FOUR QUESTIONS TO DC + CRITICAL CHIRO (CC):
1) what does the law say about informed consent for Australian chiros?
2) what info exactly do you have to provide?
3) who monitors it?
4) what published evidence do we have about compliance?
CC then posted this reply:
Here we go again you demand evidence while providing little if any for your own assumptions (poor case studies do not count. The pleural of anecdote does not equal evidence whether it’s from chiro’s or you).
We have been over this many times over many years, I cite research/provide links yet you still find it challenging to take it onboard. It is human nature to feel obligated once making a public statement to defend it no matter how much evidence is sent your way. So not surprising.
“1) what does the law say about informed consent for Australian chiros?”
It is all freely available on the national regulators website (as you know and as I have referenced in the past):
Some research by chiropractors on this topic (cited many times in the past):
Risk Management for Chiropractors and Osteopaths. Informed consent
A Common Law Requirement (2004):
Quick advanced PubMed with filters set to “Chiropractic” AND “Informed consent”.
Not rocket science
Latest paper that you wrote an ill informed blog on and the comments were not going as you expected (So I expected you to double down like Donald Trump with a new blog within days. Your getting predictable).
This paper questions the legal implications of vertebral subluxations with high powered legal input and is a broadside by evidence based chiropractors against vitalistic chiropractors. You respond a snide fantasy informed consent dialogue when you should be supporting the authors:
“2) what info exactly do you have to provide?”
“4) what published evidence do we have about compliance?”
We have discussed this as well. It is a common law requirement for every profession and is checked upon re-registration by AHPRA every year and by the professional indemnity insurers every year. No informed consent, no registration and no professional indemnity insurance.
Checked AHPRA’s panel decisions and went back 5 YEARS and found ONE decision relating to informed consent:
“3) who monitors it?”
Another of your tired old arguments that we have discussed many times over the years.
In the UK there is the “‘Chiropractic Reporting and Learning System’ (CRLS)” but this is set up by the association representing chiropractors and not the registration board that advocates for patients. Right idea and step in the right direction, wrong organization.
Here years ago there was a trial of an adverse event reporting system in a Melbourne emergency department systematically collected relevant AE information on all professions which was sent to the relevant board for investigation.
It was supported by doctors and chiropractors while physio’s were not involved. A doctor involved told me it was killed off by ER doctors who “snivelled” about the extra paperwork.
There is no AE reporting system for physio’s, chiro’s, osteo’s, GP’s in private practice etc.
Over the years you have harped on and on about this topic as if it is a failing purely of the chiropractic profession when we have supported initiatives for its implementation.
You have also kept up with the research even commenting on an chiropractic researcher on AE’s Charlotte Leboeuf-Yde (who you highly regard) yet ignored until you could take issue with two sentences written in a blog then you wrote this hatchet blog:
So you are asking for evidence yet willfully ignore an author who “I have always thought highly of Charlotte’s work”.
Stop the cynical cherry picked blogs and start supporting the researchers and reformers otherwise you are just someone standing on the sidelines blindly throwing grenades. You do not care who you hit or the damage you do to the chiropractors leading the reform you demand yet consistently fail to support.
I thought the tone of this response was oddly aggressive and found that CC had failed to understand some of my questions. Yet the link to the chiro’s code of conduct https://www.chiropracticboard.gov.au/Codes-guidelines/Code-of-conduct.aspx was useful. This is what it says about informed consent:
- the chiro suggests a manipulation of the neck;
- this often involves forcing a spinal joint beyond its physiological range of motion;
- the treatment will be short but needs repeating several times during the coming weeks;
- the expected benefits are a reduction of pain and improvement of motion;
- the total cost of the treatment series will be xy;
- there are many other treatment options for neck pain;
- most of these have a better risk/benefit profile than neck manipulation;
- having no treatment for neck pain at all is likely to lead to full resolution of the problem over time.
Apart from any doubts that chiropractors would actually comply with these requirements, the question remains: is the listed information sufficient? Does it outline a truly a fully informed consent? I think that essential aspects of informed consent are missing.
- The code does not explicidly require an explanation about the possible harms of spinal manipulation (i.e. 50% of all patients will suffer mild to moderate adverse effects lasting 2-3 days, and occasionally patients will have a stroke of which some have died).
- Moreover, the code mentions EXPECTED benefits, but not benefits supported by evidence. Chiros may well EXPECT their treatment to work, but what does the evidence show? As often discussed on this blog, the evidence is negative or very week, depending how you want to interpret it. The code does not require a chiro to inform his patients about this fact.
So, the way I see it, the code does not expressedly demand the chiro to explain his patient that the treatment he is being asked to consent to is
- not supported by sound evidence for effectiveness,
- nor that the treatment is burdened with significant risks.
And what about the other questions listed above? An Australian chiropractor who will remain anonymous gave me the following answers:
Yet, Australian chiropractors claim that they abide by the ethical imperative of informed consent. Are they taking the Mickey?
Perhaps not. Perhaps they are merely trying to make sure they do not lose the majority of their clientele. As I already pointed out in my previous post, fully informed consent would make most chiropractic patients turn round and run a mile.
Today, HRH the Prince of Wales has his 72th birthday. As every year, I send him my best wishes by dedicating an entire post to a brief, updated summary of his achievements in the area of so-called alternative medicine (SCAM).
