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

physiotherapists

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This meta-analysis of randomized clinical trials (RCTs) was aimed at evaluating the effects of massage therapy in the treatment of postoperative pain.

Three databases (PubMed, Embase, and Cochrane Central Register of Controlled Trials) were searched for RCTs published from database inception through January 26, 2021. The primary outcome was pain relief. The quality of RCTs was appraised with the Cochrane Collaboration risk of bias tool. The random-effect model was used to calculate the effect sizes and standardized mean difference (SMD) with 95% confidential intervals (CIs) as a summary effect. The heterogeneity test was conducted through I2. Subgroup and sensitivity analyses were used to explore the source of heterogeneity. Possible publication bias was assessed using visual inspection of funnel plot asymmetry.

The analysis included 33 RCTs and showed that MT is effective in reducing postoperative pain (SMD, -1.32; 95% CI, −2.01 to −0.63; p = 0.0002; I2 = 98.67%). A similarly positive effect was found for both short (immediate assessment) and long terms (assessment performed 4 to 6 weeks after the MT). Neither the duration per session nor the dose had a significant impact on the effect of MT, and there was no difference in the effects of different MT types. In addition, MT seemed to be more effective for adults. Furthermore, MT had better analgesic effects on cesarean section and heart surgery than orthopedic surgery.

The authors concluded that MT may be effective for postoperative pain relief. We also found a high level of heterogeneity among existing studies, most of which were compromised in the methodological quality. Thus, more high-quality RCTs with a low risk of bias, longer follow-up, and a sufficient sample size are needed to demonstrate the true usefulness of MT.

The authors discuss that publication bias might be possible due to the exclusion of all studies not published in English. Additionally, the included RCTs were extremely heterogeneous. None of the included studies was double-blind (which is, of course, not easy to do for MT). There was evidence of publication bias in the included data. In addition, there is no uniform evaluation standard for the operation level of massage practitioners, which may lead to research implementation bias.

Patients who have just had an operation and are in pain are usually thankful for the attention provided by carers. It might thus not matter whether it is provided by a massage or other therapist. The question is: does it matter? For the patient, it probably doesn’t; However, for making progress, it does, in my view.

In the end, we have to realize that, with clinical trials of certain treatments, scientific rigor can reach its limits. It is not possible to conduct double-blind, placebo-controlled studies of MT. Thus we can only conclude that, for some indications, massage seems to be helpful (and almost free of adverse effects).

This is also the conclusion that has been drawn long ago in some countries. In Germany, for instance, where I trained and practiced in my younger years, Swedish massage therapy has always been an accepted, conventional form of treatment (while exotic or alternative versions of massage therapy had no place in routine care). And in Vienna where I was chair of rehab medicine I employed about 8 massage therapists in my department.

When I conduct my regular literature searches, I am invariably delighted to find a paper that shows the effectiveness of a so-called alternative medicine (SCAM). Contrary to the impression that I might give to some, I like positive results as much as the next person. So, today you find me pleased to yet again report about one of my favorite SCAMs.

The purpose of this systematic review was to evaluate the effectiveness of manual lymphatic drainage (MLD) in breast cancer-related lymphedema (BCRL) patients.

In total, 11 RCTs involving 1564 patients could be included, and 10 trials were deemed viable for inclusion in the meta-analysis. Due to the effects of MLD for BCRL, statistically significant improvements were found on the incidence of lymphedema (RR = 0.58, 95% CI [0.37, 0.93], P =.02) and pain intensity (SMD = -0.72, 95% CI [-1.34, -0.09], P = .02). Besides, the meta-analysis carried out implied that the effects that MLD had on volumetric changes of lymphedema and quality of life, were not statistically significant.

The authors concluded that the current evidence based on the RCTs shows that pain of BCRL patients undergoing MLD is significantly improved, while our findings do not support the use of MLD in improving volumetric of lymphedema and quality of life. Note that the effect of MLD for preventing BCRL is worthy of discussion.

