This study was aimed at evaluating group-level and individual-level change in health-related quality of life among persons with chronic low back pain or neck pain receiving chiropractic care in the United States.
A 3-month longitudinal study was conducted of 2,024 patients with chronic low back pain or neck pain receiving care from 125 chiropractic clinics at 6 locations throughout the US. Ninety-one percent of the sample completed the baseline and 3-month follow-up survey (n = 1,835). Average age was 49, 74% females, and most of the sample had a college degree, were non-Hispanic White, worked full-time, and had an annual income of $60,000 or more. Group-level and individual-level changes on the Patient-Reported Outcomes Measurement Information System (PROMIS) v2.0 profile measure were evaluated: 6 multi-item scales (physical functioning, pain, fatigue, sleep disturbance, social health, emotional distress) and physical and mental health summary scores.
Within group t-tests indicated significant group-level change for all scores except for emotional distress, and these changes represented small improvements in health. From 13% (physical functioning) to 30% (PROMIS-29 Mental Health Summary Score) got better from baseline to 3 months later.
The authors concluded that chiropractic care was associated with significant group-level improvement in health-related quality of life over time, especially in pain. But only a minority of the individuals in the sample got significantly better (“responders”). This study suggests some benefits of chiropractic on functioning and well-being of patients with low back pain or neck pain.
These conclusions are worded carefully to avoid any statement of cause and effect. But I nevertheless feel that the authors strongly imply that chiropractic caused the observed outcomes. This is perhaps most obvious when they state that this study suggests some benefits of chiropractic on functioning and well-being of patients with low back pain or neck pain.
To me, it is obvious that this is wrong. The data are just as consistent with the opposite conclusion. There was no control group. It is therefore conceivable that the patients would have improved more and/or faster, if they had never consulted a chiropractor. The devil’s advocate therefore concludes this: the results of this study suggest that chiropractic has significant detrimental effects on functioning and well-being of patients with low back pain or neck pain.
Try to prove me wrong!
I am concerned that a leading journal (Spine) publishes such rubbish.
The aim of this RCT was to investigate the effects of an osteopathic manipulative treatment (OMT) which includes a diaphragm intervention compared to the same OMT with a sham diaphragm intervention in chronic non-specific low back pain (NS-CLBP).
Participants (N=66) with a diagnosis of NS-CLBP lasting at least 3 months were randomized to receive either an OMT protocol including specific diaphragm techniques (n=33) or the same OMT protocol with a sham diaphragm intervention (n=33), conducted in 5 sessions provided during 4 weeks.
The primary outcomes were pain (evaluated with the Short-Form McGill Pain Questionnaire [SF-MPQ] and the visual analog scale [VAS]) and disability (assessed with the Roland-Morris Questionnaire [RMQ] and the Oswestry Disability Index [ODI]). Secondary outcomes were fear-avoidance beliefs, level of anxiety and depression, and pain catastrophization. All outcome measures were evaluated at baseline, at week 4, and at week 12.
A statistically significant reduction was observed in the experimental group compared to the sham group in all variables assessed at week 4 and at week 12. Moreover, improvements in pain and disability were clinically relevant.
The authors concluded that an OMT protocol that includes diaphragm techniques produces significant and clinically relevant improvements in pain and disability in patients with NS-CLBP compared to the same OMT protocol using sham diaphragm techniques.
This seems to be a rigorous study. The authors describe in detail their well-standardised interventions in the full text of their paper. This, of course, will be essential, if someone wants to repeat the trial.
I have but a few points to add:
- What I fail to understand is this: why the authors call the interventions osteopathic? The therapist was a physiotherapist and the techniques employed are, if I am not mistaken, as much physiotherapeutic as osteopathic.
- The findings of this trial are encouraging but almost seem a little too good to be true. They need, of course, to be independently replicated in a larger study.
- If that is done, I would suggest to check whether the blinding of the patient was successful. If not, there is a suspicion that the diaphragm technique works partly or mostly via a placebo effect.
- I would also try to make sure that the therapist cannot influence the results in any way, for instance, by verbal or non-verbal suggestions.
- Finally, I suggest to employ more than one therapist to increase generalisability.
Once all these hurdles are taken, we might indeed have made some significant progress in the manual therapy of NS-CLBP.
- Despite calling themselves ‘doctors’, they are nothing of the sort.
