MD, PhD, FMedSci, FSB, FRCP, FRCPEd

back pain

As has been discussed on this blog many times before, the chiropractic profession seems to be in a bit of a crisis (my attempt at a British understatement). The Australian chiropractor, Bruce Walker, thinks that, with the adoption of his ten point plan, “the chiropractic profession has an opportunity to turn things around within a generation. Importantly, it has an obligation to the public and to successive generations of chiropractors ahead of it. By embracing this plan the profession can be set on a new path, a new beginning and a new direction. This plan should be known as the new chiropractic.”

And now you are. of course, dying to hear this 10 point plan – well, here it is [heavily abbreviated, I am afraid (the footnotes [ ] and the comments referring to them are mine)]:

  1. There is a need to improve pre professional education for chiropractors.
    Universities or private colleges?
    Chiropractic education should where possible be conducted at universities [1] and this does not mean small single purpose institutions that are deemed universities in name only. Why is this recommended? Primarily because unlike some private colleges, government funded universities insist on intellectual evidence based rigour [2] in their learning and teaching and importantly require staff to be research active. Chiropractic courses need to have an underpinning pedagogy that insists that content [3] is taught in the context of the evidence [4] and that students obtain the necessary training to question and critically appraise [5]…
    Accreditation problems
    Underpinning chiropractic education is program accreditation and this is also in need of review particularly where vitalistic subluxation [6] based courses have been legitimised by the accreditation process…
    Hospital training
    Chiropractic education should also involve specifically relevant hospital access or work experience such as hospital rounds so that students can observe patients that are truly unwell and observe the signs and symptoms taught in their theory classes. Hospital rounds would also allow chiropractic students to interact with other health providers and increase the likelihood of legitimate partnership and respect between health professions [7].
    Who should teach chiropractic students?…
  2. There is a need to establish a progressive identity.
    Chiropractors need to become solely musculoskeletal practitioners with a special emphasis on spinal pain [8]. If the profession becomes the world’s experts in this area it will command the respect deserved [9]. Importantly it will not be seen as a collective of alternative medicine practitioners with a strange belief system [10]…
  3. The profession should develop a generalised special interest.
    …Chiropractic as a profession should also develop a special interest area in the health sciences that can make a worldwide contribution to other related health sciences. This could be either research based or clinically based or indeed both. Some possibilities are: the further development and refinement of evidence based practice [11], improved posture through motor control, musculoskeletal care for the aged and elderly, improving bone density or the very important area of translating research into practice via implementation science. Whatever chosen we need to develop a special interest that sets us apart as experts in a distinctive area [12].
  4. Marginalisation of the nonsensical elements within the profession.
    As professionals chiropractors should not tolerate colleagues or leadership in the profession who demonstrate aberrant ideas. If colleagues transgress the boundaries or professionalism they should be reported to authorities and this should be followed up with action by those authorities [13]…
  5. The profession and individual practitioners should be pro public health.
    It is important to speak up openly in favour of evidence-based public health measures and to join public health associations and agencies [14]…  For example, chiropractors promoting anti-vaccination views need to be countered [15]…
  6. Support legitimate organised elements of the profession.
    Practitioners should support and become involved in chiropractic organisations that are clearly ethical and evidence based [16] and add value to them…
    …Regular collective professional advertising of the benefits of chiropractic for back pain, for example, is a worthy undertaking but the advertisements or media offerings must be evidence based [17].
  7. The profession should strive to improve clinical practice.
    Chiropractors contribute to the public health by the aggregated benefit of positive outcomes to health from their clinical practices [18]… Where restrictive practice laws relating to chiropractors prescribing medication exist the profession should seek to overturn them [19]…
  8. The profession should embrace evidence based practice.
    EBP is the amalgam of best scientific evidence plus clinical expertise plus patient values and circumstances. So what could be missing from this equation? It is clear that in the opinion of a sizable minority of the profession the elements that are missing are “practitioner ideology” and “practitioner values and circumstances”. These additional self- serving and dangerous notions should not be entertained. The adoption of evidence based practice is critical to the future of chiropractic and yet there is resistance by elements within the profession. Soft resistance occurs with attempts to change the name of “Evidence-based practice” (EBP) to “Evidence-informed practice” (EIP). It is worth noting that currently there are over 13,000 articles listed in PUBMED on EBP but less than 100 listed on EIP. So why are some of our profession so keen to use this alternate and weaker term?
    Hard resistance against EBP occurs where it is stated that the best evidence is that based on practice experience and not research. This apparently is known as Practice Based Evidence (PBE) and has a band of followers [20]…
  9. The profession must support research.Research needs to become the number one aspiration of the profession. Research informs both practice and teaching. Without research the profession will not progress. Sadly, the research contribution by the chiropractic profession can only be described as seed like. Figure 1 is a comparison of articles published in the past 45 years by decade using the key words “Physiotherapy” or “Physical Therapy” versus “Chiropractic” (source PUBMED). The Y axis is the number of articles published and the X axis is the decade, the red represents physiotherapy articles, the blue chiropractic. The difference is stark and needs urgent change [21].If the profession at large ignores research whether in its conduct, administration or its results the profession will wither on the vine [22]…
  10. Individual chiropractors need to show personal leadership to effect change.
    Change within the profession will likely only occur if individual chiropractors show personal leadership….
    As part of this personal leadership it will be critical to speak out within the profession. Speak out and become a mentor to less experienced colleagues [23]…
[1] I do wonder whether the ambition to be university-based is not more the hope for recognition than anything else.

