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The winning study of the SOSORT Award 2020 has been published

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Two years after winning the SOSORT AWARD, the study “Predicting final results of Brace Treatment of Adolescents with Idiopathic Scoliosis: First Out-of-Brace are Better than In-Brace-radiographs” has finally been published in the European Spine Journal.

 A total of 131 patients were included in the study, the researchers aimed to determine which of the two radiographs is the best predictor of the Cobb angle at the end of treatment (final radiograph). In fact, the in-brace radiograph of adolescents with idiopathic scoliosis (AIS) has been shown to reflect brace efficacy and the possibility of achieving curve correction. Conversely, the first out-of-brace radiograph could demonstrate the patient’s ability to maintain the correction.

The first out-of-brace radiograph predicts end results better than the in-brace radiograph.

“Our research has highlighted – explains Dr. Sabrina Donzelli, author of the research – how important the first x-ray taken without the brace is in predicting end-of-care results. The first out-of-brace radiograph should be considered an essential element of future predictive models and offers an excellent clinical reference for clinicians and patients. The collection of clinical data that occurs routinely during all visits to ISICO has allowed in recent years to be able to develop the so-called predictive models, i.e. we can use the characteristics of the patient to understand how the final results can be predicted or to understand if there are risk factors more important than others to consider when deciding what type of therapy to prescribe “.

The experts’ brace-classification : a newly pusblished study with video-commentary

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Studies have shown that brace treatment for AIS is effective but not all braces are the same. The classification of scoliosis braces developed by SOSORT with SRS, ISPO, and POSNA and approved by ESPRM, a study just published by The European Spine Journal, aims to produce a classification of the brace types.Studies have shown that brace treatment for AIS is effective but not all braces are the same. The classification of scoliosis braces developed by SOSORT with SRS, ISPO, and POSNA and approved by ESPRM, a study just published by The European Spine Journal, aims to produce a classification of the brace types.
Four scientific societies (SOSORT, SRS, ISPO, and POSNA) invited all their members to be part of the study. Six level 1 experts developed the initial classifications. At a consensus meeting with 26 other experts and societies’ officials, thematic analysis and general discussion allowed to define the classification (minimum 80% agreement).
The classification was applied to the braces published in the literature and officially approved by the 4 scientific societies and by ESPRM.
There are substantial differences in results published in the literature: one of the factors impairing research and leading to clinical confusion in the field is the absence of a classification to understand differences and commonalities among braces.
The only existing classification is common to all other orthoses, which is to classify braces according to the anatomical joints held underneath the brace—in the spine, these are the trunk regions. Unfortunately, according to this classification, almost all braces for spinal deformities fall in the thoracolumbosacral orthosis (TLSO) category, without other differentiations included.
As a result, clinicians cannot generalize research results on one brace to another with the same biomechanical action. Even worse, we could be inaccurately generalizing data on one brace to another brace with different biomechanical actions.
In this study the experts developed a definition for each item and were able to classify the 15 published braces into nine groups.
“This is the first edition of a brace classification that we expect to evolve further in future due to better understanding and more research – explains prof. Stefano Negrini, Scientific Director of Isico and first author of the article – It is based on expertise more than evidence, but we also must recognize that expertise is the first step of the pyramid of evidence when no better research data are available. Moreover, this expertise is shared worldwide among some of the best brace experts. The involvement and support of the leading scientific societies in the field should guarantee its dissemination”.
Watch the short video commentary of Prof. Stefano Negrini about the published study for our Isico Science corner video column

Brace wearing: tenacity is rewarded with improvements

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It is not just a question of how many hours the brace is worn but also 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 for 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 avoid worsening.

Our study demonstrates this, Consistent and regular daily wearing improves bracing results: a case-control study published in the journal Scoliosis and Spinal Disorders some years ago. 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 using 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 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; fewer hours one day and then recovering the lost hours in the following days is not ideal!

In addition to not adhering to the prescribed treatment, patients who 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, is rewarded”. 

A judo champion in brace

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My name is Giulia. I live in Genoa, and I am in my third year of Middle School. I am just like many other girls: I have my friends, I love the sea in summer, and I have my hobbies and interests, the main one being judo. 

In January 2020, I was diagnosed with idiopathic scoliosis. My parents requested several consultations before we ended up at ISICO.

It was a challenging and upsetting process for me and my parents, who struggled to know the best course of action to take.

