I have often warned that, even if chiropractic manipulations were harmless (which they are clearly not), this would not necessarily apply to those who administer them, the chiropractors. They can do harm via interfering or advising against conventional interventions (the best-research example is immunization) or by treating conditions that they are not competent to tackle (like ear infections), or giving advice that endangers the health of the patient.
Italian authors reported the case of a 67-year-old woman, who had been suffering from low back pain due to herniated discs, decided to undergo chiropractic treatment. According to the chiropractor’s prescription, the patient drank about 8 liters of water in a day. During the afternoon, she developed headaches, nausea, vomiting, and fatigue, for which reason she consulted the chiropractor, who reassured the patient and suggested continuing the treatment in order to purify the body. The next day, following the intake of another 6 liters of water, the patient developed sudden water retention, loss of consciousness, and tonic-clonic seizures; for this reason, she was admitted to the Intensive Care Unit with a coma from electrolyte alterations.
The diagnosis of water intoxication was stated based on the history reported by the family members; according to the clinical findings, the hydro-electrolytic alterations were adequately corrected, allowing the disease resolution. Once resolved the intoxication, the patient underwent surgery to treat a shoulder dislocation and a humerus fracture which occurred due to a fall consequent to the tonic-clonic seizures.
The Judicial Authority thus ordered a medico-legal evaluation of the chiropractor’s behavior in order to identify any professional liability issue.
The Italian authors commented that this case is peculiar since it shows the dangerous implications for the patients’ health and safety deriving from the prescription of a large quantity of water intake, without any control by the chiropractor, and thus underestimating the risks of such a practice, as evidenced by the suggestion to continue the water intake aiming to detoxify the body from pharmacological substances. As a consequence, the patient developed a severe form of hyponatremia, leading to life-threatening complications that could have been otherwise avoided.
The medico-legal evaluation of the case led to the admission of professional liability of the chiropractor, who
thus had to pay the damages to the patient.
It is, of course, tempting to argue that the patient was not very clever to follow this ridiculous advice (and that the chiropractor was outright stupid to give it). One might even go further and argue that most patients trusting chiros are not all that smart … one could … but it is far from me to do so.
Myofascial release (also known as myofascial therapy or myofascial trigger point therapy) is a type of low-load stretch therapy that is said to release tightness and pain throughout the body caused by the myofascial pain syndrome, a chronic muscle pain that is worse in certain areas known as trigger points. Various types of health professionals provide myofascial release, e.g. osteopaths, chiropractors, physical or occupational therapists, massage therapists, or sports medicine/injury specialists. The treatment is usually applied repeatedly, but there is also a belief that a single session of myofascial release is effective. This study was a crossover clinical trial aimed to test whether a single session of a specific myofascial release technique reduces pain and disability in subjects with chronic low back pain (CLBP).
A total of 41 participants were randomly enrolled into 3 situations in a balanced and crossover manner:
The subjects underwent a single session of myofascial release on thoracolumbar fascia and the results were compared with the control and placebo groups. A single trained and experienced therapist applied the technique.
For the control treatment, the subjects were instructed to remain in the supine position for 5 minutes. For the muscle release session, the subjects were in a sitting position with feet supported and the thoracolumbar region properly undressed. The trunk flexion goniometry of each participant was performed and the value of 30° was marked with a barrier to limit the necessary movement during the technique. The trained researcher positioned their hands on all participants without sliding over the skin or forcing the tissue, with the cranial hand close to the last rib and at the T12–L1 level on the right side of the individual’s body and the caudal hand on the ipsilateral side between the iliac crest and the sacrum. Then, the researcher caused slight traction in the tissues by moving their hands away from each other in a longitudinal direction. Then, the participant was instructed to perform five repetitions of active trunk flexion-extension (30°), while the researcher followed the movement with both hands simultaneously positioned, without losing the initial tissue traction and position. The same technique and the same number of repetitions of active trunk flexion-extension were repeated with the researcher’s hands positioned on the opposite sides. This technique lasted approximately five minutes.
