Premise
Mandate
Commission
Content
Scope, purpose and applications
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Which assessment of the patient should be performed?
-
Which conservative treatment should be provided, and how?
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How and when should bracing be applied?
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How and when should exercises be used?
Development of the Guidelines
Methods
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
|
Strength of recommendation | Meaning |
---|---|
A
| it must be applied widely and to all patients with this specific need |
B
| it is important, but can be applied not 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
Updates
Applicability
General information on idiopathic scoliosis
Definitions
Epidemiology
Etiology
Natural history
Classifications
Chronological | Angular | Topographic | |||||
---|---|---|---|---|---|---|---|
Age at diagnosis (years.months) | Cobb degrees | Apex | |||||
from | to | ||||||
Infantile | 0-2.11 | Low | Low | 5-15 | Cervical | - | Disc C6-7 |
Juvenile | 3-9.11 | Low to moderate | 16-24 | Cervico-thoracic | C7 | T1 | |
Adolescent | 10-17.11 | Moderate | Moderate | 25-34 | Thoracic | Disc T1-2 | Disc T11-12 |
Adult | 18- | Moderate to severe | 35-44 | Thoraco-lumbar | T12 | L1 | |
Severe | 45-59 | Lumbar | Disc L1-2 | - | |||
Very severe | 60 or more |
Chronological
Angular
-
under 10° of scoliosis, the diagnosis of scoliosis should not be made;
-
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.
Topographic
Evidence-Based Clinical Practice approach to Idiopathic Scoliosis
Goals of conservative treatment
General Goals
Rank | Aim | Percentage of responders |
---|---|---|
1 | Esthetics | 100% |
2 | Quality of life | 91% |
3 | Disability | 91% |
4 | Back Pain | 87% |
5 | Psychological well-being | 84% |
6 | Progression in adulthood | 84% |
7 | Breathing function | 84% |
8 | Scoliosis Cobb degrees | 84% |
9 | Need of further treatments in adulthood | 81% |
To stop curve progression at puberty (orpossibly even reduce it)
To prevent or treat respiratory dysfunctions
To prevent or treat spinal pain syndromes
To improve the appearance via postural correction
Specific goals of conservative treatment during growth
-
Absolute goal: these are the bottom line of conservative treatment. If not anything else, at least these goals should be reached.
-
Primary goal: 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
Adolescent Idiopathic Scoliosis up to 45° | Adolescent Idiopathic Scoliosis over 45° | Infantile and JuvenileIdiopathic Scoliosis | ||
---|---|---|---|---|
Radiographic aims
|
Primary
| Below 25° | Below 35° | Below 25° |
Secondary
| Below 35° | No progression | Below 50° | |
Main aims
| Avoid surgery Improve aesthetics and quality of life Reduce disability and pain |
Evidence-Based Clinical Practice approach
Cobb degrees | 0-10 + hump | 11-15 | 16-20 | 21-25 | 26-30 | 31-35 | 36-40 | 41-45 | 46-50 | Over 50 | ||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Infantile
|
Min
| Ob6 | Ob6 | Ob3 | SSB | SSB | SSB | SSB | SSB | PTRB | FTRB | |
Max
| Ob3 | Ob3 | PTRB | FTRB | FTRB | FTRB | FTRB | FTRB | Su | Su | ||
Juvenile
|
Min
| Ob3 | Ob3 | Ob3 | SSB | SSB | SSB | PTRB | PTRB | PTRB | FTRB | |
Max
| PSE | PSE | PTRB | FTRB | FTRB | FTRB | FTRB | FTRB | Su | Su | ||
Adolescent
|
Risser 0
|
Min
| Ob6 | Ob6 | Ob3 | PSE | PSE | SSB | PTRB | PTRB | PTRB | FTRB |
