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2 - Background2.1
Institutional
background
2.1.1
ISICO
history
ISICO (Istituto
Scientifico Italiano COlonna Vertebrale, or Italian Spine Scientific
Institute), was established at the end of 2002 to promote and develop an
innovative model of approach to spinal pathologies. This approach is the result
of a history that began as long ago as the early 1960s, when in Vigevano
(Italy) Antonio Negrini and Nevia Verzini founded the Scoliosis Centre “Centro Scoliosi Negrini” (CSN). The therapeutic activity was mainly directed at
scoliosis and kyphosis treatment, making use of rehabilitative methodologies
that in those days were the most popular ones in Italy. Year after year these
methodologies were enriched through the exchange of information and experiences
with the most qualified European scoliosis centres: France (Lyon, Paris and
Berck), Switzerland (Geneva), Sweden (Goteborg and Stockholm), Belgium
(Bruxelles), the Netherlands (Antwerp) and the USSR (Moscow). Particularly, the
CSN began a collaborative effort in the study and research of scoliosis with
the “Centre des Massues” in Lyon, France (Fig. 1), which in those days was considered one
of Europe’s most prestigious centres for scoliosis treatment. Together with
this French institution, in 1980-84 the CSN took part in an international
research study on the efficacy of exercise in the treatment of minor scoliosis.91 This contact with French centres allowed the
CSN to establish study and updating relationships with well-known researchers
like Stagnara, Duval-Beaupère, Perdriolle and Mollon.
Fig. 1 – From the left: Mr. and Mrs. Stagnara, Mollon and Negrini at the International Congress in Florence (1975) The huge quantity of scientific studies on the spine, as published in
the international literature throughout the 1970s and ‘80s, allowed the
CSN to gather considerable data regarding scoliosis aetiology and pathogenesis.
To delve further into this reality, in 1978 Antonio Negrini, together with a
group of Italian specialists and physicians, promoted the foundation of GSS (the
acronym for Gruppo di Studio della
scoliosi e delle patologie vertebrali, or the Italian Study Group on
Scoliosis and spinal pathologies - Fig. 2),
which today continues its thirty-year legacy in the pursuit of professional
training based on scientific evidence for Italian professionals in the field of
rehabilitation and prevention.
Fig. 2 –The logos of Scoliosis Centre Negrini (www.centronegrini.it) and the Italian Study Group on Scoliosis and Spinal Pathologies (www.gss.it). At the same time it became possible to develop a new approach to the
scoliotic patient, in which exercises were directed toward therapeutic
objectives specifically derived from the data provided by scientific research.
The principle of working only on the basis of science began to be applied, and
this was the embryo of what would later be proposed by “Evidence-Based
Medicine” in a more advanced way: a concept that now is at the root of every
protocol applied by ISICO. This exercised-based approach became widespread in
Italy during the 1980s and ‘90s thanks to the presence of CSN at many
rehabilitation centres, courses in rehabilitation and physiotherapy,
professorships in academic classes for physiotherapists and specialists,
through the teaching practices to which the centre was open, with the
elaboration of experimental degree dissertations, and with papers presented at
the most important national and international conferences.96,97,101,117,120,121 The 1985-1995 decade saw the beginning of a permanent cooperation with
one of the major Italian rehabilitative structures, the “Fondazione Don
Carlo Gnocchi.” This institution promoted the protocols developed by CSN in
Vigevano with the medical and scientific collaboration of Dr. Sibilla, the
physician in charge of the Scoliosis Unit at that institute. Paolo Sibilla
(Fig. 3) was
an orthopaedic spinal surgeon who had decided to dedicate his life to the
conservative treatment of scoliosis in order to reduce, as much as possible,
the numbers of patients undergoing surgery.
Fig. 3 – Negrini, M.me Duval-Beaupére and Sibilla at the International Congress of Rome (1985) He obtained much of his experience at Gaetano Pini Hospital in Milan,
where he primarily attended, among the others, the orthopaedic schools (whose
principles he assimilated) run by Stagnara in Lyon (EDF plaster and Lyonnaise
brace);150,152 by Agostini in Padova (Risser’s plaster);80 and by Chêneau (the homonymous brace, in its
first version dating back to the 1980s).23,24 Another important contribution to his
professionalism came, after the initial training at the rehabilitation school
in Lyon, from continuous contact with rehabilitators who were deeply involved
with medical exercises for scoliosis, which he firmly believed he could
personally verify based on the results, and thanks to which he could develop
other therapeutic ideas.29,101,144-146 The later years of his life developed into a
rehabilitative reality much like that of the “Fondazione Don Carlo Gnocchi” in
Milan, which became a research institute financed by the Italian Health
Ministry, with the possibility for further development of his theories.