EARLY INFLUENCE OF LAURENCE VAN DER POST
Aged 18, Charles went on a journey of ‘spiritual discovery’ into the Kalahari desert. His guide was Laurens van der Post (later discovered to be a fraud and compulsive fantasist and to have fathered a child with a 14-year old girl entrusted to him during a sea voyage). Van der Post wanted to awake Charles’ mind and attune it to the ideas of Carl Jung’s ‘collective unconscious’, and it is this belief in vitalism that provides the crucial link to SCAM: virtually every form of SCAM is based on the assumption that some sort of vital force exists. Charles was impressed with van der Post that he made him the godfather of Prince William. After Post’s death, he established an annual lecture in his honour (the lecture series was quickly discontinued after van der Post was discovered to be a fraud).
CHIROPRACTIC and OSTEOPATHY
Throughout the 1980s, Charles lobbied for the statutory regulation of chiropractors and osteopaths in the UK. In 1993, this finally became reality. To this day, these two SCAM professions are the only ones regulated by statute in the UK.
THE BRITISH MEDICAL ASSOCIATION
In 1982, Prince Charles was elected as President of the British Medical Association (BMA) and promptly challenged the medical orthodoxy by advocating SCAM. In a speech at his inaugural dinner as President, the Prince lectured the medics: ‘Through the centuries healing has been practised by folk healers who are guided by traditional wisdom which sees illness as a disorder of the whole person, involving not only the patient’s body, but his mind, his self-image, his dependence on the physical and social environment, as well as his relation to the cosmos.’ The BMA-officials ordered a full report on alternative medicine which promptly condemned this area as implausible nonsense.
Six years later, a second report, entitled ‘Complementary Medicine – New Approaches to Good Practice’, heralded U-turn stating that: “the demand for non-conventional therapies had become so pressing that organised medicine in Britain could no longer ignore its contribution“. At the same time, however, the BMA set in motion a further chapter in the history of SCAM by insisting that it was “unacceptable” to allow the unrestricted practice of non-conventional therapies, irrespective of training or experience.
THE FOUNDATION OF INTEGRATED HEALTH
In 1993, Charles founded his lobby group which, after being re-named several times, ended up being called the ‘Foundation for Integrated Health’ (FIH). It was closed down in 2010 amidst allegations of money laundering and fraud. Its chief executive, George Gray, was later convicted and went to jail.
In 2001, Charles worked on plans to help build a model hospital of integrated medicine. It was to train doctors to combine conventional medicine and SCAMs, such as homeopathy, Ayurvedic medicine and acupuncture, and was to have around 100 beds. The prince’s intervention marked the culmination of years of campaigning by him for the NHS to assign a greater role to SCAM.
In 2001, Charles published an editorial in the BMJ promoting his ideas around integrative medicine. Its title: THE BEST OF BOTH WORLDS. Ever since, Charles has been internationally recognised as one of the world’s most vociferous champions of integrated medicine.
In 2004, Charles publicly supported the Gerson diet as a treatment for cancer. Prof Baum, an eminent oncologists, was invited to respond in an open letter to the British Medical Journal: ” …Over the past 20 years I have treated thousands of patients with cancer and lost some dear friends and relatives to this dreaded disease…The power of my authority comes with knowledge built on 40 years of study and 25 years of active involvement in cancer research. Your power and authority rest on an accident of birth. I don’t begrudge you that authority but I do beg you to exercise your power with extreme caution when advising patients with life-threatening diseases to embrace unproven therapies.”
THE SMALLWOOD REPORT
In 2005, the ‘Smallwood-Report’ was published; it had been commissioned by Charles and paid for by Dame Shirley Porter to inform health ministers. It stated that up to 480 million pounds could be saved, if one in 10 family doctors offered homeopathy as an “alternative” to standard drugs for asthma. Savings of up to 3.5 billion pounds could be achieved by offering spinal manipulation rather than drugs to people with back pain. Because I had commented on this report, Prince Charles’ first private secretary asked my vice chancellor to investigate the alleged indiscretion; even though I was found to be not guilty of any wrong-doing, all local support at Exeter stopped which eventually led to my early retirement.
WORLD HEALTH ORGANISATION
In a 2006 speech, Prince Charles told the World Health Organisation in Geneva that SCAM should have a more prominent place in health care and urged every country to come up with a plan to integrate conventional and alternative medicine into the mainstream. Anticipating Prince Charles’s sermon in Geneva, 13 of Britain’s most eminent physicians and scientists wrote an “Open Letter” which expressed concern over “ways in which unproven or disproved treatments are being encouraged for general use in Britain’s National Health Service.” The signatories argued that “it would be highly irresponsible to embrace any medicine as though it were a matter of principle.”
TRADITIONAL CHINESE MEDICINE (TCM)
In 2007, the People’s Republic of China recorded the visit of Fu Ying, its ambassador in London at the time, to Clarence House, and announced that the Charles had praised TCM. “He hoped that it could be included in the modern medical system . . . and was willing to make a contribution to it.”
In 2009, the Prince held talks with the health Secretary to persuade him to introduce safeguards amid a crackdown by the EU that could prevent anyone who is not a registered health practitioner from selling remedies.
In the same year, Charles urged the government to protect SCAM because “we fear that we will see a black market in herbal products”, as Dr Michael Dixon, medical director of the FIH and Charles’ advisor in SCAM, put it.
UK HEALTH POLITICS
In 2009, the health secretary wrote to the Prince suggesting a meeting on the possibility of a study on integrating SCAM in England’s NHS. The Prince had written to Burnham’s predecessor, Alan Johnson, demanding greater access to SCAM in the NHS alongside conventional medicine. Charles stated that “despite waves of invective over the years from parts of the medical and scientific establishment” he continued to lobby “because I cannot bear people suffering unnecessarily when a complementary approach could make a real difference”.
