2Wanchai Chiropractic Clinic, Wanchai, Hong Kong
The present review attempts to determine if there is a trend of improvement in outcome with bracing in the last 3 decades. Manual literature search was made in the PubMed using the keywords of brace, conservative treatment and adolescent idiopathic scoliosis. Relevant English articles on the outcome of wearing rigid braces from 1990-2016 were retrieved and reviewed to determine if there is a trend towards improvement in outcome with bracing and if bracing halts progression and improves curves.
Results show that there has been an apparent improvement in the effectiveness of bracing in reducing surgical rate since 2005. Close inspection shows that the reduction in surgical rate is not due to an improvement over time, but is related to the types of brace. The effectiveness of Boston brace is not consistent over the years. The surgical rates vary and no consistent trend of improvement can be discerned in the last 2-3 decades. The surgical rate reported in 2007 for TLSO was as high at 79% and that in 2014 for Boston brace was 28%. The surgical rates with European braces (Progressive Action Short Brace (PASB), Cheneau derivatives and Lyon/Sforzesco braces), however, are consistently lower, at less than 8%. Similarly, the European braces have been found to be able to improve curves in over 50% of the at risk patients. Bracing does not therefore only halt progression of curves. Given a well-constructed brace, with good patient compliance, improvement of curves in over 50% of the patients is possible, particularly when used in conjunction with scoliosis specific exercises.
A critical review of 15 studies on bracing and 3 studies on observation showed virtually no difference in the effectiveness of Thoracolumbosacral Orthosis (TLSO) bracing versus observation . The pooled bracing surgical rate from the 18 studies was 23% compared with 22% in the observation group, showing no clear advantage of either approach.This view was similarly held by Goldberg et al (2001), who found that the incidence of surgery in their centre (28.1%) did not differ significantly from another with aggressive orthotic policy (22.4%). They questioned if bracing has any meaningful advantage .
Yet, many studies have shown that there is a decreased risk of curve progression with bracing as compared to observation [8, 9, 10]. Emans et al (1986) followed up 295 patients one year after weaning of the Boston brace . They found that 49% of the curves had no change (remained±5oof pre-brace angle). 7% of the patients worsened by ≥ 5o and 11% of the patients received surgery . Similarly, a prospective, multicenter study showed that bracing was more effective than observation and electrical stimulation . At four years the successful rate, defined as progression of ≤ 6oof bracing was 74%, whereas those of observation and electrical stimulation were 34% and 33% respectively . Yet, the study was regarded as of low methodological quality, as it was not randomized, non-blinded and the baseline differences between the groups were not statistically adjusted for and the results did not include the surgical rates [3, 6]. Danielsson and colleagues (2007) followed a subset of Swedish patients from this study for 16 years, comparing the effectiveness of bracing versus observation in two groups of patients with comparable curves and demographics . Results showed that in the braced group, no patient progressed by more than ≥ 6o. In the observation group, however, 40% of the patients progressed by ≥ 6o; 20% required brace treatment; and 6 patients (9.2%) required surgery . A multicenter study in 2013 which enrolled randomized cohort and preference cohort showed that TLSO effectively reduced the percentage of braced patients with curve progression to surgical threshold . Indeed, the difference in outcome between bracing and not bracing was so significant that the trial was stopped early .
In view of the contradiction and the difficulties of comparing different studies, which used different inclusion and outcome criteria, Scoliosis Research Society (SRS) established a guideline for bracing studies to enable ease of comparison of effectiveness of braces in subsequent studies. Reviewing 32 bracing studies, Richards et al (2005) determined the inclusion criteria that would best identify patients most at risk of progression and the most appropriate definitions for bracing effectiveness . It was determined that the patient braced should be 10 years or older, with curves between 25-40o and Risser sign of 0-2. If the patient is a female, she should be either premenarchal or less than one year postmenarchal. Assessment of brace effectiveness should include: the percentage of patients with ≤ 5o curve progression, the percentage of patients with progression ≥ 6o at skeletal maturity, the percentage of patients with curves exceeding the surgical threshold of 45o at maturity and the percentage of patients who require surgical intervention during the 2-year follow up beyond maturity . It is of note that the success of the bracing was defined as progression of ≤ 5o . Presumably, improvement of curves with bracing was deemed improbable and was not defined in the Scoliosis Research Society (SRS) guidelines .
Negrini et al (2009) defined improvement of curves as a reduction of ≥ 6o at skeletal maturity when compared to prebrace angle . This possibly stems from their findings that bracing can improve curves. Thus the successful rate as defined by SRS guidelines includes the improvement rate. To better define the terms, the present review regards change of curve ±5o as stabilization of curves. Successful rate is thus the sum of stabilization rate and improvement rate.
