Tag: scolibrace

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

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