In June 2014, BBC NEWS published the following text about a BBC4 broadcast entitled ‘THE ROYAL ACTIVIST’ aired on the same day: Prince Charles has been a well-known supporter of complementary medicine. According to a… former Labour cabinet minister, Peter Hain, it was a topic they shared an interest in. He had been constantly frustrated at his inability to persuade any health ministers anywhere that that was a good idea, and so he, as he once described it to me, found me unique from this point of view, in being somebody that actually agreed with him on this, and might want to deliver it. Mr Hain added: “When I was Secretary of State for Northern Ireland in 2005-7, he was delighted when I told him that since I was running the place I could more or less do what I wanted to do. I was able to introduce a trial for complementary medicine on the NHS, and it had spectacularly good results, that people’s well-being and health was vastly improved. And when he learnt about this he was really enthusiastic and tried to persuade the Welsh government to do the same thing and the government in Whitehall to do the same thing for England, but not successfully,” added Mr Hain.
In October 2015, the Guardian obtained the infamous “black spider memos” which revealed that Charles had repeatedly lobbied politicians in favour of SCAM.
THE COLLEGE OF MEDICINE
In 2009, it was announced that the ‘College of Integrated Medicine’ (the successor of the FIH) was to have a second base in India. In 2011, Charles forged a link between ‘The College of Medicine’ and an Indian holistic health centre. The collaboration was reported to include clinical training to European and Western doctors in Ayurveda and homoeopathy and traditional forms of medicine to integrate them in their practice. The foundation stone for the extended campus of the Royal College known as the International Institution for Holistic and Integrated Medicine was laid by Dr Michael Dixon in collaboration with the Royal College of Medicine.
In 2020, Charles became the patron of the College of Medicine which, by then, had re-christened itself ‘College of Medicine and Integrated Health’. The College chair, Michael Dixon, was quoted stating: ‘This is a great honour and will support us as an organisation committed to taking medicine beyond drugs and procedures. This generous royal endorsement will enable us to be ever more ambitious in our mission to achieve a more compassionate and sustainable health service.”
DUTCHY ORIGINALS DETOX TINCTURE
In 2011, after the launch of Charles’ range of herbal tinctures, I had the audacity to publicly criticise Charles for selling the Duchy Herbals detox tincture which I named ‘Dodgy Originals Detox Tincture’.
In 2016, speaking at a global leaders summit on antimicrobial resistance, Prince Charles warned that Britain faced a “potentially disastrous scenario” because of the “overuse and abuse” of antibiotics. The Prince explained that he had switched to organic farming on his estates because of the growing threat from antibiotic resistance and now treats his cattle with homeopathic remedies rather than conventional medication. As some of you may be aware, this issue has been a long-standing and acute concern to me,” he told delegates from 20 countries “I have enormous sympathy for those engaged in the vital task of ensuring that, as the world population continues to increase unsustainably and travel becomes easier, antibiotics retain their availability to overcome disease… It must be incredibly frustrating to witness the fact that antibiotics have too often simply acted as a substitute for basic hygiene, or as it would seem, a way of placating a patient who has a viral infection or who actually needs little more than patience to allow a minor bacterial infection to resolve itself.”
In 2017, Charles declared that he will open a centre for SCAM in the recently purchased Dumfries House in Scotland. Currently, the College of Medicine and Integrated Health is offering two-day Foundation Courses at this iconic location. Gabriel Chiu, a US celebrity cosmetic and reconstructive surgeon, and his wife Christine, joined the Prince of Wales as he opened the integrated health and wellbeing centre on the Dumfries House Estate in East Ayrshire in 2019. As he unveiled a plaque, Prince Charles said: “I’m so glad that all of you have been able to get here today, particularly because I could not be more proud to see the opening of this new integrated health centre at Dumfries House. It’s something I’ve been wanting to do for the last 35 years. I’m also so proud of all the team at Dumfries House who built it, an all in-house team.”
Generations of royals have favoured homeopathy, and allegedly it is because of this influence that homeopathy became part of the NHS in 1948. Homeopathy has also been at the core of Charles’ obsession with SCAM from its beginning. In 2017, ‘Country News’ published an article about our heir to the throne stating that Prince of Wales has revealed he uses homeopathic treatments for animals on his organic farm at Highgrove to help reduce reliance on antibiotics, the article stated. He said his methods of farming tried wherever possible to ‘‘go with the grain of nature’’ to avoid dependency on antibiotics, pesticides and other forms of chemical intervention.
In the same year, it was revealed that UK farmers were being taught how to treat their livestock with homeopathy “by kind permission of His Royal Highness, The Prince Of Wales”
In 2019, the Faculty of Homeopathy announced that His Royal Highness The Prince of Wales had accepted to become Patron of the Faculty of Homeopathy. Dr Gary Smyth, President of the Faculty of Homeopathy commented, “As the Faculty celebrates its 175th anniversary this year, it is an enormous honour for us to receive the Patronage of His Royal Highness The Prince of Wales and I am delighted to announce this news today.” Charles’ move amazed observers who saw it as a deliberate protest against the discontinuation of reimbursement of homeopathy by the NHS.
In 2020, Charles fell ill with the corona-virus and happily made a swift recovery. It was widely reported that his recovery was due to homeopathy, a notion denied by Clarence House.