Lymph drainage is so well-established in cancer care that most people would probably consider it a conventional treatment. If, however, you read for which conditions its inventor, Emil Vodder, used to promote it, they might change their minds. Vodder saw it as a cure for most illnesses, even those for which there is no plausibility or good evidence.

As far as I can see, lymph drainage works well for reducing lymph edema but, for all other conditions, it is not evidence-based. And this is the reason why I still categorize it as a SCAM.

The purpose of this review was to

  • identify and map the available evidence regarding the effectiveness and harms of spinal manipulation and mobilisation for infants, children and adolescents with a broad range of conditions;
  • identify and synthesise policies, regulations, position statements and practice guidelines informing their clinical use.

Two reviewers independently screened and selected the studies, extracted key findings and assessed the methodological quality of included papers. A descriptive synthesis of reported findings was undertaken using a level-of-evidence approach.

Eighty-seven articles were included. Their methodological quality varied. Spinal manipulation and mobilisation are being utilised clinically by a variety of health professionals to manage paediatric populations with

  • adolescent idiopathic scoliosis (AIS),
  • asthma,
  • attention deficit hyperactivity disorder (ADHD),
  • autism spectrum disorder (ASD),
  • back/neck pain,
  • breastfeeding difficulties,
  • cerebral palsy (CP),
  • dysfunctional voiding,
  • excessive crying,
  • headaches,
  • infantile colic,
  • kinetic imbalances due to suboccipital strain (KISS),
  • nocturnal enuresis,
  • otitis media,
  • torticollis,
  • plagiocephaly.

The descriptive synthesis revealed: no evidence to explicitly support the effectiveness of spinal manipulation or mobilisation for any condition in paediatric populations. Mild transient symptoms were commonly described in randomised controlled trials and on occasion, moderate-to-severe adverse events were reported in systematic reviews of randomised controlled trials and other lower-quality studies. There was strong to very strong evidence for ‘no significant effect’ of spinal manipulation for managing

  • asthma (pulmonary function),
  • headache,
  • nocturnal enuresis.

There was inconclusive or insufficient evidence for all other conditions explored. There is insufficient evidence to draw conclusions regarding spinal mobilisation to treat paediatric populations with any condition.

The authors concluded that, whilst some individual high-quality studies demonstrate positive results for some conditions, our descriptive synthesis of the collective findings does not provide support for spinal manipulation or mobilisation in paediatric populations for any condition. Increased reporting of adverse events is required to determine true risks. Randomised controlled trials examining effectiveness of spinal manipulation and mobilisation in paediatric populations are warranted.

Perhaps the most important findings of this review relate to safety. They confirm (yet again) that there is only limited reporting of adverse events in this body of research. Six reviews, eight RCTs and five other studies made no mention of adverse events or harms associated with spinal manipulation. This, in my view, amounts to scientific misconduct. Four systematic reviews focused specifically on adverse events and harms. They revealed that adverse events ranged from mild to severe and even death.

In terms of therapeutic benefit, the review confirms the findings from the previous research, e.g.:

  • Green et al (Green S, McDonald S, Murano M, Miyoung C, Brennan S. Systematic review of spinal manipulation in children: review prepared by Cochrane Australia for Safer Care Victoria. Melbourne, Victoria: Victorian Government 2019. p. 1–67.) explored the effectiveness and safety of spinal manipulation and showed that spinal manipulation should – due to a lack of evidence and potential risk of harm – be recommended as a treatment of headache, asthma, otitis media, cerebral palsy, hyperactivity disorders or torticollis.
  • Cote et al showed that evidence is lacking to support the use of spinal manipulation to treat non-musculoskeletal disorders.

In terms of risk/benefit balance, the conclusion could thus not be clearer: no matter whether chiropractors, osteopaths, physiotherapists, or any other healthcare professionals propose to manipulate the spine of your child, DON’T LET THEM DO IT!

