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.
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?
Or is it that poor trial designs generate unreliable evidence?
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.
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,
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
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.
Non-specific chronic neck pain is a common condition. There is hardly a so-called alternative medicine (SCAM) that is not advocated for it. Amongst the most common approaches are manual therapy and therapeutic exercise. But which is more effective?
This study was aimed at answering the question by comparing the effects of manual therapy and therapeutic exercise. The short-term and mid-term effects produced by the two therapies on subjects with non-specific chronic neck pain were studied. The sample was randomized into three groups:
- spinal manipulation (n=22),
- therapeutic exercise (n=23),
- sham treatment (n=20).
The therapists were physiotherapists. Patients were not allowed any other treatments that the ones they were allocated to. Pain quantified by visual analogue scale, the pressure pain threshold, and cervical disability quantified by the Neck Disability Index (NDI) were the outcome measures. They were registered on week 1, week 4, and week 12.
No statistically significant differences were obtained between the experimental groups. Spinal manipulation improved perceived pain quicker than therapeutic exercise. Therapeutic exercise reduced cervical disability quicker than spinal manipulation. Effect size showed medium and large effects for both experimental treatments.
The authors concluded that there are no differences between groups in short and medium terms. Manual therapy achieves a faster reduction in pain perception than therapeutic exercise. Therapeutic exercise reduces disability faster than manual therapy. Clinical improvement could potentially be influenced by central processes.
The paper is poorly written (why do editors accept this?) but it laudably includes detailed descriptions of the three different interventions:
Group 1: Manual therapy
“Manual therapy” protocol was composed of three techniques based on scientific evidence for the treatment of neck pain. This protocol was applied in the three treatment sessions, one per week.
- 1.High thoracic manipulation on T4. Patients are positioned supine with their arms crossed in a “V” shape over the chest. The therapist makes contact with the fist at the level of the spinous process of T4 and blocks the patient’s elbows with his chest. Following this, he introduces flexion of the cervical spine until a slight tension is felt in the tissues at the point of contact. Downward and cranial manipulation is applied. If cavitation is not achieved on the first attempt, the therapist repositions the patient and performs a second manipulation. A maximum of two attempts will be allowed in each patient.
- 2.Cervical articular mobilization (2 Hz, 2 min × 3 series). The patient is placed on the stretcher in a prone position, placing both hands under his forehead. The therapist makes contact with his two thumbs on the spinous process of the patient’s C2 vertebra and performs grade III posteroanterior impulses at a speed of 2 Hz and for 2 min. There are 3 mobilization intervals with a minute of rest between each one of them .
- 3.Suboccipital muscle inhibition (3 min). With the patient lying supine, the therapist places both hands under the subject’s head, by contacting their fingers on the lower edge of the occipital bone, and exerts constant and painless pressure in the anterior and cranial direction for 3 min.
Group 2: Therapeutic exercise
“Therapeutic exercise” protocol: this protocol is based on a progression in load composed of different phases: at first, activation and recruitment of deep cervical flexors; secondly, isometric exercise deep and superficial flexors co-contraction, and finally, eccentric recruitment of flexors and extensors. This protocol, as far as we know, has not been studied, but activation of this musculature during similar tasks to those of our protocol has been observed. This protocol was taught to patients in the first session and was performed once a day during the 3 weeks of treatment, 21 sessions in total. It was reinforced by the physiotherapist in each of the three individual sessions.
Week 1: Exercises 1 and 2.
- 1.Cranio-cervical flexion (CCF) in a supine position with a towel in the posterior area of the neck (3 sets, 10 repetitions, 10 s of contraction each repetition with 10 s of rest).
- 2.CCF sitting (3 sets, 10 repetitions, 10 s of contraction each repetition with 10 s of rest)
Week 2: Exercises 1, 2, 3, and 4.
- 3.Co-contraction of deep and superficial neck flexors in supine decubitus (10 repetitions, 10 s of contraction with 10 s of rest).
