2016 SOSORT guidelines（1）
Abstract
Background
The International Scientific Society on Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT) produced its first guidelines in 2005 and renewed them in 2011. Recently published high-quality clinical trials on the effect of conservative treatment approaches (braces and exercises) for idiopathic scoliosis prompted us to update the last guidelines’ version. The objective was to align the guidelines with the new scientific evidence to assure faster knowledge transfer into clinical practice of conservative treatment for idiopathic scoliosis (CTIS).
Methods
Physicians, researchers and allied health practitioners working in the area of CTIS were involved in the development of the 2016 guidelines. Multiple literature reviews reviewing the evidence on CTIS (assessment, bracing, physiotherapy, physiotherapeutic scoliosis-specific exercises (PSSE) and other CTIS) were conducted. Documents, recommendations and practical approach flow charts were developed using a Delphi procedure. The process was completed with the Consensus Session held during the first combined SOSORT/IRSSD Meeting held in Banff, Canada, in May 2016.
Results
The contents of the new 2016 guidelines include the following: background on idiopathic scoliosis, description of CTIS approaches for various populations with flow-charts for clinical practice, as well as literature reviews and recommendations on assessment, bracing, PSSE and other CTIS. The present guidelines include a total of 68 recommendations divided into following topics: bracing (n = 25), PSSE to prevent scoliosis progression during growth (n = 12), PSSE during brace treatment and surgical therapy (n = 6), other conservative treatments (n = 2), respiratory function and exercises (n = 3), general sport activities (n = 6); and assessment (n = 14). According to the agreed strength and level of evidence rating scale, there were 2 recommendations on bracing and 1 recommendation on PSSE that reached level of recommendation “I” and level of evidence “II”. Three recommendations reached strength of recommendation A based on the level of evidence I (2 for bracing and one for assessment); 39 recommendations reached strength of recommendation B (20 for bracing, 13 for PSSE, and 6 for assessment).The number of paper for each level of evidence for each treatment is shown in Table 8.
Conclusion
The 2016 SOSORT guidelines were developed based on the current evidence on CTIS. Over the last 5 years, high-quality evidence has started to emerge, particularly in the areas of efficacy of bracing (one large multicentre trial) and PSSE (three single-centre randomized controlled trials). Several grade A recommendations were presented. Despite the growing high-quality evidence, the heterogeneity of the study protocols limits generalizability of the recommendations. There is a need for standardization of research methods of conservative treatment effectiveness, as recognized by SOSORT and the Scoliosis Research Society (SRS) non-operative management Committee.
Keywords
Idiopathic scoliosisTreatmentGuidelines
Premise
Mandate
This is the third edition of the guidelines promoted by the international Scientific Society on Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT). The first guidelines were produced in Milan in 2005 and published in 2006 in Scoliosis and Spinal Deformities Journal [1, 2], followed by the guidelines update published in 2012 [3]. In the light of emerging evidence in the past 5 years on conservative treatment for scoliosis, we revised them again. The objective of the SOSORT Committee was to align the guidelines with the new scientific evidence and offer updated recommendations to assure faster knowledge transfer into clinical practice of conservative treatment of idiopathic scoliosis (CTIS). In the attempt to update each section in depth, it was decided that the next updates of the guidelines will be divided into different section, the next update will be on 2019 and will regard the chapter of General informations on idiopathic scoliosis, then 2 years later (2021) brace chapter will be published and updating the current knowledge. The exercises chapter will follow 2 years later in 2023, and evaluations will be updated in 2025.
Committee
The Committee was open to all SOSORT Members who decided to adhere to the project, and it is now composed by a group of SOSORT member lead by Stefano Negrini, member of the SOSORT Advisory Board and Past President of the SOSORT, helped by Angelo Gabriele Aulisa, member of the SOSORT Scientific Board.
Content
The contents of the document of the 2016 SOSORT guidelines on “Orthopaedic and Rehabilitation Treatment of Idiopathic Scoliosis During Growth” include the following:
1.
Methodology
2.
Background on idiopathic scoliosis
3.
Approach to conservative treatment of idiopathic scoliosis in different patients, with practical flow-charts
4.
Literature review and recommendations on assessment, bracing, physiotherapy, physiotherapeutic scoliosis-specific exercises (PSSE) and other conservative treatments
A detailed description of the methods is presented in Additional file 1.
Scope, purpose, and applications
The aim of these guidelines was to present the evidence-based updated review and clinical recommendations on the conservative treatment for scoliosis during growth. The multiple grey areas, important for everyday clinical practice, for which was not possible to provide evidence-based recommendations, were discussed in multiple structured surveys using Delphi method (Additional file 1).
The guidelines were meant to apply to all growing patients with idiopathic scoliosis. The main clinical questions that they assessed include the following:
How should a patient be assessed?
Which conservative treatment should be provided, and how?
How and when should bracing be applied?
How and when should exercises be used?
Development of the guidelines
Various types of professionals engaged in the conservative treatment of scoliosis have been involved: specialty physicians (orthopaedics, physical and rehabilitation medicine, psychiatry) and allied health professionals (orthotists, physiotherapists, chiropractors).
These guidelines were developed by the Society on Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT), whose focus is the conservative treatment approaches for scoliosis. The other two international scientific societies dedicated to research into, and treatment for spinal deformities, primarily focus on the surgical treatment (Scoliosis Research Society) or on general research (International Research Society on Spinal Deformities). The SRS and IRSSD did not participate in the development of the guidelines, although several members of these Societies are also members of the SOSORT. Moreover, the final Consensus was held during a joint SOSORT/IRSSD meeting.
