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

pain

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The Sunday Times reported yesterday reported that five NHS trusts currently offer moxibustion to women in childbirth for breech babies, i.e. babies presenting upside down. Moxibustion is a form of Traditional Chinese Medicine (TCM) where mugwort is burned close to acupuncture points. The idea is that this procedure would stimulate the acupuncture point similar to the more common way using needle insertion. The fifth toe is viewed as the best traditional acupuncture point for breech presentation, and the treatment is said to turn the baby in the uterus so that it can be delivered more easily.

At least four NHS trusts are offering acupuncture and reflexology with aromatherapy to help women with delayed pregnancies, while 15 NHS trusts offer hypnobirthing classes. Some women are asked to pay fees of up to £140 for it. These treatments are supposed to relax the mother in the hope that this will speed up the process of childbirth.

The Nice guidelines on maternity care say the NHS should not offer acupuncture, acupressure, or hypnosis unless specifically requested by women. The reason for the Nice warning is simple: there is no convincing evidence that these therapies are effective.

Campaigner Catherine Roy who compiled the list of treatments said: “To one degree or another, the Royal College of Midwives, the Care Quality Commission and parts of the NHS support these pseudoscientific treatments.

“They are seen as innocuous but they carry risks, can delay medical help and participate in an anti-medicalisation stance specific to ‘normal birth’ ideology and maternity care. Nice guidelines are clear that they should not be offered by clinicians for treatment. NHS England must ensure that pseudoscience and non-evidence based treatments are removed from NHS maternity care.”

Birte Harlev-Lam, executive director of the Royal College of Midwives (RCM), said: “We want every woman to have as positive an experience during pregnancy, labour, birth and the postnatal period as possible — and, most importantly, we want that experience to be safe. That is why we recommend all maternity services to follow Nice guidance and for midwives to practise in line with the code set out by the Nursing and Midwifery Council.”

A spokeswoman for Nice said it was reviewing its maternity guidelines. NHS national clinical director for maternity and women’s health, Dr Matthew Jolly, said: “All NHS services are expected to offer safe and personalised clinical care and local NHS areas should commission core maternity services using the latest NICE and clinical guidance. NHS trusts are under no obligation to provide complementary or alternative therapies on top of evidence-based clinical care, but where they do in response to the wishes of mothers it is vital that the highest standards of safety are maintained.”

On this blog, we have repeatedly discussed the strange love affair of midwives with so-called alternative medicine (SCAM), for instance, here. In 2012, we published a summary of 19 surveys on the subject. It showed that the prevalence of SCAM use varied but was often close to 100%. Much of it did not seem to be supported by strong evidence for efficacy. We concluded that most midwives seem to use SCAM. As not all SCAMs are without risks, the issue should be debated openly. Today, there is plenty more evidence to show that the advice of midwives regarding SCAM is not just not evidence-based but also often dangerous. This, of course, begs the question: when will the professional organizations of midwifery do something about 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.

Acupuncture is emerging as a potential therapy for relieving pain, but the effectiveness of acupuncture for relieving low back and/or pelvic pain (LBPP) during pregnancy remains controversial. This meta-analysis aimed to investigate the effects of acupuncture on pain, functional status, and quality of life for women with LBPP pain during pregnancy.

The authors included all RCTs evaluating the effects of acupuncture on LBPP during pregnancy. Data extraction and study quality assessments were independently performed by three reviewers. The mean differences (MDs) with 95% CIs for pooled data were calculated. The primary outcomes were pain, functional status, and quality of life. The secondary outcomes were overall effects (a questionnaire at a post-treatment visit within a week after the last treatment to determine the number of people who received good or excellent help), analgesic consumption, Apgar scores >7 at 5 min, adverse events, gestational age at birth, induction of labor and mode of birth.

Ten studies, reporting on a total of 1040 women, were included. Overall, acupuncture

  • relieved pain during pregnancy (MD=1.70, 95% CI: (0.95 to 2.45), p<0.00001, I2=90%),
  • improved functional status (MD=12.44, 95% CI: (3.32 to 21.55), p=0.007, I2=94%),
  • improved quality of life (MD=−8.89, 95% CI: (−11.90 to –5.88), p<0.00001, I2 = 57%).

