Bracing also works in patients who are overweight

According to the Isico study entitled “Overweight is not predictive of bracing failure in adolescent idiopathic scoliosis: results from a retrospective cohort study”, published in the European Spine Journal, bracing can give excellent results in overweight or obese patients, too.

This research started from a question: is overweight really a factor that can jeopardise the outcome of bracing treatment in scoliosis?
Scoliosis is a three-dimensional deformity of the spine that, in over 80% of cases, is diagnosed in adolescence.
Seven out of every 10 scoliosis patients are female, and the condition affects around 3% of the population, even though severe scoliosis is rare (occurring at a rate of 0.5 per thousand patients).
Scoliosis is more likely to affect thin or underweight subjects, or to be more aggressive in these cases. However, it is also found in overweight subjects, in whom diagnosis of the condition may be more difficult or delayed.
“The traditional view has always been that bracing in overweight or obese youngsters doesn’t work” says Dr Fabio Zaina, an Isico physiatrist and author of the study. “However, the scientific literature contains only one study, now rather dated, with data supporting this view, and that study was conducted in patients who wore their braces for just 14 hours per day. This is precisely why we decided to undertake this retrospective study, examining the data of 351 patients with curves of 25° to 50° and an age of 10-15 years at the start of treatment, all of whom had been prescribed the Sibilla or the Sforzesco brace at their first consultation, with bracing doses of over 20 hours per day. And we found that the reality is actually very different”.
Indeed, the data collected showed that it is not being underweight or overweight that determines a positive or negative treatment outcome: “Patients affected by scoliosis are usually thinner than their unaffected peers, but overweight individuals, too, can develop the condition. According to a study that has just been published” Dr Zaina goes on, “the diagnosis can be delayed in obese individuals, and when they are diagnosed, they more frequently already show more pronounced curves. Treating them is therefore more difficult. Furthermore, from a technical point of view, it is more difficult applying a brace in overweight subjects, to the point that some are induced to lose weight. But in any case, the thing that determines a more or less valid outcome is the level of adherence to the treatment, or so-called patient compliance. Obviously, the therapeutic team (consisting of physician, orthopaedic technician and physiotherapist) plays an important role, but so too does the patient’s family, because with their support the patient is more likely to wear the brace for the prescribed number of hours: our patients, unlike those taken into consideration in the old study, were wearing their braces for between 18 and 23 hours a day, with an average of 20 hours”.

Why aren’t all braces the same?


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.

Swimming is not a treatment option

Swimming is not a treatment option

Swimming is not a treatment option for scoliosis; on the contrary, if practised competitively it can, in many cases, be detrimental. And it carries the risk of causing low back pain.

This was confirmed by our study Swimming and spinal deformities: a cross-sectional study published in the Journal of Pediatrics.



The study compared a sample of 112 competitive swimmers (who swam 4-5 times a week) with an age-matched population of school students, both males and females, who swam recreationally or did not swim at all.

In both groups (the competitve swimmers and the students) we measured the following parameters: the prominence, caused by vertebral rotation kyphosis and lordosis. The youngsters were also administered a questionnaire collect data on low back pain.

The swimmers, especially the girls, showed more marked trunk asymmetries and were more likely to show hyperkyphosis (excessive curvature of the thoracic spine on the sagittal plane ) and, as a consequence, hyperlordosis (excessive inward curvature of the lower spine on the sagittal plane) and low back pain.

From a postural point of view, swimming will cause the spine to collapse” explains Fabio Zaina, a physiatrist at Isico, “because it is an activity that mainly trains the arm and shoulder muscles while the spine in unloaded. Its effect in terms of low back pain is already known: competitive swimming, precisely because it involves intensive training schedules causes low back pain.

On the basis of our data, we can certainly say that swimming should not be recommended as a treatment for scoliosis. Too much swimming can have a detrimental effect on posture and lead to low back pain”.

Obviously it all depends on the individual’s physique and how much he/she swims.

“It’s one thing doing 4-5 training sessions per week, and another doing recreational swimming. As for individuals affected by low back pain, or even scoliosis, who have been told for years to ‘go swimming as it will help’, well, that’s just not true!” says Dr Zaina.

Eurospine’s education program

Isico’s Dr Zaina is part of the team contributing to the new EUROSPINE Diploma in Interprofessional Spine Care (EDISC) course.

The 2018 Eurospine Congress held in Barcelona saw the unveiling of the new EUROSPINE Diploma in Interprofessional Spine Care (EDISC). The non-surgical task force given the mandate to develop the curriculum for this non-surgical interprofessional diploma includes Dr Fabio Zaina, who is responsible for the spinal deformities module of the course.
The aim of the EUROSPINE course is to optimise the prevention and treatment of spinal disorders and the care of affected patients, facilitating the exchange of knowledge and ideas in this field of research.
The education programme developed by the task force will benefit spine care professionals, the health care system and, more importantly, the patient. Among its outcomes, the diploma programme is expected to motivate participants to change their practice and implement evidence-based, patient-centred and collaborative care.
Two pilot modules are scheduled to take place in 2019 during the EUROSPINE Education Week in Geneva, Switzerland. Preliminary programmes and information about registration for these modules are available on www.eurospine.org.

