Tag: BRAIST

Scoliosis awareness and the BrAIST study

Posted on May 27, 2021 by - Blog

Scoliosis awareness month is almost upon us, and as usual, we’d like to take the opportunity to draw attention not only to the condition but also to the importance of ongoing research. Scoliosis awareness month, for those who don’t know, takes place in June each year – with International Scoliosis Awareness Day on the last Saturday of each June.

While Scoliosis awareness day is a great opportunity for fund and awareness-raising events, National Scoliosis Awareness Month runs throughout June and aims, in particular, to highlight the growing need for education, early detection and awareness to the public about scoliosis and its prevalence within the community.

According to the scoliosis research society, the organisers of National Scoliosis Awareness Month, its official objectives are:

  • Using the results from the BrAIST Study, highlight the importance of early detection and the effectiveness of bracing as early, non-operative care.
  • Increase public awareness of scoliosis and related spinal conditions through educational and advocacy campaigns of local activities, and community events during the month of June.
  • Unite scoliosis patients, families, physicians, and clinicians in a collaborative partnership that educate, and advocate, for patient care, patient screening, patient privacy, and patient protection
  • Build networks of community collaborations and alliances to help sustain and grow the campaign[1]

 

It’s the BrAIST study – an important landmark for scoliosis research and treatment which we’d like to discuss today.

 

The BrAIST study

The BrAIST study, overseen by Dr Stuart Weinstein and published in 2013, was perhaps the most impactful study showing the efficacy of bracing in treating scoliosis cases.  In short, the study proved that bracing of adolescents with moderate scoliosis was an effective treatment in the reduction of the number of patients who advance to the need for surgery. In addition, a dose-response was found between the number of hours of brace wear and the success rate of bracing – which is to say, there’s a strong relationship between how long a brace is worn, and how effective the treatment is. Both are critical points when considering the value of scoliosis bracing as a whole.[2]

Unlike many of the smaller studies which inform our understanding of scoliosis and best practice in treating it, the BrAIST study was coordinated between several medical centres, and allowed the highest level of medical study, a randomized clinical trial, to be undertaken. To answer the question of whether bracing is effective in growing children and adolescents with curves.

During the study,  242 patients with curves between 20 – 40 degrees participated.  Patients in the bracing group were assigned to wear a brace 18 hours per day (a typical bracing prescription).  A special monitor was embedded in the brace to keep track of how long it was used per day.  Patients in the observation-only group received no additional treatment.  The endpoint of the study was “treatment failure” defined as progression of the scoliosis to 50 degrees or “treatment success” when skeletal maturity was reached without progression to 50 degrees.

Across the survey group, 72% of brace wearers avoided surgical recommendations, but only 48% of patients in the observational group did the same. Furthermore, however, it was also shown that patients who complied fully with their bracing instructions, and wore the brace for 13 hours or more was greater than 90%, showing both that the amount of time the brace is worn is very important and that the results we can expect with solid compliance are fantastic indeed. The study, therefore, provided strong evidence to the value of brace treatment for those adolescents at high risk of progression of surgery.

 

Why the BrAIST study matters.

The BrAIST study was notable due to its size – a large sample set, its nature – a fully randomised clinical trial and the credentials of its authors – a range of expert Doctors. The impact of the BrAIST study was therefore to provide solid evidence not only for non-surgical treatment but also against the “wait and see” attitude which has existed towards scoliosis for decades.

In the past, the value of a screening examination for scoliosis has been debated due to inconclusive evidence of the success of non-operative treatment for scoliosis – simply put, without strong evidence to show it’s possible to avoid surgery, why screen, and why bother?

Thanks to the BrAIST study, this is no longer true.  It shows that early screening and non-surgical treatment may reduce the number of patients who progress to surgery and, therefore, could serve as a potential cost saving for the health care system and of great benefit to patients. According to the study, Policy statements from professional organizations and governmental agencies regarding scoliosis screening in school programs and primary care settings will need to be reassessed in order to identify at-risk patients who will benefit from bracing for scoliosis[3].

And it’s this final point that highlights why scoliosis awareness month and the BrAIST study now matter more than ever – it’s 2021, and there’s no sign of the UK government even considering screening in schools for scoliosis, and, despite many organisations best efforts, the majority of people are still unaware of scoliosis, and it’s possible treatments.

That’s why this scoliosis awareness month, we invite you to help us spread the word – and, for your own knowledge, take just a moment to read the conclusions from the BrAIST study – you can find it here and read the abstract in about 3 minutes.

Over the next month, we’ll be posting articles about different kinds of scoliosis, how to spot them and what the treatment options could be – keep an eye out and help us to raise awareness throughout June!