Happy Birthday Charles
I was alerted to an outstanding article by an unusual author, a law firm, on the subject of chiropractic. Allow me to quote a few passages from it (without changing a word or adding a comment):
When Katie May passed away suddenly from a stroke at just 34 years old, it was initially ruled an accident. After further investigation, a coroner determined the stroke that claimed the model and single mother’s life was caused by injuries sustained during neck manipulation by a chiropractor. And Ms. May is not the first to be affected by this seemingly harmless procedure…
What health issues can be caused by chiropractic manipulation?
Chiropractors typically use their hands to apply pressure to joints, aiming to help alleviate pain and improve body function. This is referred to as a chiropractic adjustment.
Adjustments are commonly performed for neck and/or back pain. Although the Mayo Clinic says the risk of a serious complication is relatively small, these complications can include:
- A herniated disk, or worsening of an existing herniated disk
- Compression of nerves in the lower spinal column
- Stroke, which can result in paralysis or death
The last item on this list is particularly concerning.
Patients who receive neck manipulation are at risk for a stroke caused by vertebral artery dissection. Located in the neck, the vertebral arteries supply blood to the brain and can be torn by stretching and sudden force applied during a neck adjustment.
How could a chiropractor be responsible for a patient’s injury?
Although the risk of being seriously injured by a chiropractor is low, tragic accidents can and do happen. If you or a loved one believe you have been the victim of medical malpractice, please contact an experienced personal injury attorney.
Explaining how an injury or medical error occurred will help your attorney determine the potential liability of a chiropractor and any other involved parties. A chiropractor’s liability could fall into a legal category such as:
- Failure to Diagnose a Medical Condition – The chiropractor breaches a duty of care to their patients by failing to diagnose an underlying medical condition. This could occur when a patient reveals or exhibits symptoms of a severe issue, such as a stroke, and is not referred for appropriate medical attention.
- Lack of Informed Consent – A patient is treated without being properly informed of the potential risks or side effects, and experiences an injury from that treatment.
- Negligent Manipulation – The patient’s body is adjusted by the chiropractor in such a way that it causes a new injury or worsens an existing injury. This could also include manipulation of a patient who is pregnant and goes into premature labor.
- Chiropractic Induced Injury – A patient suffers injury, permanent irreversible damage such as paralysis or wrongful death as the direct result of a chiropractic manipulation.
To find out whether or not you may have a case, please discuss your concerns with a qualified personal injury attorney.
What should I do if I think I have been injured by chiropractic manipulation?
A personal injury attorney can help recover compensation for victims of medical malpractice, including those who have experienced a chiropractic injury. Surviving loved ones can also pursue their case after a family member’s wrongful death.
An attorney will help you collect documents, photos and other items pertaining to your case – but staying organized early in the process will be helpful. Try to preserve important documents, such as:
- Photographs before and after treatment
- Medical records and medical bills
- Receipts, appointment confirmations and other paperwork from your chiropractor
There is a time limit to file a medical malpractice lawsuit, referred to as a statute of limitations…
The issue of informed consent has made regular appearances on this blog. It is important and has many intriguing aspects, particularly for so-called alternative medicine (SCAM). On the one hand, it is a ‘conditio sine qua non’ for any form of healthcare, while, on the other hand, it is a near impossibility in SCAM practice.
In this new article published in a chiro-journal, the authors review the origins of informed consent and trace the duty of disclosure and materiality through landmark medical consent cases in four common law (case law) jurisdictions. The duty of disclosure has evolved from a patriarchal exercise to one in which patient autonomy in clinical decision making is paramount. Passing time has seen the duty of disclosure evolve to include non-medical aspects that may influence the delivery of care. The authors argue that a patient cannot provide valid informed consent for the removal of vertebral subluxation. Further, vertebral subluxation care cannot meet code of conduct standards because it lacks an evidence base and is practitioner-centered.
The uptake of the expanded duty of disclosure has been slow and incomplete by practitioners and regulators. The expanded duty of disclosure has implications, both educative and punitive for regulators, chiropractic educators and professional associations. The authors discuss how practitioners and regulators can be informed by other sources such as consumer law. For regulators, reviewing and updating informed consent requirements is required. For practitioners it may necessitate disclosure of health status, conflict of interest when recommending “inhouse” products, recency of training after attending continuing professional development, practice patterns, personal interests and disciplinary findings.
The authors conclude that, ultimately such matters are informed by the deliberations of the courts. It is our opinion that the duty of a mature profession to critically self-evaluate and respond in the best interests of the patient before these matters arrive in court.
In their paper, the authors also provide a standard list of items required for ‘informed’ consent:
(1) emphasizing the patient’s role in shared decision-making
(2) disclosure of information
a. explaining the patient’s medical status including diagnosis and prognosis
b. describing the proposed diagnostic and therapeutic intervention, including the likelihood and effect of associated risks and benefits of the proposed action, including material risks
c. discussing alternatives to the proposed intervention, including doing nothing
(3) prompting and answering patient questions related to the proposed course of action (NB. this involves probing for understanding, not simply asking ‘do you have any questions’), and
(4) eliciting the patient’s preference (usually by signature). (NB. A signed form is not consent. The conversation between the clinician and the patient or carer is the true process of obtaining informed consent. The signature on the consent form is proof that the conversation took place and that the patient understood and agreed.)
The authors of this article – I do commend it to all chiropractors – take a mostly judicial view of informed consent (for an ethical perspective on the subject, I recommend our book). They do not discuss, whether chiropractors do, in fact, adhere to the ethical imperative of informed consent. As I have stated before, there is not much research on this issue. But the little that does exist fails to show that chiropractors care much about it.