For the placebo treatment, the subjects were not submitted to the technique of manual thoracolumbar fascia release, but they slowly performed ten repetitions of active trunk flexion-extension (30°) in the same position as the experimental situation. Due to the fact that touch can provide not only well-recognized discriminative input to the brain, but also an affective input, there was no touch from the researcher at this stage.
The outcomes, pain, and functionality, were evaluated using the numerical pain rating scale (NPRS), pressure pain threshold (PPT), and Oswestry Disability Index (ODI).
The results showed no effects between-tests, within-tests, nor for interaction of all the outcomes, i.e., NPRS (η 2 = 0.32, F = 0.48, p = 0.61), PPT (η2 = 0.73, F = 2.80, p = 0.06), ODI (η2 = 0.02, F = 0.02, p = 0.97).
The authors concluded that a single trial of a thoracolumbar myofascial release technique was not enough to reduce pain intensity and disability in subjects with CLBP.
Recently, I received this comment from a reader:
Edzard-‘I see you do not understand much of trial design’ is true BUT I wager that you are in the same boat when it comes to a design of a trial for LBP treatment: not only you but many other therapists. There are too many variables in the treatment relationship that would allow genuine , valid criticism of any design. If I have to pick one book of the several listed elsewhere I choose Gregory Grieve’s ‘Common Vertebral Joint Problems’. Get it, read it, think about it and with sufficient luck you may come to realize that your warranted prejudices against many unconventional ‘medical’ treatments should not be of the same strength when it comes to judging the physical therapy of some spinal problems as described in the book.
And a chiro added:
EE: I see that you do not understand much of trial design
Perhaps it’s Ernst who doesnt understand how to research back pain.
“The identification of patient subgroups that respond best to specific interventions has been set as a key priority in LBP research for the past 2 decades.2,7 In parallel, surveys of clinicians managing LBP show that there are strong views against generic treatment and an expectation that treatment should be individualized to the patient.6,22.”
Journal of Orthopaedic & Sports Physical Therapy
Published Online:January 31, 2017Volume47Issue2Pages44-48
Do I need to explain why the Grieve book (yes, I have it and yes, I read it) is not a substitute for evidence that an intervention or technique is effective? No, I didn’t think so. This needs to come from a decent clinical trial.
And how would one design a trial of LBP (low back pain) that would be a meaningful first step and account for the “many variables in the treatment relationship”?
How about proceeding as follows (the steps are not necessarily in that order):
- Study the previously published literature.
- Talk to other experts.
- Recruit a research team that covers all the expertise you need (and don’t have yourself).
- Formulate your research question. Mine would be IS THERAPY XY MORE EFFECTIVE THAN USUAL CARE FOR CHRONIC LBP? I know LBP is but a vague symptom. This does, however, not necessarily matter (see below).
- Define primary and secondary outcome measures, e.g. pain, QoL, function, as well as the validated methods with which they will be quantified.
- Clarify the method you employ for monitoring adverse effects.
- Do a small pilot study.
- Involve a statistician.
- Calculate the required sample size of your study.
- Consider going multi-center with your trial if you are short of patients.
- Define chronic LBP as closely as you can. If there is evidence that a certain type of patient responds better to the therapy xy than others, that might be considered in the definition of the type of LBP.
- List all inclusion and exclusion criteria.
- Make sure you include randomization in the design.
- Randomization should be to groups A and B. Group A receives treatment xy, while group B receives usual care.
- Write down what A and B should and should not entail.
- Make sure you include blinding of the outcome assessors and data evaluators.
- Define how frequently the treatments should be administered and for how long.
- Make sure all therapists employed in the study are of a high standard and define the criteria of this standard.
- Train all therapists of both groups such that they provide treatments that are as uniform as possible.
- Work out a reasonable statistical plan for evaluating the results.
- Write all this down in a protocol.
Such a trial design does not need patient or therapist blinding nor does it require a placebo. The information it would provide is, of course, limited in several ways. Yet it would be a rigorous test of the research question.
