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Displaying items by tag: bracing for scoliosis
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Back Bracing for Scoliosis. Does it work?
Spinal bracing for Adolescent Idiopathic Scoliosis has NO effect on the natural course of Adolescent Idiopathic Scoliosis (I knew it!) Please click here to receive a FREE SCOLIOSIS TREATMENT INFORMATION KIT ASAP.
Research and studies on bracing for scoliosis has had a checkered past up to this point to say the least. The growing concensus among the experts is the back bracing for scoliosis has no effect on the natural course of the condition and doesn't effectively reduce the number of patients reaching the surgical threshold.
The search for a better way in the future is on and in order to do so we need to understand where we have already been. Those whom don't know the history are doomed to repeat it.
SYMPOSIUM: PEDIATRIC SPINE Brace Management in Adolescent Idiopathic Scoliosis Jonathan R. Schiller MD, Nikhil A. Thakur MD, Craig P. Eberson MD Published online: 30 May 2009 _ The Association of Bone and Joint Surgeons1 2009 Abstract Skeletally immature patients with adolescent idiopathic scoliosis are at risk for curve progression. Although numerous nonoperative methods have been attempted, including physical therapy, exercise, massage, manipulation, and electrical stimulation, only bracing is effective in preventing curve progression and the subsequent need for surgery. Brace treatment is initiated as either full-time (TLSO, Boston) or nighttime (Charleston, Providence) wear, although patient compliance with either mode of bracing has been a documented problem. We review the natural history of adolescent idiopathic scoliosis, identify the risks for curve progression, describe the types of braces available for treatment, and review the indications for and efficacy of brace treatment. Level of Evidence: Level IV, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence. Introduction The Scoliosis Research Society (SRS) has defined adolescent idiopathic scoliosis as occurring in patients 10 years or older with an idiopathic structural lateral curve of at least 10_ measured with the Cobb technique and vertebral rotation on a standing longitudinal radiograph of the spine combined with asymmetry on forward bending [28]. It is seen in 1% to 3% of the adolescent population, more commonly in girls and, as suggested by the name, has no known etiology. This definition provides a starting point for treatment decisions in the growing spine. Left untreated in the growing child, numerous studies have demonstrated the negative long-term prognosis a progressive curve fosters into adulthood, including back pain, pulmonary compromise, cor pulmonale, psychosocial effects, and even death [8, 9, 43, 54–56]. Curve progression is the most important factor in the natural history of idiopathic scoliosis. The risk of curve progression in idiopathic scoliosis has been associated with factors that predict potential remaining spinal growth; therefore, skeletally immature patients with idiopathic scoliosis and major curves are at risk for progression and warrant some form of treatment [3, 4, 29, 57]. Bracing has been the mainstay of nonoperative treatment for idiopathic scoliosis for nearly 50 years. However, because bracing has not gained complete acceptance, Each author certifies that he or she has no commercial associations (eg, consultancies, stock ownership, equity interest, patent/licensing arrangements, etc) that might pose a conflict of interest in connection with the submitted article. This work was performed at the Department of Orthopaedics, The Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence, RI. Clin Orthop Relat Res (2010) 468:670–678 DOI 10.1007/s11999-009-0884-9 numerous other treatment modalities have been attempted, including electrical stimulation, biofeedback, manipulation, physical therapy, and exercise [10]. Although a complete discussion of these modalities is beyond the scope of this article, convincing evidence of their effectiveness does not exist. Although Goldberg reported similar surgery rates for unbraced patients compared with braced patients [14, 15], other studies demonstrate bracing is an effective nonoperative treatment modality preventing curve progression compared with no bracing or treatment with electrical stimulation [32, 44]. We reviewed three core areas of the nonoperative (bracing) treatment of patients with idiopathic scoliosis: (1) the natural history of idiopathic scoliosis and risk factors associated with curve progression; (2) the various types of braces and the efficacy of each brace treatment in an evidenced-based approach; and (3) the indications for brace treatment with respect to the type of brace and wear schedule, including our recommendations. Search Strategy and Criteria To review the literature regarding the topic of bracing in adolescent idiopathic scoliosis, we used multiple search engines, including Ovid1, MedLine1, and PubMed1, using the search string ‘‘Brace OR Bracing’’ AND ‘‘Adolescent Idiopathic Scoliosis.’’ We searched for every article available in the literature without restriction of publication date and language of publication. We identified 464 citations. We eliminated inappropriate articles comparing bracing with surgical treatment and brace treatment as an adjunct to surgical treatment because the scope of this article was to evaluate bracing as the only mode of treatment. Additionally, we eliminated articles on brace treatment in patients with scoliosis other than adolescent idiopathic scoliosis. Bracing technique articles and other unrelated studies were eliminated as well, except those for historical purposes, leaving 75 citations. Currently, there is no standard for reporting results on bracing studies; thus, we have included all 75 of the citations for full review. Natural History To determine the need for treatment of scoliosis, it is important to understand the natural history of curve progression. Progression is defined by either a 5_ or 10_ change in curve magnitude, depending on the initial curve magnitude, on a standing radiograph [28]. The two key factors in curve progression are the size of the curve at the initiation of bracing and the amount of spinal growth remaining. According to both Bunnell [3] and Lonstein and Carlson [29], nearly 70% of patients with a Risser sign of 0 progressed greater than 5_ for curves between 20_ and 30_. Weinstein and Ponseti [55] followed curves for an average of 40 years and nearly 70% of curves measuring a minimum of 30_ progressed after skeletal maturity. Similarly, Nachemson and Peterson [32] demonstrated 66% of observed patients with idiopathic scoliosis curves measuring 20_ to 35_ progressed 6_. Karol et al. [23] found 32% of boys presenting with a curve of at least 25_ and all Risser stages progressed 10_ or more. Boys tend to have curves that progress beyond Risser 4 into late adolescence, whereas girls’ growth has begun to decelerate by this time. Curve progression is also related to curve pattern, whereby double curves progress more than single curves with the least amount of progression seen in single lumbar curves [3, 29]. Large curves (30_–40_) will progress more than small curves (20_–29_) and will continue to progress even after skeletal maturity has been reached should the curve reach a large enough magnitude [3, 4, 38, 55]. Females progress more than males as evidenced by larger curves seen more often in females compared with males [3, 4, 55]. Determining maturity and risk of progression may be achieved with several methods. Tanner staging, although quite familiar to pediatricians, is often not accurately gauged by orthopaedic surgeons. Girls typically reach peak height velocity (PHV), the maximum increase in growth rate during the adolescent growth spurt, 18 to 24 months earlier than boys, typically between Tanner stages 2 and 3, whereas boys do so between stages 3 and 5 [45–47]. This phase of growth represents a period of increased risk of curve progression. Menarche can be useful in girls, although it is reached most commonly after peak height velocity and can be variable. Measuring height at each visit is important; however, because growth is often in spurts, a period of substantial growth may be missed and PHV determined only in retrospect. The most commonly used radiographic marker is the Risser sign and this can be determined without the need for additional radiographs if the iliac crest is routinely included on spinal radiographs. The probability of progression has been calculated by both Lonstein and Carlson [29] and Nachemson and Peterson [32] using curve magnitude, and Risser sign and age, respectively, and both authors concluded the younger the child, measured as Risser sign or age, and the larger the curve, the greater the probability the curve would progress. The PHV is reached when the triradiate cartilage is still open; thus, it is important radiographs include the entire pelvis. Sanders et al. [47] used Tanner-Whitehouse-III staging on hand radiographs to predict the period of rapid curve progression (curve acceleration phase [‘‘CAP’’]). Their findings are interesting, because they demonstrated patients who are Risser 0 may have different estimated CAP scores, which resulted in substantially different rates of progression. However, all patients who are Risser 0 may not have the same likelihood of progression: patients whose Tanner- Whitehouse-III stage is before the CAP are at higher risk than those beyond the CAP. Thus, a larger study may yield helpful information pertaining to the need for bracing immature patients and may in fact allow better analysis of bracing studies [45]. The natural history of the untreated patient with scoliosis may involve curve progression and lead to spine surgery. The rationale for surgery is based on evidence supporting morbidity unrelated to the musculoskeletal system as curve magnitude increases [33, 36, 37, 56]. Moderate and severe thoracic curves are associated with reduced vital capacity and total lung capacity [20, 21, 27, 48]. Untreated adolescent patients with major scoliotic curves have a mortality rate slightly higher than the general population of the same age [56]. The mechanism believed responsible for respiratory failure in idiopathic scoliosis is alveolar hypoventilation, potentially caused by decreased lung volume, increased elastic load in the thoracic cage, and impaired respiratory muscle function [21, 26]. The literature regarding pulmonary function after bracing remains controversial. Some studies demonstrate total lung capacity and forced expiratory volume reduced to 80% of prebracing level [41, 50]. However, Korovessis et al. [26] analyzed pulmonary function in 30 patients with idiopathic scoliosis treated with continuous wearing of a Boston brace and demonstrated substantial yet reversible reduction in vital capacity, forced vital capacity, functional residual capacity, and residual volume over 2 years. Long-term follow up of patients with idiopathic scoliosis has demonstrated more thoracic and lumbar back pain and degenerative disc disease [8, 54]. Danielsson et al. [8] followed 127 patients 22 years after brace treatment and found degenerative lumbar disc changes were more common than in control subjects. Additionally, brace-treated patients had more back pain than the control group; however, there was minimal functional impairment or impact on daily life. Similarly, Weinstein et al. [54] found, in a 50-year follow up of 117 untreated patients with idiopathic scoliosis, 61% of patients had low back pain, although nearly 70% of those patients reported little or moderate back pain and with little physical impairment. Haefeli et al. [17], in their review of 121 patients with idiopathic scoliosis treated nonoperatively and followed over an average of 23 years, reported substantially more pain in patients with curves greater than 45_ compared with those whose curves were smaller. This suggested curve size, rather than treatment, predicted back pain in nonoperatively treated patients. Bracing A brace is designed to apply an external force to the trunk during the adolescent growth phase to prevent progression. As demonstrated subsequently, there are a myriad of brace treatments available, differing in fabrication, area of curve treatment, duration of wear, and wear protocols (Table 1). Brace Types The Milwaukee brace [30] is a cervico-thoracic-lumbarsacral orthosis developed in the 1940s. It is used for thoracic and double curves. It consists of a plastic pelvic section with an anterior and two posterior uprights connected superiorly by a neck ring with a throat mold anteriorly and occipital pads posteriorly or a plastic contoured low-profile neck ring; corrective pads are also used. The Milwaukee brace is prescribed for full-time wear with time out for sports and extracurricular activities. Given the stigma attached to this brace and the availability of other effective braces, the use of this brace is limited. The Wilmington brace [18] is a TLSO (thoracic-lumbarsacral orthosis) type of brace. It was designed by G. Dean MacEwen to improve patient compliance by making the brace less bulky and more lightweight as compared with the Milwaukee brace. It is a custom-made plastic underarm TLSO fabricated with several plastics, the most common being Orthoplast. It is designed as a body jacket, which opens in the front and is easily removable. It is held closed with adjustable Velcro straps. Corrective molds are fabricated into the plastic of the body jacket. The Wilmington brace is typically prescribed for full-time wear (23 hours/ day), although some studies indicate 12 to 16 hours a day is satisfactory for curves measuring 40_ or less [1]. The Boston brace [35] was developed in the 1970s at Harvard University. It is also a TLSO-type brace and is made from prefabricated polypropylene pelvic module with a soft foam polyethylene