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

back pain

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Chronic back pain is often a difficult condition to treat. Which option is best suited?

A review by the US ‘Agency for Healthcare Research and Quality’ (AHRQ) focused on non-invasive nonpharmacological treatments for chronic pain. The following therapies were considered:

  • exercise,
  • mind-body practices,
  • psychological therapies,
  • multidisciplinary rehabilitation,
  • mindfulness practices,
  • manual therapies,
  • physical modalities,
  • acupuncture.

Here, I want to share with you the essence of the assessment of spinal manipulation:

  • Spinal manipulation was associated with slightly greater effects than sham manipulation, usual care, an attention control, or a placebo intervention in short-term function (3 trials, pooled SMD -0.34, 95% CI -0.63 to -0.05, I2=61%) and intermediate-term function (3 trials, pooled SMD -0.40, 95% CI -0.69 to -0.11, I2=76%) (strength of evidence was low)
  • There was no evidence of differences between spinal manipulation versus sham manipulation, usual care, an attention control or a placebo intervention in short-term pain (3 trials, pooled difference -0.20 on a 0 to 10 scale, 95% CI -0.66 to 0.26, I2=58%), but manipulation was associated with slightly greater effects than controls on intermediate-term pain (3 trials, pooled difference -0.64, 95% CI -0.92 to -0.36, I2=0%) (strength of evidence was low for short term, moderate for intermediate term).

This seems to confirm what I have been saying for a long time: the benefit of spinal manipulation for chronic back pain is close to zero. This means that the hallmark therapy of chiropractors for the one condition they treat more often than any other is next to useless.

But which other treatments should patients suffering from this frequent and often agonising problem employ? Perhaps the most interesting point of the AHRQ review is that none of the assessed nonpharmacological treatments are supported by much better evidence for efficacy than spinal manipulation. The only two therapies that seem to be even worse are traction and ultrasound (both are often used by chiropractors). It follows, I think, that for chronic low back pain, we simply do not have a truly effective nonpharmacological therapy and consulting a chiropractor for it does make little sense.

What else can we conclude from these depressing data? I believe, the most rational, ethical and progressive conclusion is to go for those treatments that are associated with the least risks and the lowest costs. This would make exercise the prime contender. But it would definitely exclude spinal manipulation, I am afraid.

And this beautifully concurs with the advice I recently derived from the recent Lancet papers: walk (slowly and cautiously) to the office of your preferred therapist, have a little rest there (say hello to the staff perhaps) and then walk straight back home.

 

One would be hard-pressed to find a form of so-called alternative medicine (SCAM) that is not being promoted for back pain: chiropractic, osteopathy, reflexology, naturopathy, homeopathy … you name it. Intriguingly, they all seem to generate similarly good – a realist would say bad – results. Faced with this large but largely ineffective options, one can hardly be surprised that enterprising innovators look for their own solutions. And few are more enterprising then this patient from Ireland who decided to devise his very own and highly unusual back pain therapy.

The 33 year old male with a history of back problems was seen complaining of severe, sudden onset lower back pain. He reported lifting a heavy steel object 3 days prior and his symptoms had progressed ever since. A physical exam of revealed an erythematous papule with a central focus on the medial aspect of his right upper limb.

The patient disclosed that he had – independent of any medical advice – intravenously injected his own semen as an innovative method to alleviate his back pain (a truly naturopathic approach, if there ever was one!). He also revealed that he had previously injected one monthly “dose” of semen for 18 consecutive months using a hypodermic needle purchased online.

On this occasion, the patient had tried to inject three “doses” of semen intra-vascularly and intra-muscularly. The erythema extended medially along his upper limb over the course of the following 24 hours.

It became indurated around the injection site where he had failed multiple attempts at injecting the semen thus causing an extravasation of his sperm into the soft tissues. Blood tests demonstrated a C-reactive protein of 150mg/L and white cell count of 13×109/L. The patient was immediately commenced on intravenous antimicrobial treatment after seeking advice regarding appropriate cover. A radiograph of the limb was obtained to exclude retained foreign body and it demonstrated a subcutaneous emphysema.

