Swiss chiropractors have just published a clinical trial to investigate outcomes of patients with radiculopathy due to cervical disk herniation (CDH). All patients had neck pain and dermatomal arm pain; sensory, motor, or reflex changes corresponding to the involved nerve root and at least one positive orthopaedic test for cervical radiculopathy were included. CDH was confirmed by magnetic resonance imaging. All patients received regular neck manipulations.
Baseline data included two pain numeric rating scales (NRSs), for neck and arm, and the Neck Disability Index (NDI). At two, four and twelve weeks after the initial consultation, patients were contacted by telephone, and the data for NDI, NRSs, and patient’s global impression of change were collected. High-velocity, low-amplitude thrusts were administered by experienced chiropractors. The proportion of patients reporting to feel “better” or “much better” on the patient’s global impression of change scale was calculated. Pre-treatment and post-treatment NRSs and NDIs were analysed.
Fifty patients were included. At two weeks, 55.3% were “improved,” 68.9% at four and 85.7% at twelve weeks. Statistically significant decreases in neck pain, arm pain, and NDI scores were noted at 1 and 3 months compared with baseline scores. 76.2% of all sub-acute/chronic patients were improved at 3 months.
The authors concluded that most patients in this study, including sub-acute/chronic patients, with symptomatic magnetic resonance imaging-confirmed CDH treated with spinal manipulative therapy, reported significant improvement with no adverse events.
In the presence of disc herniation, chiropractic manipulations have been described to cause serious complications. Some experts therefore believe that CDH is a contra-indication for spinal manipulation. The authors of this study imply, however, that it is not – on the contrary, they think it is an effective intervention for CDH.
One does not need to be a sceptic to notice that the basis for this assumption is less than solid. The study had no control group. This means that the observed effect could have been due to:
a placebo response,
the regression towards the mean,
the natural history of the condition,
or other factors which have nothing to do with the chiropractic intervention per se.
And what about the interesting finding that no adverse-effects were noted? Does that mean that the treatment is safe? Sorry, but it most certainly does not! In order to generate reliable results about possibly rare complications, the study would have needed to include not 50 but well over 50 000 patients.
So what does the study really tell us? I have pondered over this question for some time and arrived at the following answer: NOTHING!
Is that a bit harsh? Well, perhaps yes. And I will revise my verdict slightly: the study does tell us something, after all – chiropractors tend to confuse research with the promotion of very doubtful concepts at the expense of their patients. I think, there is a name for this phenomenon: PSEUDO-SCIENCE.
Neck pain is a common problem which is often far from easy to treat. Numerous therapies are being promoted but few are supported by good evidence. Could yoga be the solution?
The aim of a brand-new RCT was to evaluate the effectiveness of Iyengar yoga for chronic non-specific neck pain. Patients were randomly assigned to either yoga or exercise. The yoga group attended a 9-week yoga course, while the exercise group received a self-care manual on home-based exercises for neck pain. The primary outcome measure was neck pain. Secondary outcome measures included functional disability, pain at motion, health-related quality of life, cervical range of motion, proprioceptive acuity, and pressure pain threshold. Fifty-one patients participated in the study: yoga (n = 25), exercise (n = 26). At the end of the treatment phase, patients in the yoga group reported significantly less neck pain compared as well as less disability and better mental quality of life compared with the exercise group. Range of motion and proprioceptive acuity were improved and the pressure pain threshold was elevated in the yoga group.
The authors draw the following conclusion: “Yoga was more effective in relieving chronic nonspecific neck pain than a home-based exercise program. Yoga reduced neck pain intensity and disability and improved health-related quality of life. Moreover, yoga seems to influence the functional status of neck muscles, as indicated by improvement of physiological measures of neck pain.”
I’d love to agree with the authors and would be more than delighted, if an effective treatment for neck pain had been identified. Yoga is fairly safe and inexpensive; it promotes a generally healthy life-style, and is attractive to many patients; it has thus the potential to help thousands of suffering individuals. However, I fear that things might not be quite as rosy as the authors of this trial seem to believe.
The principle of an RCT essentially is that two groups of patients receive two different therapies and that any difference in outcome after the treatment phase is attributable to the therapy in question. Unfortunately, this is not the case here. One does not need to be an expert in critical thinking to realise that, in the present study, the positive outcome might be unrelated to yoga. For instance, it could be that the unsupervised home exercises were carried out wrongly and thus made the neck pain worse. In this case, the difference between the two treatment groups might not have been caused by yoga at all. A second possibility is that the yoga-group benefited not from the yoga itself but from the attention given to these patients which the exercise-group did not have. A third explanation could be that the yoga teachers were very kind to their patients, and that the patients returned their kindness by pretending to have less symptoms or exaggerating their improvements. In my view the most likely cause of the results seen in this study is a complex mixture of all the options just mentioned.
This study thus teaches us two valuable lessons: 1) whenever possible, RCTs should be designed such that a clear attribution of cause and effect is possible, once the results are on the table; 2) if cause and effect cannot be clearly defined, it is unwise to draw conclusions that are definite and have the potential to mislead the public.
As I have mentioned before, I like positive news as much as the next person. Therefore, I am constantly on the look-out for recently published, sound evidence suggesting that some form of alternative medicine is effective and safe for this or that condition. This new systematic review fits that description, I am pleased to report.
Its authors evaluated the effectiveness of massage therapy (MT) for neck and shoulder pain. Their extensive literature searches identified 12 high-quality studies. The meta-analyses showed significant effects of MT for neck pain and shoulder pain compared to inactive therapies. MT did not yield better effects for neck pain or shoulder pain than other active therapies administered to the control groups. Shoulder function was not significantly affected by MT. The authors concluded that “MT may provide immediate effects for neck and shoulder pain. However, MT does not show better effects on pain than other active therapies. No evidence suggests that MT is effective in functional status”.
Massage therapy is thus a promising treatment, particularly as this systematic review is by no means the only piece of encouraging evidence. It is not better than other effective treatments, but it is not associated with frequent or serious adverse effects. This means that the demonstrable benefits are likely to outweigh its risks; in other words, the risk benefit balance is positive. Regular readers of this blog will appreciate the importance of this point.
Massage is practiced by several professions: mostly, of course, by massage therapists, but occasionally also by nurses, osteopath, chiropractors etc. Chiropractors, in particular, have recently tried to make much – I think too much – of this fact. They tend to claim that, as they use treatments which are evidence-based, such as massage, chiropractic is an evidence-based profession. I think this is akin to surgeons claiming that all of surgery is evidence-based because surgeons use medications which effectively reduce post-operative pain. Chiropractors foremost employ spinal manipulation and surgeons foremost use surgery; if they want us to believe that their practice is evidence-based, they need to show us the evidence for their hall-mark interventions. In the case of surgery, the evidence is mostly established; in the case of chiropractic, it is mostly not.
Massage is backed by reasonably sound evidence not just for neck and shoulder pain but for a range of other conditions as well. WHAT DO WE CALL AN ALTERNATIVE MEDICINE THAT WORKS? WE CALL IT MEDICINE!
So why is massage not a mainstream therapy? The answer is simple: in many countries, massage therapy has long been considered to be entirely conventional. Twenty years ago, I was chair of rehabilitation medicine at the university of Vienna. Amongst my staff, there always were about 5-8 full time massage therapists and nobody thought this to be unusual in any way. Similarly, in Germany, massage is entirely conventional.
Perhaps it is time that the English-speaking countries catch up with Europe when it comes to massage therapy and the evidence that supports it?