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

back pain

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The purpose of this survey was to quantify and describe the clinical practice beliefs and behaviors associated with US chiropractors. A 10% random sample of US chiropractors (n = 8975) was selected from all 50 state regulatory board lists and invited to participate in a survey. The survey consisted of a 7-item questionnaire; 6 items were associated with chiropractic ideological and practice characteristics and 1 item was related to the self-identified role of chiropractic in the healthcare system which was utilized as the dependent variable to identify chiropractic subgroups. Multinomial logistic regression with predictive margins was used to analyze which responses to the 6 ideology and practice characteristic items were predictive of chiropractic subgroups.

The survey instrument used in this study was developed by the authors and modeled after similar chiropractic identity analyses. The survey instrument included a total of 7 items intended to elicit divergent ideologies and practice behaviors. The figure below is a copy of the survey instrument.

A total of 3538 responses were collected (39.4% response rate). Respondents self-identified into three distinct subgroups based on the perceived role of the chiropractic profession in the greater healthcare system:

  1. 57% were spine/neuromusculoskeletal focused;
  2. 22% were primary care focused;
  3. 21% were vertebral subluxation focused.

Patterns of responses to the 6 ideologies and practice characteristic items were substantially different across the three professional subgroups.

The authors concluded that respondents self-identified into one of three distinct intra-professional subgroups. These subgroups can be differentiated along themes related to clinical practice beliefs and behaviors.

Here are the results in more detail as sated by the authors:

Regarding scope of examination (survey question 1), respondents reporting the scope of their clinical examination to only include spinal analysis for the assessment of vertebral subluxation had a 70% probability of belonging to the subluxation focused subgroup, a 20% probability of belonging to the spine and neuromusculoskeletal focused subgroup, and a 10% probability of belonging to the primary care focused subgroup. Conversely, respondents who reported the scope of their clinical examination only includes a differential diagnosis had a 0% probability of belonging to the vertebral subluxation focused subgroup, an 80% probability of belonging to the spine and neuromusculoskeletal focused subgroup, and a 20% probability of belonging to the primary care focused subgroup.

Concerning conditions treated (survey question 2), respondents who reported predominantly treating vertebral subluxation as an encumbrance to health had an 80% probability of belonging to the vertebral subluxation focused subgroup, a 10% probability of belonging to the spine and neuromusculoskeletal focused subgroup, and a 10% probability of belonging to the primary care focused subgroup. In contrast, respondents reporting predominantly treating neuromusculoskeletal conditions had a 0% probability of belonging to the vertebral subluxation focused subgroup, a 90% probability of belonging to the spine and neuromusculoskeletal focused subgroup, and a 10% probability of belonging to the primary care focused subgroup.

Regarding the role of spinal manipulation for those with cancer (survey question 4), respondents reporting the role of spinal manipulation for those with cancer is to remove interference to innate intelligence had a 70% probability of belonging to the vertebral subluxation focused subgroup, a 20% probability of belonging to the spine and neuromusculoskeletal focused subgroup, and a 10% probability of belonging to the primary care focused subgroup. Respondents reporting there is no role of spinal manipulation in those with cancer also had a 10% probability of belonging to the subluxation focused subgroup, an 80% probability of belonging to the spine and neuromusculoskeletal focused subgroup, and a 10% probability of belonging to the primary care focused subgroup.

Regarding vaccination (survey question 5), respondents who strongly disagreed that vaccinations have had a positive effect on global public health had a 50% probability of belonging to the vertebral subluxation focused subgroup, an approximately 25% probability of belonging to the spine and neuromusculoskeletal focused subgroup, and an approximately 25% probability of belonging to the primary care focused subgroup. In contrast, respondents who strongly agreed that vaccinations have had a positive effect on global public health had a 0% probability of belonging to the vertebral subluxation focused subgroup, a 90% probability of belonging to the spine and neuromusculoskeletal focused subgroup, and a 10% probability of belonging to the primary care focused subgroup.

Concerning the detection of vertebral subluxation on x-ray (survey question 6), respondents who strongly agreed that x-ray is helpful in detecting vertebral subluxations had a 40% probability of belonging to the vertebral subluxation focused subgroup, a 40% probability of belonging to the spine and neuromusculoskeletal focused subgroup, and a 20% probability of belonging to the primary care focused subgroup. Respondents who strongly disagreed that x-ray is helpful in detecting vertebral subluxations had a near 0% probability of belonging to the vertebral subluxation focused subgroup, an 80% probability of belonging to the spine and neuromusculoskeletal focused subgroup, and slightly below a 20% probability of belonging to the primary care focused subgroup.