This double-blind, randomized study assessed the effectiveness of physiotherapy instrument mobilization (PIM) in patients with low back pain (LBP) and compared it with the effectiveness of manual mobilization.

Thirty-two participants with LBP were randomly assigned to one of two groups:

  • The PIM group received lumbar mobilization using an activator instrument, stabilization exercises, and education.
  • The manual group received lumbar mobilization using a pisiform grip, stabilization exercises, and education.

Both groups had 4 treatment sessions over 2-3 weeks. The following outcomes were measured before the intervention, and after the first and fourth sessions:

  • Numeric Pain Rating Scale (NPRS),
  • Oswestry Disability Index (ODI) scale,
  • Pressure pain threshold (PPT),
  • lumbar spine range of motion (ROM),
  • lumbar multifidus muscle activation.

There were no differences between the PIM and manual groups in any outcome measures. However, over the period of study, there were improvements in both groups in NPRS (PIM: 3.23, Manual: 3.64 points), ODI (PIM: 17.34%, Manual: 14.23%), PPT (PIM: ⩽ 1.25, Manual: ⩽ 0.85 kg.cm2), lumbar spine ROM (PIM: ⩽ 9.49∘, Manual: ⩽ 0.88∘), and/or lumbar multifidus muscle activation (percentage thickness change: PIM: ⩽ 4.71, Manual: ⩽ 4.74 cm; activation ratio: PIM: ⩽ 1.17, Manual: ⩽ 1.15 cm).

The authors concluded that both methods of lumbar spine mobilization demonstrated comparable improvements in pain and disability in patients with LBP, with neither method exhibiting superiority over the other.

If this conclusion is meant to tell us that both treatments were equally effective, I beg to differ. The improvements documented here are consistent with improvements caused by the natural history of the condition, regression towards the mean, and placebo effects. The data do not prove that they are due to the treatments. On the contrary, they seem to imply that patients get better no matter what therapy is used. Thus, I feel that the results are entirely in keeping with the hypothesis that spinal mobilization is a placebo treatment.

So, allow me to re-phrase the authors’ conclusion as follows:

Lumbar mobilizations do not seem to have specific therapeutic effects and might therefore be considered to be ineffective for LBP.

The aim of this evaluator-blinded randomized clinical trial was to determine if manual therapy added to a therapeutic exercise program produced greater improvements than a sham manual therapy added to the same exercise program in patients with non-specific shoulder pain.

Forty-five subjects were randomly allocated into one of three groups:

  • manual therapy (glenohumeral mobilization technique and rib-cage technique);
  • thoracic sham manual therapy (glenohumeral mobilization technique and rib-cage sham technique);
  • sham manual therapy (sham glenohumeral mobilization technique and rib-cage sham technique).

All groups also received a therapeutic exercise program. Pain intensity, disability, and pain-free active shoulder range of motion were measured post-treatment and at 4-week and 12-week follow-ups. Mixed-model analyses of variance and post hoc pairwise comparisons with Bonferroni corrections were constructed for the analysis of the outcome measures.

All groups reported improved pain intensity, disability, and pain-free active shoulder range of motion. However, there were no between-group differences in these outcome measures.

The authors concluded that the addition of the manual therapy techniques applied in the present study to a therapeutic exercise protocol did not seem to add benefits to the management of subjects with non-specific shoulder pain.

What does that mean?

I think it means that the improvements observed in this study were due to 1) exercise and 2) a range of non-specific effects, and that they were not due to the manual techniques tested.

I cannot say that I find this enormously surprising. But I would also find it unsurprising if fans of these methods would claim that the results show that the physios applied the techniques not correctly.

In any case, I feel this is an interesting study, not least because of its use of sham therapy. But I somehow doubt that the patients were unable to distinguish sham from verum. If so, the study was not patient-blind which obviously is difficult to achieve with manual treatments.

This systematic review, meta-analysis, and meta-regression investigated the effects of individualized interventions, based on exercise alone or combined with psychological treatment, on pain intensity and disability in patients with chronic non-specific low-back pain.

