neck-pain
The Anglo-European College of Chiropractic (AECC) has been promoting pediatric chiropractic for some time, and I have posted about the subject before (see, for instance, here). Now the AECC has gone one decisive step further. On the website, the AECC announced an MSc ‘Musculoskeletal Paediatric Health‘:
The MSc Musculoskeletal Paediatric Health degree is designed to develop your knowledge and skills in the safe and competent care of children of all ages. Our part-time, distance-based course blends live online classes with ready to use resources through our virtual learning environment. In addition, you will have the opportunity to observe in the AECC University College clinical services at our Bournemouth campus. The course covers topics in paediatric musculoskeletal practice with specific units on paediatric development, paediatric musculoskeletal examination, paediatric musculoskeletal interventions, and paediatric musculoskeletal management. You will address issues such as risk factors and public health, including breastfeeding, supine sleep in infancy, physical activity in children and conditions affecting the musculoskeletal health of children from birth. The paediatric specific topics are completed by other optional units such as professional development, evidence-based practice, and leadership and inter-professional collaboration. In the dissertation unit you will conduct a study relevant to musculoskeletal paediatric health.
Your learning will happen through a mix of live and recorded lectures, access to online reading materials, and access to the literature through our learning services. You will also engage with the contents taught through guided activities with your peers and staff. Clinical paediatric experience is recommended to fully engage with the course. For students with limited access to a suitable clinical environment to support their studies, or for student who wants to add to their clinical experience, we are able to offer a limited number of opportunities to observe and work alongside our clinical educators within the AECC University College clinical services. Assessments are tailor made to each unit and may include a variety of methods such as critical reviews, reflective accounts, portfolios and in the last year a research dissertation.
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The AECC emphasizes its commitment to being a leading higher education institution in healthcare disciplines, nationally and internationally recognised for quality and excellence. Therefore, it seems only fair to have another look at the science behind pediatric chiropractic. Specifically, is there any good science to show that would justify a Master of Science in ‘Musculoskeletal Paediatric Health’?
So, let’s have a look and see whether there are any good review articles supporting such a degree. Here is what I found with several Medline searches (date of the review on chiropractic for any pediatric conditions, followed by its conclusion + link [so that the reader can look up the evidence]):
2008
I am unable to find convincing evidence for any of the above-named conditions.
2009
Previous research has shown that professional chiropractic organisations ‘make claims for the clinical art of chiropractic that are not currently available scientific evidence…’. The claim to effectively treat otitis seems to
be one of them. It is time now, I think, that chiropractors either produce the evidence or abandon the claim.
2009
The … evidence is neither complete nor, in my view, “substantial.”
2010
2018
What seems to emerge is rather disappointing:
- There are no really new reviews.
- Most of the existing reviews are not on musculoskeletal conditions.
- All of the reviews cast considerable doubt on the notion that chiropractors should go anywhere near children.
But perhaps I was too ambitious. Perhaps there are some new rigorous clinical trials of chiropractic for musculoskeletal conditions. A few further searches found this (again year and conclusion):
2019
2018
I might have missed one or two trials because I only conducted rather ‘rough and ready’ searches, but even if I did: would this amount to convincing evidence? Would it be good science?
No! and No!
So, why does the AECC offer a Master of Science in ‘Musculoskeletal Paediatric Health’?
Search me!
…
…
It wouldn’t have something to do with the notion that it is good for business?
Or perhaps they just want to give science a bad name?
Anyone who has been following this blog will have noticed that we have our very own ‘resident chiro’ who comments every single time I post about spinal manipulation/chiropractic/back pain. He uses (mostly?) the pseudonym ‘DC’. Recently, DC explained why he is such an avid poster of comments:
” I read and occasionally comment on this blog for two main reasons. 1. In my opinion Ernst doesn’t do a balance reporting on the papers his shares regarding spinal manipulation and chiropractic. Thus, I offer additional insight, a more balanced perspective for the readers. 2. There are a couple of skeptics who occasionally post that do a good job of analyzing papers or topics and they do so in a respectful manner. I enjoy reading their comments. I will add a third. 3. Ernst, from what I can tell, doesn’t censor people just because they have a different view.”