If it’s an ethical imerative, why do chiropractors not abide by it?
The answer to this question is not difficult to find. Just imagine a conversation between a chiropractor (C) and a patient with neck pain (P):
- P: What’s your diagnisis?
- C: You are suffering from acute neck pain.
- P: Thanks, that much was clear to me. What do you suggest I do?
- C: I will perform a manipulation of your neck, if you agree.
- P: Why would this help?
- C: It can realign the vertebrae that are out of place, simply put.
- P: And my pain will disappear?
- C: Sometimes it does, yes.
- P: But will it disappear quicker than without manipulation.
- C: Some of the evidence says so.
- P: Ok, but what does the most reliable evidence say?
- C: It is not entirely clear cut.
- P: Hmm, that does not sound too good.
- P: So, tell me, are there any risks?
- C: About 50% of patients suffer from minor to moderate pain for 2-3 days afterwards.
- P: That’s a lot!
- P: Anything else?
- C: In some cases, neck manipulation was followed by a stroke.
- P: Gee that’s bad; how often has this happened?
- C: We know of about 500 such cases.
- P: Heavens!
- C: Now, do you want the treatment or not?
- P: How much will you charge?
- C: Only 60 Euros per session.
- P: You mean I have to come back for more, each time risking a stroke?
- C: Well… You don’t have to.
- P: Thanks for the info; I am off. Cherio!
I rest my case.
Low-level laser therapy has been used clinically to treat musculoskeletal pain; however, there is limited evidence available to support its use. The current Cochrance review fails to be positive: there are insufficient data to draw firm conclusions on the clinical effect of LLLT for low‐back pain. So, perhaps studies on animals generate clearer answers?
The objective of this study was to evaluate the clinical effectiveness of low-level laser therapy and chiropractic care in treating thoracolumbar pain in competitive western performance horses. The subjects included 61 Quarter Horses actively involved in national western performance competitions judged to have back pain. A randomized, clinical trial was conducted by assigning affected horses to either:
- laser therapy,
- or combined laser and chiropractic treatment groups.
Low-level laser therapy was applied topically to local sites of back pain. The laser probe contained four 810-nm laser diodes spaced 15-mm apart in a square array that produced a total optical output power of 3 watts. Chiropractic treatment was applied to areas of pain and stiffness within the thoracolumbar and sacral regions. A single application of a high velocity, low-amplitude (HVLA) manual thrust was applied to affected vertebral segments using a reinforced hypothenar contact and a body-centered, body-drop technique. The HVLA thrusts were directed dorsolateral to ventromedial (at a 45° angle to the horizontal plane) with a segmental contact near the spinous process with the goal of increasing extension and lateral bending within the adjacent vertebral segments. If horses did not tolerate the applied chiropractic treatment, then truncal stretching, spinal mobilization, and the use of a springloaded, mechanical-force instrument were used as more conservative forms of manual therapy in these acute back pain patients.
Outcome parameters included a visual analog scale (VAS) of perceived back pain and dysfunction and detailed spinal examinations evaluating pain, muscle tone, and stiffness. Mechanical nociceptive thresholds were measured along the dorsal trunk and values were compared before and after treatment. Repeated measures with post-hoc analysis were used to assess treatment group differences.
Low-level laser therapy, as applied in this study, produced significant reductions in back pain, epaxial muscle hypertonicity, and trunk stiffness. Combined laser therapy and chiropractic care produced similar reductions, with additional significant decreases in the severity of epaxial muscle hypertonicity and trunk stiffness. Chiropractic treatment by itself did not produce any significant changes in back pain, muscle hypertonicity, or trunk stiffness; however, there were improvements in trunk and pelvic flexion reflexes.
The authors concluded that the combination of laser therapy and chiropractic care seemed to provide additive effects in treating back pain and trunk stiffness that were not present with chiropractic treatment alone. The results of this study support the concept that a multimodal approach of laser therapy and chiropractic care is beneficial in treating back pain in horses involved in active competition.
Let me play the devil’s advocate and offer a different conclusion:
These results show that horses are not that different from humans when it comes to responding to treatments. One placebo has a small effect; two placebos generate a little more effects.
The objective of this RCT was to compare the effects of
- spinal thrust-manipulation + electrical dry needling + various medications (TMEDN-group)
- to non-thrust peripheral joint/soft-tissue mobilization + exercise + interferential current + various medications(NTMEX-group)
on pain and disability in patients with subacromial pain syndrome (SAPS).
Patients with SAPS were randomized into the TMEDN group (n=73) or the NTMEX group (n=72). Primary outcomes included the shoulder pain and disability index (SPADI) and the numeric pain rating scale (NPRS). Secondary outcomes included Global Rating of Change (GROC) and medication intake. The treatment period was 6 weeks; with follow-up at 2 weeks, 4 weeks, and 3 months.
At 3 months, the TMEDN group experienced significantly greater reductions in shoulder pain and disability compared to the NTMEX group. Effect sizes were large in favour of the TMEDN group. At 3 months, a greater proportion of patients within the TMEDN group achieved a successful outcome (GROC≥+5) and stopped taking medication.
The authors concluded that cervicothoracic and upper rib thrust-manipulation combined with electrical dry needling resulted in greater reductions in pain, disability and medication intake than non-thrust peripheral joint/soft-tissue mobilization, exercise and interferential current in patients with SAPS. These effects were maintained at 3 months.
The authors of this trial have impressive looking affiliations:
- American Academy of Manipulative Therapy Fellowship in Orthopaedic Manual Physical Therapy, Montgomery, AL.