Max
| Ob3 | PSE | PTRB | FTRB | FTRB | FTRB | FTRB | FTRB | Su | Su | ||
Risser 1
|
Min
| Ob6 | Ob6 | Ob3 | PSE | PSE | SSB | PTRB | PTRB | PTRB | FTRB | |
Max
| Ob3 | PSE | PTRB | FTRB | FTRB | FTRB | FTRB | FTRB | Su | Su | ||
Risser 2
|
Min
| Ob8 | Ob6 | Ob3 | PSE | PSE | SSB | SSB | SSB | SSB | FTRB | |
Max
| Ob6 | PSE | PTRB | FTRB | FTRB | FTRB | FTRB | FTRB | Su | Su | ||
Risser 3
|
Min
| Ob12 | Ob6 | Ob6 | Ob6 | PSE | SSB | SSB | SSB | SSB | FTRB | |
Max
| Ob6 | PSE | PTRB | FTRB | FTRB | FTRB | FTRB | FTRB | Su | Su | ||
Risser 4
|
Min
| No | Ob6 | Ob6 | Ob6 | Ob6 | Ob6 | Ob6 | Ob6 | SSB | FTRB | |
Max
| Ob12 | PSE | PTRB | FTRB | FTRB | FTRB | FTRB | FTRB | Su | Su | ||
Risser 4-5
|
Min
| No | Ob6 | Ob6 | Ob6 | Ob6 | Ob6 | Ob6 | Ob6 | SSB | FTRB | |
Max
| Ob12 | PSE | PTRB | FTRB | FTRB | FTRB | FTRB | FTRB | Su | Su | ||
Adult
|
No pain
|
Min
| No | No | No | No | No | No | No | No | Ob12 | Ob12 |
Max
| Ob12 | Ob12 | Ob12 | Ob12 | Ob12 | Ob12 | Ob12 | Ob12 | Ob6 | Ob6 | ||
Chronic Pain
|
Min
| No | PSE | PSE | PSE | PSE | PSE | PSE | PSE | PSE | PSE | |
Max
| PTRB | PTRB | PTRB | PTRB | PTRB | Su | Su | Su | Su | Su | ||
Elderly
|
No pain
|
Min
| No | No | No | No | No | No | No | No | Ob12 | Ob12 |
Max
| Ob12 | Ob12 | Ob12 | Ob12 | Ob12 | Ob12 | Ob12 | Ob12 | Ob6 | Ob6 | ||
Chronic Pain
|
Min
| No | PSE | PSE | PSE | PSE | PSE | PSE | PSE | PSE | PSE | |
Max
| PTRB | PTRB | PTRB | PTRB | PTRB | PTRB | PTRB | PTRB | Su | Su | ||
Decompensation
|
Min
| No | No | PSE | PSE | PSE | PSE | PSE | PSE | PSE | PSE | |
Max
| PTRB | PTRB | PTRB | PTRB | PTRB | PTRB | PTRB | PTRB | Su | Su |
Min | Treatment | Abb | Notes |
---|---|---|---|
0 | Nothing | No | |
1 | Observation every 36 months | Ob36 | - Observation is clinical evaluation and not x-ray everytime |
2 | Observation every 12 months | Ob12 | - X-rays are usually performed once every two clinical evaluations, unless otherwise justified in the opinion of a clinician specialized in conservative treatment of spinal deformities |
3 | Observation every 8 months | Ob8 | |
4 | Observation every 6 months | Ob6 | |
5 | Observation every 3 months | Ob3 | |
6 | Physiotherapeutic Specific Exercises (outpatient) | PSE | - The term "Physiotherapeutic" added to "Physiotherapeutic Specific Exercises" does not designate an exclusive professional proposing the exercises, but the general approach to the patient, that goes beyond the simple execution of exercises |
7 | Night-time Rigid Bracing (8-12 hours) | NTRB | - According to the actual evidence it is not possible to define which treatment is more effective than the others between PSE (#6) and PTRB (#10), consequently the progressive numbers should be regarded only as a tool to be applied to the Practical Approach table and not as a classification approved by SOSORT members |
8 | Inpatient rehabilitation | SIR | |
9 | Specific Soft Bracing | SSB | |
10 | Part-Time Rigid Bracing (12-20 hours) | PTRB | The use of a rigid brace always imply the associated use of Physiotherapeutic Specific Exercises |
11 | Full-time Rigid bracing (20-24 hours) or cast | FTRB | |
12 | Surgery | Su | |
Max |
-
It constitutes the way we have chosen to resolve the differences among the various clinicians in their everyday clinical approach, to be able to state what is presumably totally wrong (above the maximum: overtreatment-below the minimum: undertreatment) according to the actual conservative treatment knowledge.
