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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”. 

Bracing adults with scoliosis: a new published study

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The research paper “Bracing adults with chronic low back pain secondary to severe scoliosis: six months results of a prospective pilot study”, has just been published by the European Spine Journal.
It is one of the few articles published in the literature on the use of braces for adults affected by scoliosis. Although scoliosis has been estimated to affect up to 68% of the population over 60, there is scant literature about conservative treatment for adult scoliosis.
While during growth, the main concern is aesthetic, with a quite good quality of life and pain is quite unusual, backache characterizes adult scoliotic patients.

“For our research, we took into account twenty adults with chronic low back pain (cLBP) secondary to Idiopathic Scoliosis (IS) – explains dr Fabio Zaina, a specialized physiatrist of Isico and the author of the publication – Patients were evaluated at baseline immediately before starting with the brace and after six months. We have used a new brace, called “Peak”, designed to alleviate pain for adult patients with chronic pain secondary to scoliosis.”

The objective of the study was to test the efficacy of a prefabricated brace in reducing pain in adult scoliosis patients because the quality of life and pain are the main reason for seeking treatment. 
Patients, especially women with severe scoliosis, wore the brace for a few hours, from 2 to 4, a day: “This study has some shortcomings: including a limited number of females only patients, as well as not having a control group. It would have been interesting to compare this group with those who refused to wear the brace or to another similar group that only did exercises – ends dr Zaina – from the data collected, we found an initial impact on pain reduction, none instead on the quality of life according to the questionnaires filled in by patients. Considering that the extension of follow-up produced improved results, our recommendation could be to pursue the part-time brace-wearing permanently. Starting with such a short period of brace wear (2–4 h per day) would also allow the expert clinicians to increase the dosage in case of need”.

Scoliosis: is aesthetics measurable?

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When it comes to scoliosis therapy, aesthetics is one of the goals along with a healthy back.

Aesthetic deformity due to scoliosis and its impact on the patient is considered by the members of SOSORT (International Society On Scoliosis Orthopaedic and Rehabilitation Treatment) as the most important reason for treating AIS; unfortunately, only a few of scoliosis studies were found in PubMed on this topic. 

But can a goal, apparently so subjective, be measurable in a repeatable way to become objective? Yes,according to the data collected by the study Reliability, repeatability and comparison to normal of a set of new stereophotogrammetric parameters to detect trunk asymmetries, recently published by the Journal of BIOLOGICAL REGULATORS & Homeostatic Agents. 

“Aesthetic impairment is a crucial issue in Adolescent Idiopathic Scoliosis (AIS), but to date no objective measurements are available – states Dr Francesco Negrini, Isico physiatrist – for our research, we used the Formetric®, which we usually use to measure sagittal planes. We have established parameters for evaluating symmetries in patients, such as those of the shoulder blades or hips, to obtain objective data related to the aesthetic aspect. In order to validate this instrument for clinical practice, the first step and aim of this study are to evaluate the repeatability of the parameters measured by surface topography in a group of AIS subjects and to test if they can distinguish healthy subjects from AIS patients to develop an objective tool for deformity evaluation of the trunk in AIS patients. For our evaluations, we used a device for surface topography based on the principles of rasterstereography. This device (Formetric®, Diers Biomedical Solutions) can reconstruct digitally in three dimensions the back of any person”.

The study evaluated 15 selected parameters that could be good predictors of scoliosis’ impact on the patients’ trunk.
“We analysed short-term (30 seconds, 38 subjects) and medium-term (90 minutes, 14 subjects) repeatability of surface topography measures and their diagnostic validity in AIS (74 subjects, 33 AIS patients and 41 healthy subjects) – proceeds Dr Negrini – All examined parameters were highly correlated as far as short, and medium-term repeatability is concerned”. 

When it comes to aesthetics we cannot stop at Cobb degrees alone, believing that there is no objective measure: “Symmetries can be measured repetitively, as we did in our study – concludes Dr Negrini – so we can offer an objective measurement of aesthetics in patients with idiopathic scoliosis. The surface topography showed good repeatability. Moreover, some of its parameters are correlated with scoliosis, showing that it could very well evaluate deformity due to this pathology. Thanks to these findings, it will be possible to develop a tool that can objectively evaluate aesthetics in AIS patients.”.

Interrater reliability of three-dimensional reconstruction of the spine : Low-dose stereoradiography for evaluating bracing in adolescent idiopathic scoliosis

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Every year, the Italian Scoliosis Study Group selects the best published papers on conservative spine treatment from the global scientific literature.
Here is the abstract from one of these papers. 

Interrater reliability of three-dimensional reconstruction of the spine : Low-dose stereoradiography for evaluating bracing in adolescent idiopathic scoliosis.

Almansour H1, Pepke W1, Rehm J2, Bruckner T3, Spira D2, Akbar M4

Orthopade. 2020 Apr;49(4):350-358. doi: 10.1007/s00132-019-03712-x.

BACKGROUND 

Bracing constitutes the mainstay treatment for mild scoliosis. The 3D reconstruction of the spine using low-dose stereoradiographic imaging (LSI) is increasingly being used to determine the true shape of the deformity and to assess the success of bracing.

OBJECTIVE 

The aim of the study was to validate the measurement of 3D spinopelvic parameters and vertebral rotation in the setting of bracing treatment via a reliability study conducted in adherence to the guidelines for reporting reliability and agreement studies (GRRAS).