Regarding use of x-rays for new patients (survey question 7), respondents who reported prescribing x-rays for 0–20% of new patients had a 20% probability of belonging to the vertebral subluxation focused subgroup, a 60% probability of belonging to the spine and neuromusculoskeletal focused subgroup, and a 20% probability of belonging to the primary care focused subgroup. Respondents reporting prescribing x-rays for 81–100% of new patients had a 40% probability of belonging to the vertebral subluxation focused subgroup, a 40% probability of belonging to the spine and neuromusculoskeletal focused subgroup, and a 20% probability of belonging to the primary care focused subgroup.

END OF QUOTE

While I am not sure that the division into the 3 subgroups is valid and suspect that there must be a substantial overlap between them, I must admit that the paper is rich in fascinating information. Generally speaking, I find all subgroups somewhat mysterious and would ask them the following questions:

Subgroup 1: why did you not study medicine or physiotherapy?

Subgroup 2: does it not bother you that your education and training are woefully insufficient for primary care?

Subgroup 3: is it not time to abandon the obsolete nonsense of your guru, the old charlatan DD Palmer?

 

 

Static or motion manual palpation tests of the spine are commonly used by chiropractors and osteopaths to assess pain location and reproduction in low back pain (LBP) patients. But how reliable are they?

The purpose of this review was to evaluate the reliability and validity of manual palpation used for the assessment of LBP in adults. The authors systematically searched five databases from 2000 to 2019 and critically appraised the internal validity of studies using QAREL and QUADAS-2 instruments.

A total of 2023 eligible articles were identified, of which 14 were at low risk of bias. Evidence suggests that reliability of soft tissue structures palpation is inconsistent, and reliability of bony structures and joint mobility palpation is poor. Preliminary evidence was found to suggest that gluteal muscle palpation for tenderness may be valid in differentiating LBP patients with and without radiculopathy.

The authors concluded that the reliability of manual palpation tests in the assessment of LBP patients varies greatly. This is problematic because these tests are commonly used by manual therapists and clinicians. Little is known about the validity of these tests; therefore, their clinical utility is uncertain. High quality validity studies are needed to inform the clinical use of manual palpation tests.

I have repeatedly drawn attention to the fact that the diagnostic methods used by chiropractors and osteopaths are of uncertain or disproven validity (see for instance here, or here). Why is that important?

Imagine you consult a chiropractor or osteopath. Simply put, this is what is likely to happen:

  • They listen to your complaint.
  • They do a few tests which are of dubious validity.
  • They give you a diagnosis that is meaningless.
  • They treat you with manual therapies that are neither effective nor safe.
  • You pay.
  • They persuade you that you need many more sessions.
  • You pay regularly.
  • When eventually your pain has gone away, they persuade you to have useless maintenance treatment.
  • You pay regularly.

In a nutshell, they have very little to offer … which explains why they attack everyone who dares to disclose this.

In their 2019 systematic review of spinal manipulative therapy (SMT) for chronic back pain, Rubinstein et al included 7 studies comparing the effect of SMT with sham SMT.

They defined SMT as any hands-on treatment of the spine, including both mobilization and manipulation. Mobilizations use low-grade velocity, small or large amplitude passive movement techniques within the patient’s range of motion and control. Manipulation uses a high-velocity impulse or thrust applied to a synovial joint over a short amplitude near or at the end of the passive or physiological range of motion. Even though there is overlap, it seems fair to say that mobilization is the domain of osteopaths, while manipulation is that of chiropractors.

The researchers found:

  • low-quality evidence suggesting that SMT does not result in a statistically better effect than sham SMT at one month,
  • very low-quality evidence suggesting that SMT does not result in a statistically better effect than sham SMT at six and 12 months.
  • low-quality evidence suggesting that, in terms of function, SMT results in a moderate to strong statistically significant and clinically better effect than sham SMT at one month. Exclusion of an extreme outlier accounted for a large percentage of the statistical heterogeneity for this outcome at this time interval (SMD −0.27, 95% confidence interval −0.52 to −0.02; participants=698; studies=7; I2=39%), resulting in a small, clinically better effect in favor of SMT.
  • very low-quality evidence suggesting that, in terms of function, SMT does not result in a statistically significant better effect than sham SMT at six and 12 months.