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It reports a real everyday approach, since all clinicians usually chose from quite a wide panel of choices when treating a single patient; the final decision comes after discussion with the patient, and weighting of the various risk factors involved in the clinical situation. In fact, the PAS has been developed looking at the "Step by Step" Sibilla's theory [78, 91‐94]: for each single patient it is mandatory to chose 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) or undertreatment (not enough 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 (Figure 1) [95‐98]. Consequently, a single patients treatment by different clinicians, even when faced with the identical clinical situation, can vary either because of the patient preferences or because of the specific expertise of the clinician. This has the final consequence that it will never be possible to state definitively what is the only right approach to a clinical situation, but always a range of situations need to be considered.
Conservative treatments
-
Night Time Rigid Bracing (8-12 hours per day) (NTRB): wearing a brace mainly in bed.
-
Part Time Rigid Bracing (12-20 hours per day) (PTRB): wearing a brace mainly outside school and in bed.
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Full Time Rigid Bracing (20-24 hours per day) or cast (FTRB): wearing a 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 [106‐108]; others propose casting only in worst cases [92, 93, 109, 110]; a cast is considered a standard approach in infantile scoliosis [111]. Recently, a new brace has been developed that has been claimed to achieve same results as casting [77, 112, 113].
Prognostic factors
Brace treatment
Methods
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"Braces"[Mesh] AND "Scoliosis"[Mesh] AND (hasabstract[text] AND (Clinical Trial[ptyp] OR Meta-Analysis[ptyp] OR Practice Guideline[ptyp] OR Randomized Controlled Trial[ptyp] OR Review[ptyp])) (155 papers).
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("Scoliosis/therapy"[Mesh]) AND "Braces"[Mesh] AND compliance (78 papers)
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"Scoliosis"[Mesh] AND "Braces"[Mesh] AND ("infant, newborn"[MeSH Terms] OR "infant"[MeSH Terms:noexp] OR "child, preschool"[MeSH Terms]) (183 papers)
Results
Efficacy in adolescents
-
one multicenter prospective international observational study that provided very low quality evidence in favor of the efficacy of bracing [133]: Nachemson evaluated 240 patients with thoracic or thoracolumbar curves between 25° and 35°, aged between 10 and 15 years, of which 129 were only observed and 111 treated with thoracolumbar braces. Progression of 6 or more degrees at 2 radiographic follow-ups to the first visit was considered an index of failure of the selected treatment (observation versus brace treatment). At 4 years of follow-up, the success rate for brace treatment was 74% (range, 52--84%), whereas the rate for observation was 34% (range, 16--49%).
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a randomized controlled trial that demonstrated with very low quality evidence that a plastic TLSO brace is more effective than an elastic brace [134]. Wong randomized forty-three subjects to SpineCor or rigid orthosis group. Although it has been stated that the authors where not trained to fit the SpineCor brace [135] the authors concluded that 68% of the subjects in the SpineCor group and 95% of the subjects in the rigid orthosis group did not show curve progression, with a significant difference. The 2 groups had similar responses to a patient acceptance questionnaire.
-
Janicki et al [138], following the SRS criteria, retrospectively compared in an "intent-to-treat" analysis the effectiveness of the custom thoracolumbosacral (TLSO) worn 22 hours/day and the Providence orthosis worn 8-10 hours/night. There were 48 patients in the TLSO group and 35 in the Providence group. In the TLSO group, only 7 patients (15%) did not progress (< or = 5 degrees), whereas 41 patients (85%) progressed by 6 degrees or more, including the 30 patients whose curves exceeded 45 degrees. Thirty-eight patients (79%) required surgery. In the Providence group, 11 patients (31%) did not progress, whereas 24 patients (69%) progressed by 6 degrees or more, including 15 patients whose curves exceeded 45 degrees. Twenty-one patients (60%) required surgery.
-
Coillard et al [137], following the SRS criteria, studied prospectively a cohort of 254 patients treated with the Dynamic SpineCor brace. Successful treatment (correction > 5° or stabilization ± 5°) was achieved in 165 patients of the 254 patients (64.9%). 46 immature patients (18.1%) required surgical fusion whilst receiving treatment. Two patients out of 254 (0.7%) had curves exceeding 45° at maturity.
