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Daytime versus night-time bracing: what to do when scientific evidence is of no help?

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When we sit down in front of a doctor, we often expect him or her to have the solution to all our problems, but of course this is not the case. Unfortunately, that isn’t how evidence-based medicine (EBM) works!

EBM is defined as the explicit, conscientious and judicious use of the best current scientific evidence in decision making regarding the treatment of an individual patient or population. Indeed, the term “evidence” refers not to that which is “evident”, but rather to what has been discovered through specific research.

Evidence-based clinical practice is built on 3 key elements: 

– the best research evidence;

– the clinical experience of the treating physician;

– the patient’s values and expectations.

In other words, optimal clinical decision-making is based on knowledge of the best available scientific evidence, which must be combined with the values and preferences of the patient, who is involved directly in the process of choosing his or her treatment. 

But scientific evidence cannot answer all the questions that crop up in medicine. In the field of scoliosis treatment, for example, there are no studies showing that brace wearing is more effective during the day than at night. 

So, what are doctors meant to do when they are faced with situations like this? In the absence of available scientific evidence, the decision has to be based on the other two foundation stones of clinical practice (the doctor’s personal experience and the patient’s values), so as to achieve the best possible outcome. 

As far as bracing is concerned, there is an important study “Adolescent Idiopathic Scoliosis Bracing Success Is Influenced by Time in Brace: Comparative Effectiveness Analysis of BrAIST and ISICO Cohorts” which shows that the outcome, in terms of curve correction, depends on the number of hours the brace is worn: the longer it is worn the better the result will be.
On the basis of this knowledge, and also with the aim of increasing our patients’ compliance with the treatment, we at ISICO have decided that patients should always wear their brace at night, and enjoy their brace-off hours (as prescribed by their doctor) during the daytime.
After all, if patients sleep without their brace on, this means they lose 7-8 hours of correction every 24 hours. What is more, using brace-off hours during the daytime makes it easier for youngsters to take part in the daily activities they enjoy (sports, going out with friends, and so on), and this increases not only the level of compliance with the treatment, but also their quality of life.
Finally, we know that our spine does not remain passive during sleep; on the contrary, when we are in bed, swelling of the intervertebral discs (shock-absorbing “sponges” situated between our vertebrae) causes lengthening and tension of this entire structure, which is so important in growth.
This is one of the reasons why ISICO (and pretty much all practitioners worldwide) now recommend that, when the time comes to do so, bracing hours should be reduced during the daytime, until the point is finally reached when patients, in the last months of their treatment, are wearing their brace only at night. This, then, is an example of how the clinical experience of a specialist team and the particular needs of patients can together serve as the basis for making sound therapeutic choices in the absence of hard scientific evidence.

eSosort2021: Isico competes for the AWARD

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Isico, too will be present with several presentations at the annual international conference Sosort, online from April 29th to May 1st.
A presence, albeit virtual, characterized by the possibility of competing again for the SOSORT Award. We recall that Isico has been awarded already in the last two years the prestigious international recognition given by SOSORT for the best research, to which is added, in 2019, the Award won as co-authors of a research study in collaboration with the University of Hong Kong.

“In this online edition, our study Efficacy of bracing in infantile scoliosis. A 4-years prospective cohort shows that idiopathic respond better than secondary scoliosis will compete for the Award along with six other studies – explains Prof Stefano Negrini, scientific director of Isico and first author of the research – an important result that recognizes the high quality of the research we are performing in Isico. Also, the study Adults with idiopathic scoliosis: progression over 5 Cobb degrees is predicted by menopause and metabolic bone disease, which sees as first author Dr Sabrina Donzelli (who won the Award in 2020) was nominated among the 7 best research studies: Dr. Donzelli will hold the presentation but will not compete for the Award this year.”
In addition, another study, Increasing Brace Comfort, Durability and Sagittal Balance through Semi-rigid Pelvis Material does not change Short-Term Very-Rigid Sforzesco Brace Results, is among those selected for the Podium presentation and will be presented during the event by Dr Francesco Negrini, an Isico physiatrist.