If the results of the study are positive, one might consider thinking of an adequate sham treatment to match therapy xy and of other ways of firming up the evidence.
As LBP is not a disease but a symptom, the study does not aim to include patients that all are equal in all aspects of their condition. If some patients turn out to respond better than others, one can later check whether they have identifiable characteristics. Subsequently, one would need to do a trial to test whether the assumption is true.
Therapy xy is complex and needs to be tailored to the characteristics of each patient? That is not necessarily an unsolvable problem. Within limits, it is possible to allow each therapist the freedom to chose the approach he/she thinks is optimal. If the freedom needed is considerable, this might change the research question to something like ‘IS THAT TYPE OF THERAPIST MORE EFFECTIVE THAN THOSE EMPLOYING USUAL CARE FOR CHRONIC LBP?’
My trial would obviously not answer all the open questions. Yet it would be a reasonable start for evaluating a therapy that has not yet been submitted to clinical trials. Subsequent trials could build on its results.
I am sure that I have forgotten lots of details. If they come up in discussion, I can try to incorporate them into the study design.
Two chiropractors conducted a retrospective review of publicly available data from the California Board of Chiropractic Examiners. Their aim was to determine categories of offense, experience, and gender of disciplined doctors of chiropractic (DC) in California and compare them with disciplined medical physicians in California.
The DC disciplinary categories, in descending order, were
- fraud (44%),
- sexual boundary issues (22%),
- other offences (13%),
- abuse of alcohol or drugs (10%),
- negligence or incompetence (6%),
- poor supervision (2%),
- mental impairment (.3%).
The authors concluded that the professions differ in the major reasons for disciplinary actions. Two thirds (67%) of the doctors of chiropractic were disciplined for fraud and sexual boundary issues, compared with 59% for negligence and substance misuse for medical physicians. Additional study in each profession may reveal methods to identify causes and possible intervention for those who are at high risk.
The two authors of this paper should be congratulated for their courage to publish such a review. These figures seem shocking. But I think that in reality some of them might be far higher. Take the important matter of competence, for instance. If you consider it competent that chiropractors treat conditions other than back pain, you might arrive at the above-mentioned figure of 6%. If you consider this as incompetent, as I do, the figure might be one order of magnitude higher (for more on unprofessional conduct by chiropractors see here).
The abstract of the paper does not provide comparisons to the data related to the medical profession. Here they are; relative to doctors, chiropractors are:
- 2x more likely to be involved in malpractice,
- 9x more likely to be practising fraud,
- 2x more likely to transgress sexual boundaries.
The frequency of fraud is particularly striking. Come to think of it, however, it is not all that amazing. I have said it before: chiropractic is in my view mostly about money.
It has been reported that B.C.’s chiropractors are deeply divided about the future of their profession, disagreeing on everything from false advertising to the use of routine X-rays.
Chiropractors attending an extraordinary general meeting of the College of Chiropractors of B.C. were split nearly down the middle on a series of non-binding resolutions addressing actions the College has taken in recent years. By the narrowest of margins, with at most 54% support, the members voted in favor of the college’s moves to limit the use of diagnostic X-rays and ban claims that aren’t supported by scientific evidence. The question that remains is who represents the bulk of the profession in B.C. — chiropractors advocating for what they describe as evidence-based practice targeting the musculoskeletal system, or “vitalists” who argue that chiropractic treatment can help with everything from immunity to brain function.
The modernizers see it as “a deliberate attempt to take over the college by a small group of chiropractors with no respect or knowledge of regulation … funded by organizations out of the province and out of the country,” Victoria chiropractor Clark Konczak told the virtual meeting.
At issue was a series of policies the college introduced in the wake of what Konczak called “the smoothie episode.” He was referring to a video posted on Facebook in 2017 by the then-vice chair of the college’s board, Avtar Jassal, in which he falsely suggested fruit smoothies are better than vaccines at preventing the flu.