There was a significant difference in overall effects (OR=0.13, 95% CI: (0.07 to 0.23), p<0.00001, I2 = 7%). However, there was no significant difference in analgesic consumption during the study period (OR=2.49, 95% CI: (0.08 to 80.25), p=0.61, I2=61%) and Apgar scores of newborns (OR=1.02, 95% CI: (0.37 to 2.83), p=0.97, I2 = 0%). Preterm birth from acupuncture during the study period was reported in two studies. Although preterm contractions were reported in two studies, all infants were in good health at birth. In terms of gestational age at birth, induction of labor, and mode of birth, only one study reported the gestational age at birth (mean gestation 40 weeks).

The authors concluded that acupuncture significantly improved pain, functional status and quality of life in women with LBPP during the pregnancy. Additionally, acupuncture had no observable severe adverse influences on the newborns. More large-scale and well-designed RCTs are still needed to further confirm these results.

What should we make of this paper?

In case you are in a hurry: NOT A LOT!

In case you need more, here are a few points:

  • many trials were of poor quality;
  • there was evidence of publication bias;
  • there was considerable heterogeneity within the studies.

The most important issue is one studiously avoided in the paper: the treatment of the control groups. One has to dig deep into this paper to find that the control groups could be treated with “other treatments, no intervention, and placebo acupuncture”. Trials comparing acupuncture combined plus other treatments with other treatments were also considered to be eligible. In other words, the analyses included studies that compared acupuncture to no treatment at all as well as studies that followed the infamous ‘A+Bversus B’ design. Seven studies used no intervention or standard of care in the control group thus not controlling for placebo effects.

Nobody can thus be in the slightest surprised that the overall result of the meta-analysis was positive – false positive, that is! And the worst is that this glaring limitation was not discussed as a feature that prevents firm conclusions.

Dishonest researchers?

Biased reviewers?

Incompetent editors?

Truly unbelievable!!!

In consideration of these points, let me rephrase the conclusions:

The well-documented placebo (and other non-specific) effects of aacupuncture improved pain, functional status and quality of life in women with LBPP during the pregnancy. Unsurprisingly, acupuncture had no observable severe adverse influences on the newborns. More large-scale and well-designed RCTs are not needed to further confirm these results.

PS

I find it exasperating to see that more and more (formerly) reputable journals are misleading us with such rubbish!!!

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.

 

 

This study described osteopathic practise activity, scope of practice and the osteopathic patient profile in order to understand the role osteopathy plays within the United Kingdom’s (UK) health system a decade after the authors’ previous survey.

The researchers used a retrospective questionnaire survey design to ask about osteopathic practice and audit patient case notes. All UK-registered osteopaths were invited to participate in the survey. The survey was conducted using a web-based system. Each participating osteopath was asked about themselves, and their practice and asked to randomly select and extract data from up to 8 random new patient health records during 2018. All patient-related data were anonymized.

The survey response rate was 500 osteopaths (9.4% of the profession) who provided information about 395 patients and 2,215 consultations. Most osteopaths were:

  • self-employed (81.1%; 344/424 responses),
  • working alone either exclusively or often (63.9%; 237/371),
  • able to offer 48.6% of patients an appointment within 3 days (184/379).

Patient ages ranged from 1 month to 96 years (mean 44.7 years, Std Dev. 21.5), of these 58.4% (227/389) were female. Infants <1 years old represented 4.8% (18/379) of patients. The majority of patients presented with musculoskeletal complaints (81.0%; 306/378) followed by pediatric conditions (5%). Persistent complaints (present for more than 12 weeks before the appointment) were the most common (67.9%; 256/377) and 41.7% (156/374) of patients had co-existing medical conditions.

The most common treatment approaches used at the first appointment were:

  • soft-tissue techniques (73.9%; 292/395),
  • articulatory techniques (69.4%; 274/395),
  • high-velocity low-amplitude thrust (34.4%; 136/395),
  • cranial techniques (23%).