This means that SMT has effects that are very similar to placebo (the uncertain effects on function could be interpreted as the result of residual de-blinding due to a lack of an optimal placebo or sham intervention). In turn, this means that the effects patients experience are largely or completely due to a placebo response and that SMT has no or only a negligibly small specific effect on back pain. Considering the facts that SMT is by no means risk-free and that less risky treatments exist, the inescapable conclusion is that SMT cannot be recommended as a treatment of chronic back pain.

This systematic review assessed the effect of spinal manipulative therapy (SMT), the hallmark therapy of chiropractors, on pain and function for chronic low back pain (LBP) using individual participant data (IPD) meta-analyses.

Of the 42 RCTs fulfilling the inclusion criteria, the authors obtained IPD from 21 (n=4223). Most trials (s=12, n=2249) compared SMT to recommended interventions. The analyses showed moderate-quality evidence that SMT vs recommended interventions resulted in similar outcomes on

  • pain (MD -3.0, 95%CI: -6.9 to 0.9, 10 trials, 1922 participants)
  • and functional status at one month (SMD: -0.2, 95% CI -0.4 to 0.0, 10 trials, 1939 participants).

Effects at other follow-up measurements were similar. Results for other comparisons (SMT vs non-recommended interventions; SMT as adjuvant therapy; mobilization vs manipulation) showed similar findings. SMT vs sham SMT analysis was not performed, because data from only one study were available. Sensitivity analyses confirmed these findings.

The authors concluded that sufficient evidence suggest that SMT provides similar outcomes to recommended interventions, for pain relief and improvement of functional status. SMT would appear to be a good option for the treatment of chronic LBP.

In 2019, this team of authors published a conventional meta-analysis of almost the same data. At this stage, they concluded as follows: SMT produces similar effects to recommended therapies for chronic low back pain, whereas SMT seems to be better than non-recommended interventions for improvement in function in the short term. Clinicians should inform their patients of the potential risks of adverse events associated with SMT.

Why was the warning about risks dropped in the new paper?

I have no idea.

But the risks are crucial here. If we are told that SMT is as good or as bad as recommended therapies, such as exercise, responsible clinicians need to decide which treatment they should recommend to their patients. If effectiveness is equal, other criteria come into play:

  • cost,
  • risk,
  • availability.

Can any reasonable person seriously assume that SMT would do better than exercise when accounting for costs and risks?

I very much doubt it!

The objective of this systematic review was to assess the effects and reliability of sham procedures in manual therapy (MT) trials in the treatment of back pain (BP) in order to provide methodological guidance for clinical trial development. Different databases were screened up to 20 August 2020. Randomised clinical trials involving adults affected by BP (cervical and lumbar), acute or chronic, were included. Hand contact sham treatment (ST) was compared with different MT (physiotherapy, chiropractic, osteopathy, massage, kinesiology, and reflexology) and to no treatment. Primary outcomes were BP improvement, the success of blinding, and adverse effect (AE). Secondary outcomes were the number of drop-outs. Dichotomous outcomes were analysed using risk ratio (RR), continuous using mean difference (MD), 95% CIs. The minimal clinically important difference was 30 mm changes in pain score.

A total of 24 trials were included involving 2019 participants. Different manual treatments were provided:

  • SM/chiropractic (7 studies, 567 participants).
  • Osteopathy (5 trials, 645 participants).
  • Kinesiology (1 trial, 58 participants).
  • Articular mobilisations (6 trials, 445 participants).
  • Muscular release (5 trials, 304 participants).

Very low evidence quality suggests clinically insignificant pain improvement in favour of MT compared with ST (MD 3.86, 95% CI 3.29 to 4.43) and no differences between ST and no treatment (MD -5.84, 95% CI -20.46 to 8.78).ST reliability shows a high percentage of correct detection by participants (ranged from 46.7% to 83.5%), spinal manipulation being the most recognised technique. Low quality of evidence suggests that AE and drop-out rates were similar between ST and MT (RR AE=0.84, 95% CI 0.55 to 1.28, RR drop-outs=0.98, 95% CI 0.77 to 1.25). A similar drop-out rate was reported for no treatment (RR=0.82, 95% 0.43 to 1.55).

Forest plot of comparison ST versus MT in back pain outcome at short term. MT, manual therapy; ST, sham treatment.

