EVALUATION OF THE EFFICACY AND SAFETY OF NON-SURGICAL TREATMENTS
FOR ADOLESCENT SCOLIOSIS
Title.
Evaluation of the effect of bracing and exercise
on the evolution of adolescent idiopathic scoliosis: a controlled,
randomized clinical trial.
Background.
Scoliosis consists of the lateral curvature
of the spinal column. The cases in which it appears without
a clear organic cause are called "idiopathic scoliosis".
Some idiopathic scoliosis detected in adolescents are progressive.
Formerly, surgery was recommended in order to prevent the
progression of the scoliotic curve, to prevent back pain that
it supposedly generated and to prevent possible deterioration
in cardiac or respiratory functions (in the case of significant
scoliosis at the thoracic level), as well as for aesthetic
reasons.
Currently, it has been shown that, except in exceptional
cases in which a significant thoracic curve could really affect
cardiac or respiratory functions, only aesthetic considerations
justify surgery. Back pain is only more frequent in scoliosis
of more than 60º, and a significant percentage of the
cases of scoliosis diagnosed in adolescence do not progress.
In fact, studies in which the long term evolution of adolescents
who had surgery was compared with that of those who did not
suggest that there are no significant differences between
them in terms of the risk of back pain, limitations on physical
activity or quality of life and that only the "mental
image of their physical appearance" is different.
The criteria for surgery on scoliosis tends to be based on
the degree of curvature (that is, the number of degrees of
deviation). However, there is no clear and fundamented criteria
for deciding the degree of curvature above which surgery is
necessary, and since in most cases it is an operation prompted
by aesthetic considerations, the decision to operate is influenced
by not very objective factors (the aesthetic desire of the
adolescent and or his or her family, beliefs regarding the
hypothetical negative consequences of the curvature, the psychological
impact of the "deviation" on the adolescent or his/her
family, spontaneous visual perception of him/herself-which
could vary according to whether the curve occurs at the thoracic
or the lumbar level of the back and whether it is a simple
curve or a double, apparently compensated curve-criteria and
factors of the surgeon him/herself, etc.).
Before surgery, conservative treatment over a varying period
of time is usually proposed, so that surgery tends only to
be performed when the curvature progresses to the level above
which the surgeon (or the adolescent and his/her family) consider
it appropriate to operate.
In some cases, the scoliosis progresses, but in many others
it doesn't, and some earlier studies have tried to define
the parameters that make it more likely that, in a specific
case, the curvature progresses or not (even without treatment).
The primary factors found are: gender (the risk of progression
is greater in girls than in boys), age (the risk of progression
is greater under 13 years and practically null once menstruation
has appeared), the degree of skeletal maturity (the greater
the degree of skeletal maturity, the less the risk of progression),
the level of the spine at which the curvature is found (there
is a greater risk of progression in the cases in which it
is at thoracic level) and the existing degree of curvature
at the time of detection.
The aim of conservative treatment is to contribute to stopping
the progression of the curve so that surgery need not be necessary
(although there is no clear criteria regarding what the limit
from which it may become necessary, nor a reliable basis to
establish this criteria). With that aim, different treatments
have been used and nowadays two continue to be recommended:
the use of a brace (or corset) and carrying out exercises
(or swimming).
Those who recommend a brace suggest that it be worn a minimum
of 18 hours a day, which is bothersome and psychologically
traumatic. The studies made suggest that it would only be
indicated in a very few specific cases, but the low scientific
quality of the studies prevents one from considering their
results definitive. On the other hand, and while exercise
(or swimming) tends to be recommended to stop the progress
of the scoliosis curve, there are no studies irrefutably demonstrating
its effect.
While exercise (or swimming) has no side effects and is recommended
in itself, the use of a brace does have secondary effects
and is stigmatizing, so that to evaluate the efficacy of these
measures it is necessary to encourage that they continue to
be recommended (if they are shown to be effective and in the
cases in which they are justified) or to stop pressuring the
families and patients uselessly to adopt these measures (if
they are shown to be ineffective or counterproductive).
Objective.
To evaluate the effect of bracing and exercise for the treatment
of adolescent idiopathic scoliosis as opposed to doing nothing.
Methodology.
The study is currently in the design phase,
so that the general proposition this section presents is only
an approximation of what may be its final design. In principle,
the plan is to study adolescents with "idiopathic scoliosis"
and those with a greater risk of progression, and to assign
them randomly to three groups; in one the brace would be applied,
in the other two, exercises.
Given the low scientific quality of the scientific evidence
suggesting the use of the brace and the secondary effects
it has, as well as the absence of studies showing the effect
of exercise, it does not appear that there were irresolvable
ethical limitations in establishing a control group in which
no supposedly therapeutic measure was applied, although this
aspect is currently being analyzed.
The patients' evolution will be studied not only from the
point of view of the variables related to the scoliosis (degree
of curvature, etc.) but also from the point of view of functional
variables (pain, degree of activity, quality of life) and
psychological variables (anxiety, depression, etc.).
The adolescents with scoliosis who received care at the centers
participating in the study and that met the criteria established
for inclusion will be invited to participate. However, given
the high number of subjects necessary to participate in the
study for it to be viable and for its results to have statistical
significance, a "screening" at schools is being
considered in order to increase the number of cases detected
and potentially included in the study.
Participants, along with the Foundation's
Science Department.
Spanish Network of Researchers in Back Problems.
The work group that is developing the study plan (in which
afterwards all those teams tied to the Network will be invited
to participate) includes groups from the Kovacs Foundation,
the Spine Units at the Son Dureta and Vall d'Hebrón
Hospitals, the Traumatology Department of the Fundación
Jiménez Díaz, the Unit of Clinical Biostatistics
of the Hospital Ramón y Cajal and the TIASS team (Advanced
Research Techniques in Health Services).
Status.
In the design phase, at the same time, the
viability of recruiting over a reasonable period of time the
number of subjects who should participate in the study for
its results to be statistically significant is being evaluated.
The result of that analysis will determine whether or not
the study is carried out.
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