Isico also distinguished itself for the works accepted as Posters, available to subscribers to the event in an on-demand session, and they are three: Can the tilt-differences of limiting vertebrae be a prognostic factor for the worsening of the scoliosis curves treated with specific exercises? A pilot study using a series of matched patients, edited by our director of physiotherapy, Michele Romano, Reducing the pelvis constriction changes the sagittal plane in the brace. A retrospective case-control study of 37 free-pelvis vs 336 classical consecutive very-rigid Sforzesco braces and The modular MI-brace is as effective as the classical custom-made Sforzesco brace. A matched case-control study of 120 consecutive high-degree female AIS, both from Prof Stefano Negrini.

This year’s virtual meeting will begin with synchronous (live) presentations on Thursday, April 29th and Friday, April 30th, from 9 am to 11 am Eastern Time, and on Saturday, May 1st, from 9 am to 1 pm Eastern Time.

All the presentations will be recorded and be made available on-demand for a duration of 1 year on the SOSORT conference website for registered participants. For more information and registration, visit the event website https://esosort21.sosort.org

Scoliosis: why appearance matters

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To treat scoliosis solely on the basis of radiological images, assessing only the patient’s skeletal conditions, would be a huge mistake.

The evolution of scoliosis typically leads to spinal changes in the three planes of space, and it therefore causes a modification of the ribcage. Indeed, as scoliosis progresses, it also changes the appearance of the torso, and this, depending on the severity of the curve, can impact more or less markedly the patient’s appearance.
According to the international guidelines on the conservative approach to scoliosis drawn up by Sosort, improving the patient’s appearance is the second most important goal of treatment.
If the condition is not adequately treated, or the treatment is ineffective, the above-mentioned changes will become more and more marked, even to the point of severely impairing the patient’s quality of life.

The way we see our body is highly subjective. People with asymmetries of the hips or shoulder blades, or a hump, react differently to the problem, in the sense that a defect that one person hardly thinks about, may be quite unbearable to another.
“In treating scoliosis, we must be careful not to overlook this question of aesthetics, precisely because we can never assume that our patients see things the same way as we do: any asymmetry, be it major or minor, can have a considerable psychological impact – says dr Irene Ferrario, Isico Psychologist – It is also important to remember that these changes occur in a period – adolescence – that is already full of challenges, and can sometimes see youngsters struggling to build, and accept, their own body image”.

For all these reasons, addressing patients’ aesthetic concerns should not be seen as indulging them; indeed, correcting aesthetic defects is not of secondary importance compared with correcting the curve: it is a therapeutic necessity. When a patient has, for example, one flank straighter than the other, a misaligned shoulder blade, or a hump that alters the line of the upper body, these changes may be perceived as more or less visible, depending both on the individual’s relationship with his/her body, and on his/her own (entirely subjective) aesthetic parameters. Over time, however, if the disease progresses, these changes can become objectively visible and psychologically damaging.
Obviously, we are referring here to the most severe cases, but these remarks nevertheless serve to illustrate that a scoliosis treatment plan cannot exclude the issue of aesthetics. Addressing this aspect is a necessary part of the treatment.

In short, good conservative practice absolutely must take into account aesthetic considerations. Regardless of whether or not the patient highlights this aspect, considering it to be of primary importance, the physician should in any case include it as a key objective of the treatment, which may contribute to its success.
In our care pathway, it is often the parents who first “raise the alarm”, alerting the therapeutic team to these concerns. This is because they are often the first to notice changes in the child’s body, especially if he or she is still too young to have a real awareness of his/her body and body shape.
Sometimes, these “alarm bells” are justified, and sometimes not, given that mild bodily asymmetries are normal, and do not always indicate an underlying problem. Purely aesthetic concerns, especially when raised by our young patients, should never be dismissed. Identifying and acknowledging a patient’s experiences and feelings is crucial to their all-round care. 