The authors concluded that MT does not seem to have clinically relevant effect compared with ST. Similar effects were found with no treatment. The heterogeneousness of sham MT studies and the very low quality of evidence render uncertain these review findings. Future trials should develop reliable kinds of ST, similar to active treatment, to ensure participant blinding and to guarantee a proper sample size for the reliable detection of clinically meaningful treatment effects.

Essentially these findings suggest that the effects patients experience after MT are not due to MT per see but to placebo effects. The review could be criticised because of the somewhat odd mix of MTs lumped together in one analysis. Yet, I think it is fair to point out that most of the studies were of chiropractic and osteopathy. Thus, this review implies that chiropractic and osteopathy are essentially placebo treatments.

The authors of the review also provide this further comment:

Similar findings were found in other reviews conducted on LBP. Ruddock et al included studies where SM was compared with what authors called ‘an effective ST’, namely a credible sham manipulation that physically mimics the SM. Pooled data from four trials showed a very small and not clinically meaningful effect in favour of MT.

Rubinstein et al  compared SM and mobilisation techniques to recommended, non-recommended therapies and to ST. Their findings showed that 5/47 studies included attempted to blind patients to the assigned intervention by providing an ST. Of these five trials, two were judged at unclear risk of participants blinding. The authors also questioned the need for additional studies on this argument, as during the update of their review they found recent small pragmatic studies with high risk of bias. We agree with Rubinstein et al that recent studies included in this review did not show a higher quality of evidence. The development of RCT with similar characteristic will probably not add any proof of evidence on MT and ST effectiveness.

If we agree that chiropractic and osteopathy are placebo therapies, we might ask whether they should have a place in the management of BP. Considering the considerable risks associated with them, I feel that the answer is obvious and simple:

NO!

Subluxation is … a displacement of two or more bones whose articular surfaces have lost, wholly or in part, their natural connection. (D. D. Palmer, 1910)

The definition of ‘subluxation’ as used by chiropractors differs from that in conventional medicine where it describes a partial dislocation of the bony surfaces of a joint readily visible via an X-ray. Crucially, a subluxation, as understood in conventional medicine, is not the cause of disease. Spinal subluxations, according to medical terminology, are possible only if anatomical structures are seriously disrupted.

Subluxation, as chiropractors understand the term, has been central to chiropractic from its very beginning. Despite its central role in chiropractic, its definition is far from clear and has changed significantly over time.

DD Palmer (the guy who invented chiropractic) was extremely vague about most of his ideas. Yet, he remained steadfast about his claims that 95% of all diseases were due to subluxations of the spine, that subluxations hindered the flow of the ‘innate intelligence’ which controlled the vital functions of the body. Innate intelligence or ‘inate’, he believed, operated through the nerves, and subluxated vertebra caused pinched nerves, which in turn blocked the flow of the innate and thus led to abnormal function of our organs. For Palmer and his followers, subluxation is the sole or at least the main cause of all diseases (or dis-eases, as Palmer preferred).

Almost exactly 4 years ago, I published this post:

Is chiropractic subluxation a notion of the past? SADLY NOT! 

In it, I provided evidence that – contrary to what we are often told – chiropractors remain fond of the subluxation nonsense they leant in school. This can be shown by the frequency by which chiropractors advertise on Twitter the concept of chiropractic subluxation.

Today, I had another look. The question I asked myself was: has the promotion of the obsolete subluxation concept by chiropractors subsided?

The findings did not surprise me.

Even a quick glance reveals that there is still a plethora of advertising going on that uses the subluxation myth. Many chiros use imaginative artwork to get their misleading message across. Below is a small selection.

Yes, I know, this little display is not very scientific. In fact, it is a mere impression and does not intend to be anything else. So, let’s look at some more scientific data on this subject. Here are the last 2 paragraphs from the chapter on subluxation in my recent book on chiropractic:

A 2018 survey determined how many chiropractic institutions worldwide still use the term in their curricula.[1] Forty-six chiropractic programmes (18 from US and 28 non-US) participated. The term subluxation was found in all but two US course catalogues. Remarkably, between 2011 and 2017, the use of subluxation in US courses even increased. Similarly, a survey of 7455 US students of chiropractic showed that 61% of them agreed or strongly agreed that the emphasis of chiropractic intervention is to eliminate vertebral subluxations/vertebral subluxation complexes.[2]

Even though chiropractic subluxation is at the heart of chiropractic, its definition remains nebulous and its very existence seems doubtful. But doubt is not what chiropractors want. Without subluxation, spinal manipulation seems questionable – and this will be the theme of the next chapter.