This patient’s back pain improved over the course of his inpatient stay. He opted to discharge himself without availing of an incision and drainage of the local collection.

Remarkable!

For me, the most fascinating aspect of this story is the fact that the patient had previously treated himself 18 (!) times before this little mishap occurred.

Why?, one may well ask. The answer has, I think, been provided by legions of proponents of diverse forms of SCAM: BECAUSE IT WORKED! PEOPLE ARE NOT STUPID; THEY DON’T CONTINUE TREATMENTS, IF THEY DON’T WORK.

So, either intravenous semen injections are an effective way to control back pain – in which case, I recommend that NICE look into it – or…

THERE IS SOMETHING BADLY WRONG WITH THE FAVOURITE ARGUMENT OF SCAM-ENTHUSIASTS, IT WORKED FOR ME AND THEREFORE IT IS EFFECTIVE AND SAFE.

(I know which explanation I favour)

Lumbar spinal stenosis (LSS) is a common reason for spine surgery. Several non-surgical LSS treatment options are also available, but their effectiveness remains unproven. The objective of this study was to explore the comparative clinical effectiveness of three non-surgical interventions for patients with LSS:

  • medical care,
  • group exercise,
  • individualised exercise plus manual therapy.

All interventions were delivered during 6 weeks with follow-up at 2 months and 6 months at an outpatient research clinic. Patients older than 60 years with LSS were recruited from the general public. Eligibility required anatomical evidence of central canal and/or lateral recess stenosis (magnetic resonance imaging/computed tomography) and clinical symptoms associated with LSS (neurogenic claudication; less symptoms with flexion). Analysis was intention to treat.

Medical care consisted of medications and/or epidural injections provided by a physiatrist. Group exercise classes were supervised by fitness instructors. Manual therapy/individualized exercise consisted of spinal mobilization, stretches, and strength training provided by chiropractors and physical therapists. The primary outcomes were between-group differences at 2 months in self-reported symptoms and physical function measured by the Swiss Spinal Stenosis questionnaire (score range, 12-55) and a measure of walking capacity using the self-paced walking test (meters walked for 0 to 30 minutes).

A total of 259 participants were allocated to medical care (n = 88), group exercise (n = 84), or manual therapy/individualized exercise (n = 87). Adjusted between-group analyses at 2 months showed manual therapy/individualized exercise had greater improvement of symptoms and physical function compared with medical care or group exercise. Manual therapy/individualized exercise had a greater proportion of responders (≥30% improvement) in symptoms and physical function (20%) and walking capacity (65.3%) at 2 months compared with medical care (7.6% and 48.7%, respectively) or group exercise (3.0% and 46.2%, respectively). At 6 months, there were no between-group differences in mean outcome scores or responder rates.

The authors concluded that a combination of manual therapy/individualized exercise provides greater short-term improvement in symptoms and physical function and walking capacity than medical care or group exercises, although all 3 interventions were associated with improvements in long-term walking capacity.

In many ways, this is a fairly rigorous study; in one important way, however, it is odd. One can easily see why one group received the usual standard care (except perhaps for the fact that standard medical care should also include exercise). I also understand why one group attended group exercise. Yet, I fail to see the logic in the third intervention, individualised exercise plus manual therapy.

Individualised exercise is likely to be superior to group exercise. If the researchers wanted to test this hypothesis, they should not have added the manual therapy. If they wanted to find out whether manual therapy is better that the other two treatments, they should not have added individualised exercise. As it stands, they cannot claim that either manual therapy or individualised exercise are effective (yet, I am sure that the chiropractic fraternity will claim that this study shows their treatment to be indicated for LSS [three of the authors are chiropractors and the 1st author seems to have a commercial interest in the matter!]).

Manual therapy procedures used in this trial included:

  • lumbar distraction mobilization,
  • hip joint mobilization,
  • side posture lumbar/sacroiliac joint mobilization,
  • and neural mobilization.

Is there any good reason to assume that these interventions work for LSS? I doubt it!

And this is what makes the new study odd, in my view. Assuming I am correct in speculating that individualised exercise is better than group exercise, the trial would have yielded a similarly positive result, if the researchers had offered, instead of the manual therapy, a packet of cigarettes, a cup of tea, a chocolate bar, or swinging a dead cat. In other words, if someone had wanted to make a useless therapy appear to be effective, they could not have chosen a better trial design.

