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Brace wearing: tenacity is rewarded with improvements

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 closer look at the data

The study just published, A Pragmatic Benchmarking Study of an Evidence-Based Personalised Approach in 1938 Adolescents with High-Risk Idiopathic Scoliosis, focused on 1938 participants with AIS, Cobb angles of 11–45°, and Risser stage 0–2, who were studied until the end of growth. 

Using the inclusion criteria reported in existing RCTs on physiotherapeutic scoliosis-specific exercises (PSSE), plastic bracing (PB), and elastic bracing (EB), we benchmarked 590, 687, and 884 members of our study population, respectively.
The study showed EBPA to be from 40% to 70% more effective than benchmarked individual treatments, with a low number needed to treat (NNT). 

“We evaluated clinically significant results and burdensomeness of care, calculating the relative risk of success and the NNT for efficacy”, explains Dr Sabrina Donzelli, Isico physiatrist who contributed to the data analysis. “In randomised studies, patients are randomly allocated to one treatment or another, to ensure that all patients have the same probability of being treated or observed. This randomisation process is necessary to rule out factors (such as physician choice of treatment) that could affect the outcome. We compared our PB, EB, and PSSE subgroups with the corresponding paired RCTs for benchmarking purposes. The probability of success in patients treated in EBPA is between 1.5 and 3.5 times that of natural history and between 1.2 and 2.9 when compared to per-protocol treated groups. Although surgery could not be avoided completely, only 2% of our patients ultimately needed it, compared with 28% of those belonging to the comparison studies’ untreated control groups”.

Patient compliance is the factor underlying the significant difference in these results. 

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.

Bracing works better in Italy

Bracing treatment reduces the risk of needing surgery, but the proportion of patients who manage to avoid the scalpel differs between Europe and North America. The factor that makes the difference is patient compliance, i.e. a patient’s adherence to, and belief in, the course of bracing treatment prescribed. In this regard, Italian patients certainly come out on top. 
This is what emerged from a study conducted by ISICO entitled “AIS Bracing Success is Influenced by Time in Brace: Comparative Effectiveness Analysis of BrAIST and ISICO Cohorts”, which has just been published in the scientific journal Spine.

The study was based on a comparison of two populations of patients at high risk of surgery, which showed that, after bracing treatment, 39% of US patients go on to have surgery, as opposed to just 12% of patients treated by ISICO. The Italian institute sent clinical data referring to patients seen by its specialists to the University of Iowa, so that these data might be compared with those obtained in previous research published by the American group in 2014. 

“We worked in collaboration with the researchers at the University of Iowa” explains Dr Sabrina Donzelli, ISICO physician and author of the paper. “In 2014, our American colleagues published a randomized controlled multicentre trial called the “Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST)”. The resulting paper, by Lori Dolan and Stuart Weinstein, was published in the New England Journal of Medicine. Their study, the most important on this topic in the past 30 years, involved 383 patients from 25 US and Canadian institutes studied between March 2007 and February 2011. It showed that brace treatment reduced the percentage of patients requiring surgery. Given that surgeons and families in North America have always had a rather negative attitude towards bracing (unlike those in Europe, where it is well received), the authors were surprised by this finding. We took the results of the BrAIST study as the starting point for our research, comparing them with our own data. Working with our American colleagues, we selected patient subpopulations comparable for disease severity and risk of surgery”.

This comparison was a demanding task requiring clarity: the Italian researchers and the American surgeons from the Children’s Hospital of Iowa measured the radiographs of the patients from the BrAIST study and of 169 patients being treated at ISICO, in order to objectively verify the data. 
What did the comparison show? That bracing treatment at Isico works better, with the proportion of at-risk Italian patients who actually had surgery found to be just a third of the proportion recorded in the American population (12% vs 39%). It also emerged that the ISICO patients, respecting the treatment prescribed, wore their brace for a far greater number of hours than their American counterparts.

“Patient compliance is crucial,” Dr Donzelli continues “Our patients are careful to respect their doctor’s prescriptions, and the doctors and patients enjoy a good relationship based on mutual trust and faith in the proposed treatment. All this adds up to great teamwork between the patient, his/her family, the doctor, the orthopaedic technician and the physiotherapist”.