“Another aspect that should be underlined is brace wearing, as this treatment (when required) also has aesthetic implications –explains Lorenza Vallini, Isico PT – Many patients worry that their brace can be seen under their clothing, and addressing this concern is an important part of increasing the acceptability of the treatment: fitting patients with increasingly thin braces, moulded to their shape and therefore “almost invisible” to the onlooker, has proved to be a key factor in reducing and containing the deformity. Moreover, a good brace produces a truly remarkable aesthetic correction, not only immediately but also in the long term“.
Indeed, the brace wearer is rewarded with an improvement that lasts into adulthood. But arguments based on the long-term advantages are often lost on youngsters, and therefore an “invisible” brace is still crucial.
The main objective of the treatment will always be a well-balanced and harmonious body, which is as symmetrical as possible. After all, no one is perfect, not even Botticelli’s Venus. Indeed, her imperfections are part of her beauty!

Can we be sure that this brace works?

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A brace is a tool used to prevent the progression of scoliosis. They can be made of different materials: plastic (with metal parts), partly leather, or entirely elastic and fabric.

Finally, there exist numerous models with different names, such as the Cheneau, Sforzesco, PASB, Lapadula, Maguelone, and so on, not to mention variants of these different models.  

All this adds up to a real maze of terminology that the parents of a child or teenager recently diagnosed with scoliosis or a spinal disorder suddenly find themselves having to try and understand.

Why is it all so confusing?

It is not confusing, it is just that there exist different models, all designed to serve the same purpose, namely, to obtain the best possible alignment of the spine in order to counteract the evolution of the disease, which manifests itself as a progressive misalignment of the vertebrae.

Individual situations and cases vary, and braces are therefore chosen to meet the patient’s specific needs, which are determined by the severity, type and location of the curve.

The shape of the spine, viewed sideways on, is also a crucial aspect to consider when choosing a brace; this sagittal profile shows a series of physiological curves: cervical lordosis, dorsal kyphosis, lumbar lordosis and sacral kyphosis.

If these curves are correctly positioned and well balanced, your back will be strong; if not, it will be weak and vulnerable to the stresses of everyday life.

The type and construction features of the brace must be chosen by a medical specialist after a thorough assessment of the type of problem, the severity of the condition, the risk of progression, and the habit of using one brace compared with another.

One particular feature of the scoliotic spine, which we professionals must seek to address, is the presence of a deformity in the sagittal plane, in other words, a deformity of the spine as viewed from the side.

Indeed, the action of the disease can result in a reversal of the natural pattern of the curves described above. A dorsal scoliotic curve, for example, will have the effect of flattening the back, reducing or even reversing the direction of the natural dorsal kyphosis.

This makes the back look unnaturally “straight” or even causes the spine to curve inwards, creating a dorsal lordosis.

Such a deformity can seriously affect the health of the spine.

Indeed, conserving the physiological pattern of spinal curves in the sagittal plane means keeping the back strong, healthy and working efficiently.

When patients are diagnosed with dorsal scoliosis with this flattening of the back, their parents are often surprised because these youngsters, very erect, appear to have what is classically considered a “perfect” posture.

Most people associate scoliosis with a curved back and round shoulders. After all, as children, we are so often told: “Stand up straight or you’ll get scoliosis!” . Therefore, associating straightness with scoliosis seems something of a contradiction in terms.  But this is not the case at all.

A flat back, caused by dorsal scoliosis, is indeed one of the many forms that scoliosis can take: it is actually quite a frequent form and also one that can be difficult to treat using corrective tools.

Normally, a brace exerts a pushing action, but in these cases, to improve the shape of the back, the brace would need to act as a sort of suction cup, pulling the vertebrae back into position.

