MD, PhD, FMedSci, FRSB, FRCP, FRCPEd

back pain

Some experts concede that chiropractic spinal manipulation is effective for chronic low back pain (cLBP). But what is the right dose? There have been no full-scale trials of the optimal number of treatments with spinal manipulation. This study was aimed at filling this gap by trying to identify a dose-response relationship between the number of visits to a chiropractor for spinal manipulation and cLBP outcomes. A further aim was to determine the efficacy of manipulation by comparison with a light massage control.

The primary cLBP outcomes were the 100-point pain intensity scale and functional disability scales evaluated at the 12- and 24-week primary end points. Secondary outcomes included days with pain and functional disability, pain unpleasantness, global perceived improvement, medication use, and general health status.

One hundred patients with cLBP were randomized to each of 4 dose levels of care: 0, 6, 12, or 18 sessions of spinal manipulation from a chiropractor. Participants were treated three times per week for 6 weeks. At sessions when manipulation was not assigned, the patients received a focused light massage control. Covariate-adjusted linear dose effects and comparisons with the no-manipulation control group were evaluated at 6, 12, 18, 24, 39, and 52 weeks.

For the primary outcomes, mean pain and disability improvement in the manipulation groups were 20 points by 12 weeks, an effect that was sustainable to 52 weeks. Linear dose-response effects were small, reaching about two points per 6 manipulation sessions at 12 and 52 weeks for both variables. At 12 weeks, the greatest differences compared to the no-manipulation controls were found for 12 sessions (8.6 pain and 7.6 disability points); at 24 weeks, differences were negligible; and at 52 weeks, the greatest group differences were seen for 18 visits (5.9 pain and 8.8 disability points).

The authors concluded that the number of spinal manipulation visits had modest effects on cLBP outcomes above those of 18 hands-on visits to a chiropractor. Overall, 12 visits yielded the most favorable results but was not well distinguished from other dose levels.

This study is interesting because it confirms that the effects of chiropractic spinal manipulation as a treatment for cLBP are tiny and probably not clinically relevant. And even these tiny effects might not be due to the treatment per se but could be caused by residual confounding and bias.

As for the optimal dose, the authors suggest that, on average, 18 sessions might be the best. But again, we have to be clear that the dose-response effects were small and of doubtful clinical relevance. Since the therapeutic effects are tiny, it is obviously difficult to establish a dose-response relationship.

In view of the cost of chiropractic spinal manipulation and the uncertainty about its safety, I would probably not rate this approach as the treatment of choice but would consider the current Cochrane review which concludes that “high quality evidence suggests that there is no clinically relevant difference between spinal manipulation and other interventions for reducing pain and improving function in patients with chronic low-back pain” Personally, I think it is more prudent to recommend exercise, back school, massage or perhaps even yoga to cLBP-sufferers.

Researchers from the ‘International Centre for Allied Health Evidence’, University of South Australia in Adelaide wanted to determine whether massage therapy is an effective intervention for back pain. They carried out extensive literature searches to identify all systematic reviews on the subject, analysed them critically and evaluated their methodological quality. Nine systematic reviews were found. Their methodological quality varied from poor to excellent. The primary research informing these systematic reviews was generally considered to be weak quality. The findings indicated that massage may be an effective treatment option when compared to placebo or active treatment options such as relaxation, especially in the short term. There were conflicting and contradictory findings for the effectiveness of massage therapy as a treatment of non-specific low back pain when compared against other manual therapies such as mobilization, standard medical care, and acupuncture.

The authors concluded that there is an emerging body of evidence, albeit small, that supports the effectiveness of massage therapy for the treatment of non-specific low back pain in the short term. Due to common methodological flaws in the primary research, which informed the systematic reviews recommendations arising from this evidence base should be interpreted with caution.

My own systematic review from 1999 (which the authors of this systematic review of systematic reviews seem to have missed) concluded that massage seems to have some potential as a therapy for low back pain. Indeed, there seems to be unanimous agreement that massage therapy is a promising treatment. Why then do massage therapists not finally get their act together and conduct a few more high quality primary studies? Currently, we have about as many reviews as trials! Doing even more reviews will not answer the question about effectiveness!!!

And it is a damn important question. Back pain is extremely common and extremely expensive for us all. At present, we have no optimal treatment. Chiropractors and osteopaths are claiming to have found a good solution, but many experts are not convinced by their evidence and argue that the risks of spinal manipulation might not outweigh its benefits. Massage, by contrast, is almost risk-free. Considering all this, I believe we need more trials with some urgency.