Patients have been involved in the development of the guidelines, through the US National Scoliosis Foundation, representing 25,000 patients with scoliosis.
Methods
Methods are outlined in detail in the Appendix (Additional file 1). For the treatment sections, we updated the previously performed reviews of the literature looking for all papers from December 2010 to December 2015. The search strategies, the selection criteria, and the number of retrieved papers are listed in the individual sections. We also hand-searched the abstracts of all SOSORT Meetings, from 2010 to 2015; we checked the references of the included articles and consulted personal files and knowledge of all the authors. To update these guidelines, we revised the previous ones [1, 2, 3, 4]. The final documents, recommendations, and practical approach flow charts have been developed according to a Delphi procedure listed in the Appendix (Additional file 1). After a review process, the final Consensus Session was held during the 2016 Banff SOSORT and IRSSD Joint Meeting. A classical Level of Evidence (LoE) table has been adopted (Table 1). As in the Italian Guidelines and the SOSORT 2011 guidelines [2, 3], levels V and VI have been added according to the Consensus session held during the SOSORT Meeting. A Strength of Recommendation Taxonomy (SoRT) has also been used (Table 2) that states the strength that each Recommendation should have in the clinical world, balancing all typical factors involved in this decision (patients, professionals, social). The SoRT scale is meant to accompany and complement the Strength of Evidence scale and it consists of grades A, B and C.
Table 1
Strength of evidence grading used in these guidelines. Questions on effectiveness (treatment results) and diagnosis (assessment) have been considered
Strength of evidence | Question | Meaning |
I | Effectiveness | Multiple Randomized Controlled Trials or Systematic Reviews of such studies |
Diagnosis | Multiple Randomized Controlled Trials, or Cross-sectional Studies with verification by reference (gold) standard, or Systematic Reviews of such studies | |
II | Effectiveness | One Randomized Controlled Trial |
Diagnosis | One Randomized Controlled Trial, or one Cross-sectional Study with verification by reference (gold) standard | |
III | Effectiveness | Multiple Controlled nonrandomized Studies or Systematic Reviews of such studies |
Diagnosis | Multiple Cross-sectional Studies with incomplete & unbalanced verification with reference (gold) standard | |
IV | Effectiveness | Other studies |
Diagnosis | ||
V | Effectiveness | SOSORT consensus with more than 90% of agreement |
Diagnosis | ||
VI | Effectiveness | SOSORT consensus with 70 to 89% of agreement |
Diagnosis |
Table 2
Strength of recommendation grading used in these guidelines
Strength of recommendation | Meaning |
|---|---|
A | It must be applied widely and to all patients with this specific need |
B | It is important, but does not have to be applied to all patients with this specific need |
C | Less important, it can be applied on a voluntary basis |
D | Very low importance |
Target users of the guidelines
These guidelines are targeted to the professionals involved in the Conservative Treatment of Scoliosis, and their patients.
Updates
We project that these 2016 guidelines will be updated by SOSORT in 3 to 5 years. If important changes in practice occur before that, an earlier update may be warranted.
Applicability
These guidelines will be published in the Open Access Journal “Scoliosis and Spinal Disorders” (http://www.scoliosisjournal.com). Open Access will ensure the visibility and accessibility to the worldwide community of stakeholders, including researchers and practitioners interested in conservative treatment of scoliosis, as well as patients. The Consensus process, involving professionals from all over the world, should provide an objective document that a wide variety of interested organizations and third party payers may review to gain insight into the treatment modalities. In the meantime, single national adaptations should eventually be considered. The guidelines itself should serve as basis for these national documents.
Translations in different languages have been planned. These translations will be published on the Official SOSORT website: http://www.sosort.mobi.
General information on idiopathic scoliosis
Definitions
Scoliosis is a general term comprising a heterogeneous group of conditions consisting in changes in the shape and position of the spine, thorax and trunk.
Hippocrates spoke of “spina luxate”, gathering all the vertebral deviations. It is Galen who defined the first “scoliosis” (sKolios, which means crooked or curved) [5], by meaning an abnormal lateral spinal curvature. “Structural scoliosis”, or just scoliosis, must be differentiated from “functional scoliosis” that is a spinal curvature secondary to known extra spinal causes (e.g. shortening of a lower limb or paraspinal muscle tone asymmetry). It is usually partially reduced or completely subsides after the underlying cause is eliminated (e.g. in a recumbent position). Functional scoliosis is not the subject of this paper. The term idiopathic scoliosis was introduced by Kleinberg [6], and it is applied to all patients in which it is not possible to find a specific disease causing the deformity; in fact, it occurs in apparently healthy children and can progress in relation to multiple factors during any rapid period of growth. By definition, idiopathic scoliosis is of unknown origin and is probably due to several causes. Etiopathogenetically, the spinal deformity caused by idiopathic scoliosis may be defined as a sign of a syndrome with a multifactorial etiology [7, 8, 9]. Nearly always, scoliosis manifests as a solitary deformity, but further investigation may reveal other significant subclinical signs [10, 11]. Idiopathic Scoliosis has been described as a torsional deformity of the spine, with several torsional regions joined by a junctional zone, every region including a variable number of morphologically lordotic vertebrae translated and rotated to the same side [12]. Notwithstanding, although the morphological lordotization (flat back), related to a secondary relative anterior spinal overgrowth is an almost constant when looking at the middle sagittal plane of the central scoliotic region (apex), the geometry of the spine is highly variable when observing the spine on a latero-lateral radiograph (middle sagittal plane of the patient), Trunk deformity and back asymmetry correlates with the spinal deformity, but there can be significant discrepancies in some cases [13].