- Montgomery Osteopractic Physiotherapy & Acupuncture Clinic, Montgomery, AL.
- Research Physical Therapy Specialists, Columbia, SC.
- Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Spain.
- Cátedra de Clínica, Investigación y Docencia en Fisioterapia: Terapia Manual, Punción Seca y Ejercicio, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain.
- Copper Queen Community Hospital, Bisbee, AZ.
- BenchMark Physical Therapy, Atlanta, GA.
- Eastside Medical Care Center, El Paso, TX.
- Department of Physical Therapy, Georgia State University, Atlanta, GA.
- Tybee Wellness & Osteopractic, Tybee Island, Georgia, GA.
If one expected a well-designed study from all this collective expertise, one would have been disappointed.
Any such clinical trial should be answering a simple question: is therapy XX effective? It is about pinning an observed effect on to a treatment. It is about establishing cause and effect. It is about finding an answer to a clinically relevant question.
The above study does none of that. Even if we accepted its result as valid, it could be interpreted as meaning one of many different things, for instance:
- Acupuncture was effective.
- Dry needling was effective.
- The electrical current was effective.
- Mobilisation made things worse.
- Exercise made things worse.
- one or multiple positive or negative interactions between the therapies.
- The drugs in the experimental group were more effective than those taken by controls.
- The experimental group adhered to their drug prescriptions better than controls.
- Any mixture of the above.
So, the reader of this paper can chose which of the interpretations he or she prefers. I suggest that:
- Any researcher who designs a foreseeably nonsensical trial should go back to school.
- Any ethics committee that passes such a study needs to retire.
- Any funder who gives money for it wastes scarce resources.
- Any reviewer who recommends publication needs to learn about trial design.
- Any editor who publishes such a trial needs to go.
The point I am trying to make is that conducting a clinical trial comes with responsibilities. Poorly designed studies are not just a waste of resources, they are a disservice to patients, they undermine the public’s trust in science and they are unethical.
Researchers from the Department of Physiotherapy, Guru Jambheshwar University of Science and Technology, Hisar, Haryana, India, and the Mother Teresa Saket College of Physiotherapy, Saket, Panchkula, Haryana, India, have just published a systematic review which is remarkable in several ways. Let me therefore present to you the abstract unaltered:
Background: Spinal pain or misalignment is a very common disorder affecting a significant number of populations resulting in substantial disability and economic burden. Various manual therapeutic techniques such as spinal manipulations and mobilizations can be used to treat and manage pain and movement dysfunctions such as spinal mal-alignments and associated complications. These manual therapeutic techniques can affect the cardiovascular parameters.
Objective: The objective of this systematic review and meta-analysis is to assess the effect of spinal manipulation and mobilization on cardiovascular parameters.
Methods: We conducted a systematic review and meta-analysis to assess the effects of spinal mobilization and manipulation on cardiovascular responses. Mean changes in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Heart Rate (HR) were primary outcome measures. RevMan 5.3 software was used for the meta-analyses. Quality of the included studies was assessed by PEDro Rating scale. Risk of bias was assessed by Cochrane collaboration tool of risk of bias.
Results: Results of meta-analysis showed that there was statistically significant decrease in SBP ( MD=-4.56 , 95% CI=-9.20 , 0.08; p≤0.05 ) with moderate heterogeneity ( I2=75% , p<0.0002 ) in experimental group as compared to control group. There was statistically non-significant decrease in DBP ( MD=-1.96 , 95% CI=-4.60 , 0.69; p=0.15 ) with high heterogeneity ( I2=91% , p<0.00001 ), Change HR was statistically non-significant ( MD=-0.24 , 95% CI=-3.59 , 3.11; p=0.89 ) with moderate heterogeneity ( I2=60% , p=0.01 ). Exclusion of short duration studies in sensitivity analysis revealed a statistically significant change in DBP ( MD=-0.94 , 95% CCI=-1.85 , -0.03 ; p=0.04 ). However, the result was statistically non-significant for HR after sensitivity analysis.
Conclusion: Spinal manipulations and mobilizations may result in significant decrease of systolic as well as diastolic Blood Pressure.
After reading the full paper, I was uncertain whether to laugh or to cry. Then I decided for the former option.
Any paper that starts with the statement ‘spinal pain or misalignment is a very common disorder affecting a significant number of populations resulting in substantial disability and economic burden‘ can only be a hoax! In case you are uncertain about the reason of my amusement: spinal pain is not the same as spinal misalignment, and spinal misalignment (in the sense it is used here) is the figment of the imagination of a 18 carat charlatan called DD Palmer.
The rest of the article offers more superb hilarity: the authors write, for instance, that spinal malalignments (such as scoliosis) are mainly caused by body’s abnormal posture, asymmetries in bone growth and abnormalities of neuromuscular system. Scoliosis is an abnormal lateral curvature of the spine, not a spinal malalignment and certainly not one that can be treated with spinal manipulation.
Then the authors state that spinal pain and malalignment mainly occur due to structure deterioration, altered biomechanics and abnormal posture. Workplace physical and psychosocial factors, emotional problems, smoking, poor job satisfaction, awkward posture and poor work environment can be the possible risk factors for spinal pain and malalignment. This leads to various musculoskeletal, psychosomatic, cardiovascular and respiratory dysfunctions which affect the functional capacity of the patient as well as quality of life. Oh really?
So, the findings of the authors’ meta-analysis do suggest a tiny effect on blood pressure.
Compared to what?
In the paper, the review authors repeatedly try to make us believe it is compared to placebo. However, this is not true; mostly it was compared to no treatment.