Obviously, this is not possible; therefore, in these cases, the brace will be shaped in such a way as to encourage the trunk and shoulders to assume a more “hunched” position so as to try and prevent the spine from becoming “too straight”.

The most worrying and upsetting aspect for parents is precisely this: to see their “straight backed” youngsters assuming, with their brace on, this rounded position with forward slumped shoulders – after all, their posture initially seems to look worse than before!

However, they soon understand the reason for it: these patients are not being asked to “stand up straight”; instead, what they need to do is learn to assist the corrective action of the brace, which is specially designed to promote kyphotic curvature of the upper spine.

In short, it isn’t easy to be sure that a brace is working, especially when, as in cases like these, its action seems to go against traditional aesthetic parameters.

However it is important to understand that, in many cases, certain construction features of the brace are the result of complex biomechanical reasoning.

What should you do if you are concerned? Ask, without hesitation, because exchanges with experts are always useful for learning about the corrective aspects of the treatment.

SRS research evaluates AIS brace management

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The research Scoliosis Research Society survey: brace management in adolescent idiopathic scoliosis has just been published by the journal Spine Deformities. While the Scoliosis Research Society (SRS) has established criteria for brace initiation in adolescent idiopathic scoliosis (AIS), there are no recommendations concerning other management issues. As the BrAIST study reinforced the utility of bracing, the SRS Non-Operative Management Committee decided to evaluate the consensus or discord in AIS brace management developing this research.

1200 SRS members were sent an online survey in 2017, which included 21 items concerning demographics, bracing indications, management, and monitoring.

218 SRS members participated in the survey: 207 regularly evaluate and manage patients with AIS, and 205 currently prescribe bracing.  99% of respondents use bracing for AIS and the majority (89%) use the published SRS criteria, or a modified version, to initiate bracing. 85% do not use brace monitoring and 66% use both Cobb correction and fit criteria to evaluate brace adequacy. 

“From the research it emerges that in practice the variability is very large – explains Dr Sabrina Donzelli, physiatrist and researcher at Isico – the treatment protocols, the hours of wearing, the time elapsed between visits, the radiographs required, with or without brace, with what times and after how many hours of break, the brace-weaning protocols, vary considerably from one specialist to another”.

In the United States, the use of braces is recent, it spread after the publication of the results of the BrAIST study: “The management of therapies and treatments is affected by the inexperience of specialists – continues Dr Donzelli – often the indications given to patients are not precise, they are not justified by the objectives of the treatment and they are not supported by strong motivations deriving from clinical experience. Or at least this is what emerges from the survey “.
What then is the conclusion of the research? 
This variability may impact the overall efficacy of brace treatment and may be decreased with more robust guidelines from the SRS. Furthermore, brace therapy must be personalised in a pathology so complex that it cannot be simplified: “The dosage with which the brace is prescribed must be correlated with the therapeutic goal to be achieved – states Dr Donzelli – Risser 0, 1 or 2 is characterised by different progression risks, the extent of the starting curve changes the treatment objectives: sometimes it is necessary to improve the curve, sometimes it is enough to stabilise. The type of brace to be used varies according to the type of curve, their localization and the estimated evolutionary risks of the curve correlated with the problems in adult life. I want to add to the research  – concludes Dr Donzelli – that they only considered the use of the brace, nothing is said about the role of exercises, of which several research studies have efficacy already proven, alone or in association with the brace itself as for example these articles https://pubmed.ncbi.nlm.nih.gov/25729406/ and https://pubmed.ncbi.nlm.nih.gov/30145241/ published by Isico”.

Brace competition 2020: winners awarded

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An online live show full of emotion was held on Saturday 13 March to reward the winners of the 2020 Brace competition – “Concorsetto”.

Prof Stefano Negrini, clinical and scientific director of Isico and Michele Romano, director of physiotherapy, conducted the appointment, while doctors and physiotherapists presented their winning patients showing a short extract of their work: a drawing, a video or a written text.

