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

back pain

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The objective of this study is to evaluate the efficacy of an OMT intervention for reducing pain and disability in patients with chronic low back pain (LBP). It was designed as a single-blinded, crossover, randomized trial (RCT) and conducted at a university-based health system. Participants were adults, 21–65 years old, with non-specific LBP. Eligible participants (n=80) were randomized to two trial arms:
  • an immediate osteopathic manipulative therapy (OMT) intervention group,
  • a delayed OMT (waiting period) group.

The intervention consisted of three to four OMT sessions over 4–6 weeks, after which the participants switched (crossed-over) groups. The OMT techniques included a mandatory HVLA thrust technique to the lumbar spine region and any (or none) combination of the following four techniques: (i) soft tissue, (ii) muscle energy, (iii) myofascial, and (iv) articulatory. For patients who could not tolerate the HVLA treatment, a physician had to attempt this technique, minimally by attempting to place the patient in the position to perform this maneuver.

The primary clinical outcomes were average pain, current pain, Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v1.0 pain interference and physical function, and modified Oswestry Disability Index (ODI). Secondary outcomes included the remaining PROMIS health domains and the Fear Avoidance Beliefs Questionnaire (FABQ). These measures were taken at baseline (T0), after one OMT session (T1), at the crossover point (T2), and at the end of the trial (T3). Due to the carryover effects of OMT intervention, only the outcomes obtained prior to T2 were evaluated utilizing mixed-effects models and after adjusting for baseline values.

Totals of 35 and 36 participants with chronic LBP were available for the analysis at T1 in the immediate OMT and waiting period groups, respectively, whereas 31 and 33 participants were available for the analysis at T2 in the immediate OMT and waiting period groups, respectively.
After one session of OMT (T1), the analysis showed a significant reduction in the secondary outcomes of sleep disturbance and anxiety compared to the waiting period group. Following the entire intervention period (T2), the immediate OMT group demonstrated a significantly better average pain outcome. The effect size was a 0.8 standard deviation (SD), rendering the reduction in pain clinically significant. Further, the improvement in anxiety remained statistically significant. No study-related serious adverse events (AEs) were reported.
The authors concluded that OMT intervention is safe and effective in reducing pain along with improving sleep and anxiety profiles in patients with chronic LBP.The authors stared their abstract by stating that “the evidence for the efficacy of osteopathic manipulative treatment (OMT) in the management of low back pain (LBP) is considered weak … because it is generally based on low-quality studies.” This is undoubtedly true – but why then did they add one more low-quality study?, I ask myself. To mention just some of the most obvious flaws:

  • This study is far too small to allow conclusions about safety.
  • The trial compared OMT with no therapy; it is likely that the observed outcomes have little to do with OMT but are due to a placebo response.
  • The primary outcome measure showed no effect which essentially means that the study finding was that OMT is ineffective.

My conclusion:

a poor study conducted by wishful thinkers.

 

This systematic review aimed to investigate the effectiveness of cupping therapy on low back pain (LBP). Medline, Embase, Scopus and WANFANG databases were searched for relevant cupping RCTs on low back pain articles up to 2023. A complementary search was manually made on 27 September for update screening. Full-text English and Chinese articles on all ethnic adults with LBP of cupping management were included. Studies looking at acute low back pain only were excluded. Two independent reviewers screened and extracted data, with any disagreement resolved through consensus by a third reviewer. The methodological quality of the included studies was evaluated independently by two reviewers using an adapted tool. Change-from-baseline outcomes were treated as continuous variables and calculated according to the Cochrane Handbook. Data were extracted and pooled into the meta-analysis by Review Manager software (version 5.4, Nordic Cochrane Centre).

Eleven trials involving 921 participants were included. Five studies were assessed as being at low risk of bias, and six studies were of acceptable quality. The findings reveal:

  • High-quality evidence demonstrated cupping significantly improves pain at 2-8 weeks endpoint intervention (d=1.09, 95% CI: [0.35-1.83], p=0.004).
  • There was no continuous pain improvement observed at one month (d=0.11, 95% CI: [-1.02-1.23], p=0.85) and 3-6 months (d=0.39, 95% CI: [-0.09-0.87], p=0.11).
  • Dry cupping did not improve pain (d=1.06, 95% CI: [-0.34, 2.45], p=0.14) compared with wet cupping (d=1.5, 95% CI: [0.39-2.6], p=0.008) at the endpoint intervention.
  • There was no evidence indicating the association between pain reduction and different types of cupping (p=0.2).
  • Moderate- to low-quality evidence showed that cupping did not reduce chronic low back pain (d=0.74, 95% CI: [-0.67-2.15], p=0.30) and non-specific chronic low back pain (d=0.27, 95% CI: [-1.69-2.24], p=0.78) at the endpoint intervention.
  • Cupping on acupoints showed a significant improvement in pain (d=1.29, 95% CI: [0.63-1.94], p<0.01) compared with the lower back area (d=0.35, 95% CI: [-0.29-0.99], p=0.29).
  • A potential association between pain reduction and different cupping locations (p=0.05) was found.
  • Meta-analysis showed a significant effect on pain improvement compared to medication therapy (n=8; d=1.8 [95% CI: 1.22 – 2.39], p<0.001) and usual care (n=5; d=1.07 [95% CI: 0.21- 1.93], p=0.01).
  • Two studies demonstrated that cupping significantly mediated sensory and emotional pain immediately, after 24 hours, and 2 weeks post-intervention (d= 5.49, 95% CI [4.13-6.84], p<0.001).
  • Moderate evidence suggested that cupping improved disability at the 1-6 months follow-up (d=0.67, 95% CI: [0.06-1.28], p=0.03).
  • There was no immediate effect observed at the 2-8 weeks endpoint (d=0.40, 95% CI: [-0.51-1.30], p=0.39).
  • A high degree of heterogeneity was noted in the subgroup analysis (I2 >50%).

The authors concluded that high- to moderate-quality evidence indicates that cupping significantly improves pain and disability. The effectiveness of cupping for LBP varies based on treatment durations, cupping types, treatment locations, and LBP classifications. Cupping demonstrated a superior and sustained effect on pain reduction compared with medication and usual care. The notable heterogeneity among studies raises concerns about the certainty of these findings. Further research should be designed with a standardized cupping manipulation that specifies treatment sessions, frequency, cupping types, and treatment locations. The real therapeutic effects of cupping could be confirmed using a sham device or objective outcome measurements. Studies with at least six- to twelve-month follow-ups are needed to investigate the long-term efficacy of cupping in managing LBP.

Confused?

No need, it’s really quite simple: cupping can, according to this review, be shown to have some short-lasting effect, provided the study is flawed and does not control for placebo effects.

Surprised?

No need! There is hardly a form of so-called alternative medicine (SCAM) that does not have a similarly small effect of back pain, if tested in equally dodgy studies. This is particularly true for those treatments that can act as a theatrical placebo, e.g. acupuncture or chiropractic.

So, should a back pain sufferer try cupping?

If he/she insists, why not? But please don’t use wet cupping (which can do quite a bit of harm). Dry cupping (without injuring the skin) is arguably better (less risk, less expense, possibility of home treatment by your partner) than chiropractic, osteopathy, acupuncture, or many other SCAMs.

My conclusions – as mentioned many times previously – are as follows:

  1. Most SCAMs help a little with back pain (and similar conditions) because they can have a powerful placebo effect.
  2. Conventional medicine is also not convincingly effective for back pain.
  3. If you insist on SCAM, it is best to use one that is relatively harmless and inexpensive.

Since the introduction of their new Education Standards in March 2023, the General Chiropractic Council (GCC) has been working with chiropractic education providers to support them in implementing the changes to their curricula. Recently, the GCC have stated this:

We expect students to be taught evidence-based practice: integrating individual clinical expertise, the best available evidence from current and credible clinical research, and the values and preferences of patients. Chiropractors are important members of a patient’s healthcare team, and interprofessional approaches enable the best outcomes. Programmes that meet these Standards will teach ethical, professional care and produce competent healthcare professionals who can serve the needs of patients.

These are indeed most encouraging words!

Basically, they are saying that chiropractic education will now have to be solidly based on the principles of evidence-based medicine (EBM) as well as sound medical ethics. Let me spell out what this really means. Chiropractic courses must teach that:

  • The current and credible clinical evidence suggesting that spinal manipulations, the hallmark intervention of chiropractors, are effective is weak for back pain and negative or absent for all other conditions.
  • The current and credible clinical evidence suggests that spinal manipulations, the hallmark intervention of chiropractors, can cause harm which in many instances is serious.
  • The current and credible clinical evidence thus suggests that the risk/benefit balance for spinal manipulations, the hallmark intervention of chiropractors, is not positive.
  • Medical ethics require that competent healthcare professionals inform their patients that spinal manipulations, the hallmark intervention of chiropractors, may not generate more good than harm which is the reason why they cannot employ these therapies.

So, the end of chiropractic in the UK is looming!

Unless, of course, the GCC’s words are not really meant to be translated into action. They could be just window dressing and politically correct bullshit. But that’ s really far too far fetched – after all they come from the GENERAL CHIROPRACTIC COUNCIL, known for its excellent track record, e.g.:

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

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

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

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

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

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

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

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

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

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

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

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

___________________________

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

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

That explains a lot!