[2] The lack of ‘intellectual evidence based rigor’ in chiropractic might prevent from being accepted by universities.

[3] What content?

[4] What evidence?

[5] If one critically assesses chiropractic, it very quickly falls apart.

[6] Subluxation does not need to be reviewed, it needs to be scrapped once and for all.

[7] Again I wonder whether this ambition is about anything else than gaining acceptance and recognition.

[8] In what way would they then differ from physiotherapists?

[9] Same point as in 1 and 7.

[10] The strangest belief system must be that of chiropractic!

[11] This is almost comical! Chiropractic is clearly much further away from evidence practice than chiropractors are aware. In my view, this statement reveals an embarrassing degree of delusion.

[12] To me, this sounds embarrassingly naïve.

[13] If such transgressions were reported in all instances, there would be only very few chiropractors left with a clean slate, I fear.

[14] The profession has a very poor track when it comes to public health measures; as back pain specialists they also would not be in a key position for such a task.

[15] I fear there are far too many anti-vaccination chiros for this to be a realistic prospect.

[16] There is plenty of evidence to show that chiropractic is often neither ethical nor evidence-based.

[17] Advertising is ethically problematic; responsible physicians are extremely cautious and restricted in this respect.

[18] What is this supposed to mean? It sounds politically correct but seems to be little more than a platitude.

[19] So, the future of chiropractic lies in prescribing medicines?

[20] These ‘followers’ are people who want to introduce double standards in healthcare – hardly anything worthy of consideration, I think.

[21] To understand this figure better, we need to know that physiotherapy is, compared to most other areas of healthcare, also not a very research-active field.

[22] But that’s precisely what chiropractors have been doing for the last 100 years!

[23] If you want to know how chiropractors receive a colleague who ‘speaks out’, you only need to read some of the comments Preston Long attracted with his guest post on this blog.

Anyone you thinks that with such a strategy “the chiropractic profession has an opportunity to turn things around within a generation” is, in my view, naïve and deluded. The 10 points are not realistic and woefully incomplete. The most embarrassing omission is a clear statement that chiropractors are fully dedicated to making sure that they serve the best interest of their patients by doing more good than harm.

“Conflicts of interest should always be disclosed.”

This is what I wrote in the ‘RULES’ of this blog when I first started it almost 4 years ago. Sadly, very few people writing comments observe this rule. Perhaps, I just thought, I did not observe it either? So, here are my conflicts of interest: none.

Not true!!! I hear some people say. But it is!

I have no financial interest in any ‘Big Pharma’ or  ‘TINY CAM’, and I get not a penny for writing this blog.

How do I pay for my living? Mind your own business… well, on second thought, even that must not be a secret: I get a small pension and have some savings.

Still not convinced?

Perhaps it’s time to define what ‘conflicts of interests’ are. According to Wikipedia, they can be defined as  situations in which a person or organization is involved in multiple interests, financial interest, or otherwise, one of which could possibly corrupt the motivation of the individual or organization.

So, not having financial benefits from my current work does not necessarily mean that I have no conflicts of interest. The above definitions vaguely mentions ‘or otherwise’ – and that could be important. What could this mean in the context of this blog?

Well, I might have very strong beliefs, for instance (for instance, very strong beliefs that acupuncture is by definition nonsense [see below]). We all know that strong beliefs can corrupt motivation (and a lot more). And if I ask myself, do you have strong beliefs?, I have to say: Yes, absolutely!

I believe that:

  • good evidence is a prerequisite for progress in healthcare,
  • good evidence must be established by rigorous research,
  • we should not tolerate double standards in healthcare,
  • patients deserve to be treated with the best available treatments,
  • making therapeutic claims that are not supported by sound evidence is wrong.

These strong beliefs might make me biased in the eyes of many who comment on this blog. In Particular, we recently had a bunch of acupuncturists who went on the rampage attacking me personally the best they could. However, a rational analysis of my beliefs can hardly produce evidence for bias against anything other than the promotion of unproven therapies to the unsuspecting public.