Databases were searched up to January 31, 2022, to retrieve respective randomized clinical trials of individualized and/or personalized and/or stratified exercise interventions with or without psychological treatment compared to any control.

The findings show:

  • Fifty-eight studies (n = 10084) were included. At short-term follow-up (12 weeks), low-certainty evidence for pain intensity (SMD -0.28 [95%CI -0.42 to -0.14]) and very low-certainty evidence for disability (-0.17 [-0.31 to -0.02]) indicates superior effects of individualized versus active exercises, and very low-certainty evidence for pain intensity (-0.40; [-0.58 to -0.22])), but not (low-certainty evidence) for disability (-0.18; [-0.22 to 0.01]) compared to passive controls.
  • At long-term follow-up (1 year), moderate-certainty evidence for pain intensity (-0.14 [-0.22 to -0.07]) and disability (-0.20 [-0.30 to -0.10]) indicates effects versus passive controls.

Sensitivity analyses indicate that the effects on pain, but not on disability (always short-term and versus active treatments) were robust. Pain reduction caused by individualized exercise treatments in combination with psychological interventions (in particular behavioral-cognitive therapies) (-0.28 [-0.42 to -0.14], low certainty) is of clinical importance.

The certainty of the evidence was downgraded mainly due to evidence of risk of bias, publication bias, and inconsistency that could not be explained. Individualized exercise can treat pain and disability in chronic non-specific low-back pain. The effects in the short term are of clinical importance (relative differences versus active 38% and versus passive interventions 77%), especially in regard to the little extra effort to individualize exercise. Sub-group analysis suggests a combination of individualized exercise (especially motor-control-based treatments) with behavioral therapy interventions to boost effects.

The authors concluded that the relative benefit of individualized exercise therapy on chronic low back pain compared to other active treatments is approximately 38% which is of clinical importance. Still, sustainability of effects (> 12 months) is doubtable. As individualization in exercise therapies is easy to implement, its use should be considered.

Johannes Fleckenstein, the 1st author from the Goethe-University Frankfurt, Institute of Sports Sciences, Department of Sports Medicine and Exercise Physiology, sees in the study “an urgent health policy appeal” to strengthen combined services in care and remuneration. “Compared to other countries, such as the USA, we are in a relatively good position in Germany. For example, we have a lower prescription of strong narcotics such as opiates. But the rate of unnecessary X-ray examinations, which incidentally can also contribute to the chronicity of pain, or inaccurate surgical indications is still very high.”

Personally, I find the findings of this paper rather unsurprising. As a clinician, many years ago, prescribing exercise therapy for low back pain was my daily bread. None of my team would have ever conceived the idea that exercise does not need to be individualized according to the needs and capabilities of each patient. Therefore, I suggest rephrasing the last sentence of the conclusion: As individualization in exercise therapies is easy to implement, its use should be standard procedure.

 

The aim of this study was to evaluate the effectiveness of craniosacral therapy on different features in migraine patients.

Fifty individuals with migraine were randomly divided into two groups (n = 25 per group):

  • craniosacral therapy group (CTG),
  • sham control group (SCG).

The interventions were carried out with the patient in the supine position. The CTG received a manual therapy treatment focused on the craniosacral region including five techniques, and the SCG received a hands-on placebo intervention. After the intervention, individuals remained supine with a neutral neck and head position for 10 min, to relax and diminish tension after treatment. The techniques were executed by the same experienced physiotherapist in both groups.

The analyzed variables were pain, migraine severity, and frequency of episodes, functional, emotional, and overall disability, medication intake, and self-reported perceived changes, at baseline, after a 4-week intervention, and at an 8-week follow-up.

After the intervention, the CTG significantly reduced pain (p = 0.01), frequency of episodes (p = 0.001), functional (p = 0.001) and overall disability (p = 0.02), and medication intake (p = 0.01), as well as led to a significantly higher self-reported perception of change (p = 0.01), when compared to SCG. The results were maintained at follow-up evaluation in all variables.

