What is the best treatment for the millions of people who suffer from chronic low back pain (CLBP)? If we are honest, no therapy has yet been proven to be overwhelmingly effective. Whenever something like that happens in medicine, we have a proliferation of interventions which all are promoted as effective but which, in fact, work just marginally. And sure enough, in the case of CLBP, we have a constantly growing list of treatments none of which is really convincing.
One of the latest additions to this list is PILATES.
Pilates? What is this ? One practitioner describes it as follows: In Pilates, we pay a lot of attention to how our body parts are lined up in relation to each other, which is our alignment. We usually think of our alignment as our posture, but good posture is a dynamic process, dependent on the body’s ability to align its parts to respond to varying demands effectively. When alignment is off, uneven stresses on the skeleton, especially the spine, are the result. Pilates exercises, done with attention to alignment, create uniform muscle use and development, allowing movement to flow through the body in a natural way.
For example, one of the most common postural imbalances that people have is the tendency to either tuck or tilt the pelvis. Both positions create weaknesses on one side of the body and overly tight areas on the other. They deny the spine the support of its natural curves and create a domino effect of aches and pains all the way up the spine and into the neck. Doing Pilates increases the awareness of the proper placement of the spine and pelvis, and creates the inner strength to support the natural curves of the spine. This is called having a neutral spine and it has been the key to better backs for many people.
Mumbo-jumbo? Perhaps; in any case, we need evidence! Is there any at all? Surprisingly, the answer is yes. Recently, someone even published a proper systematic review.
This systematic review was aimed at evaluating the effectiveness of Pilates exercise in people with chronic low back pain (CLBP).
A search for RCTs was undertaken in 10 electronic. Two independent reviewers did the selection of evidence and evaluated the quality of the primary studies. To be included, relevant RCTs needed to be published in the English language. From 152 studies, 14 RCTs could be included.
The methodological quality of RCTs ranged from “poor” to “excellent”. A meta-analysis of RCTs was not undertaken due to the heterogeneity of RCTs. Pilates exercise provided statistically significant improvements in pain and functional ability compared to usual care and physical activity between 4 and 15 weeks, but not at 24 weeks. There were no consistent statistically significant differences in improvements in pain and functional ability with Pilates exercise, massage therapy, or other forms of exercise at any time period.
The authors drew the following conclusions: Pilates exercise offers greater improvements in pain and functional ability compared to usual care and physical activity in the short term. Pilates exercise offers equivalent improvements to massage therapy and other forms of exercise. Future research should explore optimal Pilates exercise designs, and whether some people with CLBP may benefit from Pilates exercise more than others.
So, Pilates can be added to the long list of treatments that work for CLBP, albeit not convincingly better than most other therapies on offer. Does that mean these options are all as good or as bad as the next? I don’t think so.
Let’s assume chiropractic/osteopathic manipulations, massage and various forms of exercise are all equally effective. How do we decide which is more commendable than the next? We clearly need to take other important factors into account:
- acceptability for patients
If we use these criteria, it becomes instantly clear that chiropractic and osteopathy are not favourites in this race for the most commendable CLBP-treatment. They are neither cheap nor free of risks. Massage is virtually risk-free but not cheap. This leaves us with various forms of exercise, including Pilates. But which exercise is better than the next? At present, we do not know, and therefore the last two factors are crucial: if people love doing Pilates and if they easily stick with it, then Pilates is fine.
I am sure chiropractors will (yet again) disagree with me but, to me, this logic could hardly be more straight forward.
There is some (albeit not compelling) evidence to suggest that chiropractic spinal manipulation might be effective for treating non-specific back pain. But what about specific back pain, such as the one caused by a herniated disc? Some experts believe that, in patients suffering from such a condition, manipulations are contra-indicated (because the latter can cause the former), while others think that manipulation might be an effective treatment option (although the evidence is far from compelling). Who is correct? The issue can only be resolved with data from well-designed clinical investigations. A new trial might therefore enlighten us.
The stated purposes of this study were:
- to evaluate patients with low-back pain (LBP) and leg pain due to magnetic resonance imaging-confirmed disc herniation treated with high-velocity, low-amplitude spinal manipulation in terms of their short-, medium-, and long-term outcomes of self-reported global impression of change and pain levels
- to determine if outcomes differ between acute and chronic patients using.