-
Negrini et al [78], following both the SRS and SOSORT criteria, retrospectively studied a cohort of 42 females and four males treated according to individual needs, with Risser casts, Lyon or SPoRT braces (14 for 23 hours per day, 23 for 21 h/d, and seven for 18 h/d at start). No patient progressed beyond 45 degrees, nor was any patient fused, and this remained true at the two-year follow-up for the 85% that reached it. Only two patients (4%) worsened, both with single thoracic curve, 25-30 degrees Cobb and Risser 0 at the start.
-
Aulisa et al [76], following both the SRS and SOSORT criteria, retrospectively reviewed a cohort of fifty adolescent females with thoraco-lumbar curves treated with the Progressive Action Short Brace (PASB). Curve correction was accomplished in 94% of patients, whereas a curve stabilisation was obtained in 6% of patients. No patient required surgery, nor anyone progressed beyond 45°.
-
Gammon et al [139], following the SRS criteria, compared treatment outcomes of 2 cohorts of patients treated via either a conventional rigid thoracolumbosacral orthoses (TLSO: 35 patients) or a SpineCor nonrigid orthosis (32 patients). No significant difference was found using the more strict outcome measure (< or = 5-degree curve progression) as the success rates were 60% for TLSO and 53% for SpineCor. Looking at patients who reached 45 degrees, the success rates were 80% for TLSO and 72% for SpineCor with no significant difference.
-
Finally, Zaborowska-Sapeta et al [140], including the patients according to the SRS criteria, prospectively followed 79 patients treated with Cheneau brace. At one year after weaning the brace they found improvement in 25.3%, stabilization in 22.8%, progression of the Cobb angle up to below 50° in 39.2% and progression beyond 50° in 12.7%, the latter was considered surgical indication.
-
Weiss [144] considered three hundred and forty-three scoliosis patients (females only) of various etiology, with a curvature of 33.4 degrees. Forty-one patients (11.95%) had had surgery. In patients with adolescent idiopathic scoliosis, the incidence of surgery was 7.3%.
-
Rigo [142] considered 106 patients with curves on average of 30° at start, out of which 97 were followed up, and six cases (5.6%) ultimately underwent spinal fusion. A worst case analysis, which assumes that all nine cases that were lost to follow-up had operations, brings the uppermost number of cases that could have undergone spinal fusion to 15 (14.1%).
-
Maruyama [143] reviewed 328 females with an average 32.4 degree Cobb angle. Surgery was recommended when curvature progressed to > 50 degrees. Twenty (6.1%) were treated with spinal fusion. The remaining showed no significant increase in magnitude of curvature.
Are there braces that are better than others?
-
an RCT [134], that found a TLSO more effective than SpineCor;
-
one meta-analysis [145], that was in favor of the Milwaukee brace, with Charleston being the less efficacious;
-
one systematic review [141], that found the following pooled surgery rates: Boston Brace 12-17%; various braces (Boston-Charleston-TLSOs) 27-41; nigh time braces (Providence or Charleston braces) 17-25%; TLSO or Rosenberg brace 25-33; Wilmington 19-30%;
-
Katz [148] compared the Boston Brace to the Charleston bending brace. The first was more effective than the second, both in preventing curve progression and in avoiding the need for surgery. These findings were most notable for patients with curves of 36° to 45°, in whom 83% of those treated with a Charleston brace had curve progression of more than 5 degrees, compared with 43% of those treated with the Boston Brace.
-
Howard [149] presented a retrospective cohort study on 170 patients who completed brace treatment: Forty-five patients with TLSO showed a mean progression of the curve of 1.1 degrees, 95 with Charleston worsened 6.5 degrees, and 35 with Milwaukee 6.3 degrees. Proportion of patients with more than 10 degrees of curve progression was 14% with TLSO, 28% with Charleston, and 43% with Milwaukee brace while those who underwent surgery were 18%, 31%, and 23% respectively.
-
Weiss [79] performed a comparison of the survival rates of the Cheneau versus SpineCor with respect to curve progression and duration of treatment during pubertal growth spurt in two cohorts of patients followed up prospectively. At 24 months of treatment, 73% of the patients with a Cheneau brace and 33% of the patients with the SpineCor where still under treatment with their original brace; at 42 months the same percentages were 80% and 8% respectively.
