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Modular Italian Brace works just as well as the Sforzesco

A modular brace that has the same practicality and comfort of wearing and the same proven effectiveness, even on the most severe curves, of the Sforzesco corset but with significantly reduced costs. It is the Modular Italian Brace (MIB), the latest corset developed by our institute, after the Sforzesco and the Sforzesco Free Plevis.
Its effectiveness is demonstrated by the data of one of our studies recently published in the Journal of Clinical Medicine, The New Modular Sforzesco Brace (Modular Italian Brace) Is as Effective as the Classical One: A Retrospective Controlled Study from a Prospective Cohort. “A research of considerable importance,” comments Dr. Francesco Negrini, physiatrist and author of the study. “We recently developed a new Sforzesco brace based on modularity (the Modular Italian Brace—MI brace) that could allow standardisation, facilitating global expertise diffusion, increased modifiability and adaptability, and cost savings due to longer brace life”.

We remind you that the Sforzesco brace is a very rigid push-up brace effective in adolescent idiopathic scoliosis (AIS), which revolutionised rehabilitation treatment years ago by replacing the cast but guaranteeing the same results. Recently, the “Free Pelvis” (FP) innovation has been introduced. It consists of semi-rigid material on the pelvis connected to the main rigid body of the brace on the trunk.
It was found that it does not change the in-brace and short-term results of classical very rigid braces and, consequently, can be safely applied.

The MI brace, even if built in a different way, keeps the main characteristic of the Sf brace, that is, the overall symmetry (with some asymmetries inserted in specific areas). In fact, it is the symmetry that allowed the development of the MI brace, where it is possible to recreate the asymmetrical needs of the SF brace through internal pads.

The MIB can be built and fully personalised directly for the patient, modifying the classical procedures of brace construction through CAD-CAM or casting. Moreover, the MIB can be continuously adapted during treatment, giving full adaptability to the patient during changes due to growth or treatment.

The MIB is an evolution of the SF-FP. The two braces share the semi-rigid material on the pelvis, a novelty that improves comfort and patient acceptability. On the other hand, Sf FP is built in a more traditional way, without the MIB modularity and the possibility to adapt the brace during treatment. With Sf FP, if the patient changes due to growth, the brace must be changed altogether.

“The braces considered in this paper share the same action; the question is if they also share the same results. We aimed to compare the short-term results of the two braces,” explains Dr. Negrini. “We compared in this retrospective study 231 patients with scoliosis, between 10 and 16 years old, 53 treated with a MI brace, and 178 treated with a Sforzesco brace. Both braces reduced the Cobb angle (−6◦ out-of-brace; −16◦ in-brace) without differences between groups. The results of the present study suggest that the SfB and MIB can have similar positive short-term results on moderate-to-moderate, moderate-to-severe, and severe curve brace treatment with modular braces. that could lead to easier diffusion worldwide, even where there are reduced economic means and expertise in brace treatment. Before suggesting a generalised use of the MIB as a first-line rigid brace treatment, the results should be confirmed in studies with longer follow-ups”.

Isico launches the second edition of the Sforzesco Course

After a first edition, organised in 2022, that saw participants from 13 countries worldwide, Isico is launching the second edition dedicated to the deepening and construction of its Sforzesco corset.

The combination of theoretical lessons presented by the Isico experts and the practical instructions given by the CPOs who collaborate with Isico are the winning points of this course, which recaptures the knowledge gained over 20 years of clinical practice with more than 10,000 patients wearing our Sforzesco braces.  
This second edition is entirely self-administered by the participants, and you can enrol at any time, without a deadline.
A live lesson will be held in December to summarise the material and address participants’ questions.  

Why joining? According to one of the participants in the last edition: “This training will be the starting point for the new chapter in our facility for the treatment of scoliosis. It will help me implement new strategies in current brace construction about the sagittal profile and in starting construction of the Sforzesco brace“. 
For more information and registration, visit https://en.isico.it/sforzesco-online-course/#top

Are bracing and exercises really still the only way to “solve” the problem?

This is a question many parents ask us when scoliosis is diagnosed. Perhaps their child has a particularly tricky curve, or maybe they themselves can remember dealing with the same condition when they were young. It is the same question we were recently asked by the mother of a five-year-old girl who, at this tender age, already has to reckon with a challenging treatment, “trapped” in a brace.