lining. Modules are designed with lumbar flexion. The Boston brace can be used to treat all scoliosis; however, it is recommended to be fitted with the Boston Milwaukee brace superstructure when a thoracic curve has an apex above T-10. The Boston brace is a full-time brace. The Dynamic Spine-Cor brace [6], developed in 1992- 1993, uses a specific Corrective Movement dependent on the type of the curve. The curve-specific Corrective Movement is performed, and the brace is applied according to definitions contained in the Spine-Cor Assistant software. To be effective and to obtain a neuromuscular integration, the brace must maintain and amplify the corrective movement over time. The brace must be worn 20 hours a day for a minimum of 18 months to create a neuromuscular integration of the Corrective Movement through active biofeedback. Generally, the brace is stopped at skeletal maturity (at least Risser 4). The Charleston brace [53] is a custom-molded spinal orthosis that holds the patient in an overcorrected position. The patient is casted supine in a bending position opposite the curvature while corrective force is applied at the apse of the curve. This brace is a nighttime brace only. The Providence brace [7] was developed when it was observed that substantial correction of scoliotic curves could be achieved using an acrylic frame to apply direct corrective forces to the patient. The brace can be used to treat all single and double curves. The frame was originally developed to demonstrate radiographic supine spinal flexibility for preoperative planning. The frame works by the application of controlled, direct, lateral, and rotational forces on the trunk to move the spine toward the midline or beyond the midline. A plaster impression of the patient is taken on the frame with corrective forces applied to the spine. The brace is now fabricated using computer-aided design and manufacturing techniques. The brace is fabricated of polypropylene plastic from measurements or a plaster impression. The Providence brace is a nighttimeonly type of brace. Bracing Efficacy Defining ‘‘success’’ from brace treatment of scoliosis can be a challenge. The majority of the literature uses curve progression of more than 5_ before skeletal maturity as a benchmark for bracing failure rather than spine surgery [49]. Some use 10_ of curve progression or preventing the curve from reaching 45_ at skeletal maturity [42]. To compare the effectiveness of various braces, standardized research protocols are needed. The variability defining success of brace treatment in idiopathic scoliosis was addressed by Richards et al. and the SRS Committee on Bracing and Nonoperative Management [42] in an attempt to standardize parameters for effective and reliable comparisons of bracing studies. The recommendations for bracing study inclusion were patients 10 years or older, Risser sign 0 to 2, initial curve magnitude of 25_ to 40_, and no prior treatment at the initiation of brace treatment. The outcome data should be determined from the percentage of patients with: less than 5_ or greater than 6_ of progression at maturity, curves exceeding 45_ at maturity, and progression resulting in the recommendation for surgery. Bracing studies should have a minimum of 2 years follow up beyond skeletal maturity. The first study to use these criteria determined a brace should prevent progression in 70% of patients to be considered effective [19]. Patient compliance, subjective or objective, is not factored into the analysis of the data. Regardless of the recommended standardized parameters, the goal of bracing idiopathic curves remains consistent: control the curve, prevent progression, and avoid surgical intervention. Although some of the new studies are based on the SRS guidelines for bracing studies, others are not. Hence, the results of different types of bracing are varied (Table 2). Several studies have compared full-time bracing [8, 13, 18]. Lonstein and Carlson [29] observed, in 1020 patients treated with the Milwaukee brace for adolescent idiopathic scoliosis, 78% had improvement of 1_ to 4_ when the brace was discontinued. Twenty-two percent required surgery. The rates of failure were lower than in previous series for patients with curves between 20_ and 39_. Bassett et al. [2] reported 75 patients treated with the Wilmington brace with follow up over 2 years 6 months. The average curve was 20_ to 39_ at Risser 0 or 1. The magnitude of the curves was reduced by 50% with initial brace application. There was some loss of correction (28%) with removal of brace on subsequent follow up; however, only 11% of patients needed surgery. They concluded the Wilmington brace favorably altered the natural history of 20_ to 39_ curves. Katz et al. [25] reviewed 51 patients who had average curves sizes of 36_ to 45_ treated with the Boston brace. Treatment was successful in 61% of patients, although 16% progressed more than 5_ and 31% required surgery. Coillard et al. [6] reported results of 170 patients treated with the Spine-Cor brace. Fifty-nine percent of patients were treated successfully, whereas 23% required surgery. Furthermore, 95.7% of patients treated in the brace stabilized or corrected the end of bracing Cobb angle up to 2 years after bracing. They concluded the Spine-Cor brace was effective for treatment of adolescent idiopathic scoliosis. However, as a result of the paucity of literature on the Spine-Cor brace, future studies are needed to confirm these results. Despite success with the Milwaukee, Wilmington, Spine-Cor, and Boston braces, at present none is demonstrably superior to the others with regard to treatment success, curve progression, or need for surgery. However, part-time bracing studies using the Providence and Charleston brace have also been compared with full-time bracing models with equivalent or superior results (Table 2) [19]. Price et al. [39] reported the results with the Charleston brace in 98 patients in which 63% had excellent results and, overall, 85% curves had acceptable results. Curve correction was 87% for major curves and 33% for compensatory/secondary curves. Thirteen percent of curves progressed more than 5_ and 1% of patients required surgery. Trivedi and Thomson [52] reported on 42 patients treated with the Charleston brace over a period of 10 years. Patients were Risser 0 or 1 and were followed a mean of 3.3 years after brace discontinuation. Average age at the start of bracing was 12.5 years and the average curve was 30.3_ (range, 25_–40_). Bracing was successful preventing progression of the curves in 60% of patients. Thoracic curves had the same success as thoracolumbar and lumbar curves. The authors concluded the Charleston brace was effective preventing progression of the curve. Using the Providence brace, D’Amato et al. [7] reported in-brace correction of 96% for major curves and 98% for minor curves. Seventy-four percent of patients did not progress more than 5_, whereas 26% of patients progressed more than 6_ or