So, why are such trials not forthcoming? I realise that multiple hurdles have to be taken:

  • Clinical studies of that nature are expensive, and there is no obvious funding source.
  • Massage therapists usually do not have enough research expertise to pull off a sound study.
  • There are multiple methodological problems in conduction a definitive massage trial that might convince us all.

However, none of these obstacles are insurmountable. I suggest massage therapists team up with experts who know how to run clinical trials, hammer out a reasonable study design and approach government or other official funders for support. We need a definitive answers and we need them soon: is massage effective? which type of massage? for which patients? at which stage of non-specific low back pain?

Researchers from the ‘Complementary and Integrative Medicine Research, Primary Medical Care, University of Southampton’ conducted a study of Professional Kinesiology Practice (PKP) What? Yes, PKP! This is a not widely known alternative method.

According to its proponents, it is unique and a complete kinesiology system… It was developed by a medical doctor, Dr Bruce Dewe and his wife Joan Dewe in the 1980s and has been taught since then in over 16 countries around the world with great success… Kinesiology is a unique and truly holistic science and on the cutting edge of energy medicine. It uses muscle monitoring as a biofeedback system to identify the underlying cause of blockage from the person’s subconscious mind via the nervous system. Muscle monitoring is used to access information from the person’s “biocomputer”, the brain, in relation to the problem or issue and also guides the practitioner to find the priority correction in order to stimulate the person’s innate healing capacity and support their physiology to return to normal function. Kinesiology is unique as it looks beyond symptoms. It recognizes the flows of energy within the body not only relate to the muscles but to every tissue and organ that make the human body a living ever changing organism. These energy flows can be evaluated by testing the function of the muscles, which in turn reflect the body’s overall state of structural, chemical, emotional and spiritual balance. In this way kinesiology taps into energies that the more conventional modalities overlook and helps remove all the guesswork, doubt and hard work of subjective diagnostics. This is a revolutionary way to communicate with the body/mind connection. Through muscle monitoring and the use of over 300 fingermodes we can detect and correct the cause of the problem and effect a long lasting change for better health and wellbeing. Our posture could be considered to be the visual display unit from our internal bio-computer. Our posture / life energy improves as we upgrade the way we respond to life’s constant challenges and demands.

You do not understand? Let me make it crystal clear by citing another PKP-site:

PKP is a phenomenological practice – this means practitioners use manual muscle testing to demonstrate to the client how much or how little they are able to move in relation to their problem. PKP practitioners have tests for more than 100 muscles, and dozens of other tests that they do so they can clearly show you how your movement is affected by your problem. This muscle story shows a person how their life is unfolding, and it also helps to guide on how to transcend the situation and design a future which is more in alignment with nature and the laws of the cosmos… PKP is about living life more wisely.

In case you still have not understood what PKP is, you might have to watch this youtube clip. And now that everyone knows what it is, let us have a look at the new study.

According to its authors, it was an exploratory, pragmatic single-blind, 3-arm randomised sham-controlled pilot trial with waiting list control (WLC) which was conducted in the setting of a UK private practice. Seventy participants scoring ≥4 on the Roland and Morris Disability Questionnaire (RMDQ) were randomised to real or sham PKP receiving one treatment weekly for 5 weeks or a WLC. WLC’s were re-randomised to real or sham after 6 weeks. The main outcome measure was a change in RMDQ from baseline to end of 5 weeks of real or sham PKP.

The results show an effect size of 0.7 for real PKP which was significantly different to sham. Compared to WLC, both real and sham groups had significant RMDQ improvements. Practitioner empathy (CARE) and patient enablement (PEI) did not predict outcome; holistic health beliefs (CAMBI) did, though. The sham treatment appeared credible; patients did not guess treatment allocation. Three patients reported minor adverse reactions.

From these data, the authors conclude that real treatment was significantly different from sham demonstrating a moderate specific effect of PKP; both were better than WLC indicating a substantial non-specific and contextual treatment effect. A larger definitive study would be appropriate with nested qualitative work to help understand the mechanisms involved in PKP.