 Unfortunately, despite huge strides made in the formulation of less invasive and more effective braces (such as the Sforzesco type that we at ISICO, have long used as a valid substitute for plaster casts), bracing and specific exercises remain the only conservative treatments available for scoliosis.  

No parent wants their child to suffer the same negative experiences that they themselves remember, and it is perfectly understandable to be concerned about the possibility of them living the “nightmares” we did, and to want to protect them as far as possible. On the other hand, if this is something you have gone through yourself, you will actually be ideally placed to really understand all the difficulties your child is likely to face, and to help them find the best way to cope. It is not being complaining to ask whether other options exist and whether your child really does have to wear that uncomfortable piece of plastic — these are, after all, questions that any parent would ask.

 So, to return to the question, are there any other effective and less difficult treatments? Unfortunately, as explained in a recent study, manipulation and osteopathy, like all manual treatments, have not yet been shown to be effective (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9833903/).

Given the questions we so often get asked, we feel it is essential to properly explain the reason for certain aspects of the treatment, such as the need to ensure that brace-off hours are consecutive, the importance of performing specific exercises, and the duration and dosing of the treatment.

When deciding how long the treatment will last and how aggressive it needs to be in terms of the dose (i.e., number of brace-on hours per day), the factor we consider is the potential risk of the condition worsening. This risk is assessed based on the extent of the scoliotic curve and how much growing the patient still has to do (residual growth). Scoliosis worsens with growth, therefore the earlier it arises, the more likely it is to get worse, especially during growth spurts, when the youngster gains height rapidly (these usually happen at 6/7 years of age and in puberty).

Based on this information, the treatment can be adjusted, reducing or increasing the dosage according to the period of risk.

It also follows that the earlier scoliosis arises, the longer the treatment will need to be, given that bone growth has to be complete to reach a stable situation. Then there is the question of the “brace-on” hours. It has been demonstrated that after putting on a brace, it takes at least two hours for the spine to achieve the desired correction. 
This means that, when the brace is repeatedly taken off and put back on, we have to consider, and count, not only the brace-off hours, but also the hours needed for the spine to return to its correct position inside the brace. In the same way, every time the brace is removed the back tends to spring back to its starting condition (rather like a spring that has been pulled and then reverts to its original shape).

Then, the more frequently the brace is taken off to give the patient a break, the less effective the treatment will be compared with wearing it for the same number of hours but with fewer and longer breaks. For this reason, it is essential to try and establish and maintain a regular brace-wearing schedule.

We know that bracing treatment is very challenging and also that managing the brace-off hours can be difficult, especially during the summer. For this reason, we advise families, as far as possible, to choose somewhere cooler for their holidays, and also to talk to their specialist to see whether, on some days during the summer, the brace-on hours can be reduced or the brace-off time can be split into two blocks. Obviously, these decisions have to be taken on a case-by-case basis.

As for the specific exercises for scoliosis, these are designed to help support the back when the brace is not being worn, and also to prevent loss of muscle tone (otherwise an inevitable consequence of bracing). In the case of very young children (like the little girl whose mother prompted us to write this post), we recommend lots of sport to keep the muscles in shape, because children aged 4 to 6 years often don’t yet have the concentration necessary to be able to cope with exercise sessions.

Finally, in answer to the question, yes, at present, bracing and exercises are the only conservative therapy options that have been shown to work. This kind of treatment is certainly difficult and demanding, but we have to remember that it aims to help our children reach adulthood with healthy backs, and fortunately, we do at least have these “instruments” to offer them. 

Sforzesco course: starting with participants from 12 countries around the world!