And why do I find such studies objectionable?

Mainly because they deliberately mislead many of us. In the present case, many non-critical observers might conclude that manual therapy is effective for LSS. Yet, the truth could well be that it is useless or even harmful (assuming that the effect size of individualised exercise is large, adding a harmful therapy would still render the combination effective). To put it bluntly, such trials

  • could harm patients,
  • might waste money,
  • and hinder progress.

 

On their website, the UK ‘ROYAL COLLEGE OF CHIROPRACTORS (RCC) published a short statement regarding the safety of chiropractic. Here it is in full:

Experiencing mild or moderate adverse effects after manual therapy, such as soreness or stiffness, is relatively common, affecting up to 50% of patients. However, such ‘benign effects’ are a normal outcome and are not unique to chiropractic care.

Cases of serious adverse events, including spinal or neurological problems and strokes caused by damage to arteries in the neck, have been associated with spinal manipulation. Such events are rare with estimates ranging from 1 per 2 million manipulations to 13 per 10,000 patients; furthermore, due to the nature of the underlying evidence in relation to such events (case reports, retrospective surveys and case-control studies), it is very difficult to confirm causation (Swait and Finch, 2017).

For example, while an association between stroke caused by vertebral artery damage or ‘dissection’ (VAD) and chiropractor visits has been reported in a few case-control studies, the risk of stoke has been found to be similar after seeing a primary care physician (medical doctor). Because patients with VAD commonly present with neck pain, it is possible they seek therapy for this symptom from a range of practitioners, including chiropractors, and that the VAD has occurred spontaneously, or from some other cause, beforehand (Biller et al, 2014). This highlights the importance of ensuring careful screening for known neck artery stroke risk factors, or signs or symptoms that there is an ongoing problem, is performed prior to manual treatment of patients (Swait and Finch, 2017). Chiropractors are well trained to do this on a routine basis, and to urgently refer patients if necessary.

END OF QUOTE

The statement reads well but it might not be entirely free from conflicts of interest. Yet, in the name of accuracy, completeness and truthfulness, I take the liberty of making a few slight alterations. Here is my revised version:

Experiencing mild or moderate adverse effects after chiropractic spinal manipulations, such as pain or stiffness (usually lasting 1-3 days and strong enough to impair patients’ quality of life), is very common. In fact, it affects around 50% of all patients. 

Cases of serious adverse events, including spinal or neurological problems and strokes often caused by damage to arteries in the neck, have been reported after spinal manipulation. Such events are probably not frequent (several hundred are on record including about 100 fatalities).  But, as we have never established proper surveillance systems, nobody can tell how often they occur. Furthermore, due to our reluctance of introducing such surveillance, some of us are able to question causality.

An association between stroke caused by vertebral artery damage or ‘dissection’ (VAD) and chiropractic spinal manipulation has been reported in about 20 independent investigations. Yet one much-criticised case-control study found the risk of stoke to be similar after seeing a primary care physician (medical doctor). Because patients with VAD commonly have neck pain, it is possible they seek therapy for this symptom from chiropractors, and that the VAD has occurred spontaneously, or from some other cause, beforehand (Biller et al, 2014). Ensuring careful screening for known neck artery stroke risk factors, or signs that there is an ongoing problem would therefore be important (Swait and Finch, 2017). Sadly, no reliable screening tests exist, and neck pain (the symptom that might be indicative of VAD) continues to be one of the conditions most frequently treated by chiropractors.

I do not expect the RCC to adopt my improved version. In case I am wrong, let me state this: I am entirely free of conflicts of interest and will not charge a fee for my revision. In the interest of advancing public health, I herewith offer it for free.

The most frequent of all potentially serious adverse events of acupuncture is pneumothorax. It happens when an acupuncture needle penetrates the lungs which subsequently deflate. The pulmonary collapse can be partial or complete as well as one or two sided. This new case-report shows just how serious a pneumothorax can be.