The researchers conducted a ‘prospective cohort outcomes study‘ with 148 patients with LBP, leg pain, and physical examination abnormalities with concordant lumbar disc herniations. Baseline numerical rating scale (NRS) data for LBP, leg pain, and the Oswestry questionnaire were obtained. The specific lumbar spinal manipulation was dependent upon whether the disc herniation was intraforaminal or paramedian as seen on the magnetic resonance images and was performed by a chiropractor. Outcomes included the patient’s global impression of change scale for overall improvement, the NRS for LBP, leg pain, and the Oswestry questionnaire at 2 weeks, 1, 3, and 6 months, and 1 year. The proportion of patients reporting “improvement” on the patient’s global impression of change scale was calculated for all patients and for acute vs chronic patients. Pre-treatment and post-treatment NRS scores were compared using the paired t test. Baseline and follow-up Oswestry scores were compared using the Wilcoxon test. Numerical rating scale and Oswestry scores for acute vs chronic patients were compared using the unpaired t test for NRS scores and the Mann-Whitney U test for Oswestry scores.
Significant improvements for all outcomes at all time points were reported. At 3 months, 91% of patients were “improved”, and 88% were “improved” after 1 year. Acute patients improved faster by 3 months than did chronic patients. 81.8% of chronic patients 89.2% felt “improved” at 1 year. No adverse events were reported.
The researchers concluded that a large percentage of acute and importantly chronic lumbar disc herniation patients treated with chiropractic spinal manipulation reported clinically relevant improvement.
Does this new study meaningfully contribute to our knowledge about the effectiveness of chiropractic manipulation for back pain caused by herniated discs? The short answer to this question is NO.
A longer answer might be that the report does tell us something relevant about the quality of this research project. We know from countless studies that ~50% of patients experience adverse effects after spinal manipulations by a chiropractor. This means that any report claiming that NO ADVERSE EFFECTS WERE REPORTED is puzzling to a degree that we have to seriously question its quality or even honesty. In this context, it is relevant to mention that a recent review of the evidence concluded that a cause-effect relationship exists between the manipulative treatment and the development of disc herniation.
The positive outcomes reported in this new study could, of course, be due to a range of factors which are unrelated to the manipulations administered by the chiropractors:
- natural history of disc herniation
- regression towards the mean
- other treatments employed by the patients
- social desirability
To be able to say with any degree of certainty that the manipulations had anything to do with the observed positive outcomes would require an entirely different study-design. Should we assume that this is not known in the world of chiropractic? Or should we consider that chiropractors shy away from rigorous research because they fear its results?
The term prospective cohort outcomes study, seems to be a chiropractic invention (cohort studies are by definition prospective, and observational studies are usually prospective). It seems that, behind this long and impressive word, one can easily hide the fact that this study design fails to make the slightest attempt of controlling for non-specific effects; the term sounds scientific – but when we analyse what it means, we discover that this methodology is little more than a self-serving consumer survey. Most scientists would call such an investigation quite simply an OBSERVATIONAL STUDY.
I think it is time that chiropractors start doing proper research which actually does answer some of the many open questions regarding spinal manipulation.
Many proponents of chiropractic claim that chiropractic spinal manipulation therapy (SMT) for chronic low back pain (LBP) might save health care cost. As LBP is a hugely expensive condition, this is a mighty important question. The evidence on this issue is, however, flimsy to say the least. Most experts seem to conclude that more reliable data are needed. On this background, it seems relevant to note that a new relevant study has just become available.
The purpose of this analysis was to report the incremental costs and benefits of different doses of SMT in patients with LBP.
The researchers randomized 400 patients with chronic LBP to receive doses of 0, 6, 12, or 18 sessions of SMT. Patients were scheduled for 18 visits for 6 weeks and received SMT or light massage control from a chiropractor. Societal costs in the year after study enrollment were estimated using patient reports of health care use and lost productivity. The main health outcomes were the number of pain-free days and disability-free days.
The results show that costs for treatment and lost productivity ranged from $3398 for 12 SMT sessions to $3815 for 0 SMT sessions with no statistically significant differences between groups. Baseline patient characteristics related to increase in costs were greater age, greater disability, lower quality-adjusted life year scores, and higher costs in the period preceding enrolment. Pain-free and disability-free days were greater for all SMT doses compared with control, but only SMT 12 yielded a statistically significant benefit of 22.9 pain-free days and 19.8 disability-free days. No statistically significant group differences in quality-adjusted life years were noted.