The above mentioned acupuncturists seem to think that I have always been against acupuncture for the sake of being against acupuncture. However, this is not true. The proof for this statement is very simple: I have published quite a bit of articles that concluded positively – even (WOULD YOU BELIEVE IT?) about acupuncture for back pain! A prominently published meta-analysis of 2005 (with me as senior author) concluded:  “Acupuncture effectively relieves chronic low back pain.” (This of course was 11 years ago when the evidence was, in fact, positive; today, this seems to have changed – just like the NICE guidelines [probably not a coincidence!])

Conflicts of interest? No, not on my side, I think.

But what about the ‘other side’?

The unruly horde of acupuncturists (no, this is not an ad hominem attack, it’s a fact) who recently made dozens of ad hominem attacks against me, what about them?

  • They earn their money with acupuncture.
  • They have invested in acupuncture training often for long periods of time.
  • They have invested in practice equipment etc.
  • Some of them sell books on acupuncture.
  • Others run courses.
  • And all of them very clearly and demonstrably  have strong beliefs about acupuncture.

I think the latter point constitutes by far the most important conflict of interest in this context.

And this is where the somewhat trivial story has an unexpected twist and gets truly bizarre:

I have just leant that the same group of conflicted acupuncturists are now planning to publicly attack the panel of experts responsible for drafting the NICE guidelines. The reason? They feel that this panel had significant conflicts of interest that led them to come out against acupuncture.

Perhaps I should mention that I was not a member of this group, but I suspect that some of its members might have links to the pharmaceutical industry. It is almost impossible to find top experts in any area of medicine who do not have such links. You either gather experts with potential conflicts of interest, or you get non-experts without them. Would that bias them against acupuncture or any other alternative therapy? I very much doubt it.

What I do not doubt for a minute is that conflicts of interest are of major importance in these discussions. And by that I mean the more than obvious (but nevertheless undeclared) conflicts of interest of the acupuncturists. It seems that those with the strongest conflicts of interest shout the loudest about the non-existent or irrelevant conflict of interest of those who do not happen to share their quasi-religious belief in acupuncture.

I just came across this website entitled 11 HARD QUESTIONS ABOUT CHIROPRACTIC PHYSICIANS. The title fascinated me; I am always in favour of addressing hard questions. I therefore read the 11 questions with interest; and I quite liked them. However, the answers provided by the author, a chiropractor of course, struck me as being more than a little uncritical towards chiropractic (feel free to click on the above link and see for yourself). Therefore, I decided to try my own answers (except for No 5). And then – being in the swing of it – I added a few more supplementary questions as well.

In other words, the first 11 questions are the ones posed by the chiro but the 4 additional ones are mine, and so are all the answers. Here we go:

 

Question No 1: What can a chiropractic physician do for me that another doctor can’t?

Nothing.

Question No 2: Does chiropractic therapy really work?

No. The best evidence available today fails to show that chiropractic spinal manipulations work for any condition. If one is generous, one might make an exception for back pain, but even for this symptom, the evidence is flimsy.

Question No 3: What other types of health problems can chiropractic treatment help?

None.

Question No 4: What does a chiropractic physician do to find my problem?

He/she often uses non-validated diagnostic techniques that are prone to give fantasy-results. You might also get extensive X-rays – mostly because the chiropractor wants to pay for the expensive equipment.

Question No 5: What therapies do chiropractic physicians use?
Chiropractic physicians may use manual and physical therapies including manipulation of the spine and joints of the arms and legs. Supportive therapies may also include massage, myofascial release, and therapeutic modalities such as ultrasound, electric stimulation and diathermy. Rehabilitative measures are often used such as specific corrective exercises to stabilize your problem. (This is the only answer I roughly agreed with, and I therefore left it unchanged.)

Question No 6: What is the standard length of treatment?

This depends mainly on the patient’s ability to pay. As a rule of thumb, as many treatments as possible will be given. Many chiros even advocate ‘maintenance treatment’ which means you receive regular spinal manipulations even when there is nothing wrong with you. The little porky they give you as an explanation is that this prevents future illnesses.

Question No 7: Is chiropractic care covered by insurance?

Because of very active lobbying by chiro interest groups, it may well be.

Question No 8: If I need a referral, how do I ask my doctor to refer me to a chiropractic physician?

Chiros are presently trying very hard to be accepted as ‘primary care physicians’; this means you can consult them directly without the need of a referral.

Question No 9: If I go see a chiropractor do I need to keep on going?

Only if you believe the nonsense about maintenance treatment they often tell you (see above) for which there is not a jot of convincing evidence.

Question No 10: What training do chiropractors have?

Not enough to realise that their spinal adjustments fail to generate more good than harm.

Question No 11: How should I select a good chiropractic physician?

If you are ill, it’s best to see are real doctor and avoid chiros.