A 52-year-old man underwent acupuncture and cupping treatment at an illegal Chinese medicine clinic for neck and back discomfort. Multiple 0.25 mm × 75 mm needles were utilized and the acupuncture points were located in the middle and on both sides of the upper back and the middle of the lower back. He was admitted to hospital with severe dyspnoea about 30 hours later. On admission, the patient was lucid, was gasping, had apnoea and low respiratory murmur, accompanied by some wheeze in both sides of the lungs. Because of the respiratory difficulty, the patient could hardly speak. After primary physical examination, he was suspected of having a foreign body airway obstruction. Around 30 minutes after admission, the patient suddenly became unconscious and died despite attempts of cardiopulmonary resuscitation.

Whole-body post-mortem computed tomography of the victim revealed the collapse of the both lungs and mediastinal compression, which were also confirmed by autopsy. More than 20 pinprick injuries were found on the skin of the upper and lower back in which multiple pinpricks were located on the body surface projection of the lungs. The cause of death was determined as acute respiratory and circulatory failure due to acupuncture-induced bilateral tension pneumothorax.

The authors caution that acupuncture-induced tension pneumothorax is rare and should be recognized by forensic pathologists. Postmortem computed tomography can be used to detect and accurately evaluate the severity of pneumothorax before autopsy and can play a supporting role in determining the cause of death.

The authors mention that pneumothorax is the most frequent but by no means the only serious complication of acupuncture. Other adverse events include:

  • central nervous system injury,
  • infection,
  • epidural haematoma,
  • subarachnoid haemorrhage,
  • cardiac tamponade,
  • gallbladder perforation,
  • hepatitis.

No other possible lung diseases that may lead to bilateral spontaneous pneumothorax were found. The needles used in the case left tiny perforations in the victim’s lungs. A small amount of air continued to slowly enter the chest cavities over a long period. The victim possibly tolerated the mild discomfort and did not pay attention when early symptoms appeared. It took 30 hours to develop into symptoms of a severe pneumothorax, and then the victim was sent to the hospital. There he was misdiagnosed, not adequately treated and thus died. I applaud the authors for nevertheless publishing this case-report.

This case occurred in China. Acupuncturists might argue that such things would not happen in Western countries where acupuncturists are fully trained and aware of the danger. They would be mistaken – and alarmingly, there is no surveillance system that could tell us how often serious complications occur.

The Spanish Ministries of Health and Sciences have announced their ‘Health Protection Plan against Pseudotherapies’. Very wisely, they have included chiropractic under this umbrella. To a large degree, this is the result of Spanish sceptics pointing out that alternative therapies are a danger to public health, helped perhaps a tiny bit also by the publication of two of my books (see here and here) in Spanish. Unsurprisingly, such delelopments alarm Spanish chiropractors who fear for their livelihoods. A quickly-written statement of the AEQ (Spanish Chiropractic Association) is aimed at averting the blow. It makes the following 11 points (my comments are below):

1. The World Health Organization (WHO) defines chiropractic as a healthcare profession. It is independent of any other health profession and it is neither a therapy nor a pseudotherapy.

2. Chiropractic is statutorily recognised as a healthcare profession in many European countries including Portugal, France, Italy, Switzerland, Belgium, Denmark, Sweden, Norway and the United Kingdom10, as well as in the USA, Canada and Australia, to name a few.

3. Chiropractic members of the AEQ undergo university-level training of at least 5 years full-time (300 ECTS points). Chiropractic training is offered within prestigious institutions such as the Medical Colleges of the University of Zurich and the University of Southern Denmark.

4. Chiropractors are spinal health care experts. Chiropractors practice evidence-based, patient-centred conservative interventions, which include spinal manipulation, exercise prescription, patient education and lifestyle advice.

5. The use of these interventions for the treatment of spine-related disorders is consistent with guidelines and is supported by high quality scientific evidence, including multiple systematic reviews undertaken by the prestigious Cochrane collaboration15, 16, 17.

6. The Global Burden of Disease study shows that spinal disorders are the leading cause of years lived with disability worldwide, exceeding depression, breast cancer and diabetes.

7. Interventions used by chiropractors are recommended in the 2018 Low Back Pain series of articles published in The Lancet and clinical practice guidelines from Denmark, Canada, the European Spine Journal, American College of Physicians and the Global Spine Care Initiative.