Prof. Negrini awarded at the SRS congress

Prof. Negrini awarded at the SRS congress

The SRS congress that took place in Bologna at the beginning of October has seen Isico at the forefront, primarily with the awarding of the prestigious John H. Moe award to Prof. Stefano Negrini, Isico’s scientific director, for the best research poster titled Paravertebral muscles show double-cross activation but also in single AIS curves, with a corresponding oxygen consumption: an electromyography and a near-infrared spectroscopic study, realized in collaboration with the University of Brescia and the Don Carlo Gnocchi Foundation.

A remarkable recognition for those involved in conservative treatment within a congress composed for the most part by surgeons.

“There is a growing interest in conservative treatment – explains prof. Stefano Negrini. Also Dr. Sabrina Donzelli has been invited to be part of the committee dedicated to conservative treatment which I am part of since three years. We were pleased by the intention of the SRS to support studies that compare different braces. The congress allowed us to meet researchers and representatives of important research institutes with whom we laid the foundations for future collaborations. In Isico, thanks to constant data collection through clinical software, we have a very large database of patients eligible for different possible studies with important research institutes “.

During the congress several interesting studies were presented: from those on the use of lateral flexion radiographs to those on new methods for estimating residual growth using different evaluation methods that also include humeral cartilage, so as to understand how to better estimate the period of the highest evolutionary risk.

Finally, Dr. Sabrina Donzelli, physician of Isico presented the study Brace Wearing Time is the Strongest Predictor of Final Results: A Regression Model in 1457 High Risk Consecutive Adolescents with Idiopathic Scoliosis: “We evaluated a large number of patients treated with braces and we verified that the number of wearing hours is the primary predictive factor of the final result of the therapy – comments Dr. Donzelli “.

Brace wearing: tenacity repays with improvements

It is not just a question of how many hours the brace is worn but also of patient compliance with the prescription. Take, for example, Marco and Ginevra. Both have idiopathic scoliosis, are followed by Isico specialists, and wear a Sforzesco brace for 20 and 23 hours a day, respectively. Marco complies with the prescription of wearing the brace, but he is inconsistent with the prescribed hours: sometimes he wears it for the 20 hours prescribed, others for 10, and others for 22. Ginevra instead regularly respects the prescription of 23 hours daily; this allows her to attain better results and to avoid worsening.

This is demonstrated by our study, Consistent and regular daily wearing improves bracing results: a case-control study, just published in the journal Scoliosis and Spinal Disorders. The study considered 168 patients who wore a brace for between 18 and 23 hours per day, divided according to high, medium, or low compliance and classified according to consistency or inconsistency in wearing. The data were collected through the use of Thermobrace, a temperature sensor applied to the brace to monitor its actual wearing.

Isico was the first organization to introduce Thermobrace into the daily clinical routine in 2010, and since then, its use has become commonplace. It has been verified that the relationship between doctor and patient is strengthened through the use of Thermobrace, since the therapeutic choices are based on real data; therefore, the data obtained from the sensor can be used to facilitate the use of the brace.

“The data confirmed that the brace should be worn consistently, which means that wearing the brace for a constant number of hours allows the achievement of good results,” explains Dr. Sabrina Donzelli, physiatrist and author of the publication, “also for those who are not completely compliant to the prescribed hours”. This confirms what we always recommend to patients who undergo brace therapy: the break must always be constant; less hours one day and then recovering the lost hours in the following days is not ideal!”

Patients who, in addition to not adhering to the prescribed treatment, are also not consistent in wearing the brace are at greater risk of worsening. Patients who have worn the brace for less than 70% of the prescribed duration are considered non-compliant. “The study shows that to achieve the best results, the brace must be worn for a consistent number of hours, the attempt to recover lost hours is useless,” concludes Dr. Donzelli “While tenacity together with compliance, i.e., the adherence of the patient to the prescription, are rewarded”.

SRS 2018 in Bologna: ISICO will be there, too!

SRS 2018 in Bologna: ISICO will be there, too!

ISICO will be present at the International Congress of the SRS (Society of Research on Scoliosis), to be held in Bologna from 10 to 13 October.


SRS, founded in 1966, is the oldest scientific society for the treatment of scoliosis. ‘We will present the study, Brace -Wearing Time is the Strongest Predictor of Final Results: A Regression Model in 1457 High Risk Consecutive Adolescents with Idiopathic Scoliosis – Dr. Sabrina Donzelli says – We evaluated a large number of patients treated with braces and we verified that the number of hours of brace-wearing was the primary predictive factor of the result. We thus demonstrated that the high dosage of wearing protects more and should be raised proportionally to the severity of the curves’.
Furthermore, Prof. Stefano Negrini, ISICO’s scientific director, will talk about brace therapy and patient compliance in a special session, Current trends in bracing for AIS, while we also will have the opportunity to present the preliminary results of the first phase of research (two years) on the Scoliosis Natural History funded by the SRS itself, aimed at identifying a predictive model about the evolution of scoliotic curves in untreated patients.