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

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

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

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

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

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

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

Why?

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

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

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

 

Certain aspects of yoga can be used as a non-pharmacological conservative therapeutic approach to the management of chronic low back pain (CLBP). This overview summarized and evaluated data from current systematic reviews (SRs) on the use of yoga for CLBP.

The researchers searched SRs on the use of yoga for CLBP in nine electronic databases from inception to September 2023. The methodological quality was evaluated using the Assessment of Multiple Systematic Review Scale-2 (AMSTAR-2). The reporting quality of the included SRs was evaluated using the Preferred Reporting Item for Systematic Review and Meta-Analysis-2020 (PRISMA-2020), and the quality of data was graded using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Two independent researchers performed the screening, data extraction, and quality assessment process of SRs.

A total of 13 SRs were included. The results of the AMSTAR-2 indicated that the methodological quality of the included studies was relatively low. The PRISMA-2020 checklist evaluation results indicated that methodological limitations in reporting, especially regarding data processing and presentation, were the main weaknesses. The GRADE assessment indicated that 30 outcomes were rated moderate, 42 were rated low level, and 20 were rated very low level. Downgrading factors were mainly due to the limitations of the included studies.

The authors concluded that yoga appears to be an effective and safe non-pharmacological therapeutic modality for the Management of CLBP. Currently, it may exhibit better efficacy in improving pain and functional disability associated with CLBP. However, the methodological quality and quality of evidence for SRs/MAs in the included studies were generally low, and these results should be interpreted cautiously.

Sorry, but I beg to differ!

  • The safety of a therapy cannot be ascertained on the basis of such small sample sizes.
  • The effectiveness of yoga has not been demonstrated by these data.
  • All that has been shown with this review is that the quality of the research in this area is too poor for drawing conclusions.

This study was aimed at evaluating the effectiveness of osteopathic visceral manipulation (OVM) combined with physical therapy in pain, depression, and functional impairment in patients with chronic mechanical low back pain (LBP).
A total of 118 patients with chronic mechanical LBP were assessed, and 86 who met the inclusion criteria were included in the randomized clinical trial (RCT). The patients were randomized to either:

  • Group 1 (n=43), who underwent physical therapy (5 days/week, for a total of 15 sessions) combined with OVM (2 days/week with three-day intervals),
  • or Group 2 (n=43), which underwent physical therapy (5 days/week, for a total of 15 sessions) combined with sham OVM (2 days/week with three-day intervals).

Both groups were assessed before and after treatment and at the fourth week post-treatment.

Seven patients were lost to follow-up, and the study was completed with 79 patients. Pain, depression, and functional impairment scores were all improved in both groups (p=0.001 for all). This improvement was sustained at week four after the end of treatment. However, improvement in the pain, depression, and functional impairment scores was significantly higher in Group 1 than in Group 2 (p=0.001 for all).

The authors concluded that the results suggest that OVM combined with physical therapy is useful to improve pain, depression, and functional impairment in patients with chronic mechanical low back pain. We believe that OVM techniques should be combined with other physical therapy modalities in this patient population.

OVM was invented by the French osteopath, Jean-Piere Barral. In the 1980s, he stated that through his clinical work with thousands of patients, he discovered that many health issues were caused by our inner organs being entrapped and immobile. According to its proponents, OVM is based on the specific placement of soft manual forces that encourage the normal mobility, tone and function of our inner organs and their surrounding tissues. In this way, the structural integrity of the entire body is allegedly restored.

I am not aware of good evidence to show that OVM is effective – and this, sadly, includes the study above.

In my view, the most plausible explanation for its findings have little to do with OVM itself: sham OVM was applied “by performing light pressure and touches with the palm of the hand on the selected points for OVM without the intention of treating the patient”. This means that most likely patients were able to tell OVM from sham OVM and thus de-blinded. In other words, their expectation of receiving an effective therapy (and not the OVM per se) determined the outcome.

 

The concept that the outcomes of spinal manipulation therapy (SMT) – the hallmark intervention of chiropractors which they use on practically every patient – are optimized when the treatment is aimed at a clinically relevant joint is commonly assumed and central to teaching and clinical use of chiropractic. But is the assumption true?

This systematic review investigated whether clinical effects are superior when this is the case compared to SMT applied elsewhere. Eligible study designs were randomized controlled trials that investigated the effect of SMT applied to candidate versus non-candidate sites for spinal pain.