The curvature in the frontal plane (AP radiograph in upright position) is limited by an “upper end vertebra” and a “lower end vertebra”, taken both as a reference level to measure the Cobb angle. The Scoliosis Research Society (SRS) suggests that the diagnosis is confirmed when the Cobb angle is 10° or higher and axial rotation can be recognized. Maximum axial rotation is measured at the apical vertebra. However, structural scoliosis can be seen with a Cobb angle under 10° [7], with a potential for progression. Progression is more common in girls during the growth spurt at puberty, and then, it is called progressive idiopathic scoliosis. When untreated, it may lead to severe trunk deformities, which limit the capacity and functional biomechanics of the chest, exercise capacity, general fitness and ability to work, all factors related with impairment on quality of life.
Epidemiology
In approximately 20% of cases, scoliosis is secondary to another pathological process. The remaining 80% are cases of idiopathic scoliosis. Adolescent idiopathic scoliosis (AIS) with a Cobb angle above 10° occurs in the general population in a wide range of prevalence from 0.93 to 12% [8, 9, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28,29]: 2 to 3% is the value the most often found in the literature, and it has been suggested that the incidence changes according to latitude [15, 30].
Approximately 10% of these diagnosed cases require conservative treatment and approximately 0.1–0.3% require operative correction of the deformity. Progression of AIS is much more frequently seen in females. When the Cobb angle is 10 to 20°, the ratio of affected girls to boys is similar (1.3:1), increasing to 5.4:1 for Cobb angles between 20° and 30°, and 7:1 for angle values above 30° [31, 32]. If the scoliosis angle at completion of growth exceeds a “critical threshold” (most authors assume it to be between 30° and 50° [33], there is a higher risk of health problems in adult life, decreased quality of life, cosmetic deformity and visible disability, pain and progressive functional limitations [32, 34].
Etiology
The etiopathogenesis of scoliosis has not been elucidated. The causes of scoliosis are being sought in congenital or acquired disorders of vertebral structure. Patients with this type of deformity are usually noted to suffer from such co-existent abnormalities as asymmetrical structure of the brain stem, sensory and balance impairment, disorders of blood platelet and collagen function [4, 5]. The role of genetic factors in the development of spinal axial disorders is also emphasized and is confirmed by the tendency of scoliosis to run in families, with researchers suggesting a hereditary disorder of oestrogen receptor structure and function [35]. Numerous authors indicate that the causes of scoliosis are systemic disorders of, among others, mucopolysaccharide and lipoprotein synthesis [36, 37]. In the 1990s, a group of researchers under the guidance of Dubousset proposed that scoliosis develops as a result of melatonin synthesis disorder [38, 39, 40, 41, 42]. They produced spinal curvatures in chickens via pinealectomy and later ameliorated the melatonin deficiency to find decreased incidence of scoliosis in the animals. Machida reported reduced serum melatonin levels in girls with rapidly progressive idiopathic scoliosis. His finding has been questioned by other authors, who found no differences between melatonin levels in scoliotic girls and those in a healthy control group [37, 38, 39, 40,41]. Currently, melatonin is attributed only a limited role in scoliosis pathogenesis [43]. The possible role of melatonin in scoliosis etiology is also discussed in connection to age at menarche in different geographic latitudes [15]. According to more recent studies, calmodulin may disturb melatonin levels. Kindsfater et al. [44] assessed calmodulin levels in order to determine the risk of curve progression. Based on this hypothesis, melatonin plays a secondary role in the spontaneous induction of scoliosis. It is a consequence of interaction with calmodulin, a protein that has receptors for calcium ions and is thus able to influence the contractility of skeletal muscles; it can also be found in blood platelets (its level in platelets was higher in patients with scoliotic progression rates of more than 10° over 12 months) [35]. Other authors have evaluated the possibility that gene variants of IL-6 and MMPs might be associated with scoliosis and suggest that MMP-3 and IL-6 promoter polymorphisms constitute important factors for the genetic predisposition to scoliosis [45]. More recently, an increased BNC2 expression has been implicated in the etiology of AIS [44]. In summary, the etiology of scoliosis has not been fully elucidated [46, 47]. Based on the variety of opinions on idiopathic scoliosis development, we can assume a multifactorial origin. The opinions presented above are supplementary rather than mutually exclusive. At the same time, they explain the complex determinants of and relationships between disorders of spinal development in children and adolescents.
Natural history
Idiopathic scoliosis (IS) may develop at any time during childhood and adolescence. It most commonly appears in periods of growth spurt-the first is in the first months of life, generally between 6 and 24 months, the between the age of 5 and 8 years, there is a height peak growth and at puberty the most important and rapid growth spurt, generally at age 11 to 14 years of life [2, 3, 48]. The rate of development of spinal curvature changes the most rapidly at the beginning of puberty [14, 15].