AND NOW MY SUPPLEMENTARY QUESTIONS

No 1 Are chiros really physicians?

The definition of a physician is : ‘A person trained and licensed to practice medicine; a medical doctor’. Therefore, the answer is no.

No 2 What are the risks of spinal manipulations or adjustments, the main treatments used by chiros?

~50% of all patients have mild to moderate adverse effects that last 2-3 days.

In addition, several hundred cases of severe complications have been noted, including strokes and deaths.

No 3 How are such adverse outcomes monitored?

There is no effective monitoring system at all.

No 4 Is such an omission responsible or ethical?

No.

Amidst the current controversy of chiropractic spinal manipulation for new-born babies, the previous director of Chiropractor’s Association of Australia NSW, Alex Fielding, published an interesting article. In it, he declared:

  1. I do not condone the chiropractic treatment of children for non-musculoskeletal conditions it is simply not our place. There is little to no evidence for it and it should not be done. If a chiro is report them to AHPRA.
  2. There is no evidence for “subluxation” it simply has not been shown to exist by any credible source.
  3. Chiropractic does not equal spinal manipulative therapy (SMT) or adjustment. We are trained to assess and treat musculoskeletal conditions, use exercise rehab, various forms of manual therapy including SMT, give sound evidence based advice and refer to better suited health professionals in the appropriate circumstance. To say there is no evidence for chiropractic is an ill informed politically charged statement, if you mean SMT, say SMT.

Here I only want to comment on his last point. I think it is important, not least because we hear it ad nauseam. As soon as there emerges new evidence to show that SMT does little for back or neck pain or is ineffective for non-spinal conditions, chiropractors insist that they do so much more than just SMT, and therefore any such findings do not ever lend themselves to a verdict about chiropractic care.

In my view, this argument is a bit like ‘wanting the cake and eat it’ (chiros want to be different from physios by adhering to SMT, but they don’t want to be judged by the uselessness of SMT). It begs the following questions:

  1. What other modalities do chiros use?
  2. For which conditions do they use them?
  3. What is the evidence for or against them?
  4. In what percentage of patients do chiros use SMT?

The last question may be the most important one. I am not aware of data from ‘down under’ but, in the UK, the percentage is close to 100%. This is why I often call SMT the ‘hallmark therapy of chiropractors’. No other profession employ it more frequently. It is the treatment that defines the chiropractic profession.

If the evidence for SMT is flimsy or negative or non-existent, it seems not unreasonable to voice doubts about the profession that uses it most. The fact that chiropractors also administer other modalities – most of which, by the way, have a shaky evidence-base too – is simply a smoke-screen used to mislead us.

An example might make this a bit clearer. Imagine a surgeon who takes out the tonsils of every patient he sees, regardless of any tonsillitis or other tonsil-related condition (historically, this fad once existed; tonsillectomy was even used to treat depression). This surgeon also does all sorts of other things: he prescribes pain-killers, gives antibiotics, orders bed-rest, gives life-style advice etc. etc. Yet he is a charlatan because his hallmark intervention is not effective and even puts patients at unnecessary risks.

I know, the analogy is not perfect, but it makes the point: chiropractors refuse to be judged by the uselessness of SMT. Yet it is what defines them and they continue using SMT pretty much regardless of the evidence. Fielding pleads: To say there is no evidence for chiropractic is an ill informed politically charged statement, if you mean SMT, say SMT. I’d say there is no good evidence for SMT nor for chiropractic care that includes SMT.

My advice for chiropractors therefore is: abandon SMT and become physiotherapists. This will make you a bit better grounded in evidence, but at least you would have rid yourself of the Palmer-cult with all the BS that comes with it.

Osteopathy is a confusing subject about which I have reported regularly on this blog (for instance here and here).

Recently, I came across a good article where someone had assessed 100 websites by UK osteopaths. The findings are impressive:

57% of websites in the survey published the ‘self-healing’ claim

70% publicised the fact they offered cranial therapy;

61% made a claim to treat one or more specific ailments not related to the musculoskeletal system;

48% of practitioners also personally offered another CAM therapy;

71% of all sites surveyed located in a setting where other CAM was immediately available.

In total, 93% of the randomly selected websites checked at least one, often more, of the criteria for pseudoscientific claims. The author concluded that quackery is far from existing only on the fringe of osteopathic practice.

In a previous article, the author had stated that “there’s some (not strong) evidence that manual therapy may have some benefit in the case of lower back pain.” This evidence for the assumption that osteopathy works for back pain seems to rely heavily on one researcher: Licciardone JC. He comes from ‘The Osteopathic Research Center, University of North Texas Health Science Center, Fort Worth‘. which also is the flag-ship of research into osteopathy with plenty of funds and a worldwide reputation.

