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It's the whole package

JUNE 25, 2019 by DR MATTHEW D. LONG

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It's the whole package

JUNE 25, 2019 by DR MATTHEW D. LONG

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THE CLINICAL CLARITY BLOG

It's the whole package

JUNE 25, 2019 by DR MATTHEW D. LONG

For many chiropractors the realities of clinical practice and the supposed truths of scientific research often seem irreconcilable. This is particularly apparent when reviewing research that investigates the effects of spinal manipulation upon a specific condition. Often there is little, if any, difference in outcome between the placebo (sham) intervention and the 'real' procedure. In both cases the patient is seen to improve, often quite substantially. However, the study is unable to show conclusively that the active treatment is better than the sham. This phenomenon is especially prevalent when the intervention is being tested for its capacity to reduce pain, which carries a large emotional connotation into the experimental setting. We can see this in a recent migraine study by Chaibi and colleagues (1), who concluded that the significant beneficial effect obtained by sufferers was "probably a placebo response".

To most clinicians this is deeply unsatisfying. While it is true that the science of placebo has undergone a reappraisal and a softening of opinion in recent years, the average hard working chiropractor probably feels that there is more to their daily practice than simply putting on a good show. While many experiments are based upon our ability to modulate
pain, others seek to determine how manipulation might influence the the biomechanics of a patients spine. After all, the dominant model by which spinal manipulation has been justified for over 100 years is largely mechanical in nature (whilst acknowledging the desire to reduce some sort of neural distress that resulted). Unfortunately these biomechanical experiments are sometimes even less impressive in their outcomes, and there is little difference between the active treatment and the control. However, before we become too jaded I think that we should pause for a moment and ask ourselves two important questions:
1. Are we posing research questions based upon a legacy model of spinal manipulation?
2. Can the design of these studies preclude us from finding any meaningful answers?
It is my contention that the science of neuromusculoskeletal health has evolved considerably, and yet we are perhaps still looking at the world through an outdated lens.
WHAT ARE WE DOING?
In previous articles I have discussed the evolving view of spinal manipulation (here and here), and its role as a neurological 'change agent'. You should probably read these. As a profession, we would do well to become immersed in the rapidly growing areas of brain science and neurobiology, and their implications for spinal manipulation. The evidence is quickly helping us determine that manipulation is highly complex, and capable of many things. However, it is also putting to bed many of the traditional theories about improving alignment, or simply increasing a patient's range of motion.

Some of the things we know about spinal manipulation include:
1. It is not a mechanical realignment.
2. It does
not help relieve pain by increasing range of motion.
3. It can produce changes in smoothness and quality of movement (2), which are critical for stability and control.
4. It influences the brain's perception of the spine, and how it can (and should) move (3).
Over the last decade or so we have seen a massive reappraisal of the underlying nature of spinal disorders, and this has driven an entirely new research agenda based upon the role of the brain. It has brought with it new concepts to explain patient chronicity, including; central sensitisation, distortions of the body 'schema' (4,5), 'neglect' of dysfunctional areas (6), changes to sensorimotor integration (7), segmental instability, and all manner of limbic involvement (8). These are central features of the spinal complaints that many of our patients exhibit, and it is these factors that we should investigate via research. However, in so many experimental scenarios we still see manipulation being scrutinised for its ability to alter range of motion (9), often with little to show for it. Furthermore, in our desire to tease apart the mechanisms of spinal manipulation something essential is often lost. This brings us to the second important question that we asked earlier, "Can the design of these studies preclude us finding any meaningful answers?"
LOST IN TRANSLATION
SOMETHING IS LOST IN TRANSLATION
When designing a rigorous scientific methodology it is obvious that we should seek to limit the number of variables. In the case of a spinal manipulation study this often involves many artificial constraints, designed to extract the supposed 'active ingredient' from the mix. As such, we see protocols that try to condense the clinical encounter down to the barest essence, in an attempt to avoid polluting the data with the unwanted 'noise' of practitioner influence. This was beautifully illustrated in a recent paper (10) that sought to evaluate the effects of spinal manipulative therapy on patients with chronic thoracic pain. In this study the investigators used a "servo-controlled linear actuator motor" to deliver precise doses of force to the spine of patients, who were randomised to receive either a "spinal manipulative therapy" level of force or a "spinal stiffness assessment" force. In other words, some patients were simply examined by the machine, while others received the active treatment. The results were disappointing. While the patients improved, there was no difference between those who were simply examined, and those who received the treatment. The authors concluded,
"This study showed, that in an experimental setting, the delivery of a SMT does not lead to significantly different outcomes (clinical and biomechanical) in participants with chronic thoracic pain than a control condition only including the evaluation of spinal stiffness. A decrease in pain intensity, disability, spinal stiffness and tenderness during spinal stiffness assessment following four experimental sessions was observed regardless of the group allocation."
But should we really be surprised? The authors Pagé and Descarreaux wrote about this in the 'Strengths and Limitations' section of their paper, saying:
"Some limitations also need to be considered when interpreting the results of the current study. First, the interventions were not delivered within a clinical setting; therefore, the effects related to the clinician-patient relationship, the SMT modulation during its delivery through feedback mechanisms, and to other components of patient management have not been evaluated. This constitute both a strength and a limitation of the study since it allowed the evaluation of the effect related to the SMT itself but did not capture the whole effect of a management involving this therapeutic modality."
Take a look at the setting (below) in which the treatment was administered. While no criticism is intended, it is hardly a 'warm and caring' environment.
none
The mechanical device used to deliver the spinal manipulative therapy and to assess spinal stiffness. A twin tip was used during spinal manipulative therapy delivery, while a single tip was used during the assessment of spinal stiffness.