- DCs are not adequately educated or trained to treat children.
- They nevertheless often do so, presumably because this constitutes a significant part of their income.
- Even if they felt confident to be adequately trained, we need to remember that their therapeutic repertoire is wholly useless for treating sick children effectively and responsibly.
- Therefore, harm to children is almost inevitable.
- To this, we must add the risk of incompetent advice from DCs – just think of immunisations.
Now we have more data on this subject. This new study investigated the effectiveness of adding manipulative therapy to other conservative care for spinal pain in a school-based cohort of Danish children aged 9–15 years.
The design was a two-arm pragmatic randomised controlled trial, nested in a longitudinal open cohort study in Danish public schools. 238 children from 13 public schools were included. A text message system and clinical examinations were used for data collection. Interventions included either (1) advice, exercises and soft-tissue treatment or (2) advice, exercises and soft-tissue treatment plus manipulative therapy. The primary outcome was number of recurrences of spinal pain. Secondary outcomes were duration of spinal pain, change in pain intensity and Global Perceived Effect.
No significant difference was found between groups in the primary outcomes of the control group and intervention group. Children in the group receiving manipulative therapy reported a higher Global Perceived Effect. No adverse events were reported.
The authors – well-known proponents of chiropractic (who declared no conflicts of interest) – concluded that adding manipulative therapy to other conservative care in school children with spinal pain did not result in fewer recurrent episodes. The choice of treatment—if any—for spinal pain in children therefore relies on personal preferences, and could include conservative care with and without manipulative therapy. Participants in this trial may differ from a normal care-seeking population.
The study seems fine, but what a conclusion!!!
After demonstrating that chiropractic manipulation is useless, the authors state that the treatment of kids with back pain could include conservative care with and without manipulative therapy. This is more than a little odd, in my view, and seems to suggest that chiropractors live on a different planet from those of us who can think rationally.
Kinesiology tape KT is fashionable, it seems. Gullible consumers proudly wear it as decorative ornaments to attract attention and show how very cool they are.
Am I too cynical?
But does KT really do anything more?
A new trial might tell us.
The aim of this study was to investigate whether adding kinesiology tape (KT) to spinal manipulation (SM) can provide any extra effect in athletes with chronic non-specific low back pain (CNLBP).
Forty-two athletes (21males, 21females) with CNLBP were randomized into two groups of SM (n = 21) and SM plus KT (n = 21). Pain intensity, functional disability level and trunk flexor-extensor muscles endurance were assessed by Numerical Rating Scale (NRS), Oswestry pain and disability index (ODI), McQuade test, and unsupported trunk holding test, respectively. The tests were done before and immediately, one day, one week, and one month after the interventions and compared between the two groups.
After treatments, pain intensity and disability level decreased and endurance of trunk flexor-extensor muscles increased significantly in both groups. Repeated measures analysis, however, showed that there was no significant difference between the groups in any of the evaluations.
The authors, physiotherapists from Iran, concluded that the findings of the present study showed that adding KT to SM does not appear to have a significant extra effect on pain, disability and muscle endurance in athletes with CNLBP. However, more studies are needed to examine the therapeutic effects of KT in treating these patients.
Regular readers of my blog will be able to predict what I have to say about this study design: A+B versus B is not a meaningful test of anything. I used to claim that it cannot possibly produce a negative result – and yet, here it seems to have done exactly that!
The way I see it, there are two possibilities to explain this:
- the KT has a mildly negative effect on CNLBP; thus the expected positive placebo-effect was neutralised to result in a null-effect overall;
- the study was under-powered such that the true inter-group difference could not manifest itself.
I think the second possibility is more likely, but it does really not matter at all. Because the only lesson we can learn from this trial is this: inadequate study designs will hardly ever generate anything worthwhile.
And this is, I think, a lesson that would be valuable for many researchers.
Comparing spinal manipulation with and without Kinesio Taping® in the treatment of chronic low back pain.
It is no secret to regular readers of this blog that chiropractic’s effectiveness is unproven for every condition it is currently being promoted for – perhaps with two exceptions: neck pain and back pain. Here we have some encouraging data, but also lots of negative evidence. A new US study falls into the latter category; I am sure chiropractors will not like it, but it does deserve a mention.