In 2005, he and his team published a systematic review/meta-analysis of RCTs which concluded that “osteopathic manipulative therapy (OMT) significantly reduces low back pain. The level of pain reduction is greater than expected from placebo effects alone and persists for at least three months. Additional research is warranted to elucidate mechanistically how OMT exerts its effects, to determine if OMT benefits are long lasting, and to assess the cost-effectiveness of OMT as a complementary treatment for low back pain.”

This is the article cited regularly to support the statement that osteopathy is an effective therapy for back pain. As the paper is now over 10 years old, we clearly need a more up-to-date systematic review. Such an assessment of clinical research into osteopathic intervention for chronic non-specific low back pain (CNSLBP) was recently published by an Australian team. A thorough search of the literature in multiple electronic databases was undertaken, and all articles were included that reported clinical trials; had adult participants; tested the effectiveness and/or efficacy of osteopathic manual therapies applied by osteopaths, and had a study condition of CNSLBP. The quality of the trials was assessed using the Cochrane criteria. Initial searches located 809 papers, 772 of which were excluded on the basis of abstract alone. The remaining 37 papers were subjected to a detailed analysis of the full text, which resulted in 35 further articles being excluded. There were thus only two studies assessing the effectiveness of manual therapies applied by osteopaths in adult patients with CNSLBP. The results of one trial suggested that the osteopathic intervention was similar in effect to a sham intervention, and the other implies equivalence of effect between osteopathic intervention, exercise and physiotherapy.

In other words, there seems to be an overt contradiction between the conclusions of Licciardone JC and those of the Australian team. Why? we may well ask. Perhaps the Osteopathic Research Center is not in the best position to be impartial? In order to check them out, I decided to have a closer look at their publications.

This team has published around 80 articles mostly in very low-impact osteopathic journals. They include several RCTs, and I decided to extract the conclusions of the last 10 papers reporting RCTs. Here they are:

RCT No 1 (2016)

Subgrouping according to baseline levels of chronic LBP intensity and back-specific functioning appears to be a simple strategy for identifying sizeable numbers of patients who achieve substantial improvement with OMT and may thereby be less likely to use more costly and invasive interventions.

RCT No 2 (2016)

The OMT regimen was associated with significant and clinically relevant measures for recovery from chronic LBP. A trial of OMT may be useful before progressing to other more costly or invasive interventions in the medical management of patients with chronic LBP.

RCT No 3 (2014)

Overall, 49 (52%) patients in the OMT group attained or maintained a clinical response at week 12 vs. 23 (25%) patients in the sham OMT group (RR, 2.04; 95% CI, 1.36-3.05). The large effect size for short-term efficacy of OMT was driven by stable responders who did not relapse.

RCT No 4 (2014)

These findings suggest that remission of psoas syndrome may be an important and previously unrecognized mechanism explaining clinical improvement in patients with chronic LBP following OMT.

RCT No 5 (2013)

The large effect size for OMT in providing substantial pain reduction in patients with chronic LBP of high severity was associated with clinically important improvement in back-specific functioning. Thus, OMT may be an attractive option in such patients before proceeding to more invasive and costly treatments.

RCT No 6 (2013)

The OMT regimen met or exceeded the Cochrane Back Review Group criterion for a medium effect size in relieving chronic low back pain. It was safe, parsimonious, and well accepted by patients.

RCT No 7 (2012)

This study found associations between IL-1β and IL-6 concentrations and the number of key osteopathic lesions and between IL-6 and LBP severity at baseline. However, only TNF-α concentration changed significantly after 12 weeks in response to OMT. These discordant findings indicate that additional research is needed to elucidate the underlying mechanisms of action of OMT in patients with nonspecific chronic LBP.

RCT No 8 (2010)

Osteopathic manipulative treatment slows or halts the deterioration of back-specific functioning during the third trimester of pregnancy.

RCT No 8 (2004)

The OMT protocol used does not appear to be efficacious in this hospital rehabilitation population.

RCT No 9 (2003)

Osteopathic manipulative treatment and sham manipulation both appear to provide some benefits when used in addition to usual care for the treatment of chronic nonspecific low back pain. It remains unclear whether the benefits of osteopathic manipulative treatment can be attributed to the manipulative techniques themselves or whether they are related to other aspects of osteopathic manipulative treatment, such as range of motion activities or time spent interacting with patients, which may represent placebo effects.

RCT No 10

Sorry, there is no 10th paper reporting an RCT.

Most of the remaining articles listed on Medline are comments and opinion papers. Crucially, it would be erroneous to assume that they conducted a total of 9 RCTs. Several of the above cited articles refer to the same RCT.

However, the most remarkable feature, in my view, is that the conclusions are almost invariably positive. Whenever I find a research team that manages to publish almost nothing but positive findings on one subject which most other experts are sceptical about, my alarm-bells start ringing.

