletes seeking to improve performance. It offers a reliable and practical approach that focuses on optimal physical health and function.

Has the KEOMT concept been tested and shown to be effective for LBP?

No!

So, what we have here is an equivalence trial of two manual techniques. As such it is FAR too small to yield a meaningful result. If the findings were meaningful, would they show that OMT is effective?

No!

As we have no proof that KEOMT does not impede recovery from LBP, the result could merely be due to the fact that OMT does not influence the natural history of LBP, while KEOMT has a detrimental effect.

Last question: which journal publishes such rubbish?

Ahh, it’s the remarkable Alternative therapies in health and medicine. That explains a lot!

 

This trial investigated the effect of osteopathic visceral manipulation (OVM) on disability and pain intensity in individuals with functional constipation and chronic nonspecific low back pain. It was designed as a randomized controlled trial with a blinded assessor. Seventy-six volunteers with functional constipation and chronic nonspecific low back pain were randomized to two groups: OVM and sham OVM. The primary clinical outcome was pain intensity measured using a numeric rating scale (NRS) and disability measured using the Oswestry Disability Index (ODI). The secondary outcomes were electromyographic signals measured during the flexion-extension cycle, the finger-to-floor distance during complete flexion of the trunk, and the Fear-Avoidance Beliefs Questionnaire (FABQ). All outcomes were determined after six weeks of treatment as well as three months after randomization.

The OVM group reported a reduction in pain intensity after six weeks of treatment and at the three-month evaluation (p < .0002) and the sham group reported a reduction in pain intensity after three-month evaluation (p < .007). For the ODI was also found in the OVM group six weeks after the end of treatment (treatment effect = -6.59, 95% CI: -12.01 to -1.17, p = .01) and at the three-month evaluation (treatment effect = -6.02, 95% CI: -11.55 to -0.49, p = .03). Significant differences were also found for paravertebral muscle activity during the dynamic phases (flexion and extension) six-week evaluations.

The authors concluded that the OVM group demonstrated a reduction in pain intensity and improvement in disability after six-weeks and three-month follow-up while the sham group reduction in pain three-month follow-up.

I have no access to the full paper (if someone can send me the paper, I would update my post accordingly), but from reading the abstract, it seems the reported findings are based on within-group changes. The whole point of having a control group is to compare verum and control. The other point of importance is that it would have been crucial to verify whether patients were able to tell the verum from the sham intervention. If patients were able to tell, they would no longer be blinded and the placebo effect would have not been accounted for. A third point of relevance might be that the study seems tiny and far too small for drawing general conclusions about the value of OVM.

_________________________

I have now seen the protocol of the paper – thanks for making it available – and might add the following points to the discussion:

  • The sham treatment consisted of  “light touches over the different parts of the abdomen, without any deep mobilization or movement. The osteopath applied her hands over the same points with the
    same duration as in OVM to give the patient the perception of being treated.” It is likely that patients in the control group could have guessed that they were sham-treated.
  • The stats issue cannot be resolved on the basis of just the protocol.
  • “To assess patients’ blinding to treatment allocation, patients are asked post treatment (six weeks after
    the start of treatment) to report which study treatment they think that they received (OVM/SOVM). The effect of their reports on outcome will be examined in explorative analysis.” As I have no

access to the results, I still do not know whether blinding was successful.

Lumbosacral Radicular Syndrome (LSRS) is a condition characterized by pain radiating in one or more dermatomes (Radicular Pain) and/or the presence of neurological impairments (Radiculopathy). So far, different reviews have investigated the effect of HVLA (high-velocity low-amplitude) spinal manipulations in LSRS. However, these studies included ‘mixed’ population samples (LBP patients with or without LSRS) and treatments other than HVLA spinal manipulations (e.g., mobilisation, soft tissue treatment, etc.). Hence, the efficacy of HVLAT in LSRS is yet to be fully understood.

This review investigated the effect and safety of HVLATs on pain, levels of disability, and health-related quality of life in LSRS, as well as any possible adverse events.

Randomized clinical trials (RCTs) published in English in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (PubMed), EMBASE, PEDro, and Web of Science were identified. RCTs on an adult population (18-65 years) with LSRS that compared HVLATs with other non-surgical treatments, sham spinal manipulation, or no intervention were considered. Two authors selected the studies, extracted the data, and assessed the methodological quality through the ‘Risk of Bias (RoB) Tool 2.0’ and the certainty of the evidence through the ‘GRADE tool’. A meta-analysis was performed to quantify the effect of HVLA on pain levels.

A total of 308 records were retrieved from the search strings. Only two studies met the inclusion criteria. Both studies were at high RoB. Two meta-analyses were performed for low back and leg pain levels. HVLA seemed to reduce the levels of low back (MD = -1.48; 95% CI = -2.45, -0.50) and lower limb (MD = -2.36; 95% CI = -3.28, -1.44) pain compared to other conservative treatments, at three months after treatment. However, high heterogeneity was found (I² = 0.0%, p = 0.735). Besides, their certainty of the evidence was ‘very low’. No adverse events were reported.

The authors stated that they cannot conclude whether HVLA spinal manipulations can be helpful for the treatment of LSRS or not. Future high-quality RCTs are needed to establish the actual effect of HVLA manipulation in this disease with adequate sample size and LSRS definition.

Chiropractors earn their living by applying HVLA thrusts to patients suffering from LSRS. One would therefore have assumed that the question of efficacy has been extensively researched and conclusively answered. It seems that one would have assumed wrongly!

Now that this is (yet again) in the open, I wonder whether chiropractors will, in the future, tell their patients while obtaining informed consent: “I plan to give you a treatment for which sound evidence is not available; it can also cause harm; and, of course, it will cost you – I hope you don’t mind.”

An explanatory sequential mixed methods study with three separate phases was conducted in Danish patients with lumbar radiculopathy receiving a standardized chiropractic care package (SCCP). Lumbar radiculopathy is pain and other neurological symptoms caused by the pinching of nerve roots where they leave your spinal cord in the lumbar region.

Phase one of the study was a quantitative analysis based on a survey in a prospective cohort of patients with lumbar radiculopathy in an SCCP from 2018 to 2020. Patients rated their satisfaction with the examination, information, treatment effect, and overall management of their problem on a 0–10 scale. In phase two, six semi-structured interviews conducted in 2021 were used to gain further explanatory insights into the findings from phase one. Data were analyzed using systematic text condensation. In phase three, the quantitative and qualitative data were merged in a narrative joint display to obtain a deeper understanding of the overall results.

Here I am only interested in the patients’ perception of the treatment effect. Of 303 eligible patients, 238 responded to the survey. Of these, 50% were very satisfied with the treatment effect.

The authors stated that patients in their study expected a rapid and persistent decrease in symptoms, which, unfortunately, does not match the prognosis of lumbar radiculopathy. Although the prognosis is considered good, the improvement happens gradually and often with fluctuating pain patterns, and it is not unusual to have milder symptoms for three months or longer.

So, only half of the patients who had chosen to consult chiropractors for their lumbar radiculopathy were very satisfied with the treatment results. In most patients, the symptoms decreased only gradually often with fluctuating pain patterns, and the authors comment that symptoms frequently last for three months or longer with a SCCP.

Impressive?

Might I point out that what is being described here looks to me very much like the natural history of lumbar radiculopathy? About 90% of patients with back pain caused by disc herniation see improvements within three months without therapy. Are the authors aware that their observational study is in accordance with the notion that the SCCP does nothing or very little to help patients suffering from lumbar radiculopathy?

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