- 4.Co-contraction of flexors, rotators, and lateral flexors. The patients performed cranio-cervical flexion, while the physiotherapist asked him/her to tilt, rotate, and look towards the same side while he/she opposes a resistance with his/her hand (10 repetitions, 10 s of contraction with 10 s of rest).
Week 3: Exercises 1, 2, 3, 4, 5, and 6.
- 5.Eccentric for extensors. With the patient seated, he/she should perform cervical extension. Then, he/she must realize a CCF and finish doing a cervical flexion (10 repetitions).
- 6.Eccentric for flexors. The patients, placed in a quadrupedal and neutral neck position, should perform neck flexion; then, they must have done a cranio-cervical flexion and, maintaining that posture, extend the neck and then finally lose the CCF (10 repetitions).
Group 3: Sham treatment
For the “control” protocol, the patients were placed in the supine position, while the physiotherapist placed his hands without therapeutic intention on the patient’s neck for 3 min. The physiotherapist simulated the technique of suboccipital inhibition. Later, with the laser pointer off, patients were contacted without exerting pressure for 10 s. Patients assigned to the control group received treatment 1 or 2 after completing the study.
This study has many strengths and several weaknesses (for instance the small sample sizes). Its results are not surprising. They confirm what I have been pointing out repeatedly, namely that, because exercise is cheaper and has less potential for harm, it is by far a better treatment for chronic neck pain than spinal manipulation.
The current Cochrane review of clinical trials testing the effectiveness of manipulation/mobilisation for neck pain concluded as follows:
Although support can be found for use of thoracic manipulation versus control for neck pain, function and QoL, results for cervical manipulation and mobilisation versus control are few and diverse. Publication bias cannot be ruled out. Research designed to protect against various biases is needed. Findings suggest that manipulation and mobilisation present similar results for every outcome at immediate/short/intermediate-term follow-up. Multiple cervical manipulation sessions may provide better pain relief and functional improvement than certain medications at immediate/intermediate/long-term follow-up. Since the risk of rare but serious adverse events for manipulation exists, further high-quality research focusing on mobilisation and comparing mobilisation or manipulation versus other treatment options is needed to guide clinicians in their optimal treatment choices.
Such a critical assessment must be tough for chiropractors who gain a substantial part of their income from treating such patients. What is the solution? Simple, convene a panel of chiros and issue recommendations that are more prone to stimulate their cash flow!
Exactly that seems to have just happened.
The purpose of the researchers was to develop best-practice recommendations for chiropractic management of adults with neck pain.
A steering committee of experts in chiropractic practice, education, and research drafted a set of recommendations based on the most current relevant clinical practice guidelines. Additional supportive literature was identified through targeted searches conducted by a health sciences librarian. A national panel of chiropractors representing expertise in practice, research, and teaching rated the recommendations using a modified Delphi process. The consensus process was conducted from August to November 2018. Fifty-six panelists rated the 50 statements and concepts and reached consensus on all statements within 3 rounds.
The statements and concepts covered aspects of the clinical encounter, ranging from informed consent through diagnosis, assessment, treatment planning and implementation, and concurrent management and referral for patients presenting with neck pain.
The authors concluded that these best-practice recommendations for chiropractic management of adults with neck pain are based on the best available scientific evidence. For uncomplicated neck pain, including neck pain with headache or radicular symptoms, chiropractic manipulation and multimodal care are recommended.
Let’s be clear what this amounts to: a panel of highly selected chiropractors (sponsored by a chiropractic organisation) has reached a consensus (and published it in a chiropractic) which allows them to continue to treat patients with neck pain.
Isn’t that just great?
Now let’s think ahead – what next?
I suggest the following:
- A panel of homeopaths recommending homeopathy.
- A panel of faith healers recommending faith healing.
- A panel of crystal healers recommending crystal healing.
- A panel of colon therapists recommending colonic irrigation.