In a previous blog, I have explained this in greater detail. Suffice to say that, according to my theory, the trustworthiness of the ‘Osteopathic Research Center’ is nothing to write home about.

What, I wonder, does that tell us about the reliability of the claim that osteopathy is effective for back pain?

On this blog, I have repeatedly pleaded for a change of the 2010 NICE guidelines for low back pain (LBP). My reason was that it had become quite clear that their recommendation to use spinal manipulation and acupuncture for recurrent LBP was no longer supported by sound evidence.

Two years ago, a systematic review (authored by a chiropractor and published in a chiro-journal) concluded that “there is no conclusive evidence that clearly favours spinal manipulation or exercise as more effective in treatment of CLBP.” A the time, I wrote a blog explaining that “whenever two treatments are equally effective (or, in this case, perhaps equally ineffective?), we must consider other important criteria such as safety and cost. Regular chiropractic care (chiropractors use spinal manipulation on almost every patient, while osteopaths and physiotherapists employ it less frequently)  is neither cheap nor free of serious adverse effects such as strokes; regular exercise has none of these disadvantages. In view of these undeniable facts, it is hard not to come up with anything other than the following recommendation: until new and compelling evidence becomes available, exercise ought to be preferred over spinal manipulation as a treatment of chronic LBP – and consequently consulting a chiropractor should not be the first choice for chronic LBP patients.”

Three years ago, a systematic review of acupuncture for LBP (published in a TCM-journal) concluded that the effect of acupuncture “is likely to be produced by the nonspecific effects of manipulation.” At that time I concluded my blog-post with this question: Should NICE be recommending placebo-treatments and have the tax payer foot the bill? Now NICE have provided an answer.

The new draft guideline by NICE recommends various forms of exercise as the first step in managing low back pain. Massage and manipulation by a physiotherapist should only be used alongside exercise; there is not enough evidence to show they are of benefit when used alone. Moreover, patients should be encouraged to continue with normal activities as far as possible. Crucially, the draft guideline no longer recommends acupuncture for treating low back pain.

NICE concluded that the evidence shows that acupuncture is not better than sham treatment. Paracetamol on its own is no longer recommended either, instead non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or aspirin should be tried first. Talking therapies are recommended in combination with physical therapies for patients who had no improvement on previous treatments or who have significant psychological and social barriers to recovery.

Professor Mark Baker, clinical practice director for NICE, was quoted stating “Regrettably there is a lack of convincing evidence of effectiveness for some widely used treatments. For example acupuncture is no longer recommended for managing low back pain with or without sciatica. This is because there is not enough evidence to show that it is more effective than sham treatment.”

Good news for us all, I would say:

  • good news for patients who now hear from an accepted authority what to do when they suffer from LBP,
  • good news for society who does no longer need to spend vast amounts of money on questionable therapies,
  • good news for responsible clinicians who now have clear guidance which they can show and explain to their patients.

Not so good news, I admit, for acupuncturists, chiropractors and osteopaths who just had a major source of their income scrapped. I have tried to find some first reactions from these groups but, for the moment, they seemed to be stunned into silence – nobody seems to have yet objected to the new guideline. Instead, I found a very recent website where chiropractic is not just recommended for LBP therapy but where patients are instructed that, even in the absence of pain, they need to see their chiropractor regularly: “Maintenance chiropractic care is well supported in studies for controlling chronic LBP.”

NEVER LET THE TRUTH GET IN THE WAY OF YOUR CASH-FLOW…they seem to conclude.

Mindfulness-based stress reduction (MBSR) has not been rigorously evaluated as a treatment of chronic low back pain. According to its authors, this RCT was aimed at evaluating “the effectiveness for chronic low back pain of MBSR vs cognitive behavioural therapy (CBT) or usual care.”

The investigators randomly assigned patients to receive MBSR (n = 116), CBT (n = 113), or usual care (n = 113). CBT meant training to change pain-related thoughts and behaviours and MBSR meant training in mindfulness meditation and yoga. Both were delivered in 8 weekly 2-hour groups. Usual care included whatever care participants received.

Coprimary outcomes were the percentages of participants with clinically meaningful (≥30%) improvement from baseline in functional limitations (modified Roland Disability Questionnaire [RDQ]; range, 0-23) and in self-reported back pain bothersomeness (scale, 0-10) at 26 weeks. Outcomes were also assessed at 4, 8, and 52 weeks.

There were 342 randomized participants with a mean duration of back pain of 7.3 years. They attended 6 or more of the 8 sessions, 294 patients completed the study at 26 weeks, and 290 completed it at 52 weeks. In intent-to-treat analyses at 26 weeks, the percentage of participants with clinically meaningful improvement on the RDQ was higher for those who received MBSR (60.5%) and CBT (57.7%) than for usual care (44.1%), and RR for CBT vs usual care, 1.31 [95% CI, 1.01-1.69]). The percentage of participants with clinically meaningful improvement in pain bothersomeness at 26 weeks was 43.6% in the MBSR group and 44.9% in the CBT group, vs 26.6% in the usual care group, and RR for CBT vs usual care was 1.69 [95% CI, 1.18-2.41]). Findings for MBSR persisted with little change at 52 weeks for both primary outcomes.

