The cover of the March issue of Annals of Physical and Rehabilitation Medicine is devoted to the Isico study entitled Specific exercises reduce the need for bracing in adolescents with idiopathic scoliosis: A practical clinical trial. “

To be featured on the front cover of an international journal is a first for us, and a source of great satisfaction as it underlines, in a very immediate way, the scientific value of the study we published a few months ago” remarks Prof. Stefano Negrini, scientific director of Isico.

“Indeed, the fact that one of the world’s three most prestigious and important journals in the field of rehabilitation should have chosen a study by us to grace its cover has the effect of turning the spotlight on a disease — scoliosis — that generally tends to attract less attention than other conditions”. 

Briefly, the study in question is the largest on this topic conducted to date, given that the case series numbers 327 patients observed over more than a decade’s work. It is a crucial study, given that few others in the field of spinal diseases have verified the factors capable of reducing the risk of scoliosis worsening.

On the one hand, it demonstrates the effectiveness of doing specific exercises compared with doing nothing, and on the other it shows that those whose treatment consists of a therapeutic plan of the kind we have developed at Isico will have better results than those who do normal exercises in the gym a couple of times a week. 

Furthermore, the study shows that those who adhere to the therapy continuously, without interruptions right through to the end, are rewarded with clearly better results. 

Aim: To create a classification of braces, with the help of a panel of super experts from all over the world. 
This initiative, born of the synergy between three scientific societies, SOSORT, SRS and ISPO , is being coordinated by Prof. Stefano Negrini, scientific director of Isico.

We are appealing to scoliosis bracing experts to join in this multi-society effort geared at producing a new classifica-tion system for braces. 
“Today’s braces are still named after those who invented them, and as such they are not organised into a logical classification of any kind. Although there exists an anatomical clas-sification, it doesn’t provide any data on the features of the different types of brace” explains Prof. Negrini. “We therefore need to find true experts for this project”.

What are the requirements to participate? “There will be a first group of top experts, those who have been prescribing or constructing braces at a rate of at least 500 a year for at least 15 years, and who also have documented experience at international conferences” Prof. Negrini goes on. “This group will meet and compare notes with a second group of ex-perts, who, for the past decade, have been prescribing at least 300 braces a year”. 

Anyone who meets these requirements and wants to apply to take part is invited to contact Prof. Stefano Negrini – stefano.negrini@unibs.it

Juvenile scoliosis is defined by an age at diagnosis of between 4 and 9 years; the form appearing earlier than this is termed infantile, while the one detected later is referred to as adolescent scoliosis. The juvenile form accounts for between 12% and 21% of all cases of idiopathic scoliosis occurring in youngsters.

Exercises and bracing can radically alter the natural history of juvenile scoliosis, stabilising the curvature (which tends to worsen markedly during the pubertal growth spurt, i.e. between the ages of 10 and 13 years), preventing further worsening, maintaining (after growth is complete) the correction achieved, and avoiding the need for surgery in the most severe cases. Adopting, a priori, an aggressive approach to the treatment of scoliosis can be counterproductive, as it can lead to a risk of over-treating the condition, and therefore reducing the youngster’s quality of life.

It is incorrect to say that juvenile scoliosis is always more aggressive than the adolescent form; in both, there probably exist rare cases of curves with a high potential to deteriorate. However, there is no doubt that, both in adolescent and in juvenile cases, the period of greatest risk is the pubertal growth spurt, which naturally favours a progression of scoliotic curves. It is therefore important to seek the support of a team of experts able to provide correct clinical and radiographic monitoring of the youngster’s conditions; the therapeutic team must also be committed to ensuring that the patient always receives the treatment that, for the same level of effectiveness, will least affect his/her quality of life.

The natural history of juvenile scoliosis teaches us that the curvature will worsen to more than 50°-60°, meaning that affected individuals are destined to require surgery. This view is so widespread that, as the lack of relevant literature shows, very little attention has been paid to the potential of conservative rehabilitation treatment in this form.

Very often, it is deemed best to “wait and see” what happens after the pubertal growth spurt. However, on the basis of the common knowledge that scoliosis tends to worsen in puberty, we argue that conservative rehabilitation treatment in juvenile cases can potentially produce positive results, which can be maintained after growth is complete. 

An Isico study published a few years ago, shows precisely this. The article, entitled “In favour of the definition “adolescents with idiopathic scoliosis”: juvenile and adolescent idiopathic scoliosis braced after ten years of age, [1] do not show different end results”, reports, in particular, that 92% of the patients studied got through adolescence without needing surgery. The study involved two groups. The first group comprised 27 youngsters with a diagnosis of juvenile scoliosis (based on clear X-ray evidence of scoliosis before the age of 10 years), who had started treatment after the age of 10 years. The second group was made up of 45 patients with a diagnosis of adolescent scoliosis. The patients in both groups presented curves of between 25° and 45°. The results obtained at the end of the treatment (bracing in all cases) were found to be comparable between the two groups.