Therefore, Dr. Paolo Sibilla has been a pioneer of new and more effective
orthotic solutions for scoliosis, but it was most of all his rigor and deep
humanity that brought him professional success. Amid this confluence of clinic, scientific, human and professional
experiences, ISICO’s founders could develop their experience regarding
scoliosis. The combination of all this with organisational and managerial
skills, the use of new technologies and the know-how for high-level, rigourous
scientific research became a concrete reality with the foundation of ISICO. In
all this is reflected the mission that ISICO has espoused as the
foundation of its activities: to promote a scientific approach to the
rehabilitation of spinal pathologies in Italy, proposing itself as a highly
specialised institute in the field of rehabilitation for patients with spinal
diseases. Accordingly, ISICO wants not only to accomplish the application
of this approach within its structures but also to promote its circulation,
thanks to its role as a “bridge” among the different realities in this field
(Fig. 4): the
structures of the territory, the world of research, the world of industry and
society as a whole.
Fig. 4 ISICO is born to build bridges between different worlds that sometimes have difficulties to communicate: working directly in the scientific and clinical fields, the aims of ISICO include also education, mass media communication, prevention, and research projects for industries. 2.1.2
Looking
at scoliosis from the dual perspective of Evidence-Based Medicine and
Evidence-Based Clinical Practice
The foundation we wanted to give to ISICO’s work, on the basis of
our history, has been clearly discernible from the beginning: to derive
clinical and therapeutic choices (Evidence-Based Clinical Practice,
EBCP) from scientific knowledge (Evidence-Based Medicine, EBM). In a
context such as spinal rehabilitation, in which unsuitable treatments based on
beliefs and opinions are very frequent, we felt the need to do something more
stringent. We chose to have more certainties on which to base our approach, as
well as an external reference instead of an internal, self-centred one.
In that respect, science is a reference we can trust, because it is not based
on the ideas (even if creative and clever) of one or more persons but on the
proof of research integrated with the thoughts (expert opinions) of an entire
community--the scientific community--that continues to study and grow. EBM has been defined as the “integration of the best scientific
proof coming from research with clinical experience and patients’ values”141. Therefore, it is not a supine application of
the scientific knowledge to our patients (this alone could be
meritorious as compared with the application of one’s preconceived ideas, which
is a distinguishing feature of many physiotherapeutic and therapeutic methods)
Instead, it is the integration of this knowledge in one's clinical
experience in order to produce a proposal that must then interact with
the patient, who is no longer a mere spectator of the medical act
but a participant, because he/she must be enabled to consciously choose on the
basis of his or her principles and values. In that respect, EBM tells us that
evidence is only the background from which medical practice derives. Considering the field of conservative treatment for spinal deformities
we must make another remark, which is to say that from the publication of the
Italian guidelines on scoliosis it is clear that there is a lack of research
in this field.106,107 A comparison of the available publications on
this subject versus other musculo-skeletal pathologies is striking: A Medline
search of “low back pain” produced more than 13,000 publications, while there
were only about 2,100 for idiopathic scoliosis. Moreover, in regard to its
conservative treatment there were no more than fifty-two! Among these there are
no randomised controlled trials (RCTs), i.e., the more consistent (reliable)
ones. The strongest scientific evidence has to do with brace treatment, but as
to exercises the data seem to suggest their efficacy. Given this situation, from
our perspective Evidence-Based Clinical Practice is possible by: - Maintaining the actual evidence as the stable foundation of the clinical process; - Activating a continuous quality improvement process by measuring and constantly verifying clinical outcomes, in comparison with the best existing standards; - Integrating in the approach other ethical, economic and managerial variables such as those defined in the ISICO principles (Table 1): efficacy, efficiency, research, innovation, acceptability, humanisation, teamwork, transparency, organisation, services appropriateness and reliability; - Stimulating and participating in a worldwide research effort (we contributed to the creation of SOSORT, or the Society on Scoliosis Orthopaedic and Rehabilitation Treatment) so as to integrate international experiences and develop new clinical studies, but also theoretical “basic science” reports that could in the near future prove useful in clinics, such as those on classification and measurement systems. When science is not so clear, there is room for individual and