According to the Tanner scale, which assesses tertiary sex maturation characteristics, this period corresponds to stage S2 and P2 in girls and T2 and P2 in boys [16]. The pubertal growth spurt begins with accelerated longitudinal growth of limbs, which causes a temporary disproportion of the body (long limbs and short trunk). Then, longitudinal growth is seen in the axial skeleton. It is the period of the most marked progression of IS. After approximately 2/3 of the period of pubescent growth spurt, girls experience menarche, which indicates that the peak of growth has been passed, with a gradual decrease in the risk of scoliosis progression. There is a much lower potential for progression of idiopathic scoliosis after the spinal growth is complete. In adulthood, IS may intensify as a result of progressive osseous deformities and collapsing of the spine. This phenomenon is reported especially in scoliosis that is more severe than 50°, while the risk of progression starts to increase as the curve grows above 30° [17, 21, 22, 34]; less severe idiopathic scoliosis curves often remain stable. Nevertheless, the natural history of adult scoliosis is not well known to date, and it is still possible the progression can have some peak periods [49]. Typically, in adult scoliosis, the evolution of AIS with delayed risk of rotatory dislocation is differentiated from a “de novo” scoliosis rapidly changing in a few years to the rotatory dislocation [50, 51].
Classifications
During the years, many different classifications of idiopathic scoliosis have been proposed, but not all of them are either relevant for conservative care or currently used beyond research purposes. Recent developments in 3D reconstructions of all spine deformities using standard or digital radiography allow to deepen the analysis of the scoliosis deformity in all space planes. In the text, we present the classifications endorsed by SOSORT Consensus (Table 3).
Table 3
Classifications of idiopathic scoliosis
Chronological (SoE: V) | Angular (SoE: VI) | Topographic (SoE: V) | ||||
|---|---|---|---|---|---|---|
Age at diagnosis (years.months) | Cobb degrees | Apex | ||||
from | to | |||||
Infantile | 0–2. | Low | Up to 20 | Cervical | – | Disc C6–7 |
Juvenile | 3–9. | Moderate | 21–35 | Cervico-thoracic | C7 | T1 |
Adolescent | 10–17. | Moderate to severe | 36–40 | Thoracic | Disc T1–2 | Disc T11–12 |
Adult | 18+ | Severe | 41–50 | Thoraco-lumbar | T12 | L1 |
Severe to very severe | 51–55 | Lumbar | Disc L1–2 | |||
Very severe | 56 or more |
Chronological
James [52, 53] proposed that scoliosis should be classified based on the age of the child at which the deformity was diagnosed (Table 3). This classification is important since the longer the period between diagnosis of scoliosis and completion of growth by the developing child, the greater the risk of developing a more severe and complicated deformity. Today, the general term “Early onset scoliosis” is sometimes used to classify together Infantile and Juvenile scoliosis, but we prefer the James classification, due to the fact that infantile scoliosis has a different prognosis. In fact, there are congenital postural scoliosis curves diagnosed in newborns, as a component of a syndrome usually resulting from intrauterine compression caused by malposition of the fetus during pregnancy, but they represent exceptional conditions. Such curvatures are not three-plane deformities and usually undergo spontaneous remission. As the range of hip motion is often asymmetrical and the child prefers to rest their head on one side only, exercises and correction of body position are usually employed. Examination usually reveals gradual remission of the curvature in these infants, and such scoliosis curves may thus be categorized as regressive [54].
Angular
The angle of scoliosis measured on the standing frontal radiograph according to the Cobb method is one of the decisive factors in managing idiopathic scoliosis, and it is directly correlated to all treatment decisions. Many different classifications have been proposed based on these angular measurements, but no one system today has widespread validity. Nevertheless, there is an agreement on some thresholds [32, 34,55, 56, 57]:
Under 10° of scoliosis, the diagnosis of scoliosis should not be made. The inter-reliability of the Cobb angle is well known, and the potential limitation of this criterion are clear. On the other hand, a clear and simple criterion is needed for a generally accepted and a simple agreed definition of structural scoliosis.
Over 30° of scoliosis, the risk of progression in adulthood increases, as well as the risk of health problems and reduction of quality of life.
Over 50°, there is a consensus that it is almost certain that scoliosis is going to progress in adulthood and cause health problems and reduction of quality of life.
From these thresholds, and taking into account that the recognized measurement error in measuring Cobb angles is 5° [58, 59, 60, 61, 62, 63], very important decisions are made. When measured manually on the radiograph, the most commonly cited measurement error of Cobb angle is indeed 5° [58, 59, 60, 61, 62, 63]. However, new computer-assisted measurement methods have lesser measurement errors, ranging from 1.22° to 3.6° [64]. When making clinical decisions, measurement error thresholds of a corresponding method used should be taken into account.
Topographic
Most commonly used classifications of idiopathic scoliosis are based on the anatomical site of the spinal deformity in the frontal plane. A classification developed by Ponseti [65] (based on Schulthess work [66]) distinguishes four major types of scoliosis: thoracic, lumbar, thoraco-lumbar and S-shaped. This classification is the oldest. It is reported in Table 3. It is used both in conservative treatment and in the pre-operative classification of scoliosis [67]. Two other classification systems of idiopathic scoliosis based on the anatomical site of spinal deformity have been proposed and used in preoperative planning [68, 69, 70, 71, 72, 73]. The most widely used for operative treatment is Lenke classification [69]. This classification however uses some objective criteria that make it not applicable to be used for non-operative treatment. Mild scoliosis with indication for non-operative treatment, specific exercises or bracing, cannot be properly classified according to Lenke objective criteria. Patients under non-operative treatment rarely are prescribed a side bending radiograph, and even in that case, the criterion of “finding a residual coronal curve on side-bending radiographs of at least 25° in the proximal thoracic, main thoracic, thoracolumbar or lumbar regions, as a definition of a structural curve”, is not applicable to scoliosis in the range of 15° to 30°. Since these guidelines concern conservative treatment, the abovementioned classification is not discussed beyond here. Moreover, efforts were made to clinically evaluate the third dimension, mainly for surgical purposes; recently, several 3D classifications have been proposed [74, 75, 76, 77, 78, 79, 80, 81, 82], but the most useful one in clinical practice is yet to be defined [83].