The authors drew the following conclusions from these data: a dose of 12 SMT sessions yielded a modest benefit in pain-free and disability-free days. Care of chronic LBP with SMT did not increase the costs of treatment plus lost productivity.
So, is chiropractic SMT for LBP cost-effective? I leave it to my readers to answer this question.
There is much debate about the usefulness of chiropractic. Specifically, many people doubt that their chiropractic spinal manipulations generate more good than harm, particularly for conditions which are not related to the spine. But do chiropractors treat such conditions frequently and, if yes, what techniques do they employ?
This investigation was aimed at describing the clinical practices of chiropractors in Victoria, Australia. It was a cross-sectional survey of 180 chiropractors in active clinical practice in Victoria who had been randomly selected from the list of 1298 chiropractors registered on Chiropractors Registration Board of Victoria. Twenty-four chiropractors were ineligible, 72 agreed to participate, and 52 completed the study.
Each participating chiropractor documented encounters with up to 100 consecutive patients. For each chiropractor-patient encounter, information collected included patient health profile, patient reasons for encounter, problems and diagnoses, and chiropractic care.
Data were collected on 4464 chiropractor-patient encounters between 11 December 2010 and 28 September 2012. In most (71%) cases, patients were aged 25-64 years; 1% of encounters were with infants. Musculoskeletal reasons for the consultation were described by patients at a rate of 60 per 100 encounters, while maintenance and wellness or check-up reasons were described at a rate of 39 per 100 encounters. Back problems were managed at a rate of 62 per 100 encounters.
The most frequent care provided by the chiropractors was spinal manipulative therapy and massage. The table shows the precise conditions treated
|Problem group||No. (%) of recorded diagnoses* (n = 5985)||Rate per 100 encounters (n = 4417)||95% CI||ICC|
|Back problem||2757 (46.07%)||62.42||(55.24–70.53)||0.312|
|Neck problem||683 (11.41%)||15.46||(11.23–21.30)||0.233|
|Muscle problem||434 (7.25%)||9.83||(6.64–14.55)||0.207|
|Health maintenance or preventive care||254 (4.24%)||5.75||(3.24–10.22)||0.251|
|Back syndrome with radiating pain||215 (3.59%)||4.87||(2.91–8.14)||0.165|
|Musculoskeletal symptom or complaint, or other||219 (3.66%)||4.96||(2.39–10.28)||0.350|
|Sprain or strain of joint||167 (2.79%)||3.78||(2.30–6.22)||0.115|
|Shoulder problem||87 (1.45%)||1.97||(1.37–2.83)||0.022|
|Nerve-related problem||62 (1.04%)||1.40||(0.72–2.75)||0.072|
|General symptom or complaint, other||51 (0.85%)||1.15||(0.22–6.06)||0.407|
|Bursitis, tendinitis or synovitis||47 (0.79%)||1.06||(0.71–1.60)||0.011|
|Kyphosis and scoliosis||47 (0.79%)||1.06||(0.65–1.75)||0.023|
|Foot or toe symptom or complaint||48 (0.80%)||1.09||(0.41–2.87)||0.123|
|Ankle problem||46 (0.77%)||1.04||(0.40–2.69)||0.112|
|Osteoarthrosis, other (not spine)||39 (0.65%)||0.88||(0.51–1.53)||0.023|
|Hip symptom or complaint||35 (0.58%)||0.79||(0.53–1.19)||0.006|
|Leg or thigh symptom or complaint||35 (0.58%)||0.79||(0.49–1.28)||0.012|
|Musculoskeletal injury||33 (0.55%)||0.75||(0.45–1.24)||0.013|
These findings are impressive in that they suggest that most Australian chiropractors treat non-spinal conditions for which there is no evidence that the most frequently used interventions are effective. The treatments employed are depicted in this graph:
Distribution of techniques and care provided by chiropractors, with 95% CI
[Activator = hand-held spring-loaded device that delivers an impulse to the spine. Drop piece = chiropractic treatment table with a segmented drop system which quickly lowers the section of the patient’s body corresponding with the spinal region being treated. Blocks = wedge-shaped blocks placed under the pelvis.