[1] https://chiromt.biomedcentral.com/articles/10.1186/s12998-018-0191-1

[2] https://www.ncbi.nlm.nih.gov/pubmed/25646145

In a nutshell: chiros cannot give up the concept of subluxation because, if they did, they would be physios except with a much narrower focus.

These days, I live in France (some of my time) and I am often baffled by the number of osteopaths and the high level of acceptance of osteopathy in this country. The public seems to believe everything osteopaths claim and even most doctors have long given up to object to the idiocies they proclaim.

The website of the Institute of Osteopathy in Renne is but one of many examples. The Institute informed us as follows (my translation):

In addition to back pain, the osteopath can act on functional disorders of the digestive, neurological, cardiovascular systems or conditions related to ear, nose and throat. Osteopaths can promote recovery in athletes, relieve migraines, musculoskeletal disorders such as tendonitis, or treat sleep disorders. Less known for its preventive aspect, osteopathy also helps maintain good health. It can be effective even when everything is going well because it will prevent the appearance of pain. Osteopathy is, in fact, a manual medicine that allows the rebalancing of the major systems of the body, whatever the age of the patient and his problems. The osteopath looks for the root cause of your complaint in order to develop a curative and preventive treatment.

Who are osteopathic consultations for?

Osteopathic consultations at the Institute of Osteopathy of Rennes-Bretagne are intended for the following types of patients and pathologies

BABY / CHILD

GERD (gastric reflux), plagiocephaly (cranial deformities), recurrent ENT disorders (sinusitis, ear infections…), digestive, sleep and behavioural disorders, motor delay, following a difficult birth…

ADULT

Prevention, comfort treatment of osteoarthritis, musculoskeletal pain, functional abdominal pain, digestive disorders, headaches, dizziness, postural deficiency, facial pains…

PREGNANT WOMAN

Musculoskeletal pain (lumbago, back pain), digestive disorders, preparation for childbirth, post-partum check-up.

COMPANY

Prevention and treatment of MSDs (musculoskeletal disorders) linked to workstation ergonomics, stress, pain due to repetitive movements, poor posture at work, etc.

ADOLESCENT

Scoliosis, prevention of certain pathologies linked to growth, fatigue, stress, follow-up of orthodontic treatment.

SPORTSMAN

Musculoskeletal pain, tendonitis, osteopathic preparation for competition, osteopathic assessment according to the sport practised, repetitive injury.

In case you are not familiar with the evidence for osteopathy, let me tell you that as good as none of the many claims made in the above text is supported by anything that even resembles sound evidence.

So, how can we explain that, in France, osteopathy is allowed to thrive in a virtually evidence-free space?

In France, osteopathy started developing in the 1950s. In 2002, osteopathy received legislative recognition in France, and today, it is booming; between 2016 and 2018, 3589 osteopaths were trained in France. Osteopaths can be DO doctors, DO physiotherapists, DO nurses, DO midwives, DO chiropodists, or even DO dentists.

Thus, in 2018, and out of a total of 29,612 professionals practising osteopathy, there were 17,897 osteopaths DO and 11,715 DO health professionals. The number of professionals using the title of osteopath has roughly tripled in 8 years (11608 in 2010 for 29612 in 2018). There are currently around 30 osteopathic schools in France. About 3 out of 5 French people now consult osteopaths.

But this does not answer my question why, in France, osteopathy is allowed to thrive in a virtually evidence-free space! To be honest, I do not know its answer.

Perhaps someone else does?

If so, please enlighten me.

 

 

Myofascial release (also known as myofascial therapy or myofascial trigger point therapy) is a type of low-load stretch therapy that is said to release tightness and pain throughout the body caused by the myofascial pain syndrome, a chronic muscle pain that is worse in certain areas known as trigger points. Various types of health professionals provide myofascial release, e.g. osteopaths, chiropractors, physical or occupational therapists, massage therapists, or sports medicine/injury specialists. The treatment is usually applied repeatedly, but there is also a belief that a single session of myofascial release is effective. This study was a crossover clinical trial aimed to test whether a single session of a specific myofascial release technique reduces pain and disability in subjects with chronic low back pain (CLBP).

A total of 41 participants were randomly enrolled into 3 situations in a balanced and crossover manner:

  • experimental,
  • placebo,
  • control.