So, PKP has a small specific effect in addition to generating a sizable placebo-effect? Somehow, I doubt it! This was, according to its authors, a pilot study. Such an investigation should not evaluate the effectiveness of a treatment but the feasibility of the protocol. Even if we disregard this detail, I assume that the results indicate the effects of PKP to be essentially due to placebo. The small effect which the authors label as “specific” is, in my view, almost certainly caused by residual confounding and hidden biases.

One could also go one step further and say that any treatment that is shrouded in pseudo-scientific language and has zero plausibility is an ill-conceived candidate for a clinical trial of this nature. If it should be tested at all – and thus cost money, effort and patient-participation – a rigorous study should be designed and conducted not by apologists of the intervention but by more level-headed scientists.

In 2010, NICE recommended acupuncture for chronic low back pain (cLBP). Acupuncturists were of course delighted; the British Acupuncture Council, for instance, stated that they fully support NICE’s (National Institute for Health and Clinical Excellence) decision that acupuncture be made available on the NHS for chronic lower back pain. Traditional acupuncture has been used for over 2,000 years to alleviate back pain and British Acupuncture Council members have for many many years been successfully treating patients for this condition either in private practice or working within the NHS. In effect, therefore, these new guidelines are a rubber stamp of the positive work already being undertaken as well as an endorsement of the wealth of research evidence now available in this area.

More critical experts, however, tended to be surprised about this move and doubted that the evidence was strong enough for a positive recommendation. Now a brand-new meta-analysis sheds more light on this important issue.

Its aim was to determine the effectiveness of acupuncture as a therapy for cLBP. The authors found 13 RCTs which matched their inclusion criteria. Their results show that, compared with no treatment, acupuncture achieved better outcomes in terms of pain relief, disability recovery and better quality of life. These effects were, however, not observed when real acupuncture was compared to sham acupuncture. Acupuncture achieved better outcomes when compared with other treatments. No publication bias was detected.

The authors conclude that acupuncture is an effective treatment for chronic low back pain, but this effect is likely to be produced by the nonspecific effects of manipulation.

In plain English, this means that the effects of acupuncture on cLBP are most likely due to placebo. Should NICE be recommending placebo-treatments and have the tax payer foot the bill? I think I can leave it to my readers to answer this question.

On this blog, we have repeatedly discussed the serious adverse effects of Spinal Manipulative Therapies (SMT) as frequently administered by chiropractors, osteopaths and physiotherapists. These events mostly relate to vascular accidents involving vertebral or carotid arterial dissections after SMT of the upper spine. Lower down, the spine is anatomically far less vulnerable which, however, does not mean that injuries in this region after SMT are impossible. They have been reported repeatedly but, to the best of my knowledge, there is no up-to-date review of such events – that is until recently.

Australian researchers have just filled this gap by publishing a systematic review aimed at systematically reviewing all reports of serious adverse events following lumbo-pelvic SMT. They conducted electronic searches in MEDLINE, EMBASE, CINAHL, and The Cochrane Library up to January 12, 2012. Article-selection was performed by two independent reviewers using predefined criteria. Cases were included involving individuals 18 years or older who experienced a serious adverse event following SMT applied to the lumbar spine or pelvis by any type of provider (chiropractic, medical, physical therapy, osteopathic, layperson). A serious adverse event was defined as an untoward occurrence that resulted in death or was life threatening, required hospital admission, or resulted in significant or permanent disability. Reports published in English, German, Dutch, and Swedish were included.

The searches identified a total of 2046 papers, and 41 articles reporting a total of 77 cases were included in the review. Important case details were frequently missing in these reports, such as descriptions of SMT technique, the pre-SMT presentation of the patient, the specific details of the adverse event, time from SMT to the adverse event, factors contributing to the adverse event, and clinical outcome.

The 77 adverse events consisted of cauda equina syndrome (29 cases); lumbar disk herniation (23 cases); fracture (7 cases); haematoma or haemorrhagic cyst (6 cases); and12 cases of neurologic or vascular compromise, soft tissue trauma, muscle abscess formation, disrupted fracture healing, and oesophageal rupture.

The authors’ conclusion was that this systematic review describes case details from published articles that describe serious adverse events that have been reported to occur following SMT of the lumbo-pelvic region. The anecdotal nature of these cases does not allow for causal inferences between SMT and the events identified in this review.

This review is timely and sound. Yet several factors need consideration:

1) The search strategy was thorough but it is unlikely that all relevant articles were retrieved because these papers are often well-hidden in obscure and not electronically listed journals.

2) It is laudable that the authors included languages other than English but it would have been preferable to impose no language restrictions at all.