This study evaluated the comparative effectiveness of usual care with or without chiropractic care for patients with chronic recurrent musculoskeletal back and neck pain. It was designed as a prospective cohort study using propensity score-matched controls.
Using retrospective electronic health record data, the researchers developed a propensity score model predicting likelihood of chiropractic referral. Eligible patients with back or neck pain were then contacted upon referral for chiropractic care and enrolled in a prospective study. For each referred patient, two propensity score-matched non-referred patients were contacted and enrolled. We followed the participants prospectively for 6 months. The main outcomes included pain severity, interference, and symptom bothersomeness. Secondary outcomes included expenditures for pain-related health care.
Both groups’ (N = 70 referred, 139 non-referred) pain scores improved significantly over the first 3 months, with less change between months 3 and 6. No significant between-group difference was observed. After controlling for variances in baseline costs, total costs during the 6-month post-enrollment follow-up were significantly higher on average in the non-referred versus referred group. Adjusting for differences in age, gender, and Charlson comorbidity index attenuated this finding, which was no longer statistically significant (p = .072).
The authors concluded by stating this: we found no statistically significant difference between the two groups in either patient-reported or economic outcomes. As clinical outcomes were similar, and the provision of chiropractic care did not increase costs, making chiropractic services available provided an additional viable option for patients who prefer this type of care, at no additional expense.
This comes from some of the most-renowned experts in back pain research, and it is certainly an elaborate piece of investigation. Yet, I find the conclusions unreasonable.
Essentially, the authors found that chiropractic has no clinical or economical advantage over other approaches currently used for neck and back pain. So, they say that it a ‘viable option’.
I find this odd and cannot quite follow the logic. In my view, it lacks critical thinking and an attempt to produce progress. If it is true that all treatments were similarly (in)effective – which I can well believe – we still should identify those that have the least potential for harm. That could be exercise, massage therapy or some other modality – but I don’t think it would be chiropractic care.
Elder C, DeBar L, Ritenbaugh C, Dickerson J, Vollmer WM, Deyo RA, Johnson ES, Haas M.
J Gen Intern Med. 2018 Jun 25. doi: 10.1007/s11606-018-4539-y. [Epub ahead of print]
The Royal College of Chiropractors (RCC), a Company Limited by guarantee, was given a royal charter in 2013. It has following objectives:
- to promote the art, science and practice of chiropractic;
- to improve and maintain standards in the practice of chiropractic for the benefit of the public;
- to promote awareness and understanding of chiropractic amongst medical practitioners and other healthcare professionals and the public;
- to educate and train practitioners in the art, science and practice of chiropractic;
- to advance the study of and research in chiropractic.
In a previous post, I pointed out that the RCC may not currently have the expertise and know-how to meet all these aims. To support the RCC in their praiseworthy endeavours, I therefore offered to give one or more evidence-based lectures on these subjects free of charge.
And what was the reaction?
This might be disappointing, but it is not really surprising. Following the loss of almost all chiropractic credibility after the BCA/Simon Singh libel case, the RCC must now be busy focussing on re-inventing the chiropractic profession. A recent article published by RCC seems to confirm this suspicion. It starts by defining chiropractic:
“Chiropractic, as practised in the UK, is not a treatment but a statutorily-regulated healthcare profession.”
Obviously, this definition reflects the wish of this profession to re-invent themselves. D. D. Palmer, who invented chiropractic 120 years ago, would probably not agree with this definition. He wrote in 1897 “CHIROPRACTIC IS A SCIENCE OF HEALING WITHOUT DRUGS”. This is woolly to the extreme, but it makes one thing fairly clear: chiropractic is a therapy and not a profession.
So, why do chiropractors wish to alter this dictum by their founding father? The answer is, I think, clear from the rest of the above RCC-quote: “Chiropractors offer a wide range of interventions including, but not limited to, manual therapy (soft-tissue techniques, mobilisation and spinal manipulation), exercise rehabilitation and self-management advice, and utilise psychologically-informed programmes of care. Chiropractic, like other healthcare professions, is informed by the evidence base and develops accordingly.”
Many chiropractors have finally understood that spinal manipulation, the undisputed hallmark intervention of chiropractors, is not quite what Palmer made it out to be. Thus, they try their utmost to style themselves as back specialists who use all sorts of (mostly physiotherapeutic) therapies in addition to spinal manipulation. This strategy has obvious advantages: as soon as someone points out that spinal manipulations might not do more good than harm, they can claim that manipulations are by no means their only tool. This clever trick renders them immune to such criticism, they hope.