The authors concluded that among adults with chronic low back pain, treatment with MBSR or CBT, compared with usual care, resulted in greater improvement in back pain and functional limitations at 26 weeks, with no significant differences in outcomes between MBSR and CBT. These findings suggest that MBSR may be an effective treatment option for patients with chronic low back pain.

At first glance, this seems like a well-conducted study. It was conducted by one of the leading back pain research team and was published in a top-journal. It will therefore have considerable impact. However, on closer examination, I have serious doubts about certain aspects of this trial. In my view, both the aims and the conclusions of this RCT are quite simply wrong.

The authors state that they aimed at evaluating “the effectiveness for chronic low back pain of MBSR vs cognitive behavioural therapy (CBT) or usual care.” This is not just misleading, it is wrong! The correct aim should have been to evaluate “the effectiveness for chronic low back pain of MBSR plus usual care vs cognitive behavioural therapy plus usual care or usual care alone.” One has to go into the method section to find the crucial statement: “All participants received any medical care they would normally receive.”

Consequently, the conclusions are equally wrong. They should have read as follows: Among adults with chronic low back pain, treatment with MBSR plus usual care or CBT plus usual care, compared with usual care alone, resulted in greater improvement in back pain and functional limitations at 26 weeks, with no significant differences in outcomes between MBSR and CBT.

In other words, this is yet another trial with the dreaded ‘A+B vs B’ design. Because A+B is always more than B (even if A is just a placebo), such a study will never generate a negative result (even if A is just a placebo). The results are therefore entirely compatible with the notion that the two tested treatments are pure placebos. Add to this the disappointment many patients in the ‘usual care group’ might have felt for not receiving an additional therapy for their pain, and you have a most plausible explanation for the observed outcomes.

I am totally puzzled why the authors failed to discuss these possibilities and limitations in full, and I am equally bewildered that JAMA published such questionable research.

 

Some people seem to believe that the field of alternative medicine resembles a quaint little cottage industry where money hardly matters. A new analysis shows how far from the truth this impression is.

In the 2007 US National Health Interview Survey, use of complementary health approaches, reasons for this use, and associated out of pocket (OOP) costs were captured in a nationally representative sample of 5,467 US adults. Ordinary least square regression models that controlled for co-morbid conditions were used to estimate aggregate and per person OOP costs associated with 14 painful health conditions.

The analyses suggest that individuals using complementary approaches spent a total of $14.9 billion OOP on these approaches to manage three painful conditions: arthritis, back pain and fibromyalgia. Around 7.5 billion of that total was spent on consulting practitioners such as chiropractors and acupuncturists. Total OOP expenditures seen in those using complementary approaches for their back pain ($8.7 billion) far outstripped that of any other condition, with the majority of these costs ($4.7 billion) resulting from visits to complementary providers. Annual condition-specific per-person OOP costs varied from a low of $568 for regular headaches, to a high of $895 for fibromyalgia. The total expenditure on complementary medicine was comparable to that on conventional care.

The authors concluded that adults in the United States spent $14.9 billion OOP on complementary health approaches (e.g., acupuncture, chiropractic, herbal medicines) to manage painful conditions including back pain ($8.7 billion). This back pain estimate is almost 1/3rd of total conventional healthcare expenditures for back pain ($30.4 billion) and 2/3rds higher than conventional OOP expenditures ($5.1 billion).

These are truly eye-watering sums. The obvious question is: IS THIS MONEY WELL-SPENT?

The short answer, I fear, is NO!

The alternative therapies in question are not based on compelling evidence in the management of these painful conditions. Some are clearly not better than placebo, and others are apparently supported by some research but its quality is hardly good enough to rely upon.

This level expenditure is both impressive and worrying. It highlights an enormous waste of resources, alerts us to an urgent need for truly rigorous research, and demonstrates how high the stakes really are.

Regular readers of this blog will be aware of the many bogus claims made by chiropractors. One claim, however, namely the one postulating chiropractors can effectively treat low back pain with spinal manipulation, is rarely viewed as being bogus. Chiropractors are usually able to produce evidence that does suggest the claim to be true, and therefore even most critics of chiropractic back off on this particular issue.

But is the claim really true?

A recent trial might provide the answer.

The purpose of this study was to compare the effectiveness of chiropractic spinal manipulative therapy (cSMT) to a sham intervention on pain (Visual Analogue Scale, SF-36 pain subscale), disability (Oswestry Disability Index), and physical function (SF-36 subscale, Timed Up and Go) by performing a randomized placebo-controlled trial at 2 Veteran Affairs Clinics.