The authors concluded that a protocol based on craniosacral therapy is effective in improving pain, frequency of episodes, functional and overall disability, and medication intake in migraineurs. This protocol may be considered as a therapeutic approach in migraine patients.

Sorry, but I disagree!

And I have several reasons for it:

  • The study was far too small for such strong conclusions.
  • For considering any treatment as a therapeutic approach in migraine patients, we would need at least one independent replication.
  • There is no plausible rationale for craniosacral therapy to work for migraine.
  • The blinding of patients was not checked, and it is likely that some patients knew what group they belonged to.
  • There could have been a considerable influence of the non-blinded therapists on the outcomes.
  • There was a near-total absence of a placebo response in the control group.

Altogether, the findings seem far too good to be true.

 

 

Aging often contributes to a decrease in physical activity. As age advances, a decrease in muscle mass, muscle strength, and flexibility can impair physical function. One obvious way to prevent these developments might be regular physical exercise.

This open-label, randomized trial was intended to evaluate the effects of an integrated yoga module in improving the flexibility, muscle strength, and quality of life (QOL) of older adults. Participants were 96 older adults, aged 60-75 years (64.1 ± 3.95 years). The program was a three-month, yoga-based lifestyle intervention. The participants were randomly allocated to the intervention group (n = 48) or to a waitlisted control group (n = 48). The intervention group underwent three one-hour sessions of yoga weekly, with each session including loosening exercises, asanas, pranayama, and meditation spanning.

At baseline and post-intervention, the following assessments were made:

  • spinal flexibility using a sit-and-reach test,
  • back and leg strength using a back leg dynamometer,
  • handgrip strength (HGS) and endurance (HGE) using a hand-grip dynamometer,
  • Older People’s Quality of Life (OPQOL) questionnaire.

Analysis was performed employing Wilcoxon’s Sign Rank tests and Mann-Whitney Tests, using an intention-to-treat approach.

The results show that, compared to the control group, the intervention group experienced a significantly greater increase in spinal flexibility (P < .001), back leg strength (P < .001), HGE (P < .01), and QOL (P < .001) after three months of yoga.

The authors concluded that yoga can be used safely for older adults to improve flexibility, strength, and functional QOL. Larger randomized controlled trials with an active control intervention are warranted.

I agree with the authors that this trial was too small and not properly controlled. I disagree that their study shows yoga to be effective or safe. In fact, the two sentences of the conclusion do not seem to fit together at all.

Is it surprising that doing yoga exercises is better than doing nothing at all?

No!

Is it relevant to demonstrate this fact in an RCT?

No!

If anyone wants to test the value of yoga exercises, they must compare them to conventional exercises. And why don’t they do this? Could it be because they know they would be unlikely to show that yoga is superior?

 

Musculoskeletal disorders (MSDs) are highly prevalent, burdensome, and putatively associated with an altered human resting muscle tone (HRMT). Osteopathic manipulative treatment (OMT) is commonly and effectively applied to treat MSDs and reputedly influences the HRMT. Arguably, OMT may modulate alterations in HRMT underlying MSDs. However, there is sparse evidence even for the effect of OMT on HRMT in healthy subjects.