Image from: Pagé, I., & Descarreaux, M. (2019). Effects of spinal manipulative therapy biomechanical parameters on clinical and biomechanical outcomes of participants with chronic thoracic pain: a randomized controlled experimental trial. BMC Musculoskelet Disord, 20(1), 2356–14. http://doi.org/10.1186/s12891-019-2408-4
WHAT SHOULD WE EXPECT?
I have written previously about the role of patient expectation in healthcare (here and here), and since writing those articles the supporting evidence has continued to accumulate. Indeed, there has been a cascade of interest in recent years in the relationship between an individual's expectation of recovery, and the actual unfolding of events (11-23). Suffice to say that the brain plays a pivotal role in the responsiveness of the patient to your intervention and its ultimate success. The crux of many expectation and placebo studies is that even valid treatments can be undermined if the patient does not believe that it will work. Much of this expectation can be attributed to context. A large context effect occurs with all treatments, but this is often undermined when designing an 'appropriately rigorous' study. What do we mean by context?

As Rossettini and colleagues (24) point out
"A treatment is never administered in a neutral situation, but rather in a complex set of contextual factors (CFs)...". They further go on to say that,
"CFs can be internal, external or relational. The internal factors consist of memories, emotions, expectations and psychological characteristics of the patient; the external factors include the physical aspects of therapy, such as the kind of treatment (pharmacological or manual) and the place in which the treatment is delivered. Relational factors are represented by all the social cues that characterizes the patient-physiotherapist relationship, such as the verbal information that the physiotherapist gives to the patient, the communication style or the body language."
The authors Newell et al (25) rightly stated that,
"Although placebo analgesia is the most studied phenomenon it appears it is not the only physiological system that the human CNS can modulate via conscious cues. Evidence is now incontrovertible that patient expectation of benefit as constructed by the use of such contextual cues can also powerfully modulate motor and immune function."
And,
"...the language of clinical trials continues to centre on the elimination of the placebo effect with highlighting any extra effect of the drug or intervention, the specific effect, being the central goal. However, where the placebo effect is large and clinically significant the idea of eliminating the benefits of such a phenomenon outside of clinical trials appears nonsensical."
If spinal manipulation, and indeed all treatments, require some degree of patient expectation and participation, then why do we try so hard to document the effects of such treatment in an artificially constrained scenario. It would be akin to investigating the benefits of jogging on human health and well-being, but requiring the participants to hold their breath while doing so. The point here is that manipulation is delivered within a specific environment, by a practitioner, to a patient, who comes to the interaction with a certain set of beliefs. This all creates important therapeutic context. And it is this entire 'package' that contributes to the outcome - whether it is pain relief, or a change in spinal biomechanics.