8. The AEQ supports and promotes scientific research, providing funding and resources for the development of high quality research in collaboration with institutions of high repute, such as Fundación Jiménez Díaz and the University of Alcalá de Henares.

9. The AEQ strenuously promotes among its members the practice of evidence-based, patient-centred care, consistent with a biopsychosocial model of health.

10. The AEQ demands the highest standards of practice and professional ethics, by implementing among its members the Quality Standard UNE-EN 16224 “Healthcare provision by chiropractors”, issued by the European Committee of Normalisation and ratified by AENOR.

11. The AEQ urges the Spanish Government to regulate chiropractic as a healthcare profession. Without such legislation, citizens of Spain cannot be assured that they are protected from unqualified practitioners and will continue to face legal uncertainties and barriers to access an essential, high-quality, evidence-based healthcare service.

END OF QUOTE

I think that some comments might be in order (they follow the numbering of the AEQ):

  1. The WHO is the last organisation I would consult for information on alternative medicine; during recent years, they have published mainly nonsense on this subject. How about asking the inventor of chiropractic? D.D. Palmer defined it as “a science of healing without drugs.” Chiropractors nowadays prefer to be defined as a profession which has the advantage that one cannot easily pin them down for doing mainly spinal manipulation; if one does, they indignantly respond “but we also use many other interventions, like life-style advice, for instance, and nobody can claim this to be nonsense” (see also point 4 below).
  2. Perfect use of a classical fallacy: appeal to authority.
  3. Appeal to authority, plus ignorance of the fact that teaching nonsense even at the highest level must result in nonsense.
  4. This is an ingenious mix of misleading arguments and lies: most chiros pride themselves of treating also non-spinal conditions. Very few interventions used by chiros are evidence-based. Exercise prescription, patient education and lifestyle advice are hardy typical for chiros and can all be obtained more authoratively from other healthcare professionals.
  5. Plenty of porkies here too. For instance, the AEQ cite three Cochrane reviews. The first concluded that 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. The second stated that combined chiropractic interventions slightly improved pain and disability in the short term and pain in the medium term for acute/subacute LBP. However, there is currently no evidence that supports or refutes that these interventions provide a clinically meaningful difference for pain or disability in people with LBP when compared to other interventions. And the third concluded that, although support can be found for use of thoracic manipulation versus control for neck pain, function and QoL, results for cervical manipulation and mobilisation versus control are few and diverse. Publication bias cannot be ruled out. Research designed to protect against various biases is needed. Findings suggest that manipulation and mobilisation present similar results for every outcome at immediate/short/intermediate-term follow-up. Multiple cervical manipulation sessions may provide better pain relief and functional improvement than certain medications at immediate/intermediate/long-term follow-up. Since the risk of rare but serious adverse events for manipulation exists, further high-quality research focusing on mobilisation and comparing mobilisation or manipulation versus other treatment options is needed to guide clinicians in their optimal treatment choices. Hardly the positive endorsement implied by the AEQ!
  6. Yes, but that is not an argument for chiropractic; in fact, it’s another fallacy.
  7. Did they forget the many guidelines, institutions and articles that do NOT recommend chiropractic?
  8. I believe the cigarette industry also sponsors research; should we therefore all start smoking?
  9. I truly doubt that the AEQ strenuously promotes among its members the practice of evidence-based healthcare; if they did, they would have to discourage spinal manipulation!
  10. The ‘highest standards of practice and professional ethics’ are clearly not compatible with chiropractors’ use of spinal manipulation. In our recent book, we explained in full detail why this is so.
  11. An essential, high-quality, evidence-based healthcare service? Chiropractic is certainly not essential, rarely high-quality, and clearly not evidence-based.

Nice try AEQ.

But not good enough, I am afraid.

Back pain is a huge problem: it affects many people, causes much suffering and leads to extraordinary high cost for all of us. Considering these facts, it would be excellent to identify a treatment that truly works. However, at present, we do not have found the ideal therapy; instead we have dozens of different approaches that are similarly effective/ineffective. Two of these therapies are massage and acupuncture.