Older veterans (≥ 65 years of age) who were naive to chiropractic were recruited. A total of 136 who suffered from chronic low back pain (LBP) were included in the study – with 69 being randomly assigned to cSMT and 67 to the sham intervention. Patients were treated twice per week for 4 weeks. The outcomes were assessed at baseline, 5, and 12 weeks post baseline.

Both groups demonstrated significant decrease in pain and disability at 5 and 12 weeks. At 12 weeks, there was no significant difference in pain and a statistically significant decline in disability scores in the cSMT group when compared to the control group. There were no significant differences in adverse events between the groups.

The authors concluded that cSMT did not result in greater improvement in pain when compared to our sham intervention; however, cSMT did demonstrate a slightly greater improvement in disability at 12 weeks. The fact that patients in both groups showed improvements suggests the presence of a nonspecific therapeutic effect.

Hold on, I hear you say, this does not mean that cSMT is a placebo in the treatment of LBP! There are other studies that yield positive results. Let’s not cherry-pick our evidence!

Absolutely correct! To avoid cherry-picking, lets see what the current Cochrane review tells us about cSMT and chronic LBP. Here is the conclusion of this review based on 26 RCTs: High quality evidence suggests that there is no clinically relevant difference between SMT and other interventions for reducing pain and improving function in patients with chronic low-back pain.

Convinced?

The purpose of this study was to evaluate the impact of early and guideline adherent physical therapy for low back pain on utilization and costs within the Military Health System (MHS).

Patients presenting to a primary care setting with a new complaint of LBP from January 1, 2007 to December 31, 2009 were identified from the MHS Management Analysis and Reporting Tool. Descriptive statistics, utilization, and costs were examined on the basis of timing of referral to physical therapy and adherence to practice guidelines over a 2-year period. Utilization outcomes (advanced imaging, lumbar injections or surgery, and opioid use) were compared using adjusted odds ratios with 99% confidence intervals. Total LBP-related health care costs over the 2-year follow-up were compared using linear regression models.

753,450 eligible patients with a primary care visit for LBP between 18-60 years of age were considered. Physical therapy was utilized by 16.3% (n = 122,723) of patients, with 24.0% (n = 17,175) of those receiving early physical therapy that was adherent to recommendations for active treatment. Early referral to guideline adherent physical therapy was associated with significantly lower utilization for all outcomes and 60% lower total LBP-related costs.

The authors concluded that the potential for cost savings in the MHS from early guideline adherent physical therapy may be substantial. These results also extend the findings from similar studies in civilian settings by demonstrating an association between early guideline adherent care and utilization and costs in a single payer health system. Future research is necessary to examine which patients with LBP benefit early physical therapy and determine strategies for providing early guideline adherent care.

These are certainly interesting data. Because LBP is such a common condition, it costs us all dearly. Measures to reduce this burden in suffering and expense are urgently needed. The question is whether early referral to a physiotherapist is such a measure. The present data show that this is possible but they do not prove it.

I applaud the authors for realising this point and discussing it at length: The results of this study should be examined in light of the following limitations. Given the favorable natural history of LBP, many patients improve regardless of treatment. Those referred to physical therapy early are also more likely to have a shorter duration of pain, thus the potential for selection bias to have influenced these results. We accounted for a number of co-morbidities available in the data set and excluded patients with prior visits for LBP to mitigate against this possibility. However, the retrospective observational design of this study imposes limitations on extending the associations we observed to causation. Although we attempted to exclude patients with a specific spinal pathology, it is possible that a few patients may have been inadvertently included in the data set, in which case advanced imaging may be indicated. Additionally, although our results support that early physical therapy which adheres to practice guidelines may be less resource intense, we cannot conclude without patient-centered clinical outcomes (i.e., pain, function, disability, satisfaction, etc.) that the care was more cost effective. Further, it may be that the standard we used to judge adherence to practice guidelines (CPT codes) was not sufficiently sensitive to determine whether care is consistent with clinical practice guidelines. We also did not account for indirect or out-of-pocket costs for treatments such as complementary care, which is common for LBP. However, it is likely that the observed effects on total costs would have been even larger had these costs been considered.

I was originally alerted to this paper through a tweet claiming that these results demonstrate that chiropractic has an important role in LBP. However, the study does not even imply such a conclusion. It is, of course, true that many chiropractors use physical therapies. But they do not have the same training as physiotherapists and they tend to use spinal manipulations far more frequently. Virtually every LBP-patient consulting a chiropractor would be treated with spinal manipulations. As this approach is neither based on sound evidence nor free of risks, the conclusion, in my view, cannot be to see chiropractors for LBP; it must be to consult a physiotherapist.

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