3) Under-reporting of adverse events is a huge problem, and it is anyone’s guess how large it really is [we have shown that, in our research it was precisely 100%]

4) This means that the 77 cases, which seem like a minute number, could in reality be 770 or 7700 or 77000; nobody can tell.

Cauda equina (horse tail) syndrome was the most frequent and most serious adverse event reported. This condition is caused by nerve injury at the lower end of the spinal canal. Symptoms can include leg pain along the sciatic nerve, severe back pain, altered or loss of sensation over the area around the genitals, anus and inner thighs as well as urine retention or incontinence and faecal incontinence. The condition must be treated as an emergency and usually requires surgical decompression of the injured nerves.

Disk herniation, the second most frequent adverse event, is an interesting complication of SMT. Most therapists using SMT would probably claim (no, I have no reference for that speculation!) that they can effectively treat herniated disks with SMT. The evidence for this claim is, as far as I know, non-existent. In view of the fact that SMT can actually cause a disk to herniate, I wonder whether SMT should not be contra-indicated for this condition. I am sure there will be some discussion about this question following this post.

The authors make a strong point about the fact that case reports never allow causal inference. One can only agree with this notion. However, the precautionary principle in medicine also means that, if case reports provide reasonable suspicion that an intervention might led to adverse-effects, we need to be careful and should warn patients of this possibility. It also means that it is up to the users of SMT to demonstrate beyond reasonable doubt that SMT is safe.

Tai Chi, as we know it in the West, is said to promote the smooth flow of “energy” throughout the body by performing postures, slow meditative movements and controlled breathing. Tai Chi is also supposed to help increasing flexibility, suppleness, balance and coordination. According to enthusiasts, the smooth, gentle movements of Tai Chi aid relaxation and help to keep the mind calm and focused.

Tai Chi has become popular in Western countries and is being considered for a surprisingly wide range of conditions. The patient/consumer is taught to perform postures, slow meditative movements and controlled breathing. The concepts underlying Tai Chi are strange, but that does not necessarily mean that the treatment is not effective for certain illnesses or symptoms.

There has been a surprising amount of research in this area, and some studies have generated encouraging results. A recent study which is unfortunately not available electronically ( Wu, WF; Muheremu, A; Chen, CH; Liu, WG; Sun, L. Effectiveness of Tai Chi Practice for Non-Specific Chronic Low Back Pain on Retired Athletes: A Randomized Controlled Study. JOURNAL OF MUSCULOSKELETAL PAIN 2013, 21:1, p.37-45) tested the effectiveness of Tai Chi for chronic back pain. Specifically, the researchers wanted to determine whether regular Tai Chi practice is superior to other means of sports rehabilitation in relieving non-specific chronic low back pain [LBP] in a younger population. They randomized 320 former athletes suffering from chronic LBP into a treatment [tai chi practice] and several control groups [regular sessions with swimming, backward walking or jogging, or no such interventions]. At the beginning, middle, and end of a six-month intervention, patients from all groups completed questionnaires assessing the intensity of LBP; in addition, a physical examination was conducted.

After 3 and 6 months, no statistically significant difference in the intensity of LBP was demonstrated between the Tai Chi and swimming. However, significant differences were demonstrated between the Tai Chi and backward walking, jogging, and no exercise groups.

The authors’ concluded that “Tai chi has better efficacy than certain other sports on the treatment of non-specific chronic LBP.”

This is only the second RCT of Tai chi for back pain. The first such study consisted of 160 volunteers between ages 18 and 70 years with persistent nonspecific low back pain. The experimental group (n = 80) had 18 Tai Chi sessions over a 10-week period. The waitlist control group continued with their usual health care. Bothersomeness of symptoms was the primary outcome, and secondary outcomes included pain intensity and pain-related disability. Tai Chi reduced bothersomeness of back symptoms by 1.7 points on a 0-10 scale, reduced pain intensity by 1.3 points on a 0-10 scale, and improved self-report disability by 2.6 points on the 0-24 Roland-Morris Disability Questionnaire scale. The authors of this RCT concluded that a 10-week Tai Chi program improved pain and disability outcomes and can be considered a safe and effective intervention for those experiencing long-term low back pain symptoms.

My own team have conducted their fair share of Tai Chi research. Specifically,we have published several systematic reviews of Tai Chi as an adjunctive or supportive treatment of various conditions, and the conclusions (in italics) have been mixed.