Eurospine 2018: ISICO will present two studies

At the International Eurospine Congress in Barcelona, 19 to 21 September, Dr. Fabio Zaina will present a poster titled Adolescent idiopathic bracing success rates influenced by time in brace: Comparative effectiveness analysis of the BrAIST and ISICO cohorts, while Dr. Francesca Di Felice will deliver an oral presentation about the study, ISYQOL discriminates adolescents with spinal deformities subgroups better than the SRS-22 questionnaire.


‘The first presentation confirms the effectiveness of the brace treatment for patients with adolescent idiopathic scoliosis at high risk of progression, the efficacy being highly linked to the brace-wearing dosages,’ explains Dr. Di Felice. ‘The final results obtained with the protocols of the ISICO treatment are excellent, also with respect to the data of the BrAIST, the American RCT study which had and has a huge weight in demonstrating the efficacy of the conservative treatment of scoliosis.’
The other study emphasizes how a questionnaire developed in ISICO, the ISYQOL (Italian Spine Youth Quality of Life questionnaire) has proved to be the best quality of life measurement tool for patients with vertebral deformities treated with conservative therapy, compared to the SRS-22, which is currently the gold standard of the quality of life questionnaires for scoliotic subjects.

Sosort Congress: Isico in front row

Sosort Congress: Isico in front row

There was a massive presence of ISICO specialists at the 13th edition of the International Congress of the Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) which took place in Dubrovnik, Croatia from 19–21 April.

Over 250 specialists from 38 different countries were present over the various days, while 200 participants took part in the pre-courses, one day prior to the official congress with the topic being clinical approach and research.

“We have presented seven different research papers, for sure we were the group with the largest number of studies”, said Dr. Fabio Zaina, ISICO specialist and SOSORT Past President, “and we were also nominated for the SOSORT Award. Our research concerning the quality of life of braced patients has attracted great interest, a quality that has been measured through the questionnaire we normally hand over in ISICO to our patients. The questionnaire was translated into English and Spanish for this congress and its use is also going to be spread abroad now.”

Among the studies presented we also received positive feedback for our study on scoliosis and adults that showed how the exercises can give results on pain management, for the study with the topic of back pain in children, and for the one that highlighted how sports can have positive effects on scoliosis.

During the congress, our technical director Dr. Michele Romano, passed the baton of presidency to the new president of SOSORT, Luca Stikeleather from the USA, the first orthopedic technician to take on this task.

New Guidelines

A systematic review of all scientific literature published by leading experts on the treatment of scoliosis led to the recent publication in the journal Scoliosis and Spinal Disorders of the new international guidelines drafted by the International Society for the Treatment of Scoliosis (SOSORT). The previous review was conducted in 2011, while the first publication dates back to 2005.

Among the 21 authors, from countries such as the United States, Canada, Japan, Germany, Spain, France, Poland, Greece, ISICO represented the largest group with Prof. Stefano Negrini, Scientific Director of ISICO, Dr. Fabio Zaina, Dr. Sabrina Donzelli, and Dr. Michele Romano, Technical Director of ISICO.

“We started from a review of the studies on everything related to the subject of scoliosis, from definitions to therapeutic goals and from the examinations to be carried out, to exercises, to braces and lastly to screening”, explains Dr. Sabrina Donzelli, physiatrist at ISICO, among the authors of the guidelines, “in this way, starting from the available scientific evidence, therapeutic recommendations have been elaborated, summarized in tables, which represent a fundamental tool able to guide the clinician in the ideal therapeutic choices for each patient.”

Tables are an important tool in the treatment of scoliosis as they allow the definition of therapeutic levels with respect to the age or entity of the pathology, e.g. the treatment can range from simple observation of minimum curves to the recommendation to wear a brace for up to 24 hours.

“It is a document of great importance for all professionals in the treatment of scoliosis”, continues Dr. Donzelli, “available online, in English, useful even for patients and their families. Considering the immense amount of work that is behind the guidelines, it was decided to divide in the future next editions into sub-chapters, for example scoliosis in adults, braces only, or exercises only.”

“To conclude, I would like to underline that the recommendations of the guidelines”, Dr. Donzelli tells us, “must always be accompanied by the experience of the professional team, from the doctor to the orthopedic technician, as scoliosis is a complex pathology. The guidelines recommend that scoliosis should always be treated by experienced professionals. The experience of each professional is defined by a minimum number of visits and patients that must be visited/treated each year. The guidelines also recommend using therapies in which one is skilled in order to guarantee better patient management and promote therapeutic success.”