The RCC-document has another section that I find revealing, as it harps back to what we just discussed. It is entitled ‘The evidence base for musculoskeletal care‘. Let me quote it in its entirety:
The evidence base for the care chiropractors provide (Clar et al, 2014) is common to that for physiotherapists and osteopaths in respect of musculoskeletal (MSK) conditions. Thus, like physiotherapists and osteopaths, chiropractors provide care for a wide range of MSK problems, and may advertise that they do so [as determined by the UK Advertising Standards Authority (ASA)].
Chiropractors are most closely associated with management of low back pain, and the NICE Low Back Pain and Sciatica Guideline ‘NG59’ provides clear recommendations for managing low back pain with or without sciatica, which always includes exercise and may include manual therapy (spinal manipulation, mobilisation or soft tissue techniques such as massage) as part of a treatment package, with or without psychological therapy. Note that NG59 does not specify chiropractic care, physiotherapy care nor osteopathy care for the non-invasive management of low back pain, but explains that: ‘mobilisation and soft tissue techniques are performed by a wide variety of practitioners; whereas spinal manipulation is usually performed by chiropractors or osteopaths, and by doctors or physiotherapists who have undergone additional training in manipulation’ (See NICE NG59, p806).
The Manipulative Association of Chartered Physiotherapists (MACP), recently renamed the Musculoskeletal Association of Chartered Physiotherapists, is recognised as the UK’s specialist manipulative therapy group by the International Federation of Orthopaedic Manipulative Physical Therapists, and has approximately 1100 members. The UK statutory Osteopathic Register lists approximately 5300 osteopaths. Thus, collectively, there are approximately twice as many osteopaths and manipulating physiotherapists as there are chiropractors currently practising spinal manipulation in the UK.
END OF QUOTE
To me this sounds almost as though the RCC is saying something like this:
- We are very much like physiotherapists and therefore all the positive evidence for physiotherapy is really also our evidence. So, critics of chiropractic’s lack of sound evidence-base, get lost!
- The new NICE guidelines were a real blow to us, but we now try to spin them such that consumers don’t realise that chiropractic is no longer recommended as a first-line therapy.
- In any case, other professions also occasionally use those questionable spinal manipulations (and they are even more numerous). So, any criticism of spinal manipulation should not be directed at us but at physios and osteopaths.
- We know, of course, that chiropractors treat lots of non-spinal conditions (asthma, bed-wetting, infant colic etc.). Yet we try our very best to hide this fact and pretend that we are all focussed on back pain. This avoids admitting that, for all such conditions, the evidence suggests our manipulations to be worst than useless.
Personally, I find the RCC-strategy very understandable; after all, the RCC has to try to save the bacon for UK chiropractors. Yet, it is nevertheless an attempt at misleading the public about what is really going on. And even, if someone is sufficiently naïve to swallow this spin, one question emerges loud and clear: if chiropractic is just a limited version of physiotherapy, why don’t we simply use physiotherapists for back problems and forget about chiropractors?
(In case the RCC change their mind and want to listen to me elaborating on these themes, my offer for a free lecture still stands!)
I am sure we have all seen these colourful tapes that nowadays decorate the bodies of many of our sporting heroes. The tape is supposed to be good for athletic performance – but not just that, it is also promoted for all sorts of health conditions, for instance, low back pain.
But is it worth the considerable investment?
This systematic review investigated the effectiveness of ‘Kinesiology Tape’ (KT) for patients with non-specific low back pain.
The researchers included all randomized controlled trials (RCTs) in adults with chronic non-specific low back pain that compared KT to no intervention or placebo as well as RCTs that compared KT combined with exercise against exercise alone. The methodological quality and statistical reporting of the eligible trials were measured by the 11-item PEDro scale. The quality of the evidence was assessed using the GRADE classification. Pain intensity and disability were the primary outcomes. Whenever possible, the data were pooled through meta-analysis.
Eleven RCTs were included in this systematic review. Two clinical trials compared KT to no intervention at the short-term follow-up. Four studies compared KT to placebo at short-term follow-up and two trials compared KT to placebo at intermediate-term follow-up. Five trials compared KT combined with exercises or electrotherapy to exercises or spinal manipulation alone. No statistically significant difference was found for most comparisons.