Rigo classification
Many clinicians and brace developers base the treatment on some general and individualized criteria [84, 85], rather than to a classification able to guide brace fitting and construction as in the Rigo Cheneau brace and in the Spinecor System [73, 86]. The Rigo classification has been accepted (LoE VI) by these guidelines. They have been developed specifically to correlate with Rigo-Chenau brace design and treatment. The Rigo Cheneau classification was developed in order [72] to define specific principles of correction required for efficacious brace design and fabrication. The classification includes radiological as well as clinical criteria. The radiological criteria are utilized to differentiate five basic types of curvatures including (I) imbalanced thoracic (or three curves pattern), (II) true double (or four curve pattern), (III) balanced thoracic and false double (non 3 non 4), (IV) single lumbar and (V) single thoracolumbar. In addition to the radiological criteria, the Rigo Classification incorporates the curve pattern according to SRS terminology, the balance/imbalance at the transitional point, and L4-5 counter-tilting. This classification has been evaluated for intra-and inter-observer reliability: the intra-observer Kappa value was 0.87 (acceptance > 0.70); the inter-observer Kappa values fluctuated from 0.61 to 0.81 with an average of 0.71 (acceptance > 0.70) [72].
Evidence-based clinical practice approach to idiopathic scoliosis during growth
Goals of conservative treatment
General goals
A SOSORT 2005 Consensus paper, titled “Why do we treat adolescent idiopathic scoliosis? What do we want to obtain and to avoid for our patients” [34], can serve as reference for specific insights on this topic. In the present guidelines, the most general goals of treatment are presented in Table 4 [34].
Table 4
Goals of treatment according to the SOSORT consensus paper. Only the goals that reached 80% of agreement are listed here, starting from the most important
Esthetics | |
Quality of life | |
Disability | |
Back pain | |
Psychological well-being | |
Progression in adulthood | |
Breathing function | |
Scoliosis Cobb degrees | |
Need of further treatments in adulthood |
The goals of conservative treatment of idiopathic scoliosis may be divided into two groups: morphological and functional. The first aspect is related to aesthetics which was defined as the first goal of treatment by SOSORT experts. Both aspects are related to patients’ quality of life, psychological well-being and disability (defined as the second, third and fourth goals according to the SOSORT experts) [34]. For didactic reasons, the goals will be present here in a different order. The basic objectives of comprehensive conservative treatment of Idiopathic Scoliosis are as follows:
1.
To stop curve progression at puberty (or possibly even reduce it)
2.
To prevent or treat respiratory dysfunction
3.
To prevent or treat spinal pain syndromes
4.
To improve aesthetics via postural correction
To stop curve progression at puberty (or possibly even reduce it)
Recently, a multi-centre RCT demonstrated that bracing is effective at preventing progression to the surgical range (defined as ≥ 50°) [87], although on average the curves did not improve. Moreover, a long-term RCT found that PSSE improved Cobb angles at skeletal maturity in patients with AIS [88]. Current evidence suggests that conservative treatment for scoliosis is effective at stopping curve from progression, as well as improving the curves at skeletal maturity.
It is possible and usually sufficient to prevent further progression, even if recent research papers conducted according to the SRS criteria have shown that it is also possible to obtain some amount of curve correction [89, 90, 91, 92, 93].
To prevent or treat respiratory dysfunctions
The morphological aspect of the deformity is closely related to the effects on bodily function. Depending on its degree and location, the curvature may affect respiratory function. The most prominent changes within the respiratory system are produced by curvatures of the thoracic spine [94, 95, 96, 97].
To prevent or treat spinal pain syndromes
Statistically significant differences in pain prevalence are already noted in people with scoliosis between 20 and 30 years of age. In a follow-up study of over 40 years’ duration, a three-fold higher prevalence of chronic pain-related complaints and over 20-fold higher incidence of severe and darting pain were observed in a group of people with untreated idiopathic scoliosis compared to a control group. The occurrence of pain-related complaints is probably multifactorial in origin [33, 50, 98, 99, 100, 101].
In adult with spinal deformities, sagittal parameters influence pain the most as compared to the magnitude of scoliosis curve [102]. The assessment of regional and global alignment parameters in full-length standing postero-anterior and lateral, as well as pelvic parameters, is strongly recommended due to their relation with pain and disability [103]. In addition, pain is significantly correlated to three dimensional olysthesis, L3 and L4 endplate obliquity angles, loss of lumbar lordosis, and thoracolumbar kyphosis [102].
The SRS-Schwab classification based on curve type and magnitude associated with specific index based on sagittal pelvic and spine parameters has been showed to be reliable and to correlate with quality of life in adults with spinal deformities [104]. This new classification suggests that there are specific parameters able to predict the risk of pain and disability, in adulthood. Currently, no studies have confirmed if it is possible to treat sagittal alterations during growth, or if the conservative treatment play a role in creating unbalanced spine in adults previously braced, nor if the same treatment is able to prevent future alteration of the sagittal profile of the spine and pelvis. Despite this knowledge gap, there is a general agreement among experts that the best possible treatment should take into account not only the correction of the spine in the coronal plane but also the maintenance or the restoration of the normal sagittal profile of the spine.