Chiro system = chiropractic system of care, eg, Applied Kinesiology, Sacro-Occipital Technique, Neuroemotional Technique. Flexion distraction = chiropractic treatment table that flexes in the middle to provide traction and mobilisation to the lumbar spine.]
There is no good evidence I know of demonstrating these techniques to be effective for the majority of the conditions listed in the above table.
A similar bone of contention is the frequent use of ‘maintenance’ and ‘wellness’ care. The authors of the article comment: The common use of maintenance and wellness-related terms reflects current debate in the chiropractic profession. “Chiropractic wellness care” is considered by an indeterminate proportion of the profession as an integral part of chiropractic practice, with the belief that regular chiropractic care may have value in maintaining and promoting health, as well as preventing disease. The definition of wellness chiropractic care is controversial, with some chiropractors promoting only spine care as a form of wellness, and others promoting evidence-based health promotion, eg, smoking cessation and weight reduction, alongside spine care. A 2011 consensus process in the chiropractic profession in the United States emphasised that wellness practice must include health promotion and education, and active strategies to foster positive changes in health behaviours. My own systematic review of regular chiropractic care, however, shows that the claimed effects are totally unproven.
One does not need to be overly critical to conclude from all this that the chiropractors surveyed in this investigation earn their daily bread mostly by being economical with the truth regarding the lack of evidence for their actions.
The safety of the manual treatments such as spinal manipulation is a frequent subject on this blog. Few experts would disagree with the argument that more good data are needed – and what could be better data than that coming from a randomised clinical trial (RCT)?
The aim of this RCT was to investigate differences in occurrence of adverse events between three different combinations of manual treatment techniques used by manual therapists (i.e. chiropractors, naprapaths, osteopaths, physicians and physiotherapists) for patients seeking care for back and/or neck pain.
Participants were recruited among patients seeking care at the educational clinic of the Scandinavian College of Naprapathic Manual Medicine in Stockholm. 767 patients were randomized to one of three treatment arms:
- manual therapy (i.e. spinal manipulation, spinal mobilization, stretching and massage) (n = 249),
- manual therapy excluding spinal manipulation (n = 258)
- manual therapy excluding stretching (n = 260).
Treatments were provided by students in the seventh semester (of total 8). Adverse events were monitored via a questionnaire after each return visit and categorized in to five levels:
- short minor,
- long minor,
- short moderate,
- long moderate,
This was based on the duration and/or severity of the event.
The most common adverse events were soreness in muscles, increased pain and stiffness. No differences were found between the treatment arms concerning the occurrence of these adverse event. Fifty-one percent of patients, who received at least three treatments, experienced at least one adverse event after one or more visits. Women more often had short moderate adverse events, and long moderate adverse events than men.
The authors conclude that adverse events after manual therapy are common and transient. Excluding spinal manipulation or stretching do not affect the occurrence of adverse events. The most common adverse event is soreness in the muscles. Women reports more adverse events than men.
What on earth is naprapathy? I hear you ask. Here is a full explanation from a naprapathy website:
Naprapathy is a form of bodywork that is focused on the manual manipulation of the spine and connective tissue. Based on the fundamental principles of osteopathy and chiropractic techniques, naprapathy is a holistic and integrative approach to restoring whole health. In fact, naprapathy often incorporates multiple, complimentary therapies, such as massage, nutritional counseling, electrical muscle stimulation and low-level laser therapy.
Naprapathy also targets vertebral subluxations, or physical abnormalities present that suggest a misalignment or injury of the spinal vertebrae. This analysis is made by a physical inspection of the musculoskeletal system, as well as visual observation. The practitioner will also conduct a lengthy interview with the client to help determine stress level and nutritional status as well. An imbalance along one or more of these lines may signal trouble within the musculoskeletal structure.
The naprapathy practitioner is particularly skilled in identifying restricted or stressed components of the fascial system, or connective tissue. It is believed that where constriction of muscles, ligaments, and tendons exists, there is impaired blood flow and nerve functioning. Naprapathy attempts to correct these blockages through hands-on manipulation and stretching of connective tissue. However, since this discipline embodies a holistic approach, the naprapathy practitioner is also concerned with their client’s emotional health. To that end, many practitioners are also trained in psychotherapy and even hypnotherapy.