The authors concluded that very low to moderate quality evidence shows that KT was no better than any other intervention for most the outcomes assessed in patients with chronic non-specific low back pain. We found no evidence to support the use of KT in clinical practice for patients with chronic non-specific low back pain.
So, is KT worth the often considerable investment for patients with back trouble?
Or is the current popularity of KT more of a triumph of clever marketing over scientific evidence?
I let you answer this one.
THE CONVERSATION recently carried an article shamelessly promoting osteopathy. It seems to originate from the University of Swansea, UK, and is full of bizarre notions. Here is an excerpt:
To find out more about how osteopathy could potentially affect mental health, at our university health and well-being academy, we have recently conducted one of the first studies on the psychological impact of OMT – with positive results.
For the last five years, therapists at the academy have been using OMT to treat members of the public who suffer from a variety of musculoskeletal disorders which have led to chronic pain. To find out more about the mental health impacts of the treatment, we looked at three points in time – before OMT treatment, after the first week of treatment, and after the second week of treatment – and asked patients how they felt using mental health questionnaires.
This data has shown that OMT is effective for reducing anxiety and psychological distress, as well as improving patient self-care. But it may not be suitable for all mental illnesses associated with chronic pain. For instance, we found that OMT was less effective for depression and fear avoidance.
All is not lost, though. Our results also suggested that the positive psychological effects of OMT could be further optimised by combining it with therapy approaches like acceptance and commitment therapy (ACT). Some research indicates that psychological problems such as anxiety and depression are associated with inflexibility, and lead to experiential avoidance. ACT has a positive effect at reducing experiential avoidance, so may be useful with reducing the fear avoidance and depression (which OMT did not significantly reduce).
Other researchers have also suggested that this combined approach may be useful for some subgroups receiving OMT where they may accept this treatment. And, further backing this idea up, there has already been at least one pilot clinical trial and a feasibility study which have used ACT and OMT with some success.
Looking to build on our positive results, we have now begun to develop our ACT treatment in the academy, to be combined with the osteopathic therapy already on offer. Though there will be a different range of options, one of these ACT therapies is psychoeducational in nature. It does not require an active therapist to work with the patient, and can be delivered through internet instruction videos and homework exercises, for example.
Looking to the future, this kind of low cost, broad healthcare could not only save the health service money if rolled out nationwide but would also mean that patients only have to undergo one treatment.
END OF QUOTE
So, they recruited a few patients who had come to receive osteopathic treatments (a self-selected population full of expectation and in favour of osteopathy), let them fill a few questionnaires and found some positive changes. From that, they conclude that OMT (osteopathic manipulative therapy) is effective. Not only that, they advocate that OMT is rolled out nationwide to save NHS funds.
Vis a vis so much nonsense, I am (almost) speechless!
As this comes not from some commercial enterprise but from a UK university, the nonsense is intolerable, I find.
Do I even need to point out what is wrong with it?
Not really, it’s too obvious.
But, just in case some readers struggle to find the fatal flaws of this ‘study’, let me mention just the most obvious one. There was no control group! That means the observed outcome could be due to many factors that are totally unrelated to OMT – such as placebo-effect, regression towards the mean, natural history of the condition, concomitant treatments, etc. In turn, this also means that the nationwide rolling out of their approach would most likely be a costly mistake.
The general adoption of OMT would of course please osteopaths a lot; it could even reduce anxiety – but only that of the osteopaths and their bank-managers, I am afraid.
We recently discussed the deplorable case of Larry Nassar and the fact that the ‘American Osteopathic Association’ stated that intravaginal manipulations are indeed an approved osteopathic treatment. At the time, I thought this was a shocking claim. So, imagine my surprise when I was alerted to a German trial of osteopathic intravaginal manipulations.