Earlier this year, the college introduced amendments that bar chiropractors from performing routine and repeat X-rays, saying radiography is only scientifically supported when there are red flags that something is seriously wrong. The policy change on X-rays was the flashpoint in the long-simmering tension within the profession. A group of chiropractors has filed a petition in B.C. Supreme Court, alleging the college is preventing them from providing “safe, ethical, and effective care to their patients.” Their legal action has backing from national and international vitalistic organizations. During the recent meeting, a group of chiropractors argued unsuccessfully for the new X-ray policy to be tossed. Some suggested that chiropractors who don’t perform X-rays as a matter of routine are actually harming their patients. Another extraordinary general meeting has been called for July 20 to vote on resolutions calling for the removal of four college board members.
As I have often pointed out, chiropractic is all about money. The ‘chiro-wars’ have been going on for quite a while now, and they are by no means confined to B. C. or Canada. In a nutshell, they suggest to me that a significant proportion of chiropractors prefer money to progress.
Vertebral artery dissections (VAD) are a rare but important cause of ischemic stroke, especially in younger patients. Many etiologies have been identified, including motor vehicle accidents, cervical fractures, falls, physical exercise, and, as I have often discussed on this blog, cervical chiropractic manipulation. The goal of this study was to investigate the subgroup of patients who suffered a chiropractor-associated injury and determine how their prognosis compared to other-cause VAD.
The researchers, neurosurgeons from Chicago, conducted a retrospective chart review of 310 patients with vertebral artery dissections who presented at their institution between January 2004 and December 2018. Variables included demographic data, event characteristics, treatment, radiographic outcomes, and clinical outcomes measured using the modified Rankin Scale.
Overall, 34 out of our 310 patients suffered a chiropractor-associated injury. These patients tended to be younger (p = 0.01), female (p = 0.003), and have fewer comorbidities (p = 0.005) compared to patients with other-cause VADs. The characteristics of the injuries were similar, but chiropractor-associated injuries appeared to be milder at discharge and at follow-up. A higher proportion of the chiropractor-associated group had injuries in the 0-2 mRS range at discharge and at 3 months (p = 0.05, p = 0.04) and no patients suffered severe long-term neurologic consequences or death (0% vs. 9.8%, p = 0.05). However, when a multivariate binomial regression was performed, these effects dissipated and the only independent predictor of a worse injury at discharge was the presence of a cervical spine fracture (p < 0.001).
The authors concluded that chiropractor-associated injuries are similar to VADs of other causes, and apparent differences in the severity of the injury are likely due to demographic differences between the two populations.
The authors of the present paper are clear: “chiropractic manipulations are a risk factor for vertebral artery dissections.” This fact is further supported by a host of other investigations. For instance, the Canadian Stroke Consortium found that 28% of strokes following cervical artery dissection were preceded by chiropractic neck manipulation. Dziewas et al. obtained a similar rate in patients with vertebral artery dissections. Many chiropractors are in denial; however, this is merely due to their overt conflicts of interest.
My conclusions from the accumulated evidence are this:
Spinal manipulations of the upper spine should not be routinely used for any condition. Patients who nevertheless insist on having them must be made aware of the risks and give informed consent.
I have reported about the risks of chiropractic manipulation many times before. This is not because, as some seem to believe, I have an axe to grind but because the subject is important. This week, another case of stroke after chiropractic manipulation was in the news. Some will surely say that it is alarmist to mention such reports which lack lots of crucial details. Yet, as long as chiropractors do not establish a proper monitoring system where serious adverse effects of spinal manipulation are noted, I think it is important to record even incomplete cases in this fashion.
Barbara Shand is a working mom who lives in Alberta, Canada. She went to see a chiropractor because she had neck pain. “Near the very end of the appointment, the chiropractor asked: ‘Do you want your neck adjusted?’ I said: ‘Sure.’” “As soon as she did it, everything went black,” Shand recalls.