- A panel of supplement manufacturers recommending to buy supplements.
I am sure you get the gist.
Maintenance Care is an approach whereby patients have chiropractic manipulations even when symptom-free. Thus, it is an ideal method to keep chiropractors in clover. Previous reviews concluded that evidence behind this strategy is lacking. Since then, more data have emerged. It was therefore timely to review the evidence.
Fourteen original research articles were included in the review. Maintenance Care was defined as a secondary or tertiary preventive approach, recommended to patients with previous pain episodes, who respond well to chiropractic care. Maintenance Care is applied to approximately 30% of Scandinavian chiropractic patients. Both chiropractors and patients believe in the efficacy of Maintenance Care. Four studies investigating the effect of chiropractic Maintenance Care were identified, with disparate results on pain and disability of neck and back pain. However, only one of these studies utilized all the existing evidence when selecting study subjects and found that Maintenance Care patients experienced fewer days with low back pain compared to patients invited to contact their chiropractor ‘when needed’. No studies were found on the cost-effectiveness of Maintenance Care.
The authors concluded that knowledge of chiropractic Maintenance Care has advanced. There is reasonable consensus among chiropractors on what Maintenance Care is, how it should be used, and its indications. Presently, Maintenance Care can be considered an evidence-based method to perform secondary or tertiary prevention in patients with previous episodes of low back pain, who report a good outcome from the initial treatments. However, these results should not be interpreted as an indication for Maintenance Care on all patients, who receive chiropractic treatment.
I have to admit, I have problems with these conclusions.
- Maintenance Care is not normally defined as secondary or tertitary prevention. It also includes primary prevention, which means that chiropractors recommend it for just about anyone. By definition it is long term care, that is not therapeutically necessary, but performed at regular intervals to help prevent injury and enhance quality of life. This form of care is provided after maximal therapeutic benefit is achieved, without a trial of treatment withdrawal, to prevent symptoms from returning or for those without symptoms to promote health or prevent future problems.
- I am not convinced that the evidence would be positive, even if we confined it to secondary and tertiary prevention.
To explain my last point, let’s have a look at the 4 RCT and check whether they really warrant such a relatively positive conclusion.
FIRST STUDY For individuals with recurrent or persistent non-specific low back pain (LBP), exercise and exercise combined with education have been shown to be effective in preventing new episodes or in reducing the impact of the condition. Chiropractors have traditionally used Maintenance Care (MC), as secondary and tertiary prevention strategies. The aim of this trial was to investigate the effectiveness of MC on pain trajectories for patients with recurrent or persistent LBP.
This pragmatic, investigator-blinded, two arm randomized controlled trial included consecutive patients (18–65 years old) with non-specific LBP, who had an early favorable response to chiropractic care. After an initial course of treatment, eligible subjects were randomized to either MC or control (symptom-guided treatment). The primary outcome was total number of days with bothersome LBP during 52 weeks collected weekly with text-messages (SMS) and estimated by a GEE model.
Three hundred and twenty-eight subjects were randomly allocated to one of the two treatment groups. MC resulted in a reduction in the total number of days per week with bothersome LBP compared with symptom-guided treatment. During the 12 month study period, the MC group (n = 163, 3 dropouts) reported 12.8 (95% CI = 10.1, 15.5; p = <0.001) fewer days in total with bothersome LBP compared to the control group (n = 158, 4 dropouts) and received 1.7 (95% CI = 1.8, 2.1; p = <0.001) more treatments. Numbers presented are means. No serious adverse events were recorded.
MC was more effective than symptom-guided treatment in reducing the total number of days over 52 weeks with bothersome non-specific LBP but it resulted in a higher number of treatments. For selected patients with recurrent or persistent non-specific LBP who respond well to an initial course of chiropractic care, MC should be considered an option for tertiary prevention.