The SRS criteria did not take into consideration of the standards of bracing. The Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) convened in 2008 and established a consensus concerning the standard of management of adolescent idiopathic scoliosis with bracing, with the aim to increase the efficacy and compliance to treatment . SOSORT recommends clinicians to follow the guidelines in clinical practice .
Since the establishment of SRS and SOSORT guidelines [1, 2], there have been a number of studies. With uniformity of inclusion criteria and outcome measures, comparison of the effectiveness of bracing should theoretically become easier. We review the studies in the past 2-3 decades to determine if the effectiveness of bracing has improved in terms of halting curves progression, reducing the percentage of patients requiring surgical intervention and improving curves, particularly after the adoption of the two guidelines.
The articles were screened by the lead author for relevance. Only those articles that included inclusion criteria and outcome measures similar to that stipulated by the SRS guidelines were included for comparison. Studies that reported bracing for curves in excess of 40o were not included. Data from studies published from 1990 onwards are reviewed to determine if the effectiveness of bracing has improved over the years, in terms of halting progression of curves, reducing surgical rates and improving curves in patients with AIS.
The methodologies, inclusion criteria and outcome measurements of these studies differed significantly and quantitative comparison of the outcome measurements is impossible. Comparison is made qualitatively.
From 1990 to 2002, the reviewed English studies were braces designed in USA. Braces studied included the Milwaukee braces [9, 13, 14, 15], Wilmington braces [16, 17] and Boston or TLSO braces [18 – 23]. We were not aware of any English publication on the European braces during this time period. Since 2003, however, the number of publication on the effectiveness of European braces has increased dramatically [12, 24 – 31]. This may be a result of the establishment of SOSORT in 2005.
Progression to surgical threshold was not reported in many studies. It similarly varies significantly from 3%  to 46% [20, 33].
Interestingly, European braces which include the Lyon braces [28, 34], the Cheneau derivatives [24, 26, 29, 35], the Sibilla braces [34, 36] and the PASB [27, 37] are associated with a significant lower rate of surgery. The highest surgical rate reported was 7.9% , with some studies reporting no surgery after bracing [12, 29, 31, 36, 37 ].
For the European braces, the successful rate is high as well. The highest reported was 100% [35 -37].
From 2003 onwards, we were able to identify 21 papers reporting an improvement of curves after weaning of braces at skeletal maturity [24, 25, 26, 29, 31, 38, 42, 43]. The improvement rate varies from 24.2% for the Rigo Cheneau brace  to 94% for the Progressive Action Short Brace (PASB) (Figure 3) .
When comparing the percentage of patients progressing to surgical threshold, the surgical rates and the improvement rate in the past 26 years, we find that there is a trend towards reduction in surgical rate and an increase in improvement rate. Yet, close inspection showed that the change is more related to the type of brace used, rather than an improvement in the effectiveness of a particular type of brace over time.
The surgical rates reported for the Boston braces varied from less than 10% [19, 20, 44] to above 30% [15, 17, 21]. Some of the more recent reports had surgical rates as high as 60 – 70% [32, 45]. The reasons for the high failure rate were not explained. It is possible that the high failure rate in the Spoonamore et al (2004)  study was related to the use of Rosenberger brace, which was still in the developmental stage and the Janicki et al (2007)study, which was the first study that followed the SRS guidelines, involved patients at risk of progression . Yet, not all the TLSO had as high a failure rate. Kessler et al (2008) reported a much lower percentage of patients progressing to surgical threshold, using the Los Angeles brace. The surgical rate reported was only 5% .
The authors are unable to identify any English publication before 2003 using the European braces for comparison. Most of the publications in English on European braces were after 2003. Rigo et al (2003) reported the effectiveness of Rigo Cheneau brace in the treatment of AIS . In the worst case analysis, assuming that patients who were lost to follow up progressed to surgical threshold, the percentage of patients progressing to surgical threshold was 14.1%, which was far below that reported for Boston braces and other TLSO. For the Cheneau derivatives, the surgical rates reported ranged from 0 [29, 31, 35] to less than 10% [30, 38]. Zaborowska et al reported a surgical rate of 12.7% . The percentage of patients progressing to surgical threshold was similar in the study by Maruyama et al (2015)and Rigo et al (2003) at 12.1% and 14.1% respectively [26, 30].
The PASB brace which was fabricated specifically to treat thoracolumbar and lumbar curves had the best results, with surgical rates and percentage of patients progressing to surgical threshold of 45o reported to be 0 [27, 37].