We should also not presume that this relationship between expectation and recovery is limited to pain states. While there is considerable evidence to support the notion of manipulation-induced analgesia, there are a host of other biomechanical changes that occur in response to spinal manipulation that have nothing to do with pain. However, it may be that these mechanical changes can only occur if the brain is
appropriately receptive to the intervention - again, primed by context.

An interesting paper by Ellingsen
et al (3) used functional MRI to document the effects of manipulation upon pain and fear-avoidance behaviour in patients with chronic lower back pain. It is known that those with chronic pain often exhibit maladaptive motor patterns and exaggerated fear responses during movement, associated with catastrophising and increased sensitivity. These conditioned responses even occur when affected individuals are shown videos of back-straining movements or exercises. According to Ellingsen and colleagues, "Spinal manipulative therapy (SMT) has been proposed to work partly by exposing patients to nonharmful but forceful mobilization of the painful joint, thereby disrupting the relationship among pain anticipation, fear, and movement."

They further explained,
"Conditioned responses—such as fear of potentially harmful maneuvers—can be "unlearned" when the conditioned stimulus or conditioned response consistently occurs without leading to unconditioned response (eg, a perceived harmful motion is not followed by pain or harm). There is evidence that exposing patients to (feared) nonharmful physical activity, to extinguish fear responses, can reduce avoidance behavior in chronic musculoskeletal pain. Interestingly, one proposed effect of spinal manipulative therapy (SMT), which involves salient sensory and proprioceptive feedback through passive mobilization of spine joints, is that it might help disrupt the association between fear, back-motion, and pain."
So it just may be that we need the right contextual cues to prime the patient's brain and nervous system, such that it will absorb our sensory input (spinal manipulation) and use it as a catalyst to alter muscle recruitment and motor patterns. But if we are too parsimonious in our research protocol, and try to limit the context effect as much as possible, aren't we condemning ourselves to failure?

Clearly we need to think carefully about where each patient sits on the clinical spectrum when they first present to us. Obviously, for those individuals in acute pain the problem is dominated by inflammation and disrupted anatomy. Such patients will have very real anatomical and biochemical challenges to face. However, we often see patients who are a long way down the road from early-stage trauma and dominant inflammatory mechanisms. What about these individuals? This is the time where maladaptive cognitive, functional and movement behaviours dominate, and we need to bring all of our resources to bear upon the problem. The literature now suggests that an 'integrated' approach to patient care is the most successful. In other words, we use every bit of the context effect that we can muster to achieve the maximum therapeutic effect. This has got nothing to do with old-fashioned notions of
'placebo as deception', and everything to do with 'neuroscience best practice'. Indeed, there is considerable emphasis now being placed upon the importance of blending pain neuroscience education with a manual approach to treatment (spinal manipulation, motor control exercises, graded motor imagery etc) to get the best results (26-30). Others are using cognitive functional therapy in combination with manual therapies to successfully treat difficult chronic patients (31,32).

Ultimately, this all coalesces upon one important message. Our unique approach to patient care is successful when we can maximise the therapeutic encounter, so that the patient's own contextually-driven healing resources have a chance to do their job. In other words, we need the whole package.
Something to think about...


Dr Matthew D. Long
BSc (Syd), M.Chiro (Macq)

References:

1. Chaibi, A., Benth, J. Š., Tuchin, P. J., & Russell, M. B. (2017).
Chiropractic spinal manipulative therapy for migraine: a three-armed, single-blinded, placebo, randomized controlled trial. European Journal of Neurology, 24(1), 143–153. http://doi.org/10.1111/ene.13166

2. Mieritz, R. M., Hartvigsen, J., Boyle, E., Jakobsen, M. D., Aagaard, P., & Bronfort, G. (2014).
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Effects of spinal manipulative therapy biomechanical parameters on clinical and biomechanical outcomes of participants with chronic thoracic pain: a randomized controlled experimental trial. BMC Musculoskelet Disord, 20(1), 2356–14. http://doi.org/10.1186/s12891-019-2408-4

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