A 3 × 3 factorial randomized trial was performed to investigate the effect of myofascial release (MRT), muscle energy (MET), and soft tissue techniques (STT) on the HRMT of the corrugator supercilii (CS), superficial masseter (SM), and upper trapezius muscles (UT) in healthy subjects in Hamburg, Germany. Participants were randomised into three groups (1:1:1 allocation ratio) receiving treatment, according to different muscle-technique pairings, over the course of three sessions with one-week washout periods. We assessed the effect of osteopathic techniques on muscle tone (F), biomechanical (S, D), and viscoelastic properties (R, C) from baseline to follow-up (primary objective) and tested if specific muscle-technique pairs modulate the effect pre- to post-intervention (secondary objective) using the MyotonPRO (at rest). Ancillary, we investigate if these putative effects may differ between the sexes. Data were analysed using descriptive (mean, standard deviation, and quantiles) and inductive statistics (Bayesian ANOVA). 59 healthy participants were randomised into three groups and two subjects dropped out from one group (n = 20; n = 20; n = 19–2). The CS produced frequent measurement errors and was excluded from analysis. OMT significantly changed F (−0.163 [0.060]; p = 0.008), S (−3.060 [1.563]; p = 0.048), R (0.594 [0.141]; p < 0.001), and C (0.038 [0.017]; p = 0.028) but not D (0.011 [0.017]; p = 0.527). The effect was not significantly modulated by muscle-technique pairings (p > 0.05). Subgroup analysis revealed a significant sex-specific difference for F from baseline to follow-up. No adverse events were reported.

figure 1

The authors concluded that OMT modified the HRMT in healthy subjects which may inform future research on MSDs. In detail, MRT, MET, and STT reduced the muscle tone (F), decreased biomechanical (S not D), and increased viscoelastic properties (R and C) of the SM and UT (CS was not measurable). However, the effect on HRMT was not modulated by muscle–technique interaction and showed sex-specific differences only for F.

I think that this study merits a few comments:

  • It seems unsurprising that manual manipulation can relax muscles.
  • The blinding of the volunteers was compromised because the participants were osteopathy students able to distinguish between the different interventions.
  • The mechanisms underlying these reported changes in HRMT following OMT are unclear.
  • The effects do not seem to be treatment-specific.
  • The treatments used are not typical for osteopathy.
  • Manual techniques are loosely defined or standardized.
  • The duration of the effect is unknown but probably short.
  • The size of the effect is small.
  • The clinical relevance of the effect is doubtful.

Many systematic reviews have summarized the evidence on spinal manipulative therapy (SMT) for low back pain (LBP) in adults. Much less is known about the older population regarding the effects of SMT. This paper assessed the effects of SMT on pain and function in older adults with chronic LBP in an individual participant data (IPD) meta-analysis.

Electronic databases were searched from 2000 until June 2020; reference lists of eligible trials and related reviews were also searched. Randomized controlled trials (RCTs) were considered if they examined the effects of SMT in adults with chronic LBP compared to interventions recommended in international LBP guidelines. The authors of trials eligible for the IPD meta-analysis were contacted and invited to share data. Two review authors conducted a risk of bias assessment. Primary results were examined in a one-stage mixed model, and a two-stage analysis was conducted in order to confirm the findings. The main outcomes and measures were pain and functional status examined at 4, 13, 26, and 52 weeks.

A total of 10 studies were retrieved, including 786 individuals; 261 were between 65 and 91 years of age. There was moderate-quality evidence that SMT results in similar outcomes at 4 weeks (pain: mean difference [MD] – 2.56, 95% confidence interval [CI] – 5.78 to 0.66; functional status: standardized mean difference [SMD] – 0.18, 95% CI – 0.41 to 0.05). Second-stage and sensitivity analysis confirmed these findings.

The authors concluded that SMT provides similar outcomes to recommended interventions for pain and functional status in the older adult with chronic LBP. SMT should be considered a treatment for this patient population.

This is a fine analysis. Unfortunately, its results are less than fine. Its results confirm what I have been saying ad nauseam: we do not currently have a truly effective therapy for back pain, and most options are as good or as bad as the rest. This is most frustrating for everyone concerned, but it is certainly no reason to promote SMT as usually done by chiropractors or osteopaths.

The only logical solution, in my view, is to use those options that:

  • are associated with the least risks,
  • are the least expensive,
  • are widely available.

However you twist and turn the existing evidence, the application of these criteria does not come up with chiropractic or osteopathy as an optimal solution. The best treatment is therapeutic exercise initially taught by a physiotherapist and subsequently performed as a long-term self-treatment by the patient at home.

 

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