went on to have surgery. Seventy-six percent of patients with curve apices between T8 and L1 had successful outcomes. Overall 63% of thoracic curves, 65% of double curves, 94% of lumbar curves, and 93% of thoracolumbar curves were treated successfully using the Providence brace. This may in fact be purely a reflection of compliance; it is much more tolerable for most adolescents to wear a brace that they are not required to wear to school. Currently, the literature supports initiating nighttime bracing for curves measuring less than 35_ with an apex below T9, although centers with experience with these braces may choose to expand the indications [14, 19, 27, 33–35]. Hence, future studies, like the Level 1 BrAIST study [53], will be needed to compare full-time versus part-time bracing using SRS guidelines to determine efficacy of each bracing model to prevent progression of curvature and improve function. Bracing Difficulties Multiple factors can be obstacles to successful brace treatment. Poor compliance with wear schedules is a major recurring theme in the braced patient, particularly males. Karol [22] found only 38% of males were compliant with brace wear, and 74% progressed 6_ with nearly half reaching a surgical threshold of 50_. Immature Risser status related to both progression and surgery with greater than 80% progressing a minimum 6_ and half reaching surgery. Similarly, 55% of curves measuring greater than 30_ at brace prescription progressed to surgery or greater than 50_. Yrjonen et al. [59] supported these results finding 35% of braced males were noncompliant. However, although compliant males progressed greater than 5_ 10% more frequently than the females (21%), they concluded brace treatment for idiopathic scoliosis was beneficial for both genders. Curve magnitude correlates with curve progression; thus, larger curves are more likely to progress than smaller curves. Likewise, the probability brace treatment will prevent curve progression is inversely proportional to the initial size of the curve [11, 25, 30]. Although brace treatment limits curve progression for curves larger than 35_, success has been less predictable compared with curves between 20_ and 35_ [1, 11, 25, 30]. Bracing success is similar to any prescribed treatment in orthopaedics; it relies on patient compliance. Although casts are not easily removable, braces are easily removed, not surprising given the negative cosmetic appearance, which fosters poor self-esteem and body image, as well as functional discomfort resulting from pressure points, irritation in hot weather, and restriction of movement [5, 33]. The discomfort caused by the external biomechanical forces applied by a brace, in an effort to alter spine growth, is determined by brace characteristics such as size, location, and thickness of the pads; tension of the straps; molding; and stiffness of the brace. It is these characteristics that cause bracing in the overweight patient to be ineffective and lead to increased curve progression compared with patients who are not overweight [31, 35]. Brace compliance was potentially responsible for the disparity of success between males and females treated with bracing [22, 59] and may explain the similar results of noncompliant patients with the natural history. Numerous studies have demonstrated compliant brace wear leads to successful results, yet much of the data, as acknowledged by the authors, is subjective based on incomplete assessments of compliance such as office notes, questionnaires, or phone or office interviews [22, 30, 34, 58]. Thus, this has led some to doubt the efficacy of bracing and the need for objective compliance measures [51]. To answer the question of compliance, objective compliance measures using temperature sensor loggers and pressure transducers have been developed to ascertain compliance [24, 33]. These authors used temperature data loggers at the brace-skin interface to measure time in the brace and found patients overestimated their time in brace nearly 150%. Patient compliance was best in 10-year-old patients (84%) compared with 12-year-old patients (77%) and 14-year-old patients (60%). However, Rahman was the first to correlate objective compliance with efficacy [40]. A temperature sensor and logger were placed in a Wilmington TLSO brace and patients were monitored for the duration of their treatment. Compliance for those whose curve progressed more than 5_ was 62%, whereas those that did not progress showed 85% compliance, indicating patient compliance improves the chance for a successful result. Treatment Recommendations Brace treatment for idiopathic scoliosis in the skeletally immature child remains the only effective modality limiting curve progression and the potential need for surgical intervention [1, 11, 12, 32, 39, 43]. Current recommendations from the SRS include the initiation of brace treatment in skeletally immature patients who present with curves greater than 30_ on initial presentation or in patients who progress greater than 10_ to a magnitude greater than 25_ [42]. Braces are usually worn 18 to 23 hours a day, although evidence exists demonstrating the effectiveness part-time or nighttime bracing to address patient compliance issues [7, 11, 16, 39, 43]. Part-time or nighttime bracing (Charleston, Providence) may be effective for curves less than 35_; however, curves greater than 35_ often require full-time bracing to reliably limit curve progression. Bracing should continue until growth has stopped, indicated by unchanged height measured consecutively 6 months apart, Risser sign 4 (females) or 5 (males), postmenarchal 18 to 24 months, or skeletal maturity on bone age determination [49]. Although Karol has stated bracing in boys should be continued until Risser 5 as a result of the prolonged growth period during the Risser 4 phase, 46% of her patients had curves progress to surgical correction despite brace wear [23]. She found nearly 80% of curves will progress when not braced compared with similarly braced patients and are four times as likely to require spinal instrumentation and fusion, whereas compliant patients will show minimal progression and most likely not require surgery. Bracing success is measured by preventing curve progression on standing radiographs and the avoidance of surgical management. Inadequate time prescribed in the brace and a poor-fitting brace certainly will lead to poor results and are beyond control of the patient. However, compliance appears to be the greatest concern for any treating physician and the primary cause for poor results from brace treatment. Additionally, bracing in males and obese, skeletally mature, and nonidiopathic patients is less effective. Long-term follow up suggests bracing may be beneficial into adulthood, improving life expectancy, patient satisfaction, and function, although there is a higher incidence of back pain [9, 17, 55]. At our institution, Providence bracing is initiated for curves between 25_ and 35_ in