So, now we know!
We also know that the manual therapies tested here cause adverse effects in about half of all patients. This figure ties in nicely with the ones we had regarding chiropractic: ~ 50% of all patients suffer mild to moderate adverse effects after chiropractic spinal manipulation which usually last 2-3 days and can be strong enough to affect their quality of life. In addition very serious complications have been noted which luckily seem to be much rarer events.
In my view, this raises the question: DO THESE TREATMENTS GENERATE MORE GOOD THAN HARM? I fail to see any good evidence to suggest that they do – but, of course, I would be more than happy to revise this verdict, provided someone shows me the evidence.
A meta-analysis compared the effectiveness of spinal manipulation therapies (SMT), medical management, physical therapies, and exercise for acute and chronic low back pain. Studies were chosen based on inclusion in prior evidence syntheses. Effect sizes were converted to standardized mean effect sizes and probabilities of recovery. Nested model comparisons isolated non-specific from treatment effects. Aggregate data were tested for evidential support as compared to shams.
The results suggest that, of 84% acute pain variance, 81% was from non-specific factors and 3% from treatment. No treatment was better than sham. Most acute results were within 95% confidence bands of that predicted by natural history alone. For chronic pain, 66% out of 98% was non-specific, but treatments influenced 32% of outcomes. Chronic pain treatments also fitted within 95% confidence bands as predicted by natural history. The evidential support for treating chronic back pain as compared to sham groups was weak, but chronic pain appeared to respond to SMT, while whole systems of chiropractic management did not.
The authors of this intriguing paper conclude: Meta-analyses can extract comparative effectiveness information from existing literature. The relatively small portion of outcomes attributable to treatment explains why past research results fail to converge on stable estimates. The probability of treatment superiority between treatment arms was equivalent to that expected by random selection. Treatments serve to motivate, reassure, and calibrate patient expectations – features that might reduce medicalization and augment self-care. Exercise with authoritative support is an effective strategy for acute and chronic low back pain.
This essentially indicates that none of these treatments for low back pain are convincingly effective. In turn this means we might as well stop using them. Alternatively, we could opt for the therapy that carries the least risks and cost. As the authors point out, this treatment is exercise.
Chiropractors are notorious for their overuse and misuse of x-rays for non-specific back and neck pain as well as other conditions. A recent study from the US has shown that the rate of spine radiographs within 5 days of an initial patient visit to a chiropractor is 204 per 1000 new patient examinations. Considering that X-rays are not usually necessary for patients with non-specific back pain, such rates are far too high. Therefore, a team of US/Canadian researchers conducted a study to evaluate the impact of web-based dissemination of a diagnostic imaging guideline discouraging the use of spine x-rays among chiropractors.
They disseminated an imaging guideline online in April 2008. Administrative claims data were extracted between January 2006 and December 2010. Segmented regression analysis with autoregressive error was used to estimate the impact of guideline recommendations on the rate of spine x-rays. Sensitivity analysis considered the effect of two additional quality improvement strategies, a policy change and an education intervention.
The results show a significant change in the level of spine x-ray ordering weeks after introduction of the guidelines (-0.01; 95% confidence interval=-0.01, -0.002; p=.01), but no change in trend of the regression lines. The monthly mean rate of spine x-rays within 5 days of initial visit per new patient exams decreased by 10 per 1000, a 5.26% relative decrease after guideline dissemination.
The authors concluded that Web-based guideline dissemination was associated with an immediate reduction in spine x-ray claims. Sensitivity analysis suggests our results are robust. This passive strategy is likely cost-effective in a chiropractic network setting.
These findings are encouraging because they suggest that at least some chiropractors are capable of learning, even if this means altering their practice against their financial interests – after all, there is money to be earned with x-ray investigations! At the same time, the results indicate that, despite sound evidence, chiropractors still order far too many x-rays for non-specific back pain. I am not aware of any recent UK data on chiropractic x-ray usage, but judging from old evidence, it might be very high.
It would be interesting to know why chiropractors order spinal x-rays for patients with non-specific back pain or other conditions. A likely answer is that they need them for the diagnosis of spinal ‘subluxations’. To cite just one of thousands of chiropractors with the same opinion: spinography is a necessary part of the chiropractic examination. Detailed analysis of spinographic film and motion x-ray studies helps facilitate a specific and timely correction of vertebral subluxation by the Doctor of Chiropractic. The correction of a vertebral subluxation is called: Adjustment.