To improve the appearance via postural correction
Quality of life is significantly affected by aesthetic self-perception and appearance. Therefore, visual correction of scoliosis-related external trunk deformity is an important issue in conservative treatment. Therapeutic outcomes may be subjectively visually assessed using specifically designed questionnaire or objectively assessed using surface topography and photographic methods [13, 105, 106, 107, 108, 109, 110,111].
Specific goals of conservative treatment during growth
Specific goals of conservative treatment for patients during growth should be set at baseline (X-ray before treatment). These goals should be considered as a dynamic continuum, which can be adapted during treatment according to the change in the patient clinical status (change in deformity, compliance with the treatment, proposed therapies, etc.). In this respect, we can define the following goals:
Absolute goal: these are the minimum expected goals of conservative treatment. If not anything else, at least these goals should be reached.
Primary goals: these are the “best possible” goals for patients starting treatment in each specific clinical situation.
Secondary goals: these are the compromise goals that come when it becomes clear that it is not possible to reach the primary goals
According to this approach, SOSORT has reached a Consensus (Strength of Evidence VI— Strength of Recommendation C) shown in Table 5. This table has been organized with a minimum and a maximum of primary and secondary goals that can be reached for each clinical situation. The absolute goals for all patients in every clinical situation are to avoid fusion surgery. A first similar scheme had been proposed in 2007 [112]: these goals were applied in some studies [90, 91, 112] and proved to be useful. Accordingly, we propose these goals of treatment here to be applied in clinical studies of conservative treatment of idiopathic scoliosis.
Table 5
Specific aims of conservative treatment during growth (strength of evidence VI–strength of recommendation C) at least 70% of agreement (SoE VI)
Absolute aim of treatments | Percentage | |
Avoid surgery | 90.70 | |
Improve aesthetics | 86.05 | |
Improve quality of life | 82.56 | |
Degree of curve | Primary aim | Secondary aim |
Low | Remain below 20° | Remain below 45° |
Moderate | Remain below 30° | Remain below 45° |
Severe | Remain below 45° | Postpone surgery |
Evidence-based clinical practice approach
This section is constituted mainly by a Practical Approach Scheme (PAS) (Table 6) that has been prepared through the Consensus Procedure reported in (Additional file 1). The PAS constitutes an Evidence-Based Clinical Practice approach to idiopathic scoliosis. The Level of Evidence of PAS is VI, while the Strength of Recommendation is B.
Table 6
Practical approach scheme (PAS) for an evidence-based clinical practice approach to idiopathic scoliosis (strength of evidence VI–strength of recommendation B)
1 | Obs 36 |
2 | Obs 12 |
3 | Obs 8 |
4 | Obs 6 |
5 | Obs 3 |
6 | PSSE |
7 | NTRB |
8 | SIR |
9 | SSB |
10 | HTRB |
11 | PTRB |
12 | FTRB |
13 | TTRB |
14 | Su |
Here, we present a Strength of Treatments Scheme (STS) (Table 7) that reports all the possible treatments that can be proposed for Idiopathic Scoliosis starting from the least to the most demanding (both in terms of challenge for the patient, and possible efficacy). In addition, the STS is Consensus based (Level of Evidence V—Strength of Recommendation B). Starting from the STS, it is possible to state, for each single clinical situation of the PAS, a minimum and a maximum of possible treatments that could be proposed: consequently, all treatments that in the STS are reported between this minimum and maximum can be considered for that specific clinical situation. Tables 8and 9 show the number of paper for each Level of Evidence and the Strength of recommendation for each treatment.
Table 7
Strength of treatments scheme (STS) (strength of evidence V–strength of recommendation B): it reports all the possible treatments that can be proposed for idiopathic scoliosis graduated from the less to the most demanding (both in terms of burden on
Low | Moderate | Severe | |||||
|---|---|---|---|---|---|---|---|
Min | Max | Min | Max | Min | Max | ||
Infantile | Obs3 | Obs3 | Obs3 | TTRB | TTRB | Su | |
Juvenile | Obs3 | PSSE | PSSE | FTRB | HTRB | Su | |
Adolescent | Risser 0 | Obs6 | SSB | HTRB | FTRB | TTRB | Su |
Risser 1 | Obs6 | SSB | PSSE | FTRB | FTRB | Su | |
Risser 2 | Obs6 | SSB | PSSE | FTRB | FTRB | Su | |
Risser 3 | Obs6 | SSB | PSSE | FTRB | FTRB | Su | |
Risser 4 | Obs12 | SIR | PSSE | FTRB | FTRB | Su | |
Adult up to 25 y | Nothing | PSSE | Obs12 | SIR | Obs6 | Su | |
Adult | No Pain | Nothing | PSSE | PSSE | SIR | Obs12 | HTRB |
Pain | PSSE | SSB | PSSE | HTRB | PSSE | Su | |
Elderly | No Pain | Nothing | PSSE | Obs36 | PSSE | Obs12 | HTRB |
Pain | PSSE | SSB | PSSE | HTRB | PSSE | Su | |
trunk decompensation | Obs6 | SSB | PSSE | PTRB | PSSE | Su |
Table 8
Level of evidence of recommendations: the table shows the number of papers according to the level of evidence for each treatment
I | II | III | IV | V | VI | Total | |
|---|---|---|---|---|---|---|---|
Bracing | 2 | 3 | 3 | 6 | 12 | 1 | 25 |
Specific exercises to prevent scoliosis progression during growth | 1 | 1 | 1 | 0 | 8 | 1 | 12 |
Specific exercises during brace treatment and surgical therapy | 0 | 3 | 0 | 0 | 3 | 0 | 6 |
Other conservative treatments | 0 | 0 | 0 | 0 | 2 | 0 | 2 |
Respiratory function and exercises | 0 | 0 | 0 | 0 | 3 | 0 | 3 |
Sports activities | 0 | 0 | 2 | 0 | 3 | 1 | 6 |
Assessment | 0 | 0 | 1 | 9 | 1 | 3 | 14 |
Total | 3 | 7 | 7 | 15 | 32 | 6 | 68 |
Table 9
Strength of recommendations: the table shows the strength of recommendation for each treatment
A | B | C | D | E | Total | |
|---|---|---|---|---|---|---|
Bracing | 2 | 20 | 3 | 0 | 0 | 25 |
Specific exercises to prevent scoliosis progression during growth | 0 | 7 | 5 | 0 | 0 | 12 |
Specific exercises during brace treatment and surgical therapy | 0 | 2 | 4 | 0 | 0 | 6 |
Other conservative treatments | 0 | 0 | 2 | 0 | 0 | 2 |
Respiratory function and exercises | 0 | 1 | 2 | 0 | 0 | 3 |
Sports activities | 0 | 3 | 3 | 0 | 0 | 6 |
Assessment | 1 | 6 | 4 | 1 | 2 | 14 |
Total | 3 | 39 | 23 | 1 | 2 | 68 |
The PAS has some main characteristics that constitute its strength and justification:
PAS is proposed to resolve the differences in treatment decisions between different clinicians in their clinical practice. PAS guards against presumably wrong clinical decisions (above maximum: overtreatment, below minimum: undertreatment).