The mean number of treatments per patient was 7 (mode 4). Osteopaths’ referral to other healthcare practitioners amounted to:

  • GPs 29%
  • Other complementary therapists 21%
  • Other osteopaths 18%

The authors concluded that osteopaths predominantly provide care of musculoskeletal conditions, typically in private practice. To better understand the role of osteopathy in UK health service delivery, the profession needs to do more research with patients in order to understand their needs and their expected outcomes of care, and for this to inform osteopathic practice and education.

What can we conclude from a survey that has a 9% response rate?

Nothing!

If I ignore this fact, do I find anything of interest here?

Not a lot!

Perhaps just three points:

  1. Osteopaths use high-velocity low-amplitude thrusts, the type of manipulation that has most frequently been associated with serious complications, too frequently.
  2. They also employ cranial osteopathy, which is probably the least plausible technique in their repertoire, too often.
  3. They refer patients too frequently to other SCAM practitioners and too rarely to GPs.

To come back to the question asked in the title of this post: What do UK osteopaths do? My answer is

ALMOST NOTHING THAT MIGHT BE USEFUL.

This study aimed to evaluate the number of craniosacral therapy sessions that can be helpful to obtain a resolution of the symptoms of infantile colic and to observe if there are any differences in the evolution obtained by the groups that received a different number of Craniosacral Therapy sessions at 24 days of treatment, compared with the control group which did not received any treatment.

Fifty-eight infants with colic were randomized into two groups:

  • 29 babies in the control group received no treatment;
  • babies in the experimental group received 1-3 sessions of craniosacral therapy (CST) until symptoms were resolved.

Evaluations were performed until day 24 of the study. Crying hours served as the primary outcome measure. The secondary outcome measures were the hours of sleep and the severity, measured by an Infantile Colic Severity Questionnaire (ICSQ).

Statistically significant differences were observed in favor of the experimental group compared to the control group on day 24 in all outcome measures:

  • crying hours (mean difference = 2.94, at 95 %CI = 2.30-3.58; p < 0.001);
  • hours of sleep (mean difference = 2.80; at 95 %CI = – 3.85 to – 1.73; p < 0.001);
  • colic severity (mean difference = 17.24; at 95 %CI = 14.42-20.05; p < 0.001).

Also, the differences between the groups ≤ 2 CST sessions (n = 19), 3 CST sessions (n = 10), and control (n = 25) were statistically significant on day 24 of the treatment for crying, sleep and colic severity outcomes (p < 0.001).

The authors concluded that babies with infantile colic may obtain a complete resolution of symptoms on day 24 by receiving 2 or 3 CST sessions compared to the control group, which did not receive any treatment.

Why do SCAM researchers so often have no problem leaving the control group of patients in clinical trials without any treatment at all, while shying away from administering a placebo? Is it because they enjoy being the laughingstock of the science community? Probably not.

I suspect the reason might be that often they know that their treatments are placebos and that their trials would otherwise generate negative findings. Whatever the reasons, this new study demonstrates three things many of us already knew:

  1. Colic in babies always resolves on its own but can be helped by a placebo response (e.g. via the non-blinded parents), by holding the infant, and by paying attention to the child.
  2. Flawed trials lend themselves to drawing the wrong conclusions.
  3. Craniosacral therapy is not biologically plausible and most likely not effective beyond placebo.

One of the numerous conditions chiropractors, osteopaths, and other manual therapists claim to treat effectively is tension-type headache (TTH). For this purpose, they (in particular, chiropractors) often use high-velocity, low-amplitude manipulations of the neck. They do so despite the fact that the evidence for these techniques is less than convincing.

This systematic review evaluated the evidence about the effectiveness of manual therapy (MT) on pain intensity, frequency, and impact of pain in individuals with tension-type headache (TTH).

Medline, Embase, Scopus, Web of Science, CENTRAL, and PEDro were searched in June 2020. Randomized clinical trials that applied MT not associated with other interventions for TTH were selected. The level of evidence was synthesized using GRADE, and Standardized Mean Differences (SMD) were calculated for meta-analysis.