The Italian Isico group employed different braces, which included the Sibilla brace, Lyon brace, Sforzesco brace and ART brace basing on individual patient needs also achieved good results [34, 36]. Only 1.4% of the patients progressed to surgical threshold in one study . In another study, the percentage was 0 . It has, however, to be noted that in the studies, scoliosis specific exercises were used in conjunction with bracing. Courvoiser et al (2013) using a combination of Cheneau brace, Lyon brace, Milwaukee and Charleston braces also reported zero percentage of patients progressing to surgical threshold .
For Boston brace, Piazza et al (1990) reported an improvement rate of 21% . Goldberg reported an improvement of 60% in the three lumbar patients. Fernandez-Feliberti et al (1995) reported 70% improvement rate in patients over the age 13 and with Cobb angle in excess 30o. Lange et al (2011) and Vijverman et al (2004) reported an improvement rate of 26% and 42% respectively [40, 49].
Similar improvement rates were reported for Cheneau derivatives. The reported improvement rates ranged from around 25% [30, 38, 41] to 30% [24, 31].Landauer et al (2003) reported a successful rate of 78%, using Cheneau brace. However, they did not report the improvement rate .
Similar improvement rates were reported for Cheneau derivatives. The reported improvement rates ranged from around 25% [30, 38, 41] to 30% [24, 31].Landauer et al (2003) reported a successful rate of 78%, using Cheneau brace. However, they did not report the improvement rate .
The lower percentage of patients reaching surgical threshold and the surgical rates in patients wearing European braces as compared to those wearing Boston braces may be related to the brace design and the treatment approach adopted by physicians using the braces.
Boston braces are generally employed by orthopedic surgeons. The objective of the brace is to halt progression of curves to below surgical threshold. In case the brace fails to achieve the objective, the patient can be treated surgically. On the contrary, the European braces are predominantly used by physicians who treat patients conservatively. Failure of the brace would require them to refer the patients for surgical treatment. They are motivated to improve the outcome of the brace treatment.
Boston brace was designed to have zero lumbar lordosis , as the effectiveness partially relies on the reduction of lumbar lordosis . Yet, van Loon et al (2008) have shown that forced thoracolumbar lordosis would reduce coronal curves in patients with double major scoliosis . Also, Boston braces encourage thoracic flat back, which has been shown to be detrimental to the correction of curves .
Apart from the design of the braces, the amount of in-brace correction and comfort are also important in the outcome. Large in-brace correction in excess of 50% would be accompanied by improvement at skeletal maturity [24, 56] and hours of brace wear are positively associated with the rate of treatment success [11, 17, 21, 23, 24, 57]. Well design braces that are comfortable to wear may improve compliance, which is important in improvement of the outcome. Wearing a brace full time (≥ 18 hours) is associated with a much lower surgical rate than wearing the brace part time (≤ 12 hours) .
From the review, it is noteworthy that the PASB produces remarkable improvement in thoracolumbar and lumbar curves [27, 37]. No patient progressed ≥6o and all the curves were either stabilized or improved [27, 37].
Also, bracing should not be employed alone in the management of AIS. Scoliosis specific exercises should be incorporated. The exercises improve the muscle strength of the trunk and the postural awareness of the patients. More importantly perhaps, they improved the curves [58, 59], reducing the loss of correction which frequently accompanied the weaning of brace [14, 15, 18, 19]. A recent prospective study based on SRS and SOSORT criteria showed that with a combination of brace and scoliosis specific exercises, 52.3% of the 73 patients improved .
Recently, it was reported that bracing can help reduce curves in excess of 45o . It is thus timely to discuss if the objective of the brace remains to halt progression of curves, or to improve the curves and if the indications for bracing should be broadened to include patients with curves around the surgical threshold.
Another limitation of the present review is that the surgical rates instead of the percentage of patients progressing to surgical threshold are compared. Some patients may progress to surgical threshold and yet refuse to receive surgery, especially when they are taken care of by physicians who opt for conservative treatment. Thus comparing the surgical rates may be somewhat misleading. No comparison of the percentage of patients progressing to surgical threshold was made, as only a few papers contain such data. Also many studies reported successful rate, but did not differentiate between improvement rate and stabilization rate.
To enable better comparison, future bracing studies should adopt the SRS and SOSORT guidelines. Patient population should preferably be more homogeneous, grouping by curve types as well. The in-brace correction should be reported as an assurance of the quality of brace. The compliance of the brace wearing should also be recorded. The dosage and frequency of scoliosis specific exercises, if employed should be reported. Study should also record the improvement rate, the stabilization rate, progression rate and the percentage of patients progressing to surgical threshold.
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