Was the hypotensive effect verified in hypertensive patients?
No, it was measured mostly in healthy volunteers.
Is the effect clinically relevant?
No, I don’t think so!
Is it comparable to or better than the one achievable with established treatments for hypertension?
No! In fact it is much smaller.
Does that bother the authors?
No, on the contrary, they state that in this meta-analysis, spinal manipulation and mobilization resulted in statistically significant reduction in SBP. Therefore, it can be used as an adjuvant therapy for the management of hypertension.
Were the studies using spinal manipulation as an adjuvant therapy?
No, mostly not.
Is the effect lasting long enough to be relevant for the management of hypertension?
I better stop here because already my whole body hurts from laughing so much. Please, do read the full text, if you are in need of some comic relief.
And, I almost forgot: many thanks to the Indian researchers for this hilarious hoax!
Or did you perhaps mean all that seriously?
Recently, I had a notable comment on one of my posts:
“these treatments are not the best we can offer to LBP-patients.”
Have to agree with you. As a stand alone treatment the research is underwhelming. When used as part of a suite of therapies they have some utility. All therapeutic approaches when studied in isolation are underwhelming (including exercise and rehab). Research needs to reflect how chiro’s/physio’s/osteo’s practice.
The post was about a new RCT suggesting that neither spinal manipulation nor spinal mobilization is effective treatments for chronic low back pain. And the comment came, of course, from an ardent defender of chiropractic. As I have heard this type of argument so often – from virtually all types of providers of so-called alternative medicine (SCAM) – it is perhaps worth considering it in more detail.
What does it mean?
It means that those SCAM-providers who believe in the argument think that, in order for their SCAM to work, it needs to be accompanied by some other therapy. To me, this assumption has always raised doubts.
- My fake 5£ note is worth nothing, unless you add a real fiver to it.
- This mine sweeper will work fine, as long as you use another one in parallel.
- This drink is very strong, but you need a double vodka in order to feel it.
Yes, of course, I am exaggerating. So, let’s use a few more sensible examples from the realm of healthcare:
- This new medication is effective only if you combine it with the standard drug for this disease.
- Ultrasound therapy reduces shoulder pain, as long as you also take a pain-killer.
- This slimming aid works wonders, if you stop eating while you take it.
- Chiropractic manipulations work wonders, but you need to combine them with exercise therapy.
- Crystal healing is very effective, as long as you don’t discontinue your conventional treatments.
A + B is only more than B, if A amounts to more than zero.
If A is zero, A + B = B.
If A is negative, A + B is less than B.
Of course, the argument could also mean that treatment A needs the addition of treatment B, because there is a synergism between the two. Synergism is the interaction of treatments such that the total effect is greater than the sum of the individual effects. It is a phenomenon that occurs with certain medications; it can be studied and must be proven before we can accept it as relevant. Has synergism been studied for any of the SCAMs? No, not as far as I am aware. This means, in SCAM, it is unproven. Until it is proven, we thus should not claim it.
So, what does it mean when SCAM-providers say AS A STAND-ALONE THERAPY MY SCAM IS NO GOOD; IT NEEDS ANOTHER TREATMENT TO WORK?
Call me a cynic, but I think it is an admission that the SCAM in question is ineffective (or perhaps even detrimental).
Manual therapy is a commonly recommended treatment of low back pain (LBP), yet few studies have directly compared the effectiveness of thrust (spinal manipulation) vs non-thrust (spinal mobilization) techniques. This study evaluated the comparative effectiveness of spinal manipulation and spinal mobilization at reducing pain and disability compared with a placebo control group (sham cold laser) in a cohort of young adults with chronic LBP.
This single-blinded (investigator-blinded), placebo-controlled randomized clinical trial with 3 treatment groups was conducted at the Ohio Musculoskeletal and Neurological Institute at Ohio University from June 1, 2013, to August 31, 2017. Of 4903 adult patients assessed for eligibility, 4741 did not meet inclusion criteria, and 162 patients with chronic LBP qualified for randomization to 1 of 3 treatment groups. Participants received 6 treatment sessions of (1) spinal manipulation, (2) spinal mobilization, or (3) sham cold laser therapy (placebo) during a 3-week period. Licensed clinicians (either a doctor of osteopathic medicine or physical therapist), with at least 3 years of clinical experience using manipulative therapies provided all treatments.
Primary outcome measures were the change from baseline in Numerical Pain Rating Scale (NPRS) score over the last 7 days and the change in disability assessed with the Roland-Morris Disability Questionnaire (scores range from 0 to 24, with higher scores indicating greater disability) 48 to 72 hours after completion of the 6 treatments.
A total of 162 participants (mean [SD] age, 25.0 [6.2] years; 92 women [57%]) with chronic LBP (mean [SD] NPRS score, 4.3 [2.6] on a 1-10 scale, with higher scores indicating greater pain) were randomized.
- 54 participants were randomized to the spinal manipulation group,
- 54 to the spinal mobilization group,
- 54 to the placebo group.