The subjects underwent a single session of myofascial release on thoracolumbar fascia and the results were compared with the control and placebo groups. A single trained and experienced therapist applied the technique.

For the control treatment, the subjects were instructed to remain in the supine position for 5 minutes. For the muscle release session, the subjects were in a sitting position with feet supported and the thoracolumbar region properly undressed. The trunk flexion goniometry of each participant was performed and the value of 30° was marked with a barrier to limit the necessary movement during the technique. The trained researcher positioned their hands on all participants without sliding over the skin or forcing the tissue, with the cranial hand close to the last rib and at the T12–L1 level on the right side of the individual’s body and the caudal hand on the ipsilateral side between the iliac crest and the sacrum. Then, the researcher caused slight traction in the tissues by moving their hands away from each other in a longitudinal direction. Then, the participant was instructed to perform five repetitions of active trunk flexion-extension (30°), while the researcher followed the movement with both hands simultaneously positioned, without losing the initial tissue traction and position. The same technique and the same number of repetitions of active trunk flexion-extension were repeated with the researcher’s hands positioned on the opposite sides. This technique lasted approximately five minutes.

For the placebo treatment, the subjects were not submitted to the technique of manual thoracolumbar fascia release, but they slowly performed ten repetitions of active trunk flexion-extension (30°) in the same position as the experimental situation. Due to the fact that touch can provide not only well-recognized discriminative input to the brain, but also an affective input, there was no touch from the researcher at this stage.

The outcomes, pain, and functionality, were evaluated using the numerical pain rating scale (NPRS), pressure pain threshold (PPT), and Oswestry Disability Index (ODI).

The results showed no effects between-tests, within-tests, nor for interaction of all the outcomes, i.e., NPRS (η 2 = 0.32, F = 0.48, p = 0.61), PPT (η2 = 0.73, F = 2.80, p = 0.06), ODI (η2 = 0.02, F = 0.02, p = 0.97).

The authors concluded that a single trial of a thoracolumbar myofascial release technique was not enough to reduce pain intensity and disability in subjects with CLBP.

Surprised?

I’m not!

Recently, I received this comment from a reader:

Edzard-‘I see you do not understand much of trial design’ is true BUT I wager that you are in the same boat when it comes to a design of a trial for LBP treatment: not only you but many other therapists. There are too many variables in the treatment relationship that would allow genuine , valid criticism of any design. If I have to pick one book of the several listed elsewhere I choose Gregory Grieve’s ‘Common Vertebral Joint Problems’. Get it, read it, think about it and with sufficient luck you may come to realize that your warranted prejudices against many unconventional ‘medical’ treatments should not be of the same strength when it comes to judging the physical therapy of some spinal problems as described in the book.

And a chiro added:

EE: I see that you do not understand much of trial design

Perhaps it’s Ernst who doesnt understand how to research back pain.

“The identification of patient subgroups that respond best to specific interventions has been set as a key priority in LBP research for the past 2 decades.2,7 In parallel, surveys of clinicians managing LBP show that there are strong views against generic treatment and an expectation that treatment should be individualized to the patient.6,22.”

Journal of Orthopaedic & Sports Physical Therapy
Published Online:January 31, 2017Volume47Issue2Pages44-48

Do I need to explain why the Grieve book (yes, I have it and yes, I read it) is not a substitute for evidence that an intervention or technique is effective? No, I didn’t think so. This needs to come from a decent clinical trial.

And how would one design a trial of LBP (low back pain) that would be a meaningful first step and account for the “many variables in the treatment relationship”?

How about proceeding as follows (the steps are not necessarily in that order):

  • Study the previously published literature.
  • Talk to other experts.
  • Recruit a research team that covers all the expertise you need (and don’t have yourself).
  • Formulate your research question. Mine would be IS THERAPY XY MORE EFFECTIVE THAN USUAL CARE FOR CHRONIC LBP? I know LBP is but a vague symptom. This does, however, not necessarily matter (see below).
  • Define primary and secondary outcome measures, e.g. pain, QoL, function, as well as the validated methods with which they will be quantified.
  • Clarify the method you employ for monitoring adverse effects.
  • Do a small pilot study.
  • Involve a statistician.
  • Calculate the required sample size of your study.
  • Consider going multi-center with your trial if you are short of patients.
  • Define chronic LBP as closely as you can. If there is evidence that a certain type of patient responds better to the therapy xy than others, that might be considered in the definition of the type of LBP.
  • List all inclusion and exclusion criteria.
  • Make sure you include randomization in the design.
  • Randomization should be to groups A and B. Group A receives treatment xy, while group B receives usual care.
  • Write down what A and B should and should not entail.
  • Make sure you include blinding of the outcome assessors and data evaluators.
  • Define how frequently the treatments should be administered and for how long.
  • Make sure all therapists employed in the study are of a high standard and define the criteria of this standard.
  • Train all therapists of both groups such that they provide treatments that are as uniform as possible.
  • Work out a reasonable statistical plan for evaluating the results.
  • Write all this down in a protocol.