Is one better than the other?

This study compared the efficacy of classical massage (KMT, n = 66) with acupuncture therapy (AKU, n = 66) in patients with chronic back pain. The primary endpoint was the non-inferiority of classical massage compared with the acupuncture treatment in respect of the impairment in everyday life, with the help of the Hannover function questionnaire (HFAQ) and the reduction in pain (“Von Korff”-Questionnaire) at the follow-up after one month.

In the per-protocol analysis during the period between enrollment in the study and follow-up, the responder rate of the KMT was 56.5% and thus tended to be inferior to the responder rate of the AKU with 62.5% (Δ = - 6%; KIΔ: - 23.5 to + 11.4%).

The authors concluded that classical massage therapy is not significantly inferior to acupuncture therapy in the period from admission to follow-up. Thus, the non-inferiority of the KMT to the AKU cannot be proven in the context of the defined irrelevance area.

I find such studies oddly useless.

To conduct a controlled trial, one needs an experimental treatment (the therapy that is not understood) and compare it with an intervention that is understood (such as a placebo that has no specific effects, or a treatment that has been shown to work). In comparative studies like the one above, one compares one unknown with another unknown. I do not see how such a comparison can ever produce a meaningful result.

In a way, it is like an equation with two unknowns: x + 5 = y. It is simply not possible to define either x nor y, and the equation is unsolvable.

For comparative studies of two back-pain treatments to make sense, we would need one of which the effect size is well-established. I do not think that we currently have identified such a therapy. Certainly, we cannot say that we know it for massage or acupuncture.

In other words, comparative studies like the one above are a waste of resources that cannot possibly make a meaningful contribution to our knowledge.

To put it even more bluntly: we ought to stop such pseudo-research.

On this blog, I have repeatedly discussed chiropractic research that, on closer examination, turns out to be some deplorable caricature of science. Today, I have another example of what I would call pseudo-research.

This RCT compared short-term treatment (12 weeks) versus long-term management (36 weeks) of back and neck related disability in older adults using spinal manipulative therapy (SMT) combined with supervised rehabilitative exercises (SRE).

Eligible participants were aged 65 and older with back and neck disability for more than 12 weeks. Co-primary outcomes were changes in Oswestry and Neck Disability Index after 36 weeks. An intention to treat approach used linear mixed-model analysis to detect between group differences. Secondary analyses included other self-reported outcomes, adverse events and objective functional measures.

A total of 182 participants were randomized. The short-term and long-term groups demonstrated significant improvements in back and neck disability after 36 weeks, with no difference between groups. The long-term management group experienced greater improvement in neck pain at week 36, self-efficacy at week 36 and 52, functional ability and balance.

The authors concluded that for older adults with chronic back and neck disability, extending management with SMT and SRE from 12 to 36 weeks did not result in any additional important reduction in disability.

What renders this paper particularly fascinating is the fact that its authors include some of the foremost researchers in (and most prominent proponents of) chiropractic today. I therefore find it interesting to critically consider the hypothesis on which this seemingly rigorous study is based.

As far as I can see, it essentially is this:

36 weeks of chiropractic therapy plus exercise leads to better results than 12 weeks of the same treatment.

I find this a most remarkable hypothesis.

Imagine any other form of treatment that is, like SMT, not solidly based on evidence of efficacy. Let’s use a new drug as an example, more precisely a drug for which there is no solid evidence for efficacy or safety. Now let’s assume that the company marketing this drug publishes a trial based on the hypothesis that:

36 weeks of therapy with the new drug plus exercise leads to better results than 12 weeks of the same treatment.

Now let’s assume the authors affiliated with the drug manufacturer concluded from their findings that for patients with chronic back and neck disability, extending drug therapy plus exercise from 12 to 36 weeks did not result in any additional important reduction in disability.

WHAT DO YOU THINK SUCH A TRIAL CAN TELL US?

My answer is ‘next to nothing’.

I think, it merely tells us that

  1. daft hypotheses lead to daft research,
  2. even ‘top’ chiropractors have problems with critical thinking,
  3. SMT might not be the solution to neck and back related disability.

I REST MY CASE.

 

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!

PS

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.

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