 

[1] https://www.srs.org/patients-and-families/additional-scoliosis-resources/scoliosis-awareness-month

[2]     Stuart L. Weinstein, M.D., Lori A. Dolan, Ph.D., James G. Wright, M.D., M.P.H., and Matthew B. Dobbs, M.D. Effects of Bracing in Adolescents with Idiopathic Scoliosis, N Engl J Med 2013; 369:1512-1521

[3] Stuart L. Weinstein, M.D., Lori A. Dolan, Ph.D., James G. Wright, M.D., M.P.H., and Matthew B. Dobbs, M.D. Effects of Bracing in Adolescents with Idiopathic Scoliosis, N Engl J Med 2013; 369:1512-1521

Is bracing an effective treatment for Adolescent Idiopathic Scoliosis? BRAIST study says yes!

Posted on July 9, 2018 by - Blog

Adolescent idiopathic scoliosis is characterized by a lateral curvature of the spine, with a Cobb angle of more than 10 degrees and vertebral rotation. Scoliosis develops in approximately 3% of children younger than 16 years of age, although rates of Scoliosis are typically much higher amongst at-risk groups such as dancers and gymnasts.  Curves larger than 50 degrees are typically associated with a high risk of continued worsening throughout adulthood and thus are most likely to be recommended for a surgical procedure.[1]

Scolibrace

Our Scolibrace is comfortable, effective and low-profile

Treatment with rigid bracing (thoracolumbosacral orthosis or TLSO) is the most common non-surgical treatment for the prevention of curve progression. There are many different brace designs, but with all of them, the objective is to restore the normal contours and alignment of the spine while preventing scoliosis progression. The most effective designs (like our Scolibrace system) seek to deliver superior outcomes by providing active correction of the curve.

But is bracing effective?  – Today you’ll still find some practitioners who are unclear on the outcomes you can expect from bracing. This is because although historical studies of bracing in adolescent idiopathic scoliosis had suggested that bracing decreases the risk of curve progression.[2] in some of these earlier studies results were inconsistent, the studies were observational, and only one prospective study enrolled both patients who underwent bracing and those who did not.[3] Thus, for some time the effect of bracing on curve progression and rate of surgery was unclear. This all changed thanks to the Bracing in Adolescent Idiopathic Scoliosis Trial (BRAIST), which finally determined the effectiveness of bracing – as compared with observation – in preventing progression of the curve to 50 degrees or more.

The BRAIST study was a large-scale endeavour, conducted in 25 institutions across the United States and Canada. Enrolment began in March 2007.  The target population for this study was patients with high-risk adolescent idiopathic scoliosis who met current indications for brace treatment – specifically this meant an age of 10 to 15 years, skeletal immaturity and a Cobb angle for the largest curve of 20 to 40 degrees.[4] To be eligible, patients could not have received previous treatment for adolescent idiopathic scoliosis.

 

Methods

During the BRAIST study, patients in the observation group received no specific treatment, whereas patients in the bracing group received a rigid brace, prescribed to be worn for a minimum of 18 hours per day. Participating centres prescribed the type of brace used in their normal clinical practice. Wear time was determined by means of a temperature logger embedded in the brace and programmed to log the date, time, and temperature every 15 minutes. A temperature of 28.0°C (82.4°F) or higher[5] indicated that the brace was being worn.

Both patients and clinicians were aware of the assigned treatment. However, all radiographic (x-ray) evaluations and outcome determinations which were made at the conclusion of the study were performed by experts without knowledge of the treatment protocol, to avoid bias.

 

Results

During the study, a total of 146 patients (60%) received a brace, and 96 (40%) underwent observation only. The two study groups were generally similar with respect to baseline characteristics, except that the patients in the bracing group were slightly taller on average than those in the observation group (156.5 cm vs. 153.6 cm).

The results shown at the end of the study were conclusive – the rate of treatment success was 72% in the bracing group and 48% in the observation group. By contrast, the rate of treatment failure was only 25% with bracing, but 58% with observation alone.[6]

Therefore, given a large sample set and a study carried out across reputable institutions, it was determined that adolescents with idiopathic scoliosis who were considered to be at high risk for curve progression that would eventually warrant surgery, bracing was associated with a significantly greater likelihood of reaching skeletal maturity with a curve of less than 50 degrees, as compared with observation alone.

The study also showed a significant association between the average hours of daily brace wear and the likelihood of a successful outcome. These findings corroborate those of previous prospective observational studies, which have shown a significantly lower rate of surgery among patients who wore a brace than among those who were untreated[7]and a strong relationship between wear time and outcome.[8]

 

Our analysis

The BRAIST study is without a doubt one of the most important pieces of research which informs our work here at the clinic. Since we’re strongly committed to providing the latest, most up to date treatment methodologies available we welcome any and all research which can assist us in fine turning our approach to non-surgical scoliosis treatment.