Such a trial design does not need patient or therapist blinding nor does it require a placebo. The information it would provide is, of course, limited in several ways. Yet it would be a rigorous test of the research question.

If the results of the study are positive, one might consider thinking of an adequate sham treatment to match therapy xy and of other ways of firming up the evidence.

As LBP is not a disease but a symptom, the study does not aim to include patients that all are equal in all aspects of their condition. If some patients turn out to respond better than others, one can later check whether they have identifiable characteristics. Subsequently, one would need to do a trial to test whether the assumption is true.

Therapy xy is complex and needs to be tailored to the characteristics of each patient? That is not necessarily an unsolvable problem. Within limits, it is possible to allow each therapist the freedom to chose the approach he/she thinks is optimal. If the freedom needed is considerable, this might change the research question to something like ‘IS THAT TYPE OF THERAPIST MORE EFFECTIVE THAN THOSE EMPLOYING USUAL CARE FOR CHRONIC LBP?’

My trial would obviously not answer all the open questions. Yet it would be a reasonable start for evaluating a therapy that has not yet been submitted to clinical trials. Subsequent trials could build on its results.

I am sure that I have forgotten lots of details. If they come up in discussion, I can try to incorporate them into the study design.

 

 

This systematic review assessed the effects and reliability of sham procedures in manual therapy (MT) trials in the treatment of back pain (BP) in order to provide methodological guidance for clinical trial development.

Different databases were screened up to 20 August 2020. Randomized controlled trials involving adults affected by BP (cervical and lumbar), acute or chronic, were included. Hand contact sham treatment (ST) was compared with different MT (physiotherapy, chiropractic, osteopathy, massage, kinesiology, and reflexology) and to no treatment. Primary outcomes were BP improvement, the success of blinding, and adverse effects (AE). Secondary outcomes were the number of drop-outs. Dichotomous outcomes were analyzed using risk ratio (RR), continuous using mean difference (MD), 95% CIs. The minimal clinically important difference was 30 mm changes in pain score.

A total of 24 trials were included involving 2019 participants. Most of the trials were of chiropractic manipulation. Very low evidence quality suggests clinically insignificant pain improvement in favor of MT compared with ST (MD 3.86, 95% CI 3.29 to 4.43) and no differences between ST and no treatment (MD -5.84, 95% CI -20.46 to 8.78).ST reliability shows a high percentage of correct detection by participants (ranged from 46.7% to 83.5%), spinal manipulation is the most recognized technique. Low quality of evidence suggests that AE and drop-out rates were similar between ST and MT (RR AE=0.84, 95% CI 0.55 to 1.28, RR drop-outs=0.98, 95% CI 0.77 to 1.25). A similar drop-out rate was reported for no treatment (RR=0.82, 95% 0.43 to 1.55).

The authors concluded that MT does not seem to have clinically relevant effect compared with ST. Similar effects were found with no treatment. The heterogeneousness of sham MT studies and the very low quality of evidence render uncertain these review findings. Future trials should develop reliable kinds of ST, similar to active treatment, to ensure participant blinding and to guarantee a proper sample size for the reliable detection of clinically meaningful treatment effects.

The optimal therapy for back pain does not exist or has not yet been identified; there are dozens of different approaches but none has been found to be truly and dramatically effective. Manual therapies like chiropractic and osteopathy are often used, and some data suggest that they are as good (or as bad) as most other options. This review confirms what we have discussed many times previously (e.g. here), namely that the small positive effect of MT, or specifically spinal manipulation, is largely due to placebo.

Considering this information, what is the best treatment for back pain sufferers? The answer seems obvious: it is a therapy that is as (in)effective as all the others but causes the least harm or expense. In other words, it is not chiropractic nor osteopathy but exercise.

My conclusion:

avoid therapists who use spinal manipulation for back pain.

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