MATERIAL AND METHODS 

Full spine stereoradiographs of patients with adolescent idiopathic scoliosis (AIS) who underwent Chêneau bracing were retrospectively analyzed. The 3D reconstruction was performed by two experienced operators in a blinded manner and randomized order. Rotation of every vertebra was computed in the coronal, sagittal and axial planes. Sagittal spinopelvic parameters were evaluated. All measurements were statistically compared to determine agreement of the measurement of brace correction using the intraclass correlation coefficient (ICC).

RESULTS 

In this study, 45 patients (81% females) aged 12.5 ± 2 years were included. The mean absolute difference was less than 3.5° for all measured angles, less than 4 mm for sagittal vertical axis (SVA) and less than 1.5 mm for lateral pelvic shift. The ICC was high for all parameters (ICC >0.81). Despite the overall high reliability, the reliability of axial rotation was lower in the upper and middle thoracic spine and the lower lumbar spine.

CONCLUSION

Brace wearing during full spine LSI acquisition does not affect spinal measurements. The LSI under bracing treatment produces reliable measurements of spinopelvic parameters as well as vertebral rotation. These reproducible 3D data enable spine surgeons to assess the true shape of the deformity, to quantify rotation of each vertebra and enhance the understanding of the efficacy of bracing treatment.

 https://www.ncbi.nlm.nih.gov/pubmed/30899991

Prevalence of the thoracic scoliosis in children and adolescents candidates for strabismus surgery: results from a 1935-patient cross-sectional study in China.

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Every year, the Italian Scoliosis Study Group selects the best published papers on conservative spine treatment from the global scientific literature.
Here is the abstract from one of these papers. 

Prevalence of the thoracic scoliosis in children and adolescents candidates for strabismus surgery: results from a 1935-patient cross-sectional study in China.

Pan XX, Huang CA, Lin JL, Zhang ZJ, Shi YF, Chen BD, Zhang HW, Dai ZY, Yu XP, Wang XY.

Eur Spine J. 2020 Apr;29(4):786-793. doi: 10.1007/s00586-020-06341-7. Epub 2020 Feb 28.

PURPOSE 

No study so far has paid attention to strabismus-related spinal imbalance. This study aimed to determine the epidemiology of thoracic scoliosis in children and adolescents with strabismus and investigate the association of two diseases.

METHODS AND DESIGN

A cross-sectional study. Study group consists of 1935 consecutive candidates for strabismus surgery (4-18 years); Control group consists of the age- and sex-matched patients with respiratory diseases. All subjects underwent a screening program based on chest plain radiographs using the Cobb method. Their demographic information, clinical variables and results of Cobb angle were recorded and analyzed.

RESULTS 

A significantly higher prevalence of thoracic scoliosis (289/1935, 14.94% versus 58/1935, 3.00%) was found in study group compared with control group. Among strabismic patients, the coronal thoracic scoliosis curve mainly distributed in right and in main thoracic (198/289) and in the curves 10°-19° (224/289); Age range 7-9 years (103/1935), female (179/1935) and concomitant exotropia patients (159/851) were more likely to have thoracic scoliosis. According to the logistic regression, thoracic scoliosis had no significant association with age, BMI, duration of illness and onset age (p > 0.05). However, gender, BCVA, type of strabismus and degree of strabismus showed a significant relationship with the prevalence of thoracic scoliosis (p < 0.05).

CONCLUSIONS

With a pooled prevalence of 14.94%, strabismus patients showed a great higher risk of developing thoracic scoliosis. Screening for scoliosis in strabismus patients can be helpful to discover a high prevalence of potential coronal scoliosis. More attention should be paid to ophthalmological problems in patients with scoliosis. These slides can be retrieved under Electronic Supplementary Material.

Bracing works better in Italy

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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”.

The criteria for evaluation of aesthetics in scoliosis

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Our study “Construct validity of the Trunk Aesthetic Clinical Evaluation (TRACE) in young people with idiopathic scoliosis” has recently been published by the journal Annals of Physical and Rehabilitation Medicine.

The aim of this study? Scientifically validate the criteria of evaluation of aesthetics in scoliosis.

Indeed, we recall that aesthetics is recognized as a main outcome in idiopathic scoliosis (IS) treatment, but to date, there are no standard criteria for physicians’ evaluation.

Trunk Aesthetic Clinical Evaluation (TRACE) is a simple 12-point ordinal scale to quantify symmetry as a proxy of aesthetics. TRACE is already diffused worldwide and has been used in clinical research.

” In our study, that included 1553 participants (1334 females, mean age 13 years old), we aimed to validate TRACE and improve it with Rasch analysis – explains prof. Stefano Negrini, Scientific Director of Isico – the statistical technique allows to make more precise measurements.
Let’s take the temperature measurement as an example: is it hot, warm, medium, or a little cold? With this type of analysis we develop a real thermometer, obtaining a numerical data. The same criterion is applied to the measurement of the aesthetics, reliably and effectively, as well as objective because it derives from external observation and not simply from what the patient reports “.


The TRACE ordinal scale has been converted into a Rasch-consistent, interval-level measure of trunk aesthetics in IS patients and can be used to compare different populations.

“TRACE can be used as an outcome measure and in everyday clinical evaluation of IS, even if new developments of the scale are advised – ends prof. Negrini – It is an objective tool, the only one up to now in the literature. The benchmark for the aesthetics in scoliosis which we want to improve more and more with use”