It is a bit as if an appointment had been made from all over the world for the launch of the Sforzesco online course, which started last May 18 with the first module, given that there are 12 countries from which the various participants are coming.
From Brazil to Cambodia, from Singapore to Malaysia passing through Morocco, Syria, Turkey, Japan, United States, Italy, Latvia and Bosnia-Herzegovina: a world of multi-layered experiences.
The starting point of the Course is the presentation of the Sforzesco brace in its evolution from the first years of application to the current relevant innovations, accompanied and supported by the results of research in ISICO, published in indexed international literature.
These lectures are presented by Isico physiatrists Prof Stefano Negrini and Dr Fabio Zaina, in addition to the orthopaedic Isico doctor, dr Monia Lusini accompanied by several lectures held directly by CPOs who collaborate with ISICO in the realization of the Sforzesco braces, on the various technical and practical aspects to be taken into account during the design and the fabrication.
The course is divided into 3 modules, each module ends with a live session to make the point on what has been shown and explained.
The first live lecture will be held on June 8th.

Free Pelvis Brace works: this is demonstrated by the study presented at Sosort

At the latest Sosort international conference, held a few months ago, Isico presented the study Increasing Brace Comfort, Durability and Sagittal Balance through Semi-rigid Pelvis Material does not change Short-Term Very-Rigid Sforzesco Brace Results.
For years, Isico has replaced plaster cast with the Sforzesco brace, a particular type of very rigid brace for the most demanding scoliotic curves: developed in the Institute itself in 2004, it obtained results equal to casting, highlighted in several published studies.
The Sforzesco brace is a way to avoid casting for severe curves, because of the significant costs involved both at the individual (side effects including cast syndrome, skin problems, significant psychological impact, inability to shower for months, etc.) and social (repeated inpatient treatments) levels.
“In recent years, thanks to the experience with the Sforzesco brace, we have worked to improve our brace – explains dr Francesco Negrini, physiatrist, and one of the authors of the research presented at Sosort – We have therefore recently introduced a particular innovation, the system “Free Pelvis”, which consists of releasing the pelvis corset using a less rigid material at that level, increasing comfort while wearing. The “Free Pelvis” system is a very important innovation, a potentially big step forward in conservative treatment of scoliosis”.
The study presented compared the Sforzesco brace classical version (VRB) versus the Free Pelvis one (FPB): “The results obtained showed us that the Sforzesco “Free Pelvis” has no inferior results to the classic Sforzesco – concludes dr Negrini – furthermore it reassures the effectiveness of the Sforzesco “Free Pelvis”, and allows us to continue with greater confidence and conviction in the process of introducing this new and revolutionary instrument into our regular clinical practice”.

A comparison of the Chêneau and Sforzesco braces

Unfortunately, it has become common to think of braces in the same way as we do drugs. But before we go any further, we need to make one thing clear: whereas we all know that aspirin is not the same as paracetamol, in the case of a brace, the name doesn’t really mean anything specific.
A brace is a product that is made-to-measure for the individual patient, and therefore the success of bracing treatment depends not on the name of the brace, but on how correctly it has been constructed for the particular patient. If the pads are incorrectly positioned, or if the brace is constructed so that it sits too low or presses too much on one side, it may even contribute to worsening rather than improving the scoliosis. 

The names of the different braces, therefore, are meaningful only to those who prescribe them. 

Finally, adding to the confusion, Dr Chêneau gave his name to two completely different types of brace: the first Chêneau is much more symmetrical than the second one, which, on the other hand, is clearly asymmetrical. Although the second Chêneau brace is the one most commonly used worldwide, we prefer to use the first one, for two reasons: first of all, it is discreet (practically invisible under clothes) and second, in constructing it, we are able to apply the same principles that characterise the Sforzesco, which is the brace developed at our own centre. For this reason, the Chêneau that we use at Isico has been given a new name: we call it the Sibilla- Chêneau, in honour of Dr Sibilla, a pioneer of our school.

So, how do the Sibilla-Chêneau and the Sforzesco differ? They differ in several features, which determine the choice of one over the other on a case-by-case basis. The decision to prescribe one type of brace rather than another must always be taken by a medical specialist.

Let’s start with the material: the Sibilla-Chêneau, used at Isico, is of monovalve construction and it is made of polyethylene, whereas the Sforzesco has two valves and is made from a much more rigid material. Its two parts are linked to posterior fasteners, and there is sometimes an aluminium rod at the back, too. Being more rigid, the Sforzesco has shown the same efficacy as the old system of plaster casting, but with the huge advantage of being removable for bathing/showering.