SECOND STUDY Back and neck pain are associated with disability and loss of independence in older adults. Whether long‐term management using commonly recommended treatments is superior to shorter‐term treatment is unknown. This randomized clinical trial compared short‐term treatment (12 weeks) versus long‐term management (36 weeks) of back‐ and neck‐related disability in older adults using spinal manipulative therapy (SMT) combined with supervised rehabilitative exercises (SRE).
Eligible participants were ages ≥65 years with back and neck disability for ≥12 weeks. Coprimary outcomes were changes in Oswestry Disability Index (ODI) and Neck Disability Index (NDI) scores after 36 weeks. An intent‐to‐treat approach used linear mixed‐model analysis to detect between‐group differences. Secondary analyses included other self‐reported outcomes, adverse events, and objective functional measures.
THIRD STUDY A prospective single blinded placebo controlled study was conducted. To assess the effectiveness of spinal manipulation therapy (SMT) for the management of chronic nonspecific low back pain (LBP) and to determine the effectiveness of maintenance SMT in long-term reduction of pain and disability levels associated with chronic low back conditions after an initial phase of treatments. SMT is a common treatment option for LBP. Numerous clinical trials have attempted to evaluate its effectiveness for different subgroups of acute and chronic LBP but the efficacy of maintenance SMT in chronic nonspecific LBP has not been studied. Sixty patients, with chronic, nonspecific LBP lasting at least 6 months, were randomized to receive either (1) 12 treatments of sham SMT over a 1-month period, (2) 12 treatments, consisting of SMT over a 1-month period, but no treatments for the subsequent 9 months, or (3) 12 treatments over a 1-month period, along with “maintenance spinal manipulation” every 2 weeks for the following 9 months. To determine any difference among therapies, we measured pain and disability scores, generic health status, and back-specific patient satisfaction at baseline and at 1-, 4-, 7-, and 10-month intervals. Patients in second and third groups experienced significantly lower pain and disability scores than first group at the end of 1-month period (P = 0.0027 and 0.0029, respectively). However, only the third group that was given spinal manipulations (SM) during the follow-up period showed more improvement in pain and disability scores at the 10-month evaluation. In the nonmaintained SMT group, however, the mean pain and disability scores returned back near to their pretreatment level.SMT is effective for the treatment of chronic nonspecific LBP. To obtain long-term benefit, this study suggests maintenance SM after the initial intensive manipulative therapy.
FORTH STUDY Evidence indicates that supervised home exercises, combined or not with manual therapy, can be beneficial for patients with non-specific chronic neck pain (NCNP). The objective of the study is to investigate the efficacy of preventive spinal manipulative therapy (SMT) compared to a no treatment group in NCNP patients. Another objective is to assess the efficacy of SMT with and without a home exercise program.Ninety-eight patients underwent a short symptomatic phase of treatment before being randomly allocated to either an attention-group (n = 29), a SMT group (n = 36) or a SMT + exercise group (n = 33). The preventive phase of treatment, which lasted for 10 months, consisted of meeting with a chiropractor every two months to evaluate and discuss symptoms (attention-control group), 1 monthly SMT session (SMT group) or 1 monthly SMT session combined with a home exercise program (SMT + exercise group). The primary and secondary outcome measures were represented by scores on a 10-cm visual analog scale (VAS), active cervical ranges of motion (cROM), the neck disability index (NDI) and the Bournemouth questionnaire (BQ). Exploratory outcome measures were scored on the Fear-avoidance Behaviour Questionnaire (FABQ) and the SF-12 Questionnaire. Our results show that, in the preventive phase of the trial, all 3 groups showed primary and secondary outcomes scores similar to those obtain following the non-randomised, symptomatic phase. No group difference was observed for the primary, secondary and exploratory variables. Significant improvements in FABQ scores were noted in all groups during the preventive phase of the trial. However, no significant change in health related quality of life (HRQL) was associated with the preventive phase. This study hypothesised that participants in the combined intervention group would have less pain and disability and better function than participants from the 2 other groups during the preventive phase of the trial. This hypothesis was not supported by the study results. Lack of a treatment specific effect is discussed in relation to the placebo and patient provider interactions in manual therapies. Further research is needed to delineate the specific and non-specific effects of treatment modalities to prevent unnecessary disability and to minimise morbidity related to NCNP. Additional investigation is also required to identify the best strategies for secondary and tertiary prevention of NCNP.