Different classified categories: awarded by the internal jury, by Facebook likes and the category of the youngest ones.

In this short video you can see all the more than 50 works arrived for this edition.

We look forward to seeing you next time!

Scoliosis: what positions to sleep in?

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The determination of parents, and patients, to find ways of counteracting the progression of scoliosis often leads them to come up with questions, and to look for as many new strategies as they can.

One of the issues they raise concerns the awkward and “twisted” positions that children and adolescents tend to adopt when relaxing on the sofa or bed, or when they are writing, and so on. 
Do these positions affect scoliosis in any way, and can they even cause it?  

To answer these questions, let’s start by making a few key points clear. First of all, scoliosis is a disorder that causes deviation of the spine in the three dimensions of space, and it shows a natural progression; in most cases, it first appears in the early phases of growth. Posture, like the positions a person assumes in daily life, may affect the condition, but only to an extent, and they do not trigger or cause it.

This deviation of the spine, which throws it out of line, results in non-uniform loading of the spine and can therefore drive what is known as Stokes’s vicious cycle (asymmetrical loading causes asymmetrical growth leading to progression of the deformity…).

Conservative therapeutic approaches, consisting of specific self-correction exercises or brace wearing, aim to reduce this misalignment of the spine, counteracting the natural worsening of scoliosis and allowing more physiological growth of the anatomical structures of the spine.

When we are seated or standing, spinal loading is an important issue: in these positions, the force of gravity acts vertically on the whole of the spine, causing it to be more compressed and therefore more susceptible to developing an asymmetry.
Instead, when we are lying down, be it on our back, on our front or on our side, there is much less loading of the back, as the force of gravity is no longer pushing down on the spine, but distributed horizontally over the entire body. 

During the night, precisely because we spend a number of hours lying in bed, with our backs unloaded and no longer subject to the stresses generated by loading and movements, our spine is able to “recover”: the discs situated between the vertebrae are rehydrated, and the entire spine lengthens.   

You may well remember your parents remarking of a morning, “Goodness, you’re so tall! You seem to have grown overnight!” .
Well, as it happens, there is a physiological reason for this. Some studies suggest that we can gain up to 1-2 cm in height as an effect of these nocturnal regenerative phenomena. However, this extra height is lost in the course of the day, and with the passing of the years.   

In conclusion, in the light of what has been said above, and also bearing in mind that we have no control over the positions we adopt when sleeping, our advice to patients is to carry on sleeping in the positions they find most comfortable, because there is no such thing as more or less correct positions during sleep.
Just make sure that the surface supporting your mattress (usually slats, metal bedsprings or a flat platform) ensures that it remains parallel with the ground, and that the central part does not sag. If you sleep in a brace, this isn’t even an issue, as your spine will remain correctly aligned whatever position you sleep in.

It is important to have an active lifestyle, do sport and, for those doing rehabilitation treatment, to follow the prescribed programme of physiotherapy exercises and/or brace wearing.
A final piece of advice: try not to spend too much time lying on your bed or on the sofa, unless it is to rest or watch something on TV! 

Telephysiotherapy in Isico: the published research

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In this pandemic year a lot has changed in our daily habits, much in the way we work. Something also in the way we treat patients. We had to adapt to take opportunities from difficulties. In Isico, we have done this from the beginning, overcoming the first phase of closures thanks to the online mode of medical visits and physiotherapy treatments.

It was a way not to leave our patients alone and not to waste the efforts made, a way that after some time has become an integral part of our therapeutic proposal.

We learnt a lot and this also translated into the research, published recently by the Spine Journal, “Lessons learnt in two months of the exclusive application of telephysiotherapy instead of classical physiotherapy during the lockdown in Italy“. 

“Current evidence on telemedicine mostly refers to interventions not requiring hands-on approaches, based on either technology or oral/visual interactions – explains Michele Romano, director of Isico physiotherapy and author of the research –  In a way, the pandemic offered a sudden push to telemedicine. The question is which lessons can we learn on telephysiotherapy after a few months of extensive and mandatory experience?” 