DIABETES: The existing evidence does not suggest that tai chi is an effective therapy for type 2 diabetes.

HYPERTENSION: The evidence for tai chi in reducing blood pressure in the elderly individuals is limited.

BREAST CANCER: the existing trial evidence does not show convincingly that tai chi is effective for supportive breast cancer care.

IMPROVEMENT OF AEROBIC EXCERCISE CAPACITY: the existing evidence does not suggest that regular tai chi is an effective way of increasing aerobic capacity.

PARKINSON’S DISEASE: the evidence is insufficient to suggest tai chi is an effective intervention for Parkinson’s Disease.

OSTEOPOROSIS: The evidence for tai chi in the prevention or treatment of osteoporosis is not convincing.

OSTEOARTHRITIS: there is some encouraging evidence suggesting that tai chi may be effective for pain control in patients with knee OA.

RHEUMATOID ARTHRITIS: Collectively this evidence is not convincing enough to suggest that tai chi is an effective treatment for RA.

Finally, an overview over all systematic reviews of Tai Chi suggested that the only area where the evidence is convincing is the prevention of falls in the elderly.

I think, this indicates that we should not pin our hopes too high as to the therapeutic value of Tai Chi. In particular, for back pain, the evidence might be optimistically judged as encouraging, but it is by no means convincing; the effect size seems to be small and two studies are not enough to issue general recommendations. On the other hand, considering that there is so little to offer to back pain patients, I concede that this is an area that should be studied further. Meanwhile, one could argue that Tai Chi can be fun and is devoid of risks – so, why not give it a try?

Some national and international guidelines advise physicians to use spinal manipulation for patients suffering from acute (and chronic) low back pain. Many experts have been concerned about the validity of this advice. Now an up-date of the Cochrane review on this subject seems to provide clarity on this rather important matter.

Its aim was to assess the effectiveness of spinal manipulative therapy (SMT) as a treatment of acute low back pain. Randomized controlled trials (RCTs) testing manipulation/mobilization in adults with  low back pain of less than 6-weeks duration were included. The primary outcome measures were pain, functional status and perceived recovery. Secondary endpoints were return-to-work and quality of life. Two authors independently conducted the study selection, risk of bias assessment and data extraction. The effects were examined for SMT versus  inert interventions, sham SMT,  other interventions, and for SMT as an adjunct to other forms of treatment.

The researchers identified 20 RCTs with a total number of 2674 participants, 12 (60%) RCTs had not been included in the previous version of this review. Only 6 of the 20 studies had a low risk of bias. For pain and functional status, there was low- to very low-quality evidence suggesting no difference in effectiveness of SMT compared with inert interventions, sham SMT or as adjunct therapy. There was varying quality of evidence suggesting no difference in effectiveness of SMT compared with other interventions. Data were sparse for recovery, return-to-work, quality of life, and costs of care.

The authors draw the following conclusion: “SMT is no more effective for acute low back pain than inert interventions, sham SMT or as adjunct therapy. SMT also seems to be no better than other recommended therapies. Our evaluation is limited by the few numbers of studies; therefore, future research is likely to have an important impact on these estimates. Future RCTs should examine specific subgroups and include an economic evaluation.”

In other words, guidelines that recommend SMT for acute low back pain are not based on the current best evidence. But perhaps the situation is different for chronic low back pain? The current Cochrane review of 26 RCTs is equally negative: “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. Determining cost-effectiveness of care has high priority. Further research is likely to have an important impact on our confidence in the estimate of effect in relation to inert interventions and sham SMT, and data related to recovery.”

This clearly begs the question why many of the current guidelines seem to mislead us. I am not sure I know the answer to this one; however I suspect that the panels writing the guidelines might have been dominated by chiropractors and osteopaths or their supporters who have not exactly made a name for themselves for being impartial. Whatever the reason, I think it is time for a re-think and for up-dating guidelines which are out of date and misleading.

Similarly, it might be time to question for what conditions chiropractors and osteopaths, the two professions who use spinal manipulation/mobilisation most, do actually offer anything of real value at all. Back pain and SMT are clearly their domains; if it turns out that SMT is not evidence-based for back pain, what is left? There is no good evidence for anything else, as far as I can see. To make matters worse, there are quite undeniable risks associated with SMT. The conclusion of such considerations is, I fear, obvious: the value of and need for these two professions should be re-assessed.

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