So, DC aims at offering additional insights and a more balanced perspective. That would certainly be laudable and welcome. Yet, over the years, I have gained a somewhat different impression. Almost invariably, my posts on the named subjects cast doubt on the notion that chiropractic generates more good than harm. This, of course, cannot be to the liking of chiropractors, who therefore try to undermine me and my arguments. In a way, that is fair enough.
DC, however, seems to have long pursued a very specific and slightly different strategy. He systematically attempts to distract from the evidence and arguments I present. He does that by throwing in the odd red herring or by deviating from the subject in some other way. Thus he hopes, I assume, to distract from the point that chiropractic fails to generate more good than harm. In other words, DC is a tireless (and often tiresome) fighter for the chiropractic cause and reputation.
To check whether my impression is correct, I went through the last 10 blogs on spinal manipulation/ chiropractic/ back pain. Here are my findings (first the title of and link to the blog in question, followed by one of DC’s originals distractions)
No 1
Chiropractic: “a safe form of treatment”? (edzardernst.com)
“It appears conventional medicine has a greater number of AE. This is not surprising.”
correct!
real doctors treat really sick patients
So the probability of an AE increases based upon how sick a patient is? Is there research that supports that?
No 2
Malpractice Litigation Involving Chiropractic Spinal Manipulation (edzardernst.com)
It would be interesting to know more about these 38 cases that weren’t included since that’s almost half of the 86 cases. What percentage of those cases involved SMT by a non chiropractor?
“Query of the VerdictSearch online legal database for “chiropractor” OR “chiropractic” OR “spinal manipulation” within the 22,566 listed cases classified as “medical malpractice” yielded 86 cases. Of these, 48 cases met the inclusion criteria by featuring a chiropractic practitioner as the primary defendant.”
No 3
there are three basic types of disc herniation
contained herniation
non-contained herniation
sequestered herniation
Some add a forth which are:
disc protrusion
prolapsed disc
disc extrusion
sequestered disc
where the first two are considered incomplete (contained) and the last two are called complete (non-contained) but they are all classified as a disc herniation.
You’re welcome
No 4
Multidisciplinary versus chiropractic care for low back pain (edzardernst.com)
Elaborate on what you think was my mistake regarding clinical significance.
No 5
An evidence based approach has three legs. If you wish to focus on the research leg, what does the research reveal regarding maintenance care and LBP? Have you even looked into it?
No 6
Meditation for Chronic Low Back Pain Management? (edzardernst.com)
CRITERIA in assessing the credibility of subgroup analysis.
https://www.nature.com/articles/s41433-022-01948-0/tables/1
No 7
Acute Subdural Hemorrhage Following Cervical Chiropractic Manipulation (edzardernst.com)
sigh, my use of the word require was pointing out that different problems require different solutions.
You confuse a lack of concern with my critical analysis of what some use as evidence of serious harm.
I have only used one other identifier on this blog. Some objected to my use of the word Dr in that identifier so I changed it to DC as it wasn’t worth my time to argue with them (which of course DC still refers to Doctor but it seemed to appease them).
In healthcare and particularly in manual therapy we look at increasing comfort and function because most come to us because…wait for it…a loss of comfort and function.
Yes, there is the potential to cause harm, I have never said otherwise. Most case reports suggest that serious harm is due to an improper history and exam (although other reasons may exist such as improper technique). Thus, most cases appear to be preventable with a proper history, exam and technique. That, is a different problem that, yes, requires a different solution.
So yes, spinal manipulation isn’t “required” anymore than physical therapy, NSAIDs, etc for most cases. The question is: does the intervention increase comfort and function over doing nothing and is that justified due the potential risk of harm….benefit vs risk.
Now, i shall excuse my self to prepare for a research presentation that deals with a possible new contraindication to cSMT (because I have a lack of concern, right?)