The authors obtained studies from four different databases. Risk of bias was assessed using an adjusted Cochrane risk of bias tool, adding four items for study quality. Between-group differences were extracted for any reported outcome or, when not reported, calculated from the within-group changes. Outcomes were compared for SMT applied at a ‘relevant’ site to SMT applied elsewhere. The authors prioritized methodologically robust studies when interpreting results.

Ten studies were included. They reported 33 between-group differences; five compared treatments within the same spinal region and five at different spinal regions.

None of the nine studies with low or moderate risk of bias reported statistically significant between-group differences for any outcome. The tenth study reported a small effect on pain (1.2/10, 95%CI – 1.9 to – 0.5) but had a high risk of bias. None of the nine articles of low or moderate risk of bias and acceptable quality reported that “clinically-relevant” SMT has a superior outcome on any outcome compared to “not clinically-relevant” SMT. This finding contrasts with ideas held in educational programs and clinical practice that emphasize the importance of joint-specific application of SMT.

The authors concluded that the current evidence does not support that SMT applied at a supposedly “clinically relevant” candidate site is superior to SMT applied at a supposedly “not clinically relevant” site for individuals with spinal pain.

I came across this study when I searched for the published work of Prof Stephen Perle, a chiropractor and professor at the School of Chiropractic, College of Health Sciences, University of Bridgeport, US, who recently started trolling me on this blog. Against my expectation, I find his study interesting and worthwhile.

His data quite clearly show that the effects of SMT are non-specific and mainly due to a placebo response. That in itself is not hugely remarkable and has been suspected to some time, e.g.:

What is remarkable, however, is the fact that Perle and his co-authors offer all sorts of other explanation for their findings without even seriously considering what is stareing in their faces:

SPINAL MANIPULATIONS ARE PLACEBOS

CHIROPRACTIC IS A PLACEBO THERAPY

This might be almost acceptable, if chiropractic would not also be burdened with significant risks (as we have discussed ad nauseam on this blog) – another fact of which chiros like Perle are in denial.

What does all that mean for patients?

The practical implication is fairly straight forward: the risk/benefit balance of chiropractic is negative. And this surely means the only responsible advice to patients is this:

NEVER CONSULT A CHIRO!

This review evaluated the magnitude of the placebo response of sham acupuncture in trials of acupuncture for nonspecific LBP, and assessed whether different types of sham acupuncture are associated with different responses. Four databases including PubMed, EMBASE, MEDLINE, and the Cochrane Library were searched through April 15, 2023, and randomized controlled trials (RCTs) were included if they randomized patients with LBP to receive acupuncture or sham acupuncture intervention. The main outcomes included the placebo response in pain intensity, back-specific function and quality of life. Placebo response was defined as the change in these outcome measures from baseline to the end of treatment. Random-effects models were used to synthesize the results, standardized mean differences (SMDs, Hedges’g) were applied to estimate the effect size.

A total of 18 RCTs with 3,321 patients were included. Sham acupuncture showed a noteworthy pooled placebo response in pain intensity in patients with LBP [SMD −1.43, 95% confidence interval (CI) −1.95 to −0.91, I2=89%]. A significant placebo response was also shown in back-specific functional status (SMD −0.49, 95% CI −0.70 to −0.29, I2=73%), but not in quality of life (SMD 0.34, 95% CI −0.20 to 0.88, I2=84%). Trials in which the sham acupuncture penetrated the skin or performed with regular needles had a significantly higher placebo response in pain intensity reduction, but other factors such as the location of sham acupuncture did not have a significant impact on the placebo response.

The authors concluded that sham acupuncture is associated with a large placebo response in pain intensity among patients with LBP. Researchers should also be aware that the types of sham acupuncture applied may potentially impact the evaluation of the efficacy of acupuncture. Nonetheless, considering the nature of placebo response, the effect of other contextual factors cannot be ruled out in this study.

As the authors stated in their conclusion: the effect of other contextual factors cannot be ruled out. I would go much further and say that the outcomes noted here are mostly due to effects other than placebo. Obvious candidates are:

  • regression towards the mean;
  • natural history of the condition;
  • success of patient blinding;
  • social desirability.

To define the placebo effect in acupuncture trials as the change in the outcome measures from baseline to the end of treatment – as the authors of the review do – is not just naive, it is plainly wrong. I would not be surprised, if different sham acupuncture treatments have different effects. To me this would be an expected, plausible finding. But such differences just cannot be estimated in the way the authors suggest. For that, we would need an RCT in which patients are randomized to be treated in the same setting with a range of different types of sham acupuncture. The results of such a study might be revealing but I doubt that many ethics committees would be happy to grant their approval for it.

In the absence of such data, the best we can do is to design trials such that the verum is tested against a credible placebo which, for patients, is indistinguishable from the verum, while demonstrating that blinding is successful.

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.

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