To begin with, my treatment was just daily exercises: every month, I had a session with my physiotherapist, Martina, and every four months, a medical check-up with Dr Fabio Zaina, a physiatrist at ISICO.

It was quite a tough period because I had to do my exercises every day, regardless of homework, daily judo training, and holidays. When each check-up came around, I would get really anxious about what my curve would measure.

In April this year, it was found to have gotten worse, and Dr Zaina prescribed a brace. At first, I didn’t take it very well, as I started thinking about everything this would stop me from doing. I was thinking about my sport, my summer, going to the sea, and so on. My family were alarmed, too, but we soon calmed down thanks to Martina’s support.

It only seems like yesterday when Mum and I went to the orthopaedic office to collect my brace. I remember the tests and adjustments needed to make it feel as comfortable as possible. During the first “test run”, I really felt I couldn’t breathe and struggled to do even the most basic movements. Then, gradually, something seemed to change. Together with Mum, I started doing increasingly complex movements, like sitting down and getting up from benches in the play park close to where we live, walking faster and faster until I was doing short runs. By the end of that morning, it felt like my brace and I were getting to know each other: I was starting to adapt. The first night I managed to sleep quite well, and my new life began the following day. Luckily, my prescription was for 18 hours per day, so I could plan my days, concentrating all my sporting activities during my brace-off hours. 

In those early months, I started to measure this new situation, trying to set myself goals and then working to achieve them. I wanted to know how many things I could still do from my previous life with a brace on. 

So, I made a list and started to tick them off: walk to school with a backpack on; ride a bicycle; do a handstand (this one was pretty difficult); do a head-over-heels (I managed this after lots of tries). When the summer came, and I swapped sweatshirts for lighter clothes, I found myself having to try out new solutions and change my look a bit, opting for slightly looser T-shirts, but the brace wasn’t that obvious under them. And then, it was the school holidays.

Since I spend most of my summer on the beach, I had to rethink my brace-wearing schedule to fit some sun and sea into my brace-off hours and my training, which gets more intensive in the summer. To stick to the six hours allowed, I worked out a method that actually worked well: I decided that my brace-off hours would end exactly when my training sessions did and calculated them on that basis, counting back six hours to know exactly when they should start. At the allotted time, I would take off my brace and put on a costume to enjoy the sun and the waves. On the hottest days, though, even that solution seemed impossible, and after talking to Martina, I started removing the sensor from my brace so that I could also go in the sea with it on. Gradually, everything fell into place, and my everyday life became “easy” again, basically because I could still do pretty much everything I used to do. 

After a year’s break due to the pandemic, judo competitions started again. July brought the Italian Championships, my first ever. After taking part in, and winning, the regional qualifications, I went to Ostia for the national championships. I got through three matches and then won the final, which I was amazed about because I really hadn’t expected to. I automatically qualified for the next Italian Championships in November, thanks to that result.

The summer raced by, as there was so much going on – beach time, training, family holidays. Everything was just like normal!

In September, after returning to school, I started training for the new Italian Championships in November. I was to compete in the beginners’ B -40KG category: I was determined to defend the title I had won in the summer. So, I worked out a new daily plan, including school, gym sessions and free time, and threw myself headlong into this new challenge. 

On 14 November, I went back to Ostia, in some ways more excited than the first time but also more aware of the challenge I faced. Once again, I had four matches, and I retained my title as Italian champion in my category! I was even more thrilled than the first time because more athletes were competing on this occasion and, technically, the standard was higher. That was the day I realised that if you really want something and fight for it, nothing can stop you, even a problem like ours. We are just the same as everyone else!

When I first learned that I had to start wearing a brace, I read some of the stories of others like me fighting scoliosis. They said that your brace, in the end, becomes a kind of travelling companion, a friend who is always there for you throughout the day.  I didn’t really believe that, and I thought they were just words meant to encourage others like me.

But, you know, it really is true, and even though I would have preferred not to have to go through all this, it hasn’t stopped me from reaching the highest step on the podium and being happy!

Returning to physical activity after surgery for adolescent idiopathic scoliosis

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Sport and physical activity are essential for psychosocial and physical well-being in children and adolescents, and youngsters with scoliosis are not subject to any limitations in this regard: they can do sports and other physical activities just like their peers can.

In severe scoliosis, i.e., in individuals with curves measuring more than 50° and presenting significant aesthetic and developmental deformities despite undergoing orthotic/bracing treatment properly administered according to the SOSORT criteria, surgery is indicated. 