No 8
Hmmm, let’s change that a bit…
The best approach is to consider the totality of the available evidence. By doing this, one cannot exclude the possibility that NSAIDs and opioids cause serious adverse effects. If that is so, we must abide by the precautionary principle which tells us to use other treatments that seem safer and at least as effective.
So based upon the totality of the available evidence, which is safer and at least as effective: cervical spinal manipulation vs NSAIDs/opioids?
No 9
Chiropractic spinal manipulation is not safe! (edzardernst.com)
getting the patient to sign something describing the risks. This is apparently something chiropractors don’t do before a neck manipulation.
Apparently?
No 10
Vertebral artery dissection in a pregnant woman after cervical spine manipulation (edzardernst.com)
Most case reports fail on one of two criteria, sometimes both.
1. No clear record of why the patient sought chiropractic care (symptoms that may indicate a VAD in progress or not)
2. Eliminating any other possible causes of the VAD especially in the week prior to SMT.
I would have to search but I recall a case report of a woman presenting for maintenance care (no head or neck symptoms at the time) and after cSMT was dx with a VAD. Asymptomatic VADs are very rare thus there is a high probability that cSMT induced the VAD in that case, IMO.
Although not published I had a dialogue with a MD where a patient underwent a MRI, had cSMT the next day and developed new symptoms thus another MRI was shortly done and was dx with a VAD. I encouraged her to publish the case but apparently she did not.
There was a paper published that looked at the quality of these case reports, most are poor.
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I might be mistaken but DC systematically tries to distract from the fact that chiropractic does not generate more good than harm and that there is a continuous flow of evidence suggesting it does, in fact, the exact opposite. He (I presume he is male) might not even do this consciously in which case it would suggest to me that he is full of quasi-religious zeal and unable to think critically about his own profession and creeds.
Reviewing the material above, I also realized that, by engaging with DC (and other zealots of this type), it is I who often gives him the opportunity to play his game. Therefore, I will from now on try harder to stick to my own rules that say:
- Comments must be on-topic.
- I will not post comments which are overtly nonsensical.
- I will not normally enter into discussions with people who do not disclose their full identity.
Neck pain affects a vast number of people and leads to reduced quality of life and high costs. Clinically, it is a difficult condition to manage, and the effect sizes of the currently available treatments are moderate at best. Activity and manual therapy are first-line treatment options in several guidelines. But how effective are they really?
This study investigated the combination of home stretching exercises and spinal manipulative therapy in a multicentre randomized controlled clinical trial, carried out in a multidiscipline range of primary care clinics.
The treatment modalities utilized were spinal manipulative therapy combined with home stretching exercises compared to home stretching exercises alone. Both groups received 4 treatments for 2 weeks. The primary outcome was pain, where the subjective pain experience was investigated by assessing pain intensity (NRS – 11) and the quality of pain (McGill Pain Questionnaire). Neck disability and health status were secondary outcomes, measured using the Neck Disability Indexthe EQ-5D, respectively.
One hundred thirty-one adult subjects were randomized to one of the two treatment groups. All subjects had experienced persistent or recurrent neck pain the previous 6 months and were blinded to the other group intervention. The clinicians provided treatment for subjects in both groups and could not be blinded. The researchers collecting data were blinded to treatment allocation, as was the statistician performing data analyses. An intention-to-treat analysis was used.
Sixty-six subjects were randomized to the intervention group, and 65 to the control group. For NRS – 11, a B-coefficient of – 0,01 was seen, indication a 0,01 improvement for the intervention group in relation to the control group at each time point with a p-value of 0,305. There were no statistically significant differences between groups for any of the outcome measures.
Four intense adverse events were reported in the study, three in the intervention group, and one in the control group. More adverse incidents were reported in the intervention group, with a mean pain intensity (NRS-11) of 2,75 compared to 1,22 in the control group. There were no statistically significant differences between the two groups.
The authors concluded that there is no additional treatment effect from adding spinal manipulative therapy to neck stretching exercises over 2 weeks for patients with persistent or recurrent neck pain.
This is a rigorous and well-reported study. It suggests that adjuvant manipulations are not just ineffective for neck pain, but also cause some adverse effects. This seems to confirm many previously discussed investigations concluding that chiropractors do not generate more good than harm for patients suffering from neck pain.