Here is the full and unaltered abstract of the study:
Introduction: 50 to 80% of pregnant women suffer from low back pain (LBP) or pelvic pain (Sabino und Grauer, 2008). There is evidence for the effectiveness of manual therapy like osteopathy, chiropractic and physiotherapy in pregnant women with LBP or pelvic pain (Liccardione et al., 2010). Anatomical, functional and neural connections support the relationship between intrapelvic dysfunctions and lumbar and pelvic pain (Kanakaris et al., 2011). Strain, pressure and stretch of visceral and parietal peritoneum, bladder, urethra, rectum and fascial tissue can result in pain and secondary in muscle spasm. Visceral mobility, especially of the uterus and rectum, can induce tension on the inferior hypogastric plexus, which may influence its function. Thus, stretching the broad ligament of the uterus and the intrapelvic fascia tissue during pregnancy can reinforce the influence of the inferior hypogastric plexus. Based on above facts an additional intravaginal treatment seems to be a considerable approach in the treatment of low back pain in pregnant women.
Objective: The purpose of this study was to compare the effect of osteopathic treatment including intravaginal techniques versus osteopathic treatment only in females with pregnancy-related low back pain.
Methods: Design: The study was performed as a randomized controlled trial. The participants were randomized by drawing lots, either into the intervention group including osteopathic and additional intravaginal treatment (IV) or a control group with osteopathic treatment only (OI). Setting: Medical practice in south of Germany.
Participants 46 patients were recruited between the 30th and 36th week of pregnancy suffering from low back pain.
Intervention Both groups received three treatments within a period of three weeks. Both groups were treated with visceral, mobilization, and myofascial techniques in the cervical, thoracic and lumbar spine, the pelvic and the abdominal region (American Osteopathic Association Guidelines, 2010). The IV group received an additional treatment with intravaginal techniques in supine position. This included myofascial techniques of the M. levator ani and the internal obturator muscles, the vaginal tissue, the pubovesical and uterosacral ligaments as well as the inferior hypogastric plexus.
Main outcome measures As primary outcome the back pain intensity was measured by Visual Analogue Scale (VAS). Secondary outcome was the disability index assessed by Oswestry-Low-Back-Pain-Disability-Index (ODI), and Pregnancy-Mobility-Index (PMI).
Results: 46 participants were randomly assigned into the intervention group (IV; n = 23; age: 29.0 ±4.8 years; height: 170.1 ±5.8 cm; weight: 64.2 ±10.3 kg; BMI: 21.9 ±2.6 kg/m2) and the control group (OI; n = 23; age: 32.0 ±3.9 years; height: 168.1 ±3.5 cm; weight: 62.3 ±7.9 kg; BMI: 22.1 ±3.2 kg/m2). Data from 42 patients were included in the final analyses (IV: n=20; OI: n=22), whereas four patients dropped out due to general pregnancy complications. Back pain intensity (VAS) changed significantly in both groups: in the intervention group (IV) from 59.8 ±14.8 to 19.6 ±8.4 (p<0.05) and in the control group (OI) from 57.4 ±11.3 to 24.7 ±12.8. The difference between groups of 7.5 (95%CI: -16.3 to 1.3) failed to demonstrate statistical significance (p=0.93). Pregnancy-Mobility-Index (PMI) changed significantly in both groups, too. IV group: from 33.4 ±8.9 to 29.6 ±6.6 (p<0.05), control group (OI): from 36.3 ±5.2 to 29.7 ±6.8. The difference between groups of 2.6 (95%CI: -5.9 to 0.6) was not statistically significant (p=0.109). Oswestry-Low-Back-Pain-Disability-Index (ODI) changed significantly in the intervention group (IV) from 15.1 ±7.8 to 9.2 ±3.6 (p<0.05) and also significantly in the control group (OI) from 13.8 ±4.9 to 9.2 ±3.0. Between-groups difference of 1.3 (95%CI: -1.5 to 4.1) was not statistically significant (p=0.357).
Conclusions: In this sample a series of osteopathic treatments showed significant effects in reducing pain and increasing the lumbar range of motion in pregnant women with low back pain. Both groups attained clinically significant improvement in functional disability, activity and quality of life. Furthermore, no benefit of additional intravaginal treatment was observed.
END OF QUOTE
My first thoughts after reading this were: how on earth did the investigators get this past an ethics committee? It cannot be ethical, in my view, to allow osteopaths (in Germany, they have no relevant training to speak of) to manipulate women intravaginally. How deluded must an osteopath be to plan and conduct such a trial? What were the patients told before giving informed consent? Surely not the truth!