For this reason, we want to share the experiences of exclusively telephysiotherapy treatments acquired by 38 physiotherapists working for Isico during the 2 months of lockdown from March 16th to May 11th.

It was crucial in the first phase that patients accept telephysiotherapy. Usually, the appointments are managed by the booking call-center, but after the first phone calls it was clear that this unusual and unexpected change proposed by a secretary was not well received by the patients.

Consequently, the new standard is that the appointment is made by phone call by the treating physiotherapist him/herself. That facilitates the interaction with the patient, and allows to professionally answer all eventual doubts.

How to organise to be able to carry out physiotherapy treatments online?  “An involvement of caregivers and families is necessary for the session. A free video-communication App is used (Skype or Meet) – explains Michele Romano  – Evaluation results autonomously collected by patients with the help of a caregiver, are sent before the session to fill the assessment form in advance. One caregiver is present during the session, with one camera to film the patient, to help correct mistakes and observe the right execution of specific exercises; a second device is used for the Institute App to record the exercises”.

During 2 months of lockdown, telephysiotherapy sessions have been 2,239 (100%). After the lockdown, when back to “normal” were face-to-face hands-on physiotherapy, 10% (532 out of a total of 5,091) remained telephysiotherapy sessions.

“The common feeling of patients and their caregivers was of not having been abandoned – explains Michele  Romano –  during these months we verified that the systems work properly, now this wide and sudden experience is available for the worldwide physiotherapy community. Telephysiotherapy is a not so difficult, readily available instrument.“

Obviously, limits and drawbacks referred by physiotherapists and patients included the impossibility to use hands-on, the need to simplify the approach, the limited attention of younger patients, the connection difficulties.  

Most physiotherapists and patients agreed that this type of approach is perfect in emergency, but it cannot substitute normal physiotherapy sessions in normal times.

“Yet we have found – concludes Michele Romano – that there is a group of patients who have discovered telemedicine and continue to use it even now, an additional opportunity that therefore in Isico we have decided to offer patients in the future, alongside the classical medical visits and physiotherapy treatments performed in-person.”

Natural History of Scoliosis: the development of a predictive model

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There are two abstracts on the natural history of scoliosis that Isico is going to present at the 56th SRS conference scheduled for next September in the United States: “Predicting Future Curve Severity for Juvenile Idiopathic Scoliosis: A Natural History Study” and “Predicting Future Curve Severity Requires Different Models for Adolescent and Juvenile Idiopathic Scoliosis “.
Abstracts which constitute research carried out by Isico in collaboration with the Canadian University of Alberta and Dr Erik Parent. The preliminary results of this research study will be presented by Prof Stefano Negrini at the Research Grant Outcome Symposium organized by SRS and scheduled for March 6 from 9 to 11 ET US.
Most models to predict future Scoliosis severity have not been validated; many previous samples included treated patients limiting our understanding of the natural history. 

“Our aim was to predict future curve severity at a time point of the clinician’s choice during adolescence using data from x-rays obtained before starting treatment in patients with a diagnosis of Juvenile Idiopathic Scoliosis (JIS) – explains dr Sabrina Donzelli, one of the authors of this research study – we included 2331 patients with a diagnosis of JIS, under age 26, previously untreated.
The data obtained through the radiographs confirm the factors involved in the severity of scoliosis: for juvenile scoliosis the age at onset and the extent of the curve, and for adolescent scoliosis the Risser stage and female gender. The idea is to optimize the use of this data for clinical purposes “.

That is, to be able to validate the model to verify  whether it works for another population with similar characteristics. “During the webinar to which I have been invited – says Prof. Negrini – I will present the preliminary data not only of the two abstracts but also of the other analyses developed by the Canadian university. As a team, we are continuing to validate one model with which we can create an algorithm to predict the cases with the highest development risk.”