-
Yrjonen [150] studied retrospectively the Providence nighttime used by 36 lumbar and thoracolumbar scoliosis consecutive female patients with less than 35 degrees: progression of the curve > 5 degrees occurred in 27%, versus 36 matched patients treated with the Boston full-time that progression in 22% of cases.
-
Negrini [151] compared the classical Lyon brace to the newly developed Sforzesco brace, based on the SPoRT concept (Symmetric, Patient-oriented, Rigid, Three-dimensional, active) with prospective, matched pairs controlled study. All radiographic and clinical parameters decreased significantly with treatment in both groups, apart from thoracic Cobb degrees with the Lyon brace. The Sforzesco brace had better results than the Lyon brace radiographically, for sagittal profile, aesthetics, and patient recovery (12 improved and 3 unchanged vs 8 and 5).
-
Negrini [112] also studied a prospective cohort who had refused surgery treated with the Sforzesco brace to a Risser cast retrospective control group. Results were comparable between the two groups, with only minor differences in terms of scoliosis correction. On the contrary, straightening of the spine (decrease of the sagittal physiological curves) was much higher with the cast, while it was not clinically significant with the brace.
-
new alternative concepts have been developed trying to substitute the most invasive braces: this was true some years ago for TLSOs instead of Milwaukee, more recently for night time bending braces or SpineCor instead of TLSOs, and in the last years for the Sforzesco brace instead of casting; not all these new concepts have been able to prove their efficacy.
-
in the meantime there is a struggle (mainly inside SOSORT) to progressively refine and strengthen some old concepts, like the Cheneau, Boston or Lyon braces, but also newly developed ones, like the Sforzesco and SpineCor.
Dosage, compliance and quality of bracing
Efficacy in other populations
-
scoliosis over 45° who refused to be operated [77]. Out of 28 patients (curve range 45-58° Cobb) who reached the end of treatment (brace and exercises for 4.5 years) two patients (7%) remained above 50° but six patients (21%) finished between 30° and 35° and 12 patients (43%) finished between 36° and 40° Cobb. Improvements have been found in 71% of patients and a 5° Cobb progression in one patient.
-
scoliosis of Risser 4-5 up to 20 years of age [206] (residual growth was 0.9 cm). Out of 23 patients requiring treatment or for esthetic reasons, or to try to reduce the deformity, curve improvements were found in 48% and decrease of the Esthetic Index in 30%.
Team role in bracing
Recommendation 1 (Experience-competence)
Recommendation 2 (Experience-competence)
Recommendation 3 (Behaviors)
Recommendation 4 (Behaviors)
Recommendation 5 (Behaviors)
Recommendation 6 (Prescription)
Recommendation 7 (Construction)
Recommendation 8 (Brace Check)
Recommendation 9 (Brace Check)
Recommendation 10 (Follow-up)
Recommendation 11 (Follow-up)
Recommendation 12 (Follow-up)
Recommendation 13 (Follow-up)
Recommendation 14 (Follow-up)
Other issues
Recommendations on "Bracing"
Conservative treatments other than bracing
Physiotherapeutic Specific Exercises to prevent scoliosis progression during growth
Methods
Results
Recommendations on "Physiotherapeutic Specific Exercises to prevent scoliosis progression during growth"
Physiotherapeutic Specific Exercises during brace treatment and surgical therapy
Methods
Results
Recommendations on "Physiotherapeutic Specific Exercises during brace treatment and surgical therapy"
Other conservative treatments
Methods
Results
Recommendations on "Other conservative treatments"
Respiratory function and exercises
Methods
Results
Recommendations on "Respiratory function and exercises"
Sports activities
Methods
Results
Recommendations on "Sports activities"
Assessment
-
Genetic evaluation [Ogilvie: 123-126]. Nevertheless, prudence is advised in using these tools to decide if to treat or not patients: in fact, moving from research, even if performed in wide samples of some hundreds of patients, to the general population requires caution.
Recommendations
Conclusions and future research needs
I | II | III | IV | V | VI | Total | |
---|---|---|---|---|---|---|---|
Bracing | 0 | 0 | 2 | 7 | 8 | 3 |
20
|
Specific exercises to prevent scoliosis progression during growth | 0 | 1 | 2 | 0 | 1 | 4 |
8
|
Specific exercises during brace treatment and surgical therapy | 0 | 1 | 1 | 2 | 1 | 0 