Static or motion manual palpation tests of the spine are commonly used by chiropractors and osteopaths to assess pain location and reproduction in low back pain (LBP) patients. But how reliable are they?
The purpose of this review was to evaluate the reliability and validity of manual palpation used for the assessment of LBP in adults. The authors systematically searched five databases from 2000 to 2019 and critically appraised the internal validity of studies using QAREL and QUADAS-2 instruments.
A total of 2023 eligible articles were identified, of which 14 were at low risk of bias. Evidence suggests that reliability of soft tissue structures palpation is inconsistent, and reliability of bony structures and joint mobility palpation is poor. Preliminary evidence was found to suggest that gluteal muscle palpation for tenderness may be valid in differentiating LBP patients with and without radiculopathy.
The authors concluded that the reliability of manual palpation tests in the assessment of LBP patients varies greatly. This is problematic because these tests are commonly used by manual therapists and clinicians. Little is known about the validity of these tests; therefore, their clinical utility is uncertain. High quality validity studies are needed to inform the clinical use of manual palpation tests.
I have repeatedly drawn attention to the fact that the diagnostic methods used by chiropractors and osteopaths are of uncertain or disproven validity (see for instance here, or here). Why is that important?
Imagine you consult a chiropractor or osteopath. Simply put, this is what is likely to happen:
- They listen to your complaint.
- They do a few tests which are of dubious validity.
- They give you a diagnosis that is meaningless.
- They treat you with manual therapies that are neither effective nor safe.
- You pay.
- They persuade you that you need many more sessions.
- You pay regularly.
- When eventually your pain has gone away, they persuade you to have useless maintenance treatment.
- You pay regularly.
In a nutshell, they have very little to offer … which explains why they attack everyone who dares to disclose this.
A case report was published of a 35-year-old Chinese man with no risk factors for stroke. He presented with a 2-day history of expressive dysphasia and a 1-day history of right-sided weakness. The symptoms were preceded by multiple sessions of the neck, shoulder girdle, and upper back massage for pain relief in the prior 2 weeks. A CT-scan of the brain demonstrated an acute left middle cerebral artery infarct and left internal carotid artery dissection. The MRI cerebral angiogram confirmed left carotid arterial dissection and intimal oedema of bilateral vertebral arteries. In the absence of other vascular comorbidities and risk factors, massage-induced internal carotid arterial dissection was deemed to be the most likely cause of the near-fatal cerebrovascular event.
INSIDER reported further details of the case: the patient told the doctors who treated him that he had seen the chiropractor for two weeks before he experienced trouble reading, writing and talking. After experiencing those symptoms for two days and one day of pain on his right side, a friend convinced the patient to consult a neurologist. This led to the hospital admission, the above-named tests, and diagnosis. After three months of therapy and rehab, the patient showed “significant improvement,” according to the doctors.
What remains unclear is the exact nature of the neck treatment that is believed to have caused the arterial dissection. A massage is mentioned but massages have rarely been associated with such problems. Neck manipulations, on the other hand, are the hallmark therapy of chiropractors and have, as I have pointed out regularly, often been reported to cause arterial dissections.
Chiropractors usually deny this fact; alternatively, they claim that only poorly trained practitioners cause these adverse events or that their frequency is exceedingly small. However, without a proper post-marketing surveillance system, this argument is hardly convincing.
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 and meta-analysis was aimed at investigating the effect and safety of acupuncture for the treatment of chronic spinal pain.
The authors included 22 randomized controlled trials (RCTs) involving patients with chronic spinal pain treated by acupuncture versus sham acupuncture, no treatment, or another treatment were included. Chronic spinal pain was defined as:
- chronic neck pain,
- chronic low back pain,
- or sciatica for more than 3 months.