This, of course, merely highlights the futility of this practice: despite the fact that the concept is still deeply engrained in the teaching of chiropractic, ‘subluxation’ is a mystical entity or dogma which “is similar to the Santa Claus construct”, characterised by a “significant lack of evidence to fulfil the basic criteria of causation”. But even if chiropractic ‘subluxation’ were real, it would not be diagnosable with spinal x-ray investigations.
The inescapable conclusion from all this, I believe, is that the sooner chiropractors abandon their over-use of x-ray studies, the better for us all.
If we ask how effective spinal manipulation is as a treatment of back pain, we get all sorts of answers. Therapists who earn their money with it – mostly chiropractors, osteopaths and physiotherapists – are obviously convinced that it is effective. But if we consult more objective sources, the picture changes dramatically. The current Cochrane review, for instance, arrives at this conclusion: SMT is no more effective in participants with acute low-back pain than inert interventions, sham SMT, or when added to another intervention. SMT also appears to be no better than other recommended therapies.
Such reviews tend to pool all studies together regardless of the nature of the practitioner. But perhaps one type of clinician is better than the next? Certainly many chiropractors are on record claiming that they are the best at spinal manipulations. Yet it is conceivable that physiotherapists who do manipulations without being guided by the myth of ‘adjusting subluxations’ have an advantage over chiropractors. Three very recent systematic reviews might go some way to answer these questions.
The purpose of the first systematic review was to examine the effectiveness of spinal manipulations performed by physiotherapists for the treatment of patients with low back pain. The authors found 6 RCTs that met their inclusion criteria. The most commonly used outcomes were pain rating scales and disability indexes. Notable results included varying degrees of effect sizes favouring spinal manipulations and minimal adverse events resulting from this intervention. Additionally, the manipulation group in one study reported significantly less medication use, health care utilization, and lost work time. The authors concluded that there is evidence to support the use of spinal manipulation by physical therapists in clinical practice. Physical therapy spinal manipulation appears to be a safe intervention that improves clinical outcomes for patients with low back pain.
The second systematic Review was of osteopathic intervention for chronic, non-specific low back pain (CNSLBP). Only two trials met the authors’ inclusion criteria. They had a lack of methodological and clinical homogeneity, precluding a meta-analysis. The trials used different comparators with regards to the primary outcomes, the number of treatments, the duration of treatment and the duration of follow-up. The authors drew the following conclusions: There are only two studies assessing the effect of the manual therapy intervention applied by osteopathic clinicians in adults with CNSLBP. One trial concluded that the osteopathic intervention was similar in effect to a sham intervention, and the other suggests similarity of effect between osteopathic intervention, exercise and physiotherapy. Further clinical trials into this subject are required that have consistent and rigorous methods. These trials need to include an appropriate control and utilise an intervention that reflects actual practice.
The third systematic review sought to determine the benefits of chiropractic treatment and care for back pain on well-being, and aimed to explore to what extent chiropractic treatment and care improve quality of life. The authors identified 6 studies (4 RCTs and two observational studies) of varying quality. There was a high degree of inconsistency and lack of standardisation in measurement instruments and outcome measures. Three studies reported reduced use of other/extra treatments as a positive outcome; two studies reported a positive effect of chiropractic intervention on pain, and two studies reported a positive effect on disability. The authors concluded that it is difficult to defend any conclusion about the impact of chiropractic intervention on the quality of life, lifestyle, health and economic impact on chiropractic patients presenting with back pain.
Yes, yes, yes, I know: the three reviews are not exactly comparable; so we cannot draw firm conclusions from comparing them. Five points seem to emerge nevertheless:
- The evidence for spinal manipulation as a treatment for back pain is generally not brilliant, regardless of the type of therapist.
- There seem to be considerable differences according to the nature of the therapist.
- Physiotherapists seem to have relatively sound evidence to justify their manipulations.
- Chiropractors and osteopaths are not backed by evidence which is as reliable as they so often try to make us believe.
- Considering that the vast majority of serious complications after spinal manipulation has occurred with chiropractors, it would seem that chiropractors are the profession with the worst track record regarding manipulation for 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?