collective beliefs; for the patient’s and operator’s principles; for philosophy
that, in ISICO’s case, is clearly defined by our principles; and by the country
of origin, Italy. From this come: - An underlying humanity, even if in the rigour of science and in the demand for a result; - Continuous attention to the patient, but with awareness that psychological attention can never surpass the physical one; - Consideration for cosmetic appearance and style, which is innate in being Italian. However, let’s return to the basic issue: if there are so many variables
concurring to build a clinical approach, does EBM really help? We think it
does. We established our organisation to give EBM answers to patients, and
EBM has become a daily clinical practice at our facilities. The Italian
guidelines on scoliosis,106 that are rigourous and internationally
innovative, and fully an EBM national project that ISICO helped to develop, for
our organisation are a definite policy of clinical practice. Additionally, this
means we are always ready to change our ideas in the face of new scientific
evidence in the literature. We continuously investigate our results to build
our daily clinical approach on objective results, not on ideas, presumptions,
traditions and trends. EBM is a way of thinking that becomes a daily behaviour. 2.2
Scientific
background
2.2.1
What
scoliosis is, and what is important for treatment
Scoliosis is a three-dimensional deformity of the spine (Fig. 5).99,155,157 Today it is anachronistic to describe it as “a lateral deviation
of the normal vertical line of the spine . . . scoliosis consists of a lateral
curvature of the spine with a rotation of the vertebrae within the curve,”
as would still be apparent when looking at the Scoliosis Research Society
website and the related Terminology Committee.149 It is a pathology that presents very complex
aspects and, in some ways, even a certain appeal for healthcare professionals
who want to cure it. For these reasons, we believe the definition proposed in
the Italian National Guidelines106 is more complete: “a complex structural
deformity of the spine that turns on the three spatial planes: on the frontal
plane, it manifests itself with a lateral flexion, on the sagittal one with a
change in the curvatures (very often causing their reversal), and on the axial
with a rotational movement.” Based on the age at detection, we can
distinguish infantile (until three years of age), juvenile (from three years
until puberty), adolescent (from puberty until complete bone maturity)
scoliosis. In fact, more than 80% of scoliosis is diagnosed during adolescence.
It is normally accepted that the earliest the occurrence is the worst the
prognosis will be.74 Considering curvatures > 10° Cobb, the
scoliosis prevalence rate is
2%-2.5%. If we take into consideration curves > 6°, the rate increases to
4.5%; beyond 21°, the prevalence diminishes to 0.29%. It is interesting to note
that while distribution based on
sex is nearly identical for curvatures of 6°-10°, for those beyond 21° the
ratio of females to males is 5.4:1, while it increases to 7:1 if we consider
scoliosis patients who undergo treatment (brace or surgery).169
A B Fig. 5.3D representation of a real pathological spine (right thoracic, left lumbar scoliosis). In this figure the projections of the spine in the three spatial planes are represented: the frontal (xoy) plane is usually seen in the AP radiographs, the sagittal (yoz) is the one of the typical LL x-rays, while the horizontal (yoz) plane (Top View) is not usually considered and it is the one studied here. The Top View doesn’t allow to see the effect of the y axis, but joins together the sagittal and frontal plane deviations: in this respect it represents a useful auxiliary plane to have a quasi-3D projection of the spine. The Top View can be seen in a global (bodily) reference system (on the left: A) in which the vertical (y) axis is the gravity line, or in a spinal reference system (on the right: B) in which the vertical (y) axis is the line joining C7 and S1. In this case, the one that proved to be useful and it is adopted throughout our studies, the entire reference system rotates with respect to the gravity line, as it can be seen on the right (B). These figures refer to the same single subject: note the differences between global (A) and spinal (B) Top Views.98,99,114 Only in a few patients is it possible to
determine the cause of scoliosis. Among
these causes, the most frequent ones are congenital malformations of the spine
or thorax, and pathologies correlated to neurological or muscular disorders.