“In some cases, patients who undergo corrective surgery for scoliosis may reduce their level of physical activity postoperatively due to a loss of spinal flexibility and pain. This inevitably impacts negatively on their quality of life – says dr Carmelo Pulici, physiatrist – No guidelines have yet been published on the resumption of physical activity after surgery for adolescent idiopathic scoliosis, and “expert opinion” is therefore all we have to rely on. Consequently, different surgeons may give different indications, depending on their experience and the particular type of approach”.

There are also individual factors at play, and the decision to resume physical activity may therefore depend on: the type of surgery performed, how the body responds and adapts to the metal rods inserted to correct the spine, the extent of the fusion, how recently the surgery was carried out, the characteristics of the patient, and also the type of sport practised (non-contact, contact or collision).  

For example, while some surgeons allow contact sports to be resumed six months after surgery, others recommend waiting a year, and some even rule out the resumption of collision sports altogether (https://pubmed.ncbi.nlm.nih.gov/26920125/). 

“In one study, return to sport/physical activities after surgery was examined using a specially created questionnaire (https://pubmed.ncbi.nlm.nih.gov/28604495/). By six months, most patients had returned to the activities they did before the surgery” – explains Dr Pulici. “The authors found that patients returned to athletics much earlier than expected. Despite this, there were no cases of loss of correction, implant failure or complications among the 95 patients included in the study”. 

A new surgical technique

In recent years, there has been a growing interest in vertebral body tethering (VBT), a new surgical technique used only in children and in early adolescence and, even then, only in carefully selected patients, given that the method is still experimental. VBT is proposed as a possible alternative to spinal fusion (currently the most widely used technique for the surgical treatment of scoliosis). Unlike spinal fusion, it does not reduce the mobility of the spine. 

“According to a recent study, VBT allows daily activities and sports to be resumed within three months of the surgery” Dr Pulici goes on. “Furthermore, most of the patients examined in the study reported an improvement in their athletic performance, and some were found to be doing more sports than before undergoing VBT”.

Even though surgeons today tend to allow patients to return to sports (even high-intensity ones) earlier than in the past (https://pubmed.ncbi.nlm.nih.gov/34267153/), we are still a long way from seeing a common approach to the management of postoperative resumption of physical activity in this patient population.

In the absence of guidelines, we at Isico recommend that patients turn to an experienced therapist in the post-operative period to ensure a gradual and safe return to physical activity, obviously following the instructions received from their surgeon.

It is important to avoid falling into the vicious cycle of a sedentary lifestyle. The less active you are, the less you feel inclined to do physical activity and the greater the risks to your health due to your lack of movement.

A predictive model of scoliosis: the research will be published in 2022

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During these months, Isico carried out the study funded by the SRS (Research Society on Scoliosis), aimed at identifying a predictive model on the evolution of scoliotic curves in untreated patients, in collaboration with the University of Alberta, in Canada. Collected the data, presented preliminarily in March by Prof. Stefano Negrini, scientific director of Isico, in a webinar during the Research Grant Outcome Symposium organized by SRS, we moved to the writing phase of the study that will be published in 2022.
The radiographic measurements collected (we recall that the research included 431 patients with a diagnosis of JIS, below age 26, previously untreated) were used to create a model that allows predicting the curve’s progression.
“Let’s take an example – explains Dr Sabrina Donzelli, a physiatrist who is following the research – with an 8-year-old patient and a 20-degree curve, the equation derived from the sample allows us to calculate how much it will evolve in the first year from diagnosis. Another equation instead will predict the curve at the end of growth. To refine the prediction, the sample was then divided into different risk categories to estimate the potential progression in groups of patients different for age and risk of progressivity, based on the Risser. The models developed were then validated through artificial intelligence “.
In the article that will be published, the researchers will provide the equation that allows calculating the evolutionary potential of scoliosis.

ISICO evidence-based treatment decided in agreement with patient and family: the best solution

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How effective is a personalised scoliosis treatment, which means a treatment supported by clinical experience combined with available scientific evidence on risk factors; based on the specific therapeutic objective; and adapted to the patient’s particular needs to encourage compliance? In other words, how effective is the treatment approach adopted by Isico compared with a simplified protocol based on a single, standardised type of brace and a set number of brace-wearing hours? 