patients with substantial growth remaining. Occasionally, patients seen before peak height velocity with curves that are already becoming cosmetically objectionable (ie, thoracolumbar curves) will be braced for curves over 20_, although this is a relative indication. For patients presenting with larger curves, or for patients who progress with nighttime-only bracing, we prefer to add a TLSO for daytime use (total 18–20 hours per day). Assuming appropriate in-brace correction in the Providence brace, the addition of a Boston brace should be additive in terms of forces applied to the spine as opposed to changing brace treatment completely. We have found the combination of braces is well tolerated, putting pressure on slightly different locations to avoid brace irritation. Bracing continues until growth stops or curve progression cannot be controlled and spine surgery is indicated. For successful treatment, this is usually through Risser 4 in girls and Risser 5 in boys. A review of patients followed to maturity at our institution is underway to determine the effectiveness of our combined brace protocol. Discussion The natural history of idiopathic scoliosis has been well documented throughout the literature. Left untreated, the younger the patient (i.e., the amount of skeletal growth remaining) and the larger the curve at the initiation of bracing, the greater the chance of curve progression, thus necessitating surgery. Brace treatment with full-time (Boston,Wilmington, and Milwaukee) or nighttime (Charleston and Providence) bracing continues to be the only efficacious mode of nonoperative treatment in idiopathic scoliosis. To date, a major criticism of the bracing literature remains the absence of a prospective, randomized study to determine the efficacy of brace treatment. The ongoing Level-1 BrAIST study will hopefully address the limitations of prior work. Nonetheless, assumptions can be made based on the existing literature. Newer methods of determining the period of rapid curve progression may help guide treatment decisions. The availability of successful nighttime treatment regimens has the potential improve compliance and, thus, success rates. However, brace treatment demands participation from the patient and their support network; parents, family, and friends; the orthopaedist; and the orthotist. Each has an integral part in fostering bracing success and potentially is the difference in preventing curve progression and the need for spine surgery. References 1. Allington NJ, Bowen JR. Adolescent idiopathic scoliosis: treatment with the Wilmington brace. A comparison of full-time and part-time use. J Bone Joint Surg Am. 1996;78:1056–1062. 2. Bassett GS, Bunnell WP, MacEwen GD. Treatment of idiopathic scoliosis with the Wilmington brace. Results in patients with a twenty to thirty-nine-degree curve. J Bone Joint Surg Am. 1986;68:602–605. 3. Bunnell WP. The natural history of idiopathic scoliosis. Clin Orthop Relat Res. 1988;229:20–25. 4. Bunnell WP. The natural history of idiopathic scoliosis before skeletal maturity. Spine. 1986;11:773–776. 5. Clayson D, Luz-Alterman S, Cataletto MM, Levine DB. 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Pulmonary function in scoliosis. Orthop Clin North Am. 1979;10:761–768. 28. Lonstein JE. Scoliosis: surgical versus nonsurgical treatment. Clin Orthop Relat Res. 2006;443:248–259. 29. Lonstein JE, Carlson JM. The prediction of curve progression in untreated idiopathic scoliosis during growth. J Bone Joint Surg Am. 1984;66:1061–1071. 30. Lonstein JE, Winter RB. The Milwaukee brace for the treatment of adolescent idiopathic scoliosis. A review of one thousand and twenty patients. J Bone Joint Surg Am. 1994;76:1207–1221. 31. Moreland M. Bracing in scoliosis. Curr Opin Orthop. 1998;9:66–71. 32. 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. 33. Nicholson GP, Ferguson-Pell MW, Smith K, Edgar M, Morley T. The objective measurement of spinal orthosis use for the treatment of adolescent idiopathic scoliosis. Spine. 2003;28:2243–2250; discussion 2250–2251. 34. Noonan KJ, Weinstein SL, Jacobson WC, Dolan LA. Use of the Milwaukee brace for progressive idiopathic scoliosis. J Bone Joint Surg Am. 1996;78:557–567. 35. O’Neill PJ, Karol LA, Shindle MK, Elerson EE, BrintzenhofeSzoc KM, Katz DE, Farmer KW, Sponseller PD. Decreased orthotic effectiveness in overweight patients with adolescent idiopathic scoliosis. J Bone Joint Surg Am. 2005; 87:1069–1074. 36. Pehrsson K, Larsson S, Oden A, Nachemson A. Long-term follow- up of patients with untreated scoliosis. A study of mortality, causes of death, and symptoms. Spine. 1992;17:1091–1096. 37. Pehrsson K, Nachemson A, Olofson J, Strom K, Larsson S. Respiratory failure in scoliosis and other thoracic deformities. A survey of patients with home oxygen or ventilator therapy in Sweden. Spine. 1992;17:714–718. 38. Picault C, deMauroy JC, Mouilleseaux B, Diana G. Natural history of idiopathic scoliosis in girls and boys. Spine. 1986;11:777–778. 39. Price CT, Scott DS, Reed FR Jr, Sproul JT, Riddick MF. Nighttime bracing for adolescent idiopathic scoliosis with the Charleston Bending Brace: long-term follow-up. J Pediatr Orthop. 1997;17:703–707. 40. Rahman T, Bowen JR, Takemitsu M, Scott C. The association between brace compliance and outcome for patients with idiopathic scoliosis. J Pediatr Orthop. 2005;25:420–422. 41. Refsum HE, Naess-Andresen CF, Lange JE. Pulmonary function and gas exchange at rest and exercise in adolescent girls with mild idiopathic scoliosis during treatment with Boston thoracic brace. Spine. 1990;15:420–423. 42. 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. 2005;30:2068–2075; discussion 2076–2077. 43. Rowe DE. The Scoliosis Research Society Brace Manual. Milwaukee, WI: Scoliosis Research Society; 1998:1–9. 44. Rowe DE, Bernstein SM, Riddick MF, Adler F, Emans JB, Gardner-Bonneau D. A meta-analysis of the efficacy of nonoperative treatments for idiopathic scoliosis. J Bone Joint Surg Am. 1997;79:664–674. 45. Sanders JO. Maturity indicators in spinal deformity. J Bone Joint Surg Am. 2007;89 Suppl 1:14–20. 46. Sanders JO, Browne RH, Cooney TE, Finegold DN, McConnell SJ, Margraf SA. Correlates of the peak height velocity in girls with idiopathic scoliosis. Spine. 2006;31:2289–2295. 47. Sanders JO, Browne RH, McConnell SJ, Margraf SA, Cooney TE, Finegold DN. Maturity assessment and curve progression in girls with idiopathic scoliosis. J Bone Joint Surg Am. 2007;89:64–73. 48. Sevastikoglou JA, Linderholm H, Lindgren U. Effect of the Milwaukee brace on vital and ventilatory capacity of scoliotic patients. Acta Orthop Scand. 1976;47:540–545. 49. Shaughnessy WJ. Advances in scoliosis brace treatment for adolescent idiopathic scoliosis. Orthop Clin North Am. 2007; 38:469–475. 50. Smyth RJ, Chapman KR, Wright TA, Crawford JS, Rebuck AS. Pulmonary function in adolescents with mild idiopathic scoliosis. Thorax. 1984;39:901–904. Please click here to receive a FREE SCOLIOSIS TREATMENT INFORMATION KIT ASAP.