For all the others, we use the definition “idiopathic scoliosis.” Perhaps
it wouldn’t be far from the truth to think of these scolioses as a family of
several types of pathologies that are more or less prevalent in every single
patient. Scoliosis could probably be considered a complex, multifactorial
genetic pathology. Often (but not always), we find a positive family history,
but the heredity model is not completely clear. Regarding natural history, too, we must admit
that we lack truly exhaustive knowledge, even though in recent years we have
filled in some gaps thanks to some long-term studies. We can therefore indicate
some cardinal points (exclusively referring to adolescent idiopathic
scoliosis), as follows:4,16,60,74,109,169 - No reduction in life expectancy; - Cardiopulmonary function is compromised only in high-grade thoracic curvatures (> 80°) associated with hypo-kyphosis; - For curves < 30°, at the end of bone maturity worsening in adult age is exceptional; - Back-pain incidence is comparable to that of the general population but prevalence is significantly higher; pain intensity does not correlate to curve magnitude; and curve type can be associated with more severe pain; thoraco-lumbar curves seem to be the most painful, while the double curves are less painful; - Mild to moderate curves do not worsen during pregnancy; there are no differences in childbirth type (natural or Caesarean) nor in complications during or after childbirth; - Psychosocial implications do not seem to be correlated to the magnitude of curvature; small curves can have a great psychological impact with real problems in social life, while other patients with serious deformities accept their condition in a positive way. It is interesting to note that cosmetic concerns are main reasons adult patients with untreated adolescent idiopathic scoliosis seek consultations with surgeons (Fig. 6).
Fig. 6. Two adult
scoliosis very well known are those of Nostradamus, the Hunchback of Notre
Dame, with an important thoracic scoliosis, and some Disney representations
like Witch Hazel, who is anteriorly and laterally flexed on the lumbar spine
due to a lumbar scoliosis. Knowing the natural history of a pathology
means having the tools to understand whether the therapeutic measures thus
adopted will be effective or not. Most therapeutic decisions are made on the
basis of curve progression or its potential evolution. We found several factors
that influence progression probability in a
skeletally immature patient, as follows:74,169 - Two factors correlate with the curvature: double curvatures have a greater tendency to progress when compared to single ones; the greater the curvature at detection, the greater the risk of progression will be. - Other factors relate to growth (Fig. 7): age and bone maturity both correlate to progression, in the sense that the earlier the onset is the greater the risk of worsening will be; - Other factors are biomechanical: some authors have underlined the loss of thoracic kyphosis for thoracic curvatures and the presence of laterolisthesis for lumbar curves.
Fig. 7. The graph of Duval-Beaupére represents the progression history of scoliosis.150 It has been developed for neuromuscular scoliosis, but it fits quite well also for idiopathic scoliosis, in which anyway generally the slope of each single tract of the graph is reduced The cause of most scolioses is unknown, so it
is not possible to implement a primary prevention. Therefore, early diagnosis
must enable us to implement at least a secondary prevention.106 The validity of scoliosis screening has been extensively
debated in recent years (Fig. 8). On the basis of analyses regarding the
cost-benefit relationship and risks of hyper-treatment in parts of the
population that should not undergo specific scoliosis therapies, we have the
quasi philosophical contrast between two groups: those who believe they have good
weapons with which to fight the progression of scoliosis, reduce cosmetic
impact caused by deformity and avoid permanent disabilities,16,74,106 and those who, in a
fence-sitting logic, reserve treatment (at this point only surgical) to
scolioses that exceed certain curvature values.35,53
Fig. 8. The Bunnell measurement during Adams’ forward bending test is the
best known and most used evaluation during screening for scoliosis. A value
threshold of 5° to 7° Bunnell degrees according to different authors is
considered significant for scoliosis16,74,106 Serious attention must be paid to pathogenetic mechanisms that, starting from
an unknown aetiologic moment, cause the formation and the development (over
time and on the three spatial planes) of spine curvature. Beginning with
Stokes’ studies,13,83,159 the establishment of
a real vicious cycle has been emphasised to a considerable extent (Fig. 9): Scoliotic curvature increases during growth
because of the asymmetry of loads that act on each vertebra. According to Heuter-Volkmann law19,174 (saying that an increase of compressive loads
on a fertile epiphysis reduces growth, while on the contrary an increase of
distractive forces accelerates growth) it will happen that, in a scoliotic
curve, load asymmetry will cause a growth reduction on the concave side of the vertebral plate and an increase on
the convexity side. This is the essence of the vicious cycle that determines
curve progression, if only because of increased height as a result of growth.
From this comes the extreme importance of the earliest possible diagnosis and
of adequate therapeutic strategies against the progression of scoliosis.
