MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

physiotherapists

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I was criticised for not referencing this article in a recent post on adverse effects of spinal manipulation. In fact the commentator wrote: Shame on you Prof. Ernst. You get an “E” for effort and I hope you can do better next time. The paper was published in a third-class journal, but I will nevertheless quote the ‘key messages’ from this paper, because they are in many ways remarkable.

  • Adverse events from manual therapy are few, mild, and transient. Common AEs include local tenderness, tiredness, and headache. Other moderate and severe adverse events (AEs) are rare, while serious AEs are very rare.
  • Serious AEs can include spinal cord injuries with severe neurological consequences and cervical artery dissection (CAD), but the rarity of such events makes the provision of epidemiological evidence challenging.
  • Sports-related practice is often time sensitive; thus, the manual therapist needs to be aware of common and rare AEs specifically associated with spinal manipulative therapy (SMT) to fully evaluate the risk-benefit ratio.

The author of this paper is Aleksander Chaibi, PT, DC, PhD who holds several positions in the Norwegian Chiropractors’ Association, and currently holds a position as an expert advisor in the field of biomedical brain research for the Brain Foundation of the Netherlands. I feel that he might benefit from reading some more critical texts on the subject. In fact, I recommend my own 2020 book. Here are a few passages dealing with the safety of SMT:

Relatively minor AEs after SMT are extremely common. Our own systematic review of 2002 found that they occur in approximately half of all patients receiving SMT. A more recent study of 771 Finish patients having chiropractic SMT showed an even higher rate; AEs were reported in 81% of women and 66% of men, and a total of 178 AEs were rated as moderate to severe. Two further studies reported that such AEs occur in 61% and 30% of patients. Local or radiating pain, headache, and tiredness are the most frequent adverse effects…

A 2017 systematic review identified the characteristics of AEs occurring after cervical spinal manipulation or cervical mobilization. A total of 227 cases were found; 66% of them had been treated by chiropractors. Manipulation was reported in 95% of the cases, and neck pain was the most frequent indication for the treatment. Cervical arterial dissection (CAD) was reported in 57%, and 46% had immediate onset symptoms. The authors of this review concluded that there seems to be under-reporting of cases. Further research should focus on a more uniform and complete registration of AEs using standardized terminology…

In 2005, I published a systematic review of ophthalmic AEs after SMT. At the time, there were 14 published case reports. Clinical symptoms and signs included:

  • central retinal artery occlusion,
  • nystagmus,
  • Wallenberg syndrome,
  • ptosis,
  • loss of vision,
  • ophthalmoplegia,
  • diplopia,
  • Horner’s syndrome…

Vascular accidents are the most frequent serious AEs after chiropractic SMT, but they are certainly not the only complications that have been reported. Other AEs include:

  • atlantoaxial dislocation,
  • cauda equina syndrome,
  • cervical radiculopathy,
  • diaphragmatic paralysis,
  • disrupted fracture healing,
  • dural sleeve injury,
  • haematoma,
  • haematothorax,
  • haemorrhagic cysts,
  • muscle abscess,
  • muscle abscess,
  • myelopathy,
  • neurologic compromise,
  • oesophageal rupture
  • pneumothorax,
  • pseudoaneurysm,
  • soft tissue trauma,
  • spinal cord injury,
  • vertebral disc herniation,
  • vertebral fracture…

In 2010, I reviewed all the reports of deaths after chiropractic treatments published in the medical literature. My article covered 26 fatalities but it is important to stress that many more might have remained unpublished. The cause usually was a vascular accident involving the dissection of a vertebral artery (see above). The review also makes the following important points:

  • … numerous deaths have been associated with chiropractic. Usually high-velocity, short-lever thrusts of the upper spine with rotation are implicated. They are believed to cause vertebral arterial dissection in predisposed individuals which, in turn, can lead to a chain of events including stroke and death. Many chiropractors claim that, because arterial dissection can also occur spontaneously, causality between the chiropractic intervention and arterial dissection is not proven. However, when carefully evaluating the known facts, one does arrive at the conclusion that causality is at least likely. Even if it were merely a remote possibility, the precautionary principle in healthcare would mean that neck manipulations should be considered unsafe until proven otherwise. Moreover, there is no good evidence for assuming that neck manipulation is an effective therapy for any medical condition. Thus, the risk-benefit balance for chiropractic neck manipulation fails to be positive.
  • Reliable estimates of the frequency of vascular accidents are prevented by the fact that underreporting is known to be substantial. In a survey of UK neurologists, for instance, under-reporting of serious complications was 100%. Those cases which are published often turn out to be incomplete. Of 40 case reports of serious adverse effects associated with spinal manipulation, nine failed to provide any information about the clinical outcome. Incomplete reporting of outcomes might therefore further increase the true number of fatalities.
  • This review is focussed on deaths after chiropractic, yet neck manipulations are, of course, used by other healthcare professionals as well. The reason for this focus is simple: chiropractors are more frequently associated with serious manipulation-related adverse effects than osteopaths, physiotherapists, doctors or other professionals. Of the 40 cases of serious adverse effects mentioned above, 28 can be traced back to a chiropractor and none to a osteopath. A review of complications after spinal manipulations by any type of healthcare professional included three deaths related to osteopaths, nine to medical practitioners, none to a physiotherapist, one to a naturopath and 17 to chiropractors. This article also summarised a total of 265 vascular accidents of which 142 were linked to chiropractors. Another review of complications after neck manipulations published by 1997 included 177 vascular accidents, 32 of which were fatal. The vast majority of these cases were associated with chiropractic and none with physiotherapy. The most obvious explanation for the dominance of chiropractic is that chiropractors routinely employ high-velocity, short-lever thrusts on the upper spine with a rotational element, while the other healthcare professionals use them much more sparingly.

Another review summarised published cases of injuries associated with cervical manipulation in China. A total of 156 cases were found. They included the following problems:

  • syncope (45 cases),
  • mild spinal cord injury or compression (34 cases),
  • nerve root injury (24 cases),
  • ineffective treatment/symptom increased (11 cases),
  • cervical spine fracture (11 cases),
  • dislocation or semi-luxation (6 cases),
  • soft tissue injury (3 cases),
  • serious accident (22 cases) including paralysis, deaths and cerebrovascular accidents.

Manipulation including rotation was involved in 42% of all cases. In total, 5 patients died…

To sum up … chiropractic SMT can cause a wide range of very serious complications which occasionally can even be fatal. As there is no AE reporting system of such events, we nobody can be sure how frequently they occur.

[references from my text can be found in the book]

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,
  • chiropractic,
  • 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:

  1. Acupuncture was effective.
  2. Dry needling was effective.
  3. The electrical current was effective.
  4. Mobilisation made things worse.
  5. Exercise made things worse.
  6. one or multiple positive or negative interactions between the therapies.
  7. The drugs in the experimental group were more effective than those taken by controls.
  8. The experimental group adhered to their drug prescriptions better than controls.
  9. 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?

No.

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?

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:

  1. 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).
  2. The patients had rather mild symptoms; one could argue that patients with severe pain might respond differently.
  3. 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.
  4. 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?

CH: Yes, V DabbsW J Lauretti have shown this very clearly in their seminal paper comparing drug treatments with chiropractic. 

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.

 

On this blog, I have discussed the adverse events (AEs) of spinal manipulative therapy (SMT) with some regularity, and we have seen that ~ 50% of patients who receive SMT from a chiropractor experience some kind of AE. In addition there are many serious complications. In my book, I discuss, apart from the better-known vascular accidents followed by a stroke or death, the following:

  • atlantoaxial dislocation,
  • cauda equina syndrome,
  • cervical radiculopathy,
  • diaphragmatic paralysis,
  • disrupted fracture healing,
  • dural sleeve injury,
  • haematoma,
  • haematothorax,
  • haemorrhagic cysts,
  • muscle abscess,
  • muscle abscess,
  • myelopathy,
  • neurologic compromise,
  • oesophageal rupture
  • pneumothorax,
  • pseudoaneurysm,
  • soft tissue trauma,
  • spinal cord injury,
  • vertebral disc herniation,
  • vertebral fracture,
  • central retinal artery occlusion,
  • nystagmus,
  • Wallenberg syndrome,
  • ptosis,
  • loss of vision,
  • ophthalmoplegia,
  • diplopia,
  • Horner’s syndrome.

Considering this long list, we currently have far too little reliable information. A recent publication offers further information on this important topic.

The aim of this study was to identify beliefs, perceptions and practices of chiropractors and patients regarding benign AEs post-SMT and potential strategies to mitigate them. Clinicians and patients from two chiropractic teaching clinics were invited to respond to an 11-question survey exploring their beliefs, perceptions and practices regarding benign AEs post-SMT and strategies to mitigate them.