“The study showed that it is possible to contain the natural tendency of scoliotic curves to worsen during puberty” – says Isico physiatrist Claudia Fusco – “What is more, the improvement was found to be greater in those cases whose treatment was started earlier, and was more challenging because of the severity of the curvature (greater than 30°). Take, for example, the case of one patient, a girl, who we had been treating solely with exercises ever since she first came to us as a child with mild scoliosis. Her bracing treatment began with a Cheneau brace and then, as she grew, this was replaced first with a Lyon and then a Sforzesco one; meanwhile, her brace wearing time was gradually increased from 12 to 18 hours per day. The progression was greatest at the age of 12 years, after which her condition stabilised, while the severity of the curve has decreased. At the age of 16 years, this patient had a 34° curve, down from a peak of 41°: a great success!”

How important, in scoliosis treatment, is the type of therapeutic instrument used? Obviously, both the treatment itself and the instrument chosen are very important factors. After all, while it is true that one brace may not be as good as another, it is also true that even an excellent one must be managed through an adequate therapeutic approach, which determines how, and how much, it should be worn.

Obviously, the physician plays a key role in mediating this relationship, but the tolerability of the brace and the patient’s acceptance of it are fundamental elements, too. All these factors combined can increase the final effectiveness of the therapy.

Let’s examine this one step at time. First of all, what is scoliosis?    
Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine and trunk. Even though it is a fairly common disorder, affecting about 1–3% of the population, only about 10% of diagnosed cases require treatment, and only 0.1–0.3% require surgery. The most important parameter when deciding on the type of treatment is the Cobb angle, which is measured on an upright full-spine radiograph. The therapeutic approaches to scoliosis range from observation alone to specific exercises, bracing and, in the most serious cases, surgery.
Bracing is an effective method of treating scoliosis, used for moderate and severe curves or when a patient refuses surgical treatment.

What exactly is a brace (the therapeutic instrument)?
A brace is a device (technically an orthosis) that applies external corrective forces to the trunk in order to correct the deformity.
According to guidelines published by SOSORT (International Society on Scoliosis Orthopaedic and Rehabilitation Treatment) in 2016, the aims of bracing as a treatment for scoliosis are to stop the disease from progressing during puberty, improve the patient’s appearance, prevent or treat pain, and prevent or treat respiratory dysfunctions.

How is a brace made?
Brace construction techniques have evolved over the years, but the objectives remain the same: to obtain maximum reduction of the curve through a design that can be well tolerated.
The construction process begins with a plaster cast or a 3D optical scan if CAD/CAM technology is being used, or alternatively with trunk measurements and the use of theoretical reference models.
In traditional construction, a plaster cast of the patient’s body is made and then split open to be used as a “mould” serving to reproduce the patient’s trunk. The resulting replica of the trunk is then modified manually in order to produce a model of the “corrected” trunk on which to construct the brace. If, instead, CAD/CAM technology is being used, the image is captured by scanners and then modified using software. Once the replica has been modified, it is sent to a milling machine which finishes the corrected “positive” model.
From this point on, the procedure is the same for all techniques: a plastic sheet is heated and wrapped around the positive model. The thickness of the plastic used may differ (ranging from 2 to 5 mm), as may its stiffness. Even though they are all made using similar methods, there exist different types of brace and they don’t all work in the same way.

A classification of braces
Braces work in different ways because they apply different biomechanical principles. What is more, they are custom-built devices, and so each one is unique!
A classification was recently developed based on the mode of action of different braces. There exist the following types:
    ⁃    traction braces: for obtaining upward vertical elongation of the spine (e.g. the Milwaukee brace);
    ⁃    Three-point braces: these act at three points in two or three planes of space (Boston, Lyon, PASB, Sibilla braces);
    ⁃    postural braces: these have a three-dimensional action (Cheneau, RCS, ART braces);
    ⁃    hypercorrective nighttime braces: these are used only at night (Charleston, Providence braces);
    ⁃    braces that push in a down-up direction: these braces produce a three-dimensional elongation, which is obtained by pushing the spine in a down-up direction. The Sforzesco brace, developed at the Isico centre by Prof. Stefano Negrini, is an example of this type of brace;
    ⁃    elastic braces, like SpineCor, which are used to treat mild-moderate scoliosis (between 20° and 35°) and to delay the use of a rigid brace. SpineCor is a dynamic brace based on the principle of the corrective SpineCor movement; this movement is maintained over time by means of the elastic bands. Unlike a rigid brace, it is practically invisible under clothes, and permits all trunk movements. However, it is less effective than other treatments.            
It is very difficult for doctors to assess and manage all these different bracing options, even if they are experts in this condition. To increase the quality of the intervention and enhance the outcome for the patient, the best thing is to work with few models and only a few orthopaedic workshops.