Fourteen studies had a high risk of bias, 5 studies had a low risk of bias, and 5 studies had an unclear risk of bias. Pooled analysis revealed that:
- acupuncture can reduce chronic spinal pain compared to sham acupuncture (weighted mean difference [WMD] -12.05, 95% confidence interval [CI] -15.86 to -8.24),
- acupuncture can reduce chronic spinal pain compared to mediation control (WMD -18.27, 95% CI -28.18 to -8.37),
- acupuncture can reduce chronic spinal pain compared to usual care control (WMD -9.57, 95% CI -13.48 to -9.44),
- acupuncture can reduce chronic spinal pain compared to no treatment control (WMD -17.10, 95% CI -24.83 to -9.37).
In terms of functional disability, acupuncture can improve physical function at
- immediate-term follow-up (standardized mean difference [SMD] -1.74, 95% CI -2.04 to -1.44),
- short-term follow-up (SMD -0.89, 95% CI -1.15 to -0.62),
- long-term follow-up (SMD -1.25, 95% CI -1.48 to -1.03).
Trials assessed as having a high risk of bias (WMD −13.45, 95% CI −17.23 to −9.66, I 2 96.2%, moderate-quality evidence, including 14 studies and 1379 patients) found greater effects of acupuncture treatment than trials assessed as having a low risk of bias (WMD −11.99, 95% CI −13.94 to −10.03, I 2 44.6%, high-quality evidence, including 4 studies and 432 patients), but smaller effects than trials assessed as having an unclear risk of bias (WMD −14.51, 95% CI −17.25 to −11.78, I 2 0%, high-quality evidence, including 3 studies and 190 patients).
Only 6 trials provided information on adverse events. No trial reported data on serious adverse events during acupuncture treatment. The most frequent adverse events were temporarily worsened pain and needle pain at the acupuncture site, which can decrease quickly after a short period of rest.
The authors concluded that compared to no treatment, sham acupuncture, or conventional therapy such as medication, massage, and physical exercise, acupuncture has a significantly superior effect on the reduction in chronic spinal pain and function improvement. Acupuncture might be an effective treatment for patients with chronic spinal pain and it is a safe therapy.
I think this is a thorough review which produced interesting findings. I agree with most of what the authors report, except with their conclusions which I find too optimistic. In view of the facts that
- only 5 RCTs had a low risk of bias,
- collectively, the rigorous trials reported smaller effect sizes,
- the majority of trials failed to mention adverse effects which, in my view, casts considerable doubt on their quality and ethical standard,
I would have phrased the conclusion differently: compared to no treatment, sham acupuncture, or conventional therapies, acupuncture seems to have a significantly superior effect on pain and function. Due to the lack rigour of most studies, these effects are less certain than one would have wished. Many trials fail to report adverse effects which reflects poorly on their quality and ethics and prevents conclusions about the safety of acupuncture. In essence, this means that the effectiveness and safety of acupuncture as a treatment of chronic spinal pain remains uncertain.
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.
But why?
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.
Tasuki is a sort of sash for holding up the sleeves on a kimono. It also retracts the shoulders and keeps the head straight up. By correcting the wearer’s posture, it might even prevent or treat neck pain. The greater the forward head posture, for example, the more frequent are neck problems. However, there is little clinical evidence to support or refute this hypothesis.
This study was conducted to determine whether Tasuki-style posture supporter improves neck pain compared to waiting-list. It was designed as an individually-randomized, open-label, waiting-list-controlled study. Adults with non-specific chronic neck pain who reported 10 points or more on modified Neck Disability Index (mNDI: range, 0-50; higher points indicate worse condition) were enrolled. Participants were randomly assigned 1:1 to the intervention group or to a waiting-list control group. The primary outcome was the change in mNDI at 1 week.
In total, 50 participants were enrolled. Of these participants, 26 (52%) were randomly assigned to the intervention group and 24 to the waiting-list. Attrition rate was low in both groups (1/50). The mean mNDI change score at 1 week was more favourable for Tasuki than waiting-list (between-group difference, -3.5 points (95% confidence interval (CI), -5.3 to -1.8); P = .0002). More participants (58%) had moderate benefit (at least 30% improvement) with Tasuki than with waiting-list (13%) (relative risk 4.6 (95% CI 1.5 to 14); risk difference 0.45 (0.22 to 0.68)).