This is an interesting article that highlights the controversy surrounding the continued use of brace treatment for scoliosis. I don't believe that the future of scoliosis treatment will include the continued use of bracing for scoliosis. Professional Opinion Concerning the Effectiveness of Bracing Relative to Observation in Adolescent Idiopathic Scoliosis Lori A. Dolan, PhD,* Melanie J. Donnelly, MD,Þ Kevin F. Spratt, PhD,Þ and Stuart L. Weinstein, MD*
Objective: To determine if community equipoise exists concerning the effectiveness of bracing in adolescent idiopathic scoliosis.
Background Data: Bracing is the standard of care for adolescent idiopathic scoliosis despite the lack of strong reasearch evidence concerning its effectiveness. Thus, some researchers support the idea of a randomized trial, whereas others think that randomization in the face of a standard of care would be unethical.
Methods: A random of Scoliosis Research Society and Pediatric Orthopaedic Society of North America members were asked to consider 12 clinical profiles and to give their opinion concerning the radiographic outcomes after observation and bracing.
Results: An expert panel was created from the respondents. They expressed a wide array of opinions concerning the percentage of patients within each scenario who would benefit from bracing. Agreement was noted concerning the risk due to bracing for postmenarchal patients only.
Conclusions: This study found a high degree of variability in opinion among clinicians concerning the effectiveness of bracing, suggesting that a randomized trial of bracing would be ethical.
Key Words: adolescent idiopathic scoliosis, bracing, concensus, effectiveness, standard of care (J Pediatr Orthop 2007;27:270Y276)
Bracing was adopted as the standard of care for nonoperative treatment of adolescent idiopathic scoliosis (AIS) long before the application of the current standards of scientific evidence. It is questionable whether a new technology would enjoy such widespread use if it was based on a literature with limitations similar to those noted in bracing: of the multiple published studies of bracing effectiveness, the overwhelming majority are level IV case series, with only a few level III case-control or retrospective cohort studies, and only 1 level II prospective cohort study. Another important limitation of the literature is the paucity of evidence concerning the effect of bracing on surgical rates despite the suggestion that the progression to surgery indicates the ultimate failure of bracing treatment.1 To our knowledge, only 2 studies2,3 have quantified (relative to observation) the risk reduction (RR) in surgical rates due to bracing. The science of bracing has been hampered, ironically, by the publication of uncontrolled studies to support bracing as the standard of care. Consequently, researchers have hesitated to conduct a randomized trial, stating that it would be unethical to deny treatment (not brace) when bracing is considered an effective therapy that has Bstood the test of time[4 even when that test has been less than rigorous. To the proponents of bracing, this may not be bothersome; however, to those who are unconvinced by the evidence, following the standard of care and prescribing a brace can itself be an ethical battle. More than 50 pediatric orthopaedic surgeons volunteered to participate in a recent randomized trial proposed to compare bracing with the observation on AIS.5 However, several of those approached to participate declined on ethical grounds. Concerned about this objection, we decided to test the validity of the conclusion that a randomized study comparing bracing with observation is unethical using the criteria of clinical equipoise.6 Clinical equipoise has been defined as Bthe state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment 6[. Other similar definitions of equipoise include the state of uncertainty on the part of the pertinent community, the opinion that no one arm of the trial is known to offer greater harm or benefit,7 and the lack of consensus within the expert community about the comparative merits of the treatments being tested. Random assignment of treatments, under the condition of equipoise, is not then a default on the obligation to give the most appropriate treatment because this is unknown.8 Judgments concerning the presence or absence of equipoise can come from 3 sources of information: (1) informal information from the opinions of local clinicians; (2) semiformal information from evidence of different practices across physicians or localities or from differing opinions in the literature; and (3) formal information derived from the specific measurement of expert opinion.8 In the literature, only 2 published natural history studies report a rate of surgery: Bunnell,9 in 1986, reported an overall surgery rate of 16% in curves diagnosed as having an angle of between 16 and 96 degrees, whereas Goldberg et al4 reported a 28% surgery rate in curves with angle ranging from 10 to greater than 60 degrees. Table 1 summarizes the results of bracing outcome studies. Several uncontrolled retrospective case series of braced patients have been published; those reporting surgical rates demonstrate widely varying outcomes ranging from 7% to 43%.10Y22 Two studies have simultaneously compared untreated and braced curves.2,3 Fernandez-Feliberti et al2 reported a 26% surgery rate in the braced cases compared with 38% in the observed cases. Miller et al,3 in their case-control study of small curves, found a 2% surgical rate in untreated curves compared with 5% in the braced group. These variations in outcomes are likely caused by different inclusion criteria, including Cobb angle and sex. The literature on surgical rates, then, is extremely variable and does not support the superiority of bracing over observation with any certainty. This variability provides some evidence of equipoise; however, the evidence for a medical intervention does not always equal the degree to which clinicians endorse the intervention or agree on its outcomes. We therefore sought another source of information, a formal survey of expert opinion concerning the effect of bracing relative to observation on cases of AIS. Sufficient variability and lack of consensus in these estimates would provide additional evidence of community equipoise and would therefore support the ethics of randomization in a trial of bracing on cases of AIS.