It reports a real approach, since most clinicians usually choose a variety of treatments for a single patient; the final decision comes after discussion with the patient, and weighting the various risk factors involved in the clinical situation. In fact, the PAS has been developed according to the “Step by Step” Sibilla’s theory [92,112, 113, 114, 115], which states that for each patient, it is mandatory to choose the correct step of treatment, where the most efficacious is also the most demanding. Accordingly, coming to a wrong decision means facing one of the two main mistakes in conservative treatment of idiopathic scoliosis, overtreatment (too much burden on the patient, without improved efficacy) or undertreatment (treatment that leads to little or no efficacy).
Evidence-Based Clinical Practice is by definition the best integration between the knowledge offered by Evidence-Based Medicine, individual clinical expertise and patients’ preferences [116, 117, 118]. Consequently, different clinicians will treat a patient with the same clinical problem differently; the variation can be due to the patient’s preferences or because of the specific expertise of the clinician. Therefore, proposing a definitive clinical approach for a certain clinical situation is problematic. Rather, a range of options should be considered.
Conservative treatments
All the treatment approaches below are listed in the STS (Table 7) and are presented from the treatments having least impact to those having greatest impact. For more details about each approach, it is possible to refer to the Brace Technology and the Rehabilitation Schools for Scoliosis Series [119, 120] and the Consensus paper on Terminology [121], published by the Scoliosis and Spinal disorders journal.
Nothing (No): No treatment is needed.
Observation (Ob): It is the first step of an active approach to idiopathic scoliosis, and it consists of regular clinical evaluation with a specific follow-up period. Timing of this follow-up can range from 2 to 3 to 36–60 months according to the specific clinical situation. Clinical evaluation does not need to include taking radiographs: radiographs are usually performed during alternate clinical evaluations.
Physiotherapeutic scoliosis-specific exercises (PSSE): PSSE include all forms of outpatient physiotherapies with evidence of having an effect on some scoliosis outcomes and which will gradually be published in the Rehabilitation Schools for Scoliosis Series [120] in the Scoliosis and Spinal Disorders journal. They have been listed in the 3rd part of these guidelines. The frequency of therapeutic sessions varies from twice to 7 days a week depending on the complexity of the techniques, motivation and the ability of the patient to carry out the treatment. Long-term outpatient physiotherapy sessions usually take place two to four times a week if the patient is willing to cooperate fully. The actual form of exercise depends mainly on the character of the selected therapeutic method.
Special Inpatient Rehabilitation (SIR): If SIR is recommended, patients spend several weeks (usually 3–6) at a specialized health centre (hospital department, sanatorium or a similar form of health care) where they undergo an intensive PSSE treatment (several hours per day).
Bracing: It consists of using a brace (a corrective orthosis) for a specified period of time each day. Usually, it is worn until maturity. The main therapeutic goal is to halt the scoliosis curves from progression. According to SOSORT, the use of a rigid brace implies the use of exercises when out of the brace. Bracing includes the following:
Night Time Rigid Bracing (8–12 h per day) (NTRB): wearing a brace mainly in bed.
Soft Bracing (SB): it includes mainly the SpineCor brace [122, 123] but also other similar designs [124, 125].
Part Time Rigid Bracing (12–20 h per day) (PTRB): wearing a rigid brace mainly outside school and in bed.
Full Time Rigid Bracing (20–24 h per day) or cast (FTRB): wearing a rigid brace all the time (at school, at home, in bed, etc.). Casts have been included here as well. Casts are used by some schools as the first stage to achieve correction to be maintained afterwards with rigid brace [126, 127, 128]; a cast is considered a standard approach in infantile scoliosis [129, 130, 131, 132]. Recently, a new brace has been developed that has been claimed to achieve same results as casting [91, 133, 134].