The author concluded that this trial suggests that wearing Tasuki might moderately improve neck pain. With its low-cost, low-risk, and easy-to-use nature, Tasuki could be an option for those who suffer from neck pain.
In the previous two posts, we discussed how lamentably weak the evidence for acupuncture and spinal manipulation is regarding the management of pain such as ‘mechanical’ neck pain. Here we have a well-reported study with a poor design (no control for non-specific effects) which seems to suggest that simply wearing a Tasuki is just as effective as acupuncture or spinal manipulation.
What is the lesson from this collective evidence?
Is it that we should forget about acupuncture and spinal manipulation for chronic neck pain?
Perhaps.
Or is it that poor trial designs generate unreliable evidence?
More likely.
Or is it that any treatment, however daft, will generate positive outcomes, if the researchers are sufficiently convinced of its benefit?
Yes, I think so.
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PS
If you had chronic neck pain, would you rather have your neck manipulated, needles stuck into your body, or get a Tasuki? (Spoiler: Tasuki is risk-free, the other two treatments are not!)
As recently reported, the most thorough review of the subject showed that the evidence for acupuncture as a treatment for chronic pain is very weak. Yesterday, NICE published a draft report that seems to somewhat disagree with this conclusion (and today, this is being reported in most of the UK daily papers). The draft is now open to public consultation until 14 September 2020 and many of my readers might want to comment.
The draft report essentially suggests that people with chronic primary pain (CPP) should not get pain-medication of any type, but be offered supervised group exercise programmes, some types of psychological therapy, or acupuncture. While I understand that chronic pain should not be treated with long-term pain-medications – I did even learn this in medical school all those years ago – one might be puzzled by the mention of acupuncture.
But perhaps we need first ask, WHAT IS CPP? The NICE report informs us that CPP represents chronic pain as a condition in itself and which can’t be accounted for by another diagnosis, or where it is not the symptom of an underlying condition (this is known as chronic secondary pain). I find this definition most unsatisfactory. Pain is usually a symptom and not a disease. In many forms of what we now call CPP, an underlying disease does exist but might not yet be identifiable, I suspect.
The evidence on acupuncture considered for the draft NICE report included conditions like:
- neck pain,
- myofascial pain,
- radicular arm pain,
- shoulder pain,
- prostatitis pain,
- mechanical neck pain,
- vulvodynia.
I find it debatable whether these pain syndromes can be categorised to be without an underlying diagnosis. Moreover, I find it problematic to lump them together as though they were one big entity.
The NICE draft document is huge and far too big to be assessed in a blog like mine. As it is merely a draft, I also see little point in evaluating it or parts of in detail. Therefore, my comments are far from detailed, very brief and merely focussed on pain (the draft NICE report considers several further outcome measures).
There is a separate document for acupuncture, from which I copy what I consider the key evidence:
Acupuncture versus sham acupuncture
Pain reduction
Very low quality evidence from 13 studies with 1230 participants showed a clinically
important benefit of acupuncture compared to sham acupuncture at ≤3 months. Low quality
evidence from 2 studies with 159 participants showed a clinically important benefit of
acupuncture compared to sham acupuncture at ≤3 months.
Low quality evidence from 4 studies with 376 participants showed no clinically important
difference between acupuncture and sham acupuncture at >3 months. Moderate quality
evidence from 2 studies with 159 participants showed a clinically important benefit of
acupuncture compared to sham acupuncture at >3 months. Low quality evidence from 1
study with 61 participants showed no clinically important difference between acupuncture
and sham acupuncture at >3 months.
As acupuncture has all the features that make a perfect placebo (slightly invasive, mildly painful, exotic, involves touch, time and attention), I see little point in evaluating its efficacy through studies that make no attempt to control for placebo effects. This is why the sham-controlled studies are central to the question of acupuncture’s efficacy, no matter for what condition.
Reading the above evidence carefully, I fail to see how NICE can conclude that CPP patients should be offered acupuncture. I am sure that some readers will disagree and am looking forward to reading their comments.