METHODS Expert Panel With institutional review board approval, we used the membership rosters of the Scoliosis Research Society (SRS) and the Pediatric Orthopaedic Society of North America as the sampling frame for this study. Most members of both societies are practicing physicians, although both include small numbers of nurses, scientists, and other allied health professionals involved in the care of children with orthopaedic conditions. Both societies have official publications that regularly publish research concerning the natural history and treatment outcomes of AIS and include such articles and posters at their national meetings. A sample of 423 members was randomly selected. The responses were anonymous and no attempt was made to follow up the nonresponders. All responses were returned within 3 months after they were mailed. The members were also asked to supply information concerning the following professional characteristics: number of years in practice, specialty, whether they completed a fellowship in that specialty, percentage of practice devoted to AIS, and a self-rating of their familiarity with the literature concerning bracing and AIS on a scale ranging from 1 to 3. Surveys The surveys were designed to gather the opinion of the respondents concerning the radiographic outcomes of bracing and the observation at the endpoint of skeletal maturity. Skeletal maturity was chosen as the endpoint because the risk of continued progression drops significantly after this point is reached.23 The 45-degree-angle outcome was chosen as a proxy for surgical indication, as in the studies by Little et al17 and Upadhyay et al.20 Each member received instructions and examples on how to complete the surveys. The members were asked to imagine patients between the ages of 10 and 15 years with differing clinical profiles who present to their practice for initial evaluation of AIS. The profiles included combinations of 3 curve types (thoracic, thoracolumbar/lumbar, and double major), the presence or absence of menarche, and the size of the Cobb angle (25Y34 degrees or 35Y45 degrees). The survey was structured as 6 decision trees, each presenting (1) a treatment (bracing or observation); (2) branches for the clinical profiles; and (3) branches for 2 radiographic outcomes (e45 or >45 degrees). Examples of the decision trees are given in Figures 1A and B. The members were also asked to estimate the percentage of patients from their practice presenting with each clinical profile. These estimates of practice mix were not used in the analysis but were elicited to help the respondents concentrate on each separate profile. Then, they were asked to estimate the percentage of patients in whom they would expect to achieve a curve with an angle less than 45 degrees (success) of 45 degrees or greater (failure) at skeletal maturity after both an observation (natural history) and a full course of bracing. The members were instructed to use their knowledge of the AIS literature and their experience to make these estimates.
Statistical Analysis Descriptive statistics were calculated for the (1) percentage of patients defined as successes after bracing and after observation, (2) the RR due to bracing (the percentage of failure under observation minus the percentage of failure after bracing), and (3) the number of profiles where the respondents agreed on the RR. Agreement was defined similar to the previous work of Wright et al24 and Dunn et al.25 Agreement was present if greater than 80% of the respondents_ RR estimates were within a given range (low, 0%Y39% RR; moderate, 40%Y69% RR; and high, 70%Y100% RR). The influence of curve type and profile on the outcomes was quantified using analysis of variance and W2 tests of association.
RESULTS Sample A total of 423 surveys were mailed and 92 responses were received. Of these, 10 were from clinicians who declined to participate, and 4 responses were deemed invalid because of bracing failure rates that were uniformly higher than observation failure rates. Therefore, usable data was obtained from 78 respondents (19%). Considering the low response rate and, therefore, the questionable generalizability across all clinicians, we decided instead to use an expert panel approach similar to that used by Latthe et al26 and Lilford27 in their studies of clinical equipoise. From the 78 respondents, we chose an expert panel of those who reportedly devote more than 25% of their practice to AIS and who also consider themselves very familiar with the AIS and bracing literature. Of these 29 experts, 20 (69%) listed pediatric orthopaedics as their subspecialty; 3 (10%), spine; and 4, pediatric spine. On average, the panel had spent 22.55 years in their specialty (range, 6Y45 years) and 24 (83%) had completed a fellowship in that specialty. The average percentage of practice devoted to AIS was 49% (range, 28%Y100%).
Outcome Estimates Table 2 summarizes the success estimates (percentage of curves progressing to a Cobb angle less than 45 degrees) FIGURE 1. Examples of survey. A, Estimates of observation outcomes. B, Estimates of bracing outcomes. Dolan et al J Pediatr Orthop & Volume 27, Number 3, April/May 2007 272 * 2007 Lippincott Williams & Wilkins Copyr ight © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited. for each of the profiles and the treatments (bracing or observation). Although the average estimates indicate that the group felt that bracing demonstrates an advantage over observation in the risk of surgery, the estimates for both bracing and observation varied widely. For example, the panel estimated that anywhere from 20% to 80% of small thoracic curves in immature patients would succeed without treatment. For the same group of curves, the success rates after bracing ranged from 49% to 90%. The type of curve alone had no significant effect on the estimates, but the estimates were higher or lower depending on the profile (a statistical interaction of curve size and menarcheal status; P G 0.0001). This interaction is illustrated by the estimates for thoracic curves. The average success estimate for small thoracic curves in premenarcheal patients without treatment was 44.87% compared with 77.22% for small curves in postmenarcheal patients (difference of approximately 22%), whereas the average success estimate for large thoracic curves was 20.39% in premenarcheal patients and 55.85% in postmenarcheal patients (difference of approximately 35%). Figure 2 summarizes these relationships. Table 3 summarizes the RR estimates for each clinical profile. The RR estimates were obtained by subtracting the bracing failure rates from the observation failure rates. Like the raw success rate estimates, there was wide variation in the RR estimates. The minimum RR was 0% for all profiles, and the maximum ranged from 55% (small curves in postmenarcheal patients with thoracolumbar/lumbar curves) to 75% (small thoracic curves in postmenarcheal patients and large thoracic curves in premenarcheal patients). Another way to demonstrate the variability between the raters is to look at the median estimates. For example, the median RR for postmenarcheal patients with large thoracic curves was 30%; therefore, one half of the panel thought that the RR due to bracing was 0% to 30%, whereas the other half thought that it was 30% to 75%. The RR estimates did not significantly differ across curve types, but they were significantly different between profiles (P G 0.0001). This is expected considering the interaction observed for the raw success estimates. The interaction suggests that on average, the panel thought that the impact of bracing was dependent on both the curve size and the menarcheal status of the patient. Consistently, however, the RR estimates for premenarcheal patients were greater than those for the postmenarcheal patients. Thus, the panel responses suggest that bracing has a greater positive impact for premenarcheal patients than for postmenarcheal patients. Boxplots summarizing the RR estimates are provided in Figure 3. Agreement We divided the range of RR estimates into 3 intervals: small effect (0%Y39% fewer failures with bracing), medium effect (40%Y69% fewer failures with bracing), and large effect (70%Y100% fewer failures with bracing). Clinical agreement was present if more than 80% of the experts_ estimates were within 1 of the 3 intervals. We evaluated whether there was clinical agreement on the outcomes of each of the 12 profiles. According to this definition, there was clinical agreement on only 4 of the 12 profiles, all of which proposed a small RR due to bracing in postmenarcheal patients. These agreements are highlighted in Table 4. More than 80% of the experts indicated that bracing would have a small effect on postmenarcheal patients with thoracic curves (for both small and large curves), postmenarcheal patients with small thoracolumbar/lumbar curves, and postmenarcheal patients with small double major curves. The respondents were very close to agreement (77% and 79%) that bracing would have only a small effect on postmenarcheal patients with either large thoracolumbar/lumber curves or double major curves.