Fig. 9. The “vicious cycle hypothesis of pathogenesis” by Ian Stokes84,154,156,158,159 is considered today as one of the best representations of the biomechanical progression of scoliosis: the hypothesis is that in progressive scoliosis vertebral body wedging during adolescent growth results from asymmetric muscular loading in a "vicious cycle" by affecting vertebral body growth plates (endplate physes). We believe in scoliosis conservative treatment. This not
for merely faith but is based on scientific studies,95,105 and because daily
experience shows us the efficacy of treatment.189 Therapy must be
early, adequate and prolonged, as follows:144,145 -
Therapy
must begin early because, if it is true that the earlier the onset the
greater the progression, we must be likewise early in implementing therapies in
the presence of clear signs of progression. -
Therapy
must be adequate to prevent gravity and the future potentials of the
single scoliosis we have to face, with options that go from exercises to braces
and then to the choice of daily brace-wear hours (Fig. 10).
Fig. 10. Representation of the
“step by step” Sibilla’s theory144,145 of treatment
of scoliosis. each step represents an increase in strength of treatment, but
also in requirements to patients: good
physicians are able to start from the right step, so avoiding over-treatment
with higher impact on quality of life, as well as under-treatment that
engenders progression -
Therapy must
be prolonged until the end of bone maturity. To be successful, the therapy must use the
active cooperation of the entire therapeutic team: physician,
therapist, orthotist. The team includes also, and most of all, the young
patient and his/her family, whose confidence and cooperation we must gain. That
is an indispensable requirement for success in treatment. All this is said without forgetting the
ineluctable usefulness of scoliosis surgical therapy in the most serious cases. Surgery,
however, means the failure of orthopaedy
(from the ancient Greek, “the art
of having children grow straight”) (Fig. 11).
Fig. 11. The original logo of orthopaedy. 2.2.2
Why
and when to treat scoliosis
The SOSORT
consensus paper, “Why do we treat adolescent idiopathic scoliosis? What we want
to obtain and to avoid for our patients”109 lists the goals of treatment in
order of importance, as defined by SOSORT experts: - Aesthetics -
Quality of life -
Disability -
Back pain - Psychological well-being -
Progression in adulthood -
Breathing function -
Radiographic and clinical data -
Need for further treatment in
adulthood - Outcomes related to posture, balance and movement - Cognitive outcome These
outcomes are ISICO’s outcomes. We are not interested in straight spines but in spines
that provide good functioning in adulthood, present within well-developed
bodies and psyches. Bearing this in mind, during the contact with a single
patient and his/her family we continuously shape the principles of treatment to
derive the unique proposal that is needed. This way, basing our behaviour on
data from literature that indicate the need to be as far as we can from the two
recognised thresholds of scoliosis (50 degrees, i.e. the near certainty
of progression in adulthood; and 30 degrees, i.e. possible progression) (Tab. 1),108 and considering that risk does not
mean the certainty of progression, we determine the choices of treatment case
by case.
Table 1. The meaningful thresholds of scoliosis according to possible problems in adulthood based on the current knowledge in literature.109 All treatments must be adapted according to these thresholds, so to remain as far as possible (according to starting point) from possible future problems. In this perspective, scoliosis treatment is always secondary prevention.106 We will
have patients for which aesthetics is not a problem, while others feel
their bodily appearance as the core of their treatment. Quality of life,
disability and psychological well-being in early adolescence are different
from those at the end of growth or in childhood. Additionally, we know they
change according to environmental and family factors. Therefore, we must take
care of these outcomes in the short but also in the long term, which means
deciding today according to the already proposed thresholds so as to reduce the
future impacts of the pathology. Breathing function is a potentially
life-threatening issue, and together with pain it’s a very well
understood aim for parents, not for the patient him/herself. Outcomes
related to posture, balance and movement greatly contribute to quality of
life and the reduction of disability in adulthood: they are rarely perceived by
the family as being important but must always be so in our minds. Cognitive
outcomes are crucial to understanding treatment and goals; obtaining
compliance; recognizing what are real possible and correct results versus
parental dreams; and finally, acting in a proper way throughout the treatment
and beyond. Accordingly, we start with fixed radiographic goals because they
will presumably be the most important determinants of our patient’s future,109 defined according to the starting
point of treatment. For example, if we start with 50° curves, Risser 0, and the
first signs of puberty, obtaining 30° at the end of treatment is almost always
only a dream. On the contrary, we aim at finishing between 20° and 25° whenever
possible. Bearing these goals in mind, we continuously adapt ourselves according
to what we obtain, and to how the patient behaves and feels, thus respecting
the other aims. We establish and constantly renew a contract with the patient
and his/her parents, who in this way are fully integrated in the rehabilitation
team.
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