A total of 39 clinicians (67% response rate) and 203 patients (82.9% response rate) completed the survey. The results show that:

  • 97% of the chiropractors believed benign AEs occur.
  • 82% reported their own patients have experienced an AE.
  • 55% of the patients reported experiencing benign AEs post-SMT, with the most common symptoms being pain/soreness, headache and stiffness.
  • 61.5% of the chiropractors reported trying a mitigation strategy with their patients.
  • Yet only 21.2% of patients perceived their clinicians had tried any mitigation strategy.
  • Chiropractors perceived that patient education is most likely to mitigate benign AEs, followed by soft tissue therapy and/or icing after SMT.
  • Patients perceived stretching was most likely to mitigate benign AEs, followed by education and/or massage

 

The authors concluded that this is the first study comparing beliefs, perceptions and practices from clinicians and patients regarding benign AEs post-SMT and strategies to mitigate them. This study provides an important step towards identifying the best strategies to improve patient safety and improve quality of care.

The question that I have often asked before, and I am bound to ask again after seeing such results, is this:

If there were a drug that causes temporary pain/soreness, headache and stiffness in 55% of all patients (plus an unknown frequency of a long list of serious complications), while being of uncertain benefit, do you think it would still be on the market?

 

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.

___________________

 

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!)

 

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:

  1. spinal manipulation (n=22),
  2. therapeutic exercise (n=23),
  3. 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. 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. 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 [13].
    3. 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. 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. 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.

    1. 3.Co-contraction of deep and superficial neck flexors in supine decubitus (10 repetitions, 10 s of contraction with 10 s of rest).
    2. 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.

    1. 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).
    2. 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.

In my never-ending search for novel so-called alternative medicines (SCAMs) I came across WATSU. If you had never heard of WATSU, you are in good company (for instance mine). WATSU (water and shiatsu) is a form of passive hydrotherapy in chest-deep thermoneutral water. It was created in the early 1980s by the California-based Shiatsu teacher Harold Dull and combines elements of myofascial stretching, joint mobilization, massage, and shiatsu and is used to address physical and mental issues.

To me, this sounds as though an old physiotherapeutic approach has been re-vamped in order to seem more attractive to the affluent sections of the SCAM brigade. My suspicion seems to be confirmed by SCAM ueber-guru Dr Andrew Weil’s comments:

Dr. Weil has received the therapy many times and often recommends it.

While other bodywork modalities are based on touch in a stationary, two-dimensional world, Watsu offers a different experience. A three-dimensional environment, nearly free from gravity, within a warm and comforting fluid-space and the opportunity to connect with another person all have obvious therapeutic potential.

Achieving states of deep relaxation combined with the therapeutic benefits of good massage therapy can be of great benefit in controlling pain, relieving stress, and recovering from emotional and physical trauma.

But never mind the one-dimensional Dr Weil. The question is: does WATSU work? According to a recent paper, it is effective for a wide range of conditions.

The objective of this systematic review and meta-analyses was to assess the applications, indications, and the effects of WATSU to form a basis for further studies.

Literature searches for “WATSU OR watershiatsu OR (water AND shiatsu)” were conducted without any restrictions in 32 databases. Peer reviewed original articles addressing WATSU as a stand-alone hydrotherapy were assessed for risk of bias. Quantitative data of effects on pain, physical function, and mental issues were processed in random model meta-analyses with subgroup analyses by study design.

Of 1,906 unique citations, 27 articles regardless of study design were assessed for risk of bias. WATSU has been applied to individuals of all ages. Indications covered acute (e.g. pregnancy related low back pain) and chronic conditions (e.g. cerebral palsy) with beneficial effects of WATSU regarding e.g. relaxation or sleep quality. Meta-analyses suggest beneficial effect sizes of WATSU on pain, physical function, and mental issues.

The authors concluded that various applications, indications and beneficial effects of WATSU were identified. The grade of this evidence is estimated to be low to moderate at the best. To strengthen the findings of this study, high-quality RCTs are needed.

Of the 27 studies included in this review, most were case-reports or case series, and only 5 were RCTs. Of these RCTs, none was robust. Some, for instance compared WATSU against no treatment at all, thus not controlling for placebo effects. All of these RCTs had small sample sizes, and all had been published in odd journals of dubious repute.

So, is it justified to categorically conclude that beneficial effects of WATSU were identified?

No, I don’t think so.

That physiotherapy in water can have positive effects on some symptoms would hardly be surprising. But, to convince people who think more critically than Dr Weil, better evidence would be needed.

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