According to our study A Pragmatic Benchmarking Study of an Evidence-Based Personalised Approach in 1938 Adolescents with High-Risk Idiopathic Scoliosis, just published in the Journal of Clinical Medicine (link), the answer is hugely effective! 

Our study, featuring a retrospective observation of a prospective database, includes nearly 2000 patients from our centre, recruited between 2004 and 2017, and is therefore the largest on conservative treatment of scoliosis in the current literature. 

The evidence-based personalised approach (EBPA) for idiopathic scoliosis in adolescents (AIS), routinely adopted in clinical practice by Isico, was compared with data from existing randomised controlled trials (RCTs), as paradigms of single treatments, to verify EBPA efficacy and burdensomeness in high-risk AIS.

“We compared the results recorded by Isico, in terms of the probability of avoiding surgery, with those of two randomised studies: one conducted using SpineCor® the other based on the use of a rigid brace”, explains Prof. Stefano Negrini, scientific director of Isico and first author of the study.
“We found that an evidence-based and personalised approach like ours yielded far better results than standardised treatments where strict protocols are followed. This is because it combines evidence with physician expertise and consideration of the patient’s preferences. At Isico, every patient follows a unique and personalised treatment pathway, both in terms of the brace chosen — other centres instead tend to offer only the one they are most familiar with —, but also in terms of the dosing of the treatment (brace-wearing time): in short, we offer an “à la carte” approach that allows us to find exactly the right balance, for the patient, between a series of factors and considerations: the degree of invasiveness, the risk of progression, and the mutually agreed goals of the treatment. In this way, in line with the great importance nowadays attached to patient-centred care, it might be decided that the treatment should be only as burdensome as is strictly necessary, or as burdensome as the patient is willing to accept. Throughout, the patient is involved in the therapeutic decision-making process and also made to feel he/she is actively contributing to the pursuit of the final goal of treatment. All this is achieved in a stepwise manner, in such a way as to ensure we provide the most effective treatment with the lowest impact.”

To ensure informed and shared decisions, the treating physician systematically informed the participants about their clinical and aesthetic condition, their progression risk, and the significance of Cobb angle thresholds (30° and 50°) and how these could influence their health and possible results. We discussed alternatives: to either reduce the burdensomeness of the treatment or increase the probability of success.

In short, greater patient involvement was found to lead to greater compliance and better results, which is exactly what was shown by another study published by our group several years ago entitled Adolescent Idiopathic Bracing Success Rates Influenced by Time in Brace: Comparative Effectiveness Analysis of the BrAIST and ISICO Cohorts. 

“Back then, in that study, which compared our findings with those of the “BrAIST” randomised multicentre study by Lori Dolan and Stuart Weinstein, we were already showing that Isico treatment works better”, Prof. Negrini goes on. “Indeed, it reduced the rate of recourse to surgery to a third of that recorded in the American study: this is because Isico patients, adhering to the prescribed treatment, wear their brace for a far greater number of hours. And now, this latest, pragmatic, observational study of a large prospective cohort benchmarked to published RCTs has shown higher efficacy of EBPA compared with standardised protocols, to the point that only 2 % of our patients had surgery, compared with 28% of those in groups receiving standardised treatment. In addition to being initiated early on and prolonged over time, the treatment delivered by Isico is also carefully personalised based on the severity of the current condition and its risk of progressing. Accordingly, the treatment offered ranges from simple exercises to bracing, with the number of brace-wearing hours per day varying according to need. It is thus a stepwise approach that progresses from observation, through exercises, SpineCor®, rigid and super rigid bracing (at Isico, instead of plaster casts, we use the equally effective Sforzesco brace), and finally to surgery as a last resort. What explains the success of this treatment? Well, the team of experts of course, but above all the trust and cooperation we receive from our young patients and their families”.

Isico among the attendees of the November SRS webinar

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A new webinar for professionals is scheduled for November 7, part of the cycle of those organized in recent months by the SRS (available on the pages of the society’s website).

Two specialists from Isico, our scientific director, Prof. Stefano Negrini and Dr. Fabio Zaina, Isico physiatrist will be taking part in this online event titled Current Status of Bracing in Adults and Adolescents:An SRS-SOSORT Collaboration.

Join the SRS Non-Operative Committee and the Society on Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT) for a webinar analyzing the current evidence and practice guidelines for bracing for adolescent and adult patients with spinal deformity.