I honestly do not think that the findings from these 4 small trials justify the far-reaching conclusion that Maintenance Care can be considered an evidence-based method… For that statement to be evidence-based, one would need to see more and better studies. Therefore, the honest conclusion, I think, is that maintenance care is not supported by sound evidence for effectiveness; as chiropractic manipulations are costly and not risk-free, its risk/benefit balance fails to be positive. Therefore, this approach cannot be recommended.
Spinal epidural haematoma is a potentially serious condition that can occur due to trauma, such as spinal manipulation, particularly in the presence of a blood clotting abnormality. A case has been published of a patient who, after performing self-neck manipulation, suffered spinal epidural haematoma and subsequent paralysis of all 4 limbs.
A 63-year-old man presented to the emergency department with worsening inter-scapular pain radiating to his neck one day after performing self-manipulation of his cervical spine. He was anti-coagulated with warfarin therapy for the management of his atrial fibrillation. Approximately 48 h after the manipulation, the patient became acutely quadriparetic and hypotensive. Urgent magnetic resonance imaging revealed a multilevel spinal epidural haematoma from the lower cervical to thoracic spine.
a Pre-operative sagittal T2-weighted MRI of the cervical spine demonstrates an epidural hematoma (arrows) with the cranial extent at the C6/7 level. The hematoma is mixed signal intensity, consistent with various stages of bleeding. Severe spinal cord (asterisk) compression is present at the C7 level. b Pre-operative axial T2-weighted MRI at the C7 level demonstrates a loculated epidural hematoma (arrow) compressing the spinal cord (asterisk). Due to the urgent nature of the MRI, image quality is degraded
With identification of an active bleed and an INR remaining close to 7.0, the patient’s hypercoaguable state was reversed prior to emergency surgery. The patient underwent partial C7, complete T1 and T2, and partial T3 bilateral laminectomy for evacuation of haematoma. Placement of an epidural drainage catheter was also performed.
During the first 6 days following surgery, the patient recovered some function of the upper and lower extremities while undergoing hospital-based physical therapy. Post-operative MRI showed resolution of the haematoma and cord compression without resultant cord damage.
The patient completed a 2-week course of acute interdisciplinary rehabilitation. The epidural drainage catheter remained in place for most of his post-operative stay. His neurogenic bladder with urinary retention resolved. At hospital discharge, the patient’s greatest deficits remained his fine motor skills to his right hand along with residual paraesthesia in his lower extremities. He also exhibited mild dyspraxia with finger-to-nose testing on the right and heel-to-shin testing bilaterally. The patient regained full manual muscle strength of all 4 extremities and ultimately returned to his baseline functional status, which included ambulating independently with a cane and independence with activities of daily living.
The authors concluded that partial C7, complete T1 and T2, and partial T3 bilateral laminectomy was performed for evacuation of the spinal epidural hematoma. Following a 2-week course of acute inpatient rehabilitation, the patient returned to his baseline functional status. This case highlights the risks of self-manipulation of the neck and potentially other activities that significantly stretch or apply torque to the cervical spine. It also presents a clinical scenario in which practitioners of spinal manipulation therapy should be aware of patients undergoing anticoagulation therapy.
In the present case, the spinal manipulation was self-inflicted. Usually it is performed by a chiropractor, and there are published case reports where chiropractic spinal manipulations have caused epidural haematoma. No matter who does this treatment, it is, I think, wise to consider the fact that the risks of spinal manipulations do not demonstrably outweigh its benefits.