DISCUSSION This study used the experts_ opinion of radiographic outcomes to estimate the surgical rates after observation and bracing for cases of AIS. These rates varied widely within the panel for both treatments, as did the consequent RR due to bracing. The reported RR ratios indicate a wide spectrum of opinion, from substantial benefit from brace use to no benefit at all. Agreement, defined as greater than 80% endorsement, existed in about one third of the profiles. These data demonstrate significant uncertainty within this expert group concerning the outcomes of observation and bracing. Consequently, we think that there is evidence of community equipoise for most clinical profiles contained in this survey and that the equipoise requirement for an ethical randomized trial has been met. The method of expert group input has been widely used in other health research applications, including technology assessment, education and training, priorities and information, and development of clinical practice.28 The design used here allowed a panel of geographically dispersed experts to be surveyed efficiently and confidentially.29 All clinicians reviewed exactly the same material, with no uncertainty concerning Cobb angle measurement or other evaluations that might occur in actual practice. In addition, because these estimates reflect the initial clinical judgments in the absence of knowledge of the estimates of other clinicians, they provide an indication of the extent of interclinician variation that might occur in actual practice. Some might argue that the contrived situation of this research design does not reflect clinical practice. However, would the outcomes be any less variable if it was a parent, rather than a researcher, asking BOf children like mine, how many will need surgery without treatment? How many will need surgery after treatment?[ It seems very unlikely that the results of this exercise overestimate the extent of interclinician variation in predicting the effectiveness of bracing in this population. Several recent articles have reported on the clinical agreement concerning the indications and the outcomes of medical treatment for other purposes in addition to clinical trial planning.24Y26,30,31 Two of these papers involve orthopaedics and each defined agreement similarly to this paper. Wright et al24 demonstrated disagreement similar to that shown in this article in their survey concerning the indications and the outcomes of total knee replacement. For example, their respondents indicated that anywhere from 1% to 95% of patients would require a revision within 10 years of their primary replacement. Dunn et al25 also found a significant variation in decision making and a lack of clinical agreement concerning the indications for rotator cuff surgery. To our knowledge, there have been only 3 published reports measuring community equipoise to specifically assess the ethics and the feasibility of conducting randomized clinical trials. Young et al32 mailed surveys to all members of a vascular surgery professional organization and asked the members to rate several common clinical scenarios describing 2 alternative treatments for the same condition. The respondents showed great variability in their responses, and each treatment was endorsed to some degree in all of the scenarios. There were only 1 in 6 scenarios where more than 70% of the respondents agreed that the same treatment was preferable. The authors conclude that this variation indicates equipoise within the membership and, therefore, that randomized clinical trials would be ethically justified. Lilford27 surveyed the expectations of a 10-member expert panel concerning the probable relative risk of morbidity resulting from immediate or delayed delivery in scenarios involving at-risk fetuses. For each scenario the average result was no relative RR, but the range in estimates for each scenarios was large. In 1 scenario, the estimates ranged from a 75% decrease to a 25% increase in the risk to a fetus delivered early. Lambert et al33 investigated the perceptions of the parents and the members of the Pediatric Ophthalmology and Strabismus Society concerning the treatment for infants with congenital cataracts. On a scale ranging from 1 to 10, with 1 strongly favoring an intraocular implant and 10 strongly favoring a contact lens, the median score of the respondents was 7.5. This range of opinions also manifested itself as a support for randomized controlled trials because 61% of the respondents indicated that they would be willing to randomize children to one of these 2 treatments. These studies indicate that clinical disagreement is a reality across specialties and interventions. Three possible explanations for clinical disagreement demonstrated by studies such as these include the limitations of available knowledge, the controversy within the research literature, and the inadequate dissemination or adoption of available information. 24 A recent article by the SRS Bracing Committee34 addresses these issues by calling for completeness and uniformity in the subjects, endpoints, and outcomes of bracing studies to maximize the likelihood of developing a coherent, accepted body of knowledge concerning this disease. If future articles adopt this approach, disagreements may diminish. It has been suggested that progression to surgery indicates the ultimate failure of bracing treatment.1 The key question of any future study of bracing, randomized or not, must be BHow many patients avoided surgery because of bracing treatment?[ This study found a high degree of variability in opinion among experts concerning the effectiveness of bracing. Yet, bracing is the standard of care for AIS, and all 362 respondents to a recent survey from the SRS35 indicated that they advocate its use. This implies a major disconnect between opinions of effectiveness and endorsement of bracing by the community. Patients considering their treatment options need to be aware of this disconnect; instead of considering bracing as the only option, they should take this variation into account along with their personal goals and tolerance for risk. In addition, these results indicate that a randomized trial of bracing would not only be ethical but also necessary.
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