BRAIST has shown conclusively that bracing is an effective way to treat scoliosis non-surgically, and also confirms a link between correctly prescribed wear time and positive outcomes. At the UK scoliosis clinic, we’re also committed to helping to find ways to treat the 25% of individuals who didn’t get the result they would have liked from the BRAIST study. One of the ways we do this is by offering what we believe is the best scoliosis bracing system available, the Scolibrace system – which is an active correction, individually customised brace designed for maximum correction. Since a variety of braces were used during this study, we hypothesise that the successful treatment figures could have been even higher if more modern concepts in brace design had been adopted for the study. You can learn more about scolibrace here.

 

[1] Weinstein SL, Ponseti IV. Curve progression in idiopathic scoliosis. J Bone Joint Surg Am 1983;65:447-455

[2] Dolan LA, Weinstein SL. Surgical rates after observation and bracing for adolescent idiopathic scoliosis: an evidence-based review. Spine (Phila Pa 1976;32:Suppl:S91-S100

Dolan LA, Weinstein SL. Best treatment for adolescent idiopathic scoliosis: what do current reviews tell us? In: Wright JG, ed. Evidence-based orthopaedics: the best answers to clinical questions. Philadelphia: Saunders, 2009.

Focarile FA, Bonaldi A, Giarolo MA, Ferrari U, Zilioli E, Ottaviani C. Effectiveness of nonsurgical treatment for idiopathic scoliosis: overview of available evidence. Spine (Phila Pa 1976;16:395-401

Lenssinck ML, Frijlink AC, Berger MY, Bierman-Zeinstra SM, Verkerk K, Verhagen AP. Effect of bracing and other conservative interventions in the treatment of idiopathic scoliosis in adolescents: a systematic review of clinical trials. Phys Ther 2005;85:1329-1339

Negrini S, Minozzi S, Bettany-Saltikov J, et al. Braces for idiopathic scoliosis in adolescents. Cochrane Database Syst Rev 2010;1:CD006850-CD006850

Rowe DE, Bernstein SM, Riddick MF, Adler F, Emans JB, Gardner-Bonneau D. A meta-analysis of the efficacy of non-operative treatments for idiopathic scoliosis. J Bone Joint Surg Am 1997;79:664-674

Screening for idiopathic scoliosis in adolescents. Rockville, MD: Preventive Services Task Force, June 2004 (http://www.uspreventiveservicestaskforce.org/uspstf/uspsaisc.htm).

[3] Nachemson AL, Peterson LE. Effectiveness of treatment with a brace in girls who have adolescent idiopathic scoliosis: a prospective, controlled study based on data from the Brace Study of the Scoliosis Research Society. J Bone Joint Surg Am 1995;77:815-822

Danielsson AJ, Hasserius R, Ohlin A, Nachemson AL. A prospective study of brace treatment versus observation alone in adolescent idiopathic scoliosis: a follow-up mean of 16 years after maturity. Spine (Phila Pa 1976;32:2198-2207)

[4] Richards BS, Bernstein RM, D’Amato CR, Thompson GH. Standardization of criteria for adolescent idiopathic scoliosis brace studies: SRS Committee on Bracing and Nonoperative Management. Spine (Phila Pa 1976;30:2068-2075)

[5] Dolan LA, Weinstein SL, Adams BS. Temperature as a diagnostic test for compliance with a thoracolumbosacral orthosis. Presented at the Annual Meeting of the Pediatric Orthopaedic Society of North America, Waikaloa, HI, May 3–7, 2010 (poster).

Helfenstein A, Lankes M, Ohlert K, et al. The objective determination of compliance in treatment of adolescent idiopathic scoliosis with spinal orthoses. Spine (Phila Pa 1976;31:339-344

[6] Stuart L. Weinstein, M.D., Lori A. Dolan, Ph.D., James G. Wright, M.D., M.P.H., and Matthew B. Dobbs, M.D. Effects of Bracing in Adolescents with Idiopathic Scoliosis N Engl J Med 2013; 369:1512-1521

DOI: 10.1056/NEJMoa1307337

[7] Danielsson AJ, Hasserius R, Ohlin A, Nachemson AL. A prospective study of brace treatment versus observation alone in adolescent idiopathic scoliosis: a follow-up mean of 16 years after maturity. Spine (Phila Pa 1976;32:2198-2207

[8] Katz DE, Herring JA, Browne RH, Kelly DM, Birch JG. Brace wear control of curve progression in adolescent idiopathic scoliosis. J Bone Joint Surg Am 2010;92:1343-1352