The patient was then rushed to a hospital by ambulance. “When I did open my eyes, I couldn’t focus. It was all blurry, I had massive vertigo, I didn’t know what was up or down,” Shand told the journalist. The diagnosis, Shand explains, was a right vertebral artery dissection, followed by a stroke. Mrs. Sands continues to struggle with coordination and balance.
The Alberta College and Association of Chiropractors acknowledges “there have been reported cases of stroke associated with visits to various healthcare practitioners, including those that provide cervical spine manipulation.” But they claim it is rare. They did not comment on the informed consent which, according to Shand’s description, was more than incomplete.
The fact that the ACAC admits that such events have happened before is laudable and a step in the right direction (some chiropractic organizations don’t even go that far). Yet, their caveat that such cases are rare is problematic. Without a monitoring system, nobody can tell how frequent they are! What we do see is merely the tip of a much bigger iceberg. There have been hundreds of cases like Mrs. Shand. The truth of the matter is this: Chiropractic neck manipulations are not supported by sound evidence of effectiveness for any condition. This means that even rare risks (if they are truly rare) would tilt the risk/benefit balance into the negative.
The conclusion is, I think, to avoid neck manipulations at all costs. Or, as one neurologist once put it:
don’t let the buggars touch your neck!
This systematic review assessed the effects and reliability of sham procedures in manual therapy (MT) trials in the treatment of back pain (BP) in order to provide methodological guidance for clinical trial development.
Different databases were screened up to 20 August 2020. Randomized controlled trials involving adults affected by BP (cervical and lumbar), acute or chronic, were included. Hand contact sham treatment (ST) was compared with different MT (physiotherapy, chiropractic, osteopathy, massage, kinesiology, and reflexology) and to no treatment. Primary outcomes were BP improvement, the success of blinding, and adverse effects (AE). Secondary outcomes were the number of drop-outs. Dichotomous outcomes were analyzed using risk ratio (RR), continuous using mean difference (MD), 95% CIs. The minimal clinically important difference was 30 mm changes in pain score.
A total of 24 trials were included involving 2019 participants. Most of the trials were of chiropractic manipulation. Very low evidence quality suggests clinically insignificant pain improvement in favor of MT compared with ST (MD 3.86, 95% CI 3.29 to 4.43) and no differences between ST and no treatment (MD -5.84, 95% CI -20.46 to 8.78).ST reliability shows a high percentage of correct detection by participants (ranged from 46.7% to 83.5%), spinal manipulation is the most recognized technique. Low quality of evidence suggests that AE and drop-out rates were similar between ST and MT (RR AE=0.84, 95% CI 0.55 to 1.28, RR drop-outs=0.98, 95% CI 0.77 to 1.25). A similar drop-out rate was reported for no treatment (RR=0.82, 95% 0.43 to 1.55).
The authors concluded that MT does not seem to have clinically relevant effect compared with ST. Similar effects were found with no treatment. The heterogeneousness of sham MT studies and the very low quality of evidence render uncertain these review findings. Future trials should develop reliable kinds of ST, similar to active treatment, to ensure participant blinding and to guarantee a proper sample size for the reliable detection of clinically meaningful treatment effects.
The optimal therapy for back pain does not exist or has not yet been identified; there are dozens of different approaches but none has been found to be truly and dramatically effective. Manual therapies like chiropractic and osteopathy are often used, and some data suggest that they are as good (or as bad) as most other options. This review confirms what we have discussed many times previously (e.g. here), namely that the small positive effect of MT, or specifically spinal manipulation, is largely due to placebo.
Considering this information, what is the best treatment for back pain sufferers? The answer seems obvious: it is a therapy that is as (in)effective as all the others but causes the least harm or expense. In other words, it is not chiropractic nor osteopathy but exercise.
avoid therapists who use spinal manipulation for back pain.
The purpose of this study was to describe changes in opioid-therapy prescription rates after a family medicine practice included on-site chiropractic services. It was designed as a retrospective analysis of opioid prescription data. The database included opioid prescriptions written for patients seeking care at the family medicine practice from April 2015 to September 2018. In June 2016, the practice reviewed and changed its opioid medication practices. In April 2017, the practice included on-site chiropractic services. Opiod-therapy use was defined as the average rate of opioid prescriptions overall medical providers at the practice.