A common feature of all forms of conservative treatment is the need to actively involve the patient and caregivers [135]. Therefore, education, psychotherapy, systematic monitoring of outcomes, assessment of patient’s compliance, and verification and modification of methods in the course of the therapy are deemed crucial elements of conservative treatment. In order to achieve the best possible outcome, conservative treatment should be delivered by an experienced therapeutic team including a physician, a physiotherapist, an orthotist and possibly a psychologist [135]. Support groups and Internet forums are also important in conservative treatment.
Prognostic factors
Prognostic factors should be used with PAS, to select options appropriately between the minimum and maximum strength of treatment. The following factors have been suggested as possible determinants of a higher risk of scoliosis progression: positive family history, laxity of skin and joints (connective tissue defect), flattening of physiological thoracic kyphosis (impedes efficient bracing), angle of trunk rotation exceeding 10°, and growth spurt [136].
Bunnell reported that the risk of progression at the beginning of puberty is 20% in 10° scoliosis, 60% in 20° scoliosis, and as much as 90% in 30° scoliosis [55, 137]. At the age of peak height growth (13 years of osseous age in girls), the risk of progression is 10, 30 and 60%, in the curve severity threshold categories above, respectively. During the final stage of puberty (at least Risser grade II), the risk of deformity progression becomes considerably lower, falling to 2% in 10° scoliosis, 20% in 20° scoliosis and 30% in 30° scoliosis. The prognosis regarding IS progression seems to be more optimistic for boys [138].
Considering that the sagittal spine profile of mild (10°–20°) scoliotic curves was found to be similar to the lateral spine profile of their healthy controls [139], it has been proposed that thoracic hypokyphosis, coupled with axial rotation, could be compensatory rather than etiological in IS pathogenesis [140].
Scoliosis can affect the spine not only through translation in the frontal, and rotation about horizontal plane, but also through changes in the sagittal profile of the spine. Different types of scoliosis present with different sagittal profiles; one example is the typical association of flat back in thoracic scoliosis. Although the etiology of scoliosis is unknown, some authors have hypothesized that patients with certain sagittal spinal profiles seem more prone to developing scoliosis than others [141, 142, 143, 144, 145]. It has been demonstrated that the sagittal profile of the spine depends on the pelvic placement playing a major role in determining the sagittal balance of the spine [146,147, 148, 149].
The pathologic mechanism of progression of IS curve is described in recent publications [46, 47, 150, 151]. The factors that contribute to progression include the effect of gravity, the muscle action, the reactive forces causing increased lordosis, the human gait, and the growth induced torsion. The intervertebral disc could be included as an additional morphological factor involved in the progression of an IS curve [120,152, 153].
Recently developed genetic assessment, with 53 identified loci [56, 154], can now help predict the risk of IS progression. The determination of the polymorphism of selected genes is meant to facilitate the assignment of a patient to a progressive or stable group [155, 156, 157]. Unfortunately, the data originating from one population often are not confirmed in replication studies involving other populations [158, 159]. A prognostic genetic test, known as ScoliScore, has also been developed [160]. Although these initial results have been promising, their generalizability is still uncertain [161].
Finally, during recent years, there have been several prognostic formulas that have been proposed [48, 162, 163]. The previous SOSORT guidelines [3] were based on the Lonstein and Carlson factor of progression [48] for the assessment of the risk of idiopathic scoliosis. Since there are no formulas that have been applied in specific studies after their development to verify their real accuracy, we do not apply them in these guidelines.
The wide range of normative values, already demonstrated in large population of healthy children, and the recognized changes of pelvic and sagittal parameters during growth [164, 165] can significantly affect these results and make it very difficult to reach definite conclusion. In addition, curve magnitude influences the sagittal profile of the spine. Therefore, some differences may be related to the mean Cobb angle of the population included in each study. Even though there still remain many unanswered questions, it appears that the sagittal parameters are correlated with the development of the spinal deformities, and we recommend they be monitored during therapy.
Brace treatment
Methods
In November 2015, we performed a search in MEDLINE from its inception, with no language limitations. We used the following search strategies:
“Braces”[Mesh] AND “Scoliosis”[Mesh] AND (has abstract[text] AND (Clinical Trial[ptyp] OR Meta-Analysis[ptyp] OR Practice Guideline[ptyp] OR Randomized Controlled Trial[ptyp] OR Review[ptyp])) (198 papers).
(“Scoliosis/therapy”[Mesh]) AND “Braces”[Mesh] AND compliance (100 papers)
“Scoliosis”[Mesh] AND “Braces”[Mesh] AND (“infant, newborn”[MeSH Terms] OR “infant”[MeSH Terms:noexp] OR “child, preschool”[MeSH Terms]) (194 references).
We selected from the titles a total of 250 references, and looking at the abstracts, 102 were selected and retrieved in full text. We also searched the following: the abstracts of all SOSORT meetings, from the first one in 2003 to 2010; the personal files and knowledge of all the authors; the articles retrieved with all the other searches listed in these guidelines; and the references sections of all retrieved papers. The selection criteria used in all these searches were as follows: pertinence for the topic “Brace treatment”; presence of the abstract; numerical results in relation to scoliosis; retrievability in full text; all languages.
Results
SOSORT has published in Scoliosis and Spinal Disorders Journal two Consensus Papers on bracing titled “SOSORT consensus paper on brace action: TLSO biomechanics of correction (investigating the rationale for force vector selection)” [131] and “Guidelines on ‘Standards of management of idiopathic scoliosis with corrective braces in everyday clinics and in clinical research’: SOSORT Consensus 2008” [135]; in addition, previously published guidelines are also freely available in the Journal web page [3], which can serve as reference for specific insights.