There were no significant group differences for sex, age, body mass index, duration of LBP symptoms, depression, fear avoidance, current pain, average pain over the last 7 days, and self-reported disability. At the primary end point, there was no significant difference in change in pain scores between spinal manipulation and spinal mobilization (0.24 [95% CI, -0.38 to 0.86]; P = .45), spinal manipulation and placebo (-0.03 [95% CI, -0.65 to 0.59]; P = .92), or spinal mobilization and placebo (-0.26 [95% CI, -0.38 to 0.85]; P = .39). There was no significant difference in change in self-reported disability scores between spinal manipulation and spinal mobilization (-1.00 [95% CI, -2.27 to 0.36]; P = .14), spinal manipulation and placebo (-0.07 [95% CI, -1.43 to 1.29]; P = .92) or spinal mobilization and placebo (0.93 [95% CI, -0.41 to 2.29]; P = .17). A comparison of treatment credibility and expectancy ratings across groups was not statistically significant (F2,151 = 1.70, P = .19), indicating that, on average, participants in each group had similar expectations regarding the likely benefit of their assigned treatment.
The authors concluded that in this randomized clinical trial, neither spinal manipulation nor spinal mobilization appeared to be effective treatments for mild to moderate chronic LBP.
This is an exceptionally well-reported study. Yet, one might raise a few points of criticism:
- The comparison of two active treatments makes this an equivalence study, and much larger sample sizes are required or such trials (this does not mean that the comparisons are not valid, however).
- The patients had rather mild symptoms; one could argue that patients with severe pain might respond differently.
- Chiropractors could argue that the therapists were not as expert at spinal manipulation as they are; had they employed chiropractic therapists, the results might have been different.
- A placebo control group makes more sense, if it allows patients to be blinded; this was not possible in this instance, and a better placebo might have produced different findings.
Despite these limitations, this study certainly is a valuable addition to the evidence. It casts more doubt on spinal manipulation and mobilisation as an effective therapy for LBP and confirms my often-voiced view that these treatments are not the best we can offer to LBP-patients.
One of the many issues that needs addressing about chiropractic is its safety. On this blog, we have had dozens of posts and debates on this topic. Today, I want to try and summarise them by providing a fictitious dialogue between a critic and a chiropractor.
Here we go:
Critic (CR): It seems to me that most of the chiros I talk to are convinced that their hallmark therapy, spinal manipulation, is risk-free.
Chiro (CH): Hallmark therapy? Not true! Osteopaths, physios, doctors they all use spinal manipulation.
CR: I know, but name me a profession that employs it more regularly than you chiros.
CH: In any case, it is as good as risk-free; nothing is totally devoid of risk, but chiropractic spinal manipulation (CSMT) is generally very safe, because we are better trained at it than the others.
CR: Do you say that because you believe it or because you know it?
CH: I know it.
CR: That means you have the evidence to prove it?
CH: Yes, of course. Over the years, I have treated over a thousand patients and never heard of any problems.
CR: Without a monitoring system of adverse events that occur after chiropractic spinal manipulation, this is pretty meaningless.
CH: Monitoring systems do not establish causality.
CR: No, but they are a start and can tell you whether there is a problem that requires looking into.
CH: Let me remind you please that the question of safety is foremost an issue for conventional medicine; this is why a monitoring system is useful for drugs. We actually do not need one, because CSMT is safe.
CR: Are you sure?
CR: The much-cited paper by Dabbs and Lauretti is out-dated, poor quality, and heavily biased. It provides no sound basis for an evidence-based judgement on the relative risks of cervical manipulation and NSAIDs. The notion that cervical manipulations are safer than NSAIDs is therefore not based on reliable data. Thus, it is misleading and irresponsible to repeat this claim. Is there not a better comparison for supporting your point?
CH: Not as far as I know. But you can trust our collective experience: CSMT is safe!
CR: Don’t you think that the issue is too important to rely purely on experience? Your collective experience can be very misleading, you know.
CH: Then tell me why chiros pay only a fraction of the insurance premium compared to doctors.
CR: Yes, that is the argument many chiros love. But it also is a very poor one: doctors treat patients who are often very ill, while chiros treat mostly sore backs. Don’t you think that explains a lot about the difference in insurance premiums?
CH: Perhaps, but if you claim CSMT to be harmful, how about you supporting your claim with evidence?
CR: Sure, the best is to review systematically all prospective studies on the topic; and if you do this, the conclusion is that data from prospective studies suggest that minor, transient adverse events occur in approximately half of all patients receiving spinal manipulation. The most common serious adverse events are vertebrobasilar accidents, disk herniation, and cauda equina syndrome. Estimates of the incidence of serious complications range from 1 per 2 million manipulations to 1 per 400,000. Given the popularity of spinal manipulation, its safety requires rigorous investigation.
CH: I bet these are studies done by people who are against chiropractic.
CR: No, actually the primary studies were all done by chiropractors.
CH: Minor transient problems! These are merely what we expect; things often need to get worse before they get better.
CR: Imagine that a drug company claims such BS about the side-effects of a new drug.
CH: But that’s different!
CR: In what way?
CH: Big Pharma is only out to make money.
CR: And chiros?
CH: That’s different too.
CR: What about the serious adverse events like vertebrobasilar accidents, disk herniation, and cauda equina syndrome? Are you going to deny they exist?
CH: Some of those serious complications, while rare, are conditions that existed prior to CSMT being performed with the practitioner missing it upon initial examination.
CR: How do you know?
CH: I know this from experience.
CR: I already told you that experience is unreliable.
CH: Then show me the evidence that I am wrong.
CR: No, you have to come up with the evidence; the burden of proof is evidently on your shoulders.
CH: Whatever! As long as there is no good evidence, I cannot accept that serious complications are a real problem.
CR: That’s just fine: you say “as long as there is no good evidence…” and, at the same time, you prevent good evidence from emerging by preventing a decent AE monitoring system.
CH: I always knew that one cannot have a reasonable discussion with you. I consider that I have won this debate; this issue is now closed.