This webinar will provide a systematic analysis of the current evidence and best practice guidelines for bracing management of patients with spinal deformity in both adolescents and adults. With variations in brace design and documentation of long-term benefits, use the consensus discussed to clarify your current practice and brace selections.
There will be an update on the current training of Orthotists, including specialization, fabrication, fitting and deformity correction.

To register please visit the page of the SRS website

Digital Transformation at ISPO: Isico is there

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The theme of the international online conference of the International Society for Prosthetics and Orthotics (ISPO), scheduled from 1 to 4 November will be “Digital Transformation in an Evolving World”: the World Congress will explore how digital transformation affects all aspects of using and working with assistive technology, from booking a clinic appointment and electronic health records to computer-aided design, microprocessor-controlled prostheses or orthoses, or video conferencing and social media.

 During the event, Prof.Stefano Negrini, Scientific Director of Isico, will present one poster, Modular Effective as Custom-Made. A Matched Case-Control Study of Modular Italian MI-brace vs Very-Rigid Sforzesco Brace in AIS” and two oral presentations “Introducing Pelvis Semi-Rigid Material does not change Short-Term Very-Rigid Sforzesco Brace Results. A Matched Case-Control Study in AIS” and “Reducing the Pelvis Constriction Changes the Sagittal Plane. A Retrospective Case-Control Study of Free Pelvis vs Classical Very-Rigid Sforzesco Braces”. 

Furthermore, Prof. Negrini will also hold a workshop on November 2nd on Innovations in the Design of Hard Rigid Braces for Adolescent Idiopathic Scoliosis Treatment in collaboration with Guerrino Rosellini and Fabrizio Tessadri of the orthotist’s shops ITOP and Orthotecnica.

Can bracing improve trunk asymmetries in young adults?

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Scoliosis is a condition characterised by the presence of a vertebral deformity in the three planes of space. The extent to which this deformity is visible externally varies from case to case. As stated in the guidelines recently developed by SOSORT, one of the primary objectives of scoliosis rehabilitation treatment is to improve trunk asymmetries. Achieving this objective has important implications for quality of life — after all, having a positive self-image helps to ensure a good level of psychological wellbeing and this, in turn, translates into a better quality of life.

Not uncommonly, adolescents with scoliosis lack the willpower or motivation to undertake bracing treatment, or perhaps have never had a medical specialist recommend it to them; others, quite simply, may not even have realised that they had scoliosis.
Basically, many different factors can affect what scoliosis treatment a person received, or did not receive, in adolescence. But the fact is that some people reach adulthood before realising, for example, that they have one waist straighter than the other, that part of their rib cage protrudes, or that one breast is higher than the other.

What can be done to improve these asymmetries?

“Although there is no scientific evidence available to help us answer this question with precision, we at ISICO have performed some bracing treatments in young adults (up to 25 years of age) – explains dr Fabio Zaina, physiatrist – In such cases, our doctors, during the consultation, are clear from the outset: this is a long and demanding course of treatment. For the first few months, the brace should be worn full time, i.e., for 23 hours a day, after which the brace-wearing time is reduced very gradually in an effort to maintain the results obtained”.

Patients wanting to start bracing must be absolutely convinced about it and highly motivated, too, because any sudden interruption of the treatment, without respecting the abovementioned weaning-off phase, can negatively affect the stability of the spine.

On the subject of stability, we should also point out that bracing treatment must always be combined with specific exercises based on self-correction. The purpose of these exercises is to keep the back muscles strong and teach the patient how to keep their trunk correctly positioned during the various activities of daily life.

Can adults obtain a radiographic improvement?

Unfortunately, radiographic improvements cannot be achieved in adulthood. In individuals who have reached full skeletal maturity, bracing is never proposed with this aim in mind.

In other words, bracing in adults can improve the external asymmetries related to the scoliotic curves, but it cannot reduce the Cobb degrees of the curves themselves.

Are there no other options available for adults who are reluctant to wear a brace?  

“Adults can always follow a specific physiotherapy programme based on self-correction exercises – explains Valentina Premoli, physiotherapist- These exercises are a way to act on the postural component of scoliosis. They serve to counteract the spine’s tendency to collapse to one side, and can thus improve the functioning of the back generally. This type of treatment helps to limit the worsening of the asymmetries that accompanies the spine’s tendency to give way in the direction of the curves — a tendency that becomes increasingly marked as we get older”.