There was a significant decrease of 22% in the average monthly rate of opioid prescriptions after the inclusion of chiropractic services (F1,40 = 10.69; P < .05). There was a significant decrease of 32% in the prescribing rate of schedule II opioids after the inclusion of chiropractic services (F2,80 = 6.07 for the Group × Schedule interaction; P < .05). The likelihood of writing schedule II opioid prescriptions decreased by 27% after the inclusion of chiropractic services (odds ratio, 0.73; 95% confidence interval, 0.59-0.90). Changes in opioid medication practices by the medical providers included prescribing a schedule III or IV opioid rather than a schedule II opioid (F6,76 = 29.81; P < .05) and a 30% decrease in the daily doses of opioid prescriptions (odds ratio, 0.70; 95% confidence interval, 0.50-0.98).
The authors concluded that this study demonstrates that there were decreases in opioid-therapy prescribing rates after a family medicine practice included on-site chiropractic services. This suggests that inclusion of chiropractic services may have had a positive effect on prescribing behaviors of medical physicians, as they may have been able to offer their patients additional nonpharmaceutical options for pain management.
The authors are correct in concluding the inclusion of chiropractic services MAY have had a positive effect. And then again, it may not!
Cause and effect cannot be established by correlation alone.
CORRELATION IS NOT CAUSATION!
And even if the inclusion of chiropractic services caused the positive effect, it would not prove that chiropractic is effective in the management of pain. It would only mean that the physicians had an option that helped them to write fewer opioid prescriptions. Had they hired a crystal healer or a homeopath or a faith healer or any other practitioner of an ineffective therapy, the findings might have been very similar.
The long and short of it is this: if we want to use fewer opioids, there is only one way to achieve it: we must prescribe less.
The objective of this systematic review was to examine whether back pain is associated with increased mortality risk and, if so, whether this association varies by age, sex, and back pain severity.
A systematic search of published literature was conducted and English-language prospective cohort studies evaluating the association of back pain with all-cause mortality with follow-up periods >5 years were included. Three reviewers independently screened studies, abstracted data, and appraised risk of bias using the Quality in Prognosis Studies (QUIPS) tool. A random-effects meta-analysis estimated combined odds ratios (OR) and 95% confidence intervals (CI), using the most adjusted model from each study. Potential effect modification by a priori hypothesized factors (age, sex, and back pain severity) was evaluated with meta-regression and stratified estimates.
Eleven studies with a total of 81,337 participants were included. Follow-up periods ranged from 5 to 23 years. The presence of any back pain, compared to none, was not associated with an increase in mortality (OR, 1.06; 95% CI, 0.97 to 1.16). However, back pain was associated with mortality in studies of women (OR, 1.22; 95% CI, 1.02 to 1.46) and among adults with more severe back pain (OR, 1.26; 95% CI, 1.14 to 1.40).
The authors concluded that back pain was associated with a modest increase in all-cause mortality among women and those with more severe back pain.
I bet that back pain is associated with hundreds of things. The question is whether there might be a causal association; could it be that people die earlier BECAUSE of back pain?
Unless someone’s back pain is so unbearable that she commits suicide, I cannot see how the two can be directly linked in a cause/effect relationship. But there could be indirect causal links. For instance, certain cancers can cause both back pain and death. Or someone’s back pain might make him take treatment against a life-threatening condition less seriously and thus hasten his death.
It has also occurred to me that chiropractors might jump on the bandwagon and use the association between back pain and mortality for boosting their business. Something like this:
Back pain is a risk factor for premature death.
Come to us, and we treat your back pain.
This will make you live longer.
Chiropractic prolongs life!
That would, of course, be daft. Firstly, chiropractic is not all that effective for back pain (or anything else). Secondly, getting rid of back pain is unlikely to prolong your life.
Correlation is not causation!