My second thoughts were about the scientific validity of this study: the hypothesis which this trial claims to be testing is a far-fetched extrapolation, to put it mildly; in fact, it is not a hypothesis, it’s a very daft idea. The control-intervention is inadequate in that it cannot control for the (probably large) placebo effects of intravaginal manipulations. The observed outcomes are based on within-group comparisons and are therefore most likely unrelated to the treatments applied. The conclusion is as barmy as it gets; a proper conclusion should clearly and openly state that the results did not show any effects of the intravaginal manipulations.
In summary, this is a breathtakingly idiotic trial, and everyone involved in it (ethics committee, funding body, investigators, statistician, reviewers, journal editor) should be deeply ashamed and apologise to the poor women who were abused in a most deplorable fashion.
This week, I find it hard to decide where to focus; with all the fuzz about ‘Homeopathy Awareness Week’ it is easy to forget that our friends, the chiros are celebrating Chiropractic Awareness Week (9-15 April). On this occasion, the British Chiropractic Association (BCA), for instance, want people to keep moving to make a positive impact on managing and preventing back and neck pain.
Good advice! In a recent post, I even have concluded that people should “walk (slowly and cautiously) to the office of their preferred therapist, have a little rest there (say hello to the staff perhaps) and then walk straight back home.” The reason for my advice is based on the fact that there is precious little evidence that the spinal manipulations of chiropractors make much difference plus some worrying indications that they may cause serious damage.
It seems to me that, by focussing their PR away from spinal manipulations and towards the many other things chiropractors sometimes do – they often call this ‘adjunctive therapies’ – there is a tacit admission here that the hallmark intervention of chiros (spinal manipulation) is of dubious value.
A recent article entitled ‘Spinal Manipulative Therapy and Other Conservative Treatments for Low Back Pain: A Guideline From the Canadian Chiropractic Guideline Initiative’ seems to confirm this impression. Its objective was to develop a clinical practice guideline on the management of acute and chronic low back pain (LBP) in adults. The specific aim was to develop a guideline to provide best practice recommendations on the initial assessment and monitoring of people with low back pain and address the use of spinal manipulation therapy (SMT) compared with other commonly used conservative treatments.
The topic areas were chosen based on an Agency for Healthcare Research and Quality comparative effectiveness review, specific to spinal manipulation as a non-pharmacological intervention. The panel updated the search strategies in Medline and assessed admissible systematic reviews and randomized controlled trials. Evidence profiles were used to summarize judgments of the evidence quality and link recommendations to the supporting evidence. Using the Evidence to Decision Framework, the guideline panel determined the certainty of evidence and strength of the recommendations. Consensus was achieved using a modified Delphi technique. The guideline was peer reviewed by an 8-member multidisciplinary external committee.
For patients with acute (0-3 months) back pain, we suggest offering advice (posture, staying active), reassurance, education and self-management strategies in addition to SMT, usual medical care when deemed beneficial, or a combination of SMT and usual medical care to improve pain and disability. For patients with chronic (>3 months) back pain, we suggest offering advice and education, SMT or SMT as part of a multimodal therapy (exercise, myofascial therapy or usual medical care when deemed beneficial). For patients with chronic back-related leg pain, we suggest offering advice and education along with SMT and home exercise (positioning and stabilization exercises).
The authors concluded that a multimodal approach including SMT, other commonly used active interventions, self-management advice, and exercise is an effective treatment strategy for acute and chronic back pain, with or without leg pain.
I find this paper most interesting and revealing. Considering that it originates from the ‘Canadian Chiropractic Guideline Initiative’, it is remarkably shy about recommending SMT – after all their vision is “To enhance the health of Canadians by fostering excellence in chiropractic care.” They are thus not likely to be overly critical of the treatment chiropractors use most, i. e. SMT.
Perhaps this is also the reason why, in their conclusion, they seem to have rather a large blind spot, namely the risks of SMT. I have commented on this issue more often than I care to remember. Most recently, I posted this:
The reason why my stance, as expressed on this blog and elsewhere, is often critical about certain alternative therapies is thus obvious and transparent. For none of them (except for massage) is the risk/benefit balance positive. And for spinal manipulation, it even turns out to be negative. It goes almost without saying that responsible advice must be to avoid treatments for which the benefits do not demonstrably outweigh the risks.
HAPPY CHIROPRACTIC AWARENESS WEEK EVERYONE!