The Sibilla-Chêneau tends to be used to treat milder cases with less rigid scoliotic curves; it is also preferred for pre-pubertal patients. The Sforzesco, on the other hand, is used for more severe scoliosis with more rigid curves (for example, in youngsters with greater bone maturation). 

In some cases, patients start off with a Sibilla-Chêneau brace but subsequently switch to a Sforzesco one if the scoliosis becomes too aggressive (a decision reflecting the concept that the treatment should evolve gradually): on a hypothetical treatment scale, we can say that the Sforzesco (a super-rigid brace) is one step up from the Sibilla-Chêneau (a rigid brace).

At Isico, both these braces are prepared in accordance with the SPoRT (Symmetrical, Patient-oriented, Rigid, Three-dimensional) concept of bracing.

 “Symmetrical” means that the brace, externally, appears almost perfectly symmetrical, which makes it unobtrusive and helps to replicate the natural shape of the human body. In other words, for aesthetic reasons, it is outwardly symmetrical. By contrast, internally the brace acts asymmetrically, exerting a three-dimensional corrective action on the deformity. 

The brace is defined “Patient-oriented” on account of its wearability, and therefore tolerability. Being very closely fitting, it moves with the patient, and it does not restrict arm and leg movements at all. Furthermore, since it is easy to conceal, patients accept it readily, rather than merely putting up with it.

The term “Rigid” refers to the type of material used.

Finally, “Three-dimensional” refers to the corrective action of this type of brace on the spine; technically speaking, the brace pushes in a down-up direction; overall, the transmission of the corrective forces to the spine is carefully balanced in such a way as to obtain optimal correction in all three planes of space, without any of the three being allowed to dominate.

As explained at the start, another type of Chêneau brace is also used worldwide; in Italy, we call this the Chêneau 2000: it is an asymmetrical brace that uses expansion chambers. It remains clearly asymmetrical, even externally.  We, on the other hand, prefer to use the symmetrical version of the Chêneau, in order to respect the SPoRT concept mentioned above and also because it favours compliance. Indeed, applying our school of thought, we have obtained, in our patients, the best bracing results recorded anywhere in the world, and this is thanks, in part, to the type of braces we use. Naturally, braces only work if patients actually wear them, and the easier they are to conceal under clothes, the more patients will wear them.

Sforzesco in-brace corrections visible with EOS images

The aim of our study “The three-dimensional analysis of the Sforzesco brace correction ”, published by Scoliosis and Spinal Disorders, is to analyse the Sforzesco Brace correction, through all the parameters provided by Eos 3D imaging system. This is a cross-sectional study from a prospective database started in March 2003.
The study took into account 16 AIS girls (mean age 14.01) in Sforzesco brace treatment, with EOS x-rays, at start, in brace after one month and out of brace after the first four months of treatment
One of the major revolutions in the field of adolescent idiopathic scoliosis during the past 10 years is the development of 3D imaging devices in standing position, such as EOS Imaging – explains dr. Sabrina Donzelli, physiatrist of Isico and one of the authors of the study –  Through the 3D reconstructions produced by dedicated user-friendly software, it is possible to calculate and visualise a series of regional and local parameters characterising the spinal deformity. This new technology allows the clinician to deepen the direct effect of braces in all three spatial planes”.
Brace efficacy can play a role in determining the final outcome of a treatment. In recent years, braces have become really three dimensional, adding a detorsion action and addressing the whole shape of the trunk and its deformity. 
Different braces can act in different ways and may act in one plane more than in the other. Therefore, personalised prescription of the brace can optimise treatment.
According to the results, the Sforzesco brace has its strongest influence on the middle of the spine in the axial plane, while the Torsion Index cannot be considered an index of brace correction.
The three-dimensional elongation effect, which is typical of the Sforzesco brace, can be responsible for the main effect focused on the middle part of the spine and seen in the axial plane.
The main limitation of this study is a very small sample size, associated with a large heterogeneity of data which threaten the internal validity of the study. The lack of distinction in curve types, magnitude, bone maturity and age is a threaten for the external validity too, but “of course this preliminary study gives some interesting insight into the mechanism of the Sforzesco brace action and it suggests that EOS imaging could be very useful also to improve the immediate in-brace correction“.