The fundamental importance of the therapeutic approach
Whatever type of brace the physician recommends, the management of the therapy is still the most important thing.
Prescriptive protocols envisage that treatment should be started with a very high dosage (21-23 hours of brace wearing per day), before gradually reducing this, in such a way as to allow the spine to grow, and the postural control system to adapt and get used to maintaining the correction imposed by the brace. This latter aspect is supported by specific exercises, which enhance the spine’s ability to maintain the correction.
Bracing is an effective therapy providing the brace is worn for the number of hours prescribed by the physician.
Until a few years ago, the only way of checking that patients were using their braces correctly was to rely on information provided by family members and the patients themselves at follow-up appointments. Nowadays, however, we can use heat sensors to obtain accurate assessments of compliance (i.e. to assess the extent to which the patient and his/her family have adhered to the prescribed treatment).

A well-constructed brace
According to the five rules set out by Prof. Sibilla in 1995, a brace will work well if it is properly prescribed, properly made, properly tested, properly worn, and accompanied by appropriate exercises.
We would add a further rule: brace treatment must be carefully monitored by a complete, expert and vigilant team of professionals.
A brace must be worn for the prescribed number of hours; for this to be possible, it must be tested by qualified medical staff who have the ability to make the small changes necessary to avoid any need to interrupt the treatment. Each patient and his/her family must then be followed up over time by a physician, physiotherapist and orthopaedic technician. Each of these professionals plays a crucially important role in helping patients to complete the course of treatment, minimising its impact on their daily lives.

The revolutionary SFORZESCO brace
The Sforzesco brace, named after the Medieval Sforza family to recall its links with the city of Milan where it was developed, was created in 2004 by Prof. Stefano Negrini, scientific director of Isico, and Gianfranco Marchini, an orthopaedic technician. Their aim? To find a solution, based on some of the characteristics of the Risser plaster cast and the Lyon, Sibilla and Milwaukee braces, that would make it possible for severe scoliosis patients to avoid having to wear a plaster brace. To correct the curve, it acts mainly by pushing the spine in a down-up direction.
It is an effective but also a readily acceptable brace, given its optimal wearability.
The Sforzesco is a “super-rigid brace”. It has an external envelope that reproduces the natural shape of the human body, and the corrective action of this brace is enhanced by the addition of several pushing pads (which exert a pushing action).
According to published scientific evidence (particularly that contained in the 2011 paper Brace technology thematic series – The Sforzesco and Sibilla braces, and the SPoRT Symmetric, Patient oriented, Rigid, Three-dimensional, active concept), the Sforzesco brace is more effective than the Lyon brace and as effective as the Risser cast in the presence of severe curves. It has also been found to be effective from an aesthetic point of view, helping to improve the appearance of affected patients. Its action is different from that of other brace types, being based on traction, posture, three-point correction and movement-based correction. It was in fact created according to the SPoRT (Symmetric, Patient-oriented, Rigid, Three-dimensional, active) concept of bracing.
In the process of developing this new brace type, the concept of symmetry was gradually superseded. Nowadays the external envelope is no longer perfectly symmetrical, although it remains unobtrusive and therefore an aesthetically valid solution.
The fact that patients come to see it as an extension of themselves helps us to make this treatment more readily accepted by them; and ready acceptance translates into increased compliance and greater effectiveness. The material used and the type of construction confer high rigidity, which means more effective pushing compared with that provided by other brace types.
The Sforzesco brace has a three-dimensional action on the spine. It grants the four limbs total freedom of movement, and allows the patient maximum freedom in activities of daily living. The trunk moves inside the brace in accordance with the direction of the correction, while movements in the direction of progression of the deformity are completely prevented. This is why these brace types are defined active.
Whatever type of brace the physician recommends, the management of the therapy is still the most important thing.

From this point on, the procedure is the same for all techniques: a plastic sheet is heated and wrapped around the positive model. The thickness of the plastic used may differ (ranging from 2 to 5 mm), as may its stiffness. Even though they are all made using similar methods, there exist different types of brace and they don’t all work in the same way.

How important, in scoliosis treatment, is the type of therapeutic instrument used? Obviously, both the treatment itself and the instrument chosen are very important factors. After all, while it is true that one brace may not be as good as another, it is also true that even an excellent one must be managed through an adequate therapeutic approach, which determines how, and how much, it should be worn. Obviously, the physician plays a key role in mediating this relationship, but the tolerability of the brace and the patient’s acceptance of it are fundamental elements, too. All these factors combined can increase the final effectiveness of the therapy.

Whatever type of brace the physician recommends, the management of the therapy is still the most important thing.
Prescriptive protocols envisage that treatment should be started with a very high dosage (21-23 hours of brace wearing per day), before gradually reducing this, in such a way as to allow the spine to grow, and the postural control system to adapt and get used to maintaining the correction imposed by the brace. This latter aspect is supported by specific exercises, which enhance the spine’s ability to maintain the correction.