Fifteen studies were included with a total sample of 1131 individuals. The analyses show that high-velocity, low-amplitude techniques were not superior to no treatment in reducing pain intensity (SMD = 0.01, low evidence) and frequency (SMD = -0.27, moderate evidence). Soft tissue interventions were superior to no treatment in reducing pain intensity (SMD = -0.86, low evidence) and frequency of pain (SMD = -1.45, low evidence). Dry needling was superior to no treatment in reducing pain intensity (SMD = -5.16, moderate evidence) and frequency (SMD = -2.14, moderate evidence). Soft tissue interventions were not superior to no treatment and other treatments on the impact of headache.

The authors concluded that manual therapy may have positive effects on pain intensity and frequency, but more studies are necessary to strengthen the evidence of the effects of manual therapy on subjects with tension-type headache. Implications for rehabilitation soft tissue interventions and dry needling can be used to improve pain intensity and frequency in patients with tension type headache. High velocity and low amplitude thrust manipulations were not effective for improving pain intensity and frequency in patients with tension type headache. Manual therapy was not effective for improving the impact of headache in patients with tension type headache.

So, this review shows that:

  • soft tissue interventions are better than no treatment,
  • dry needling is better than no treatment.

These two results fail to impress me. Due to a placebo effect, almost any treatment should be better than no therapy at all.

ALMOST, because high-velocity, low-amplitude techniques were not superior to no treatment in reducing the intensity and frequency of pain. This, I feel, is an important finding that needs an explanation.

As it is only logical that high-velocity, low-amplitude techniques must also produce a positive placebo effect, the finding can only mean that these manipulations also generate a negative effect that is strong enough to cancel the positive response to placebo. (In addition, they can also cause severe complications via arterial dissections, as discussed often on this blog.)

Too complicated?

Perhaps; let me, therefore, put it simply and use the blunt words of a neurologist who once was quoted saying this:

DON’T LET THE BUGGARS TOUCH YOUR NECK!

 

Osteopathy is becoming under increasing criticism – not just in the UK but also in other countries. Here are the summary points from a very good overview from Canada:

– Osteopathy is based on the belief that illness comes from the impaired movement of muscles, bones, and their connecting structures, and that an osteopath can restore proper movement using their hands
– Offshoots of osteopathy include visceral osteopathy and craniosacral osteopathy, which make extraordinary claims that are not backed up by good evidence
– There is an absence of good quality evidence to support the use of osteopathy to address musculoskeletal issues
– Osteopathy has been reformed in the United States, with osteopathic physicians receiving training comparable to medical doctors and few of them regularly using osteopathic manual manipulations

An article from Germany is equally skeptical. Here is my translation of an excerpt from a recent article:

When asked which studies prove the effectiveness, the VOD kindly and convincingly handed the author of this article a list of about 20 studies. And emphasized that these were listed in Medline, i.e. a recognized medical database. But a close examination of the studies reveals: Almost without exception, all of them qualify their results and point to uncertainties.
The treatment is “possibly helpful,” for example, they say, the study quality is “very low,” “low” to “moderate,” there are too few studies, they are small, the “evidence is preliminary” and “insufficient to draw definitive conclusions. Again and again it is emphasized that further, methodically better, more sustainable studies are needed, which also record more precisely what happened in osteopathic treatment in the first place.

Another article was published by myself in ‘L’Express’. As it is in French, I translated the conclusion for you:

… would I recommend consulting an osteopath? My answer is a carefully considered NO! For patients with back pain, the evidence is as good (or bad, depending on your point of view) as for many other proposed therapies. So if a patient insists on osteopathy, I might support it, but I would still prefer physical therapy. For all other musculoskeletal conditions, there is not enough evidence to make positive recommendations. For patients with conditions other than musculoskeletal, I would advise against osteopathy.

All this comes after it has been shown that worldwide research into osteopathy is scarce and has hardly any impact at all. The question we should therefore ask is this:

why do we need osteopaths?

PS

Osteopaths in the US have studied medicine, rarely practice manual treatments, and are almost indistinguishable from MDs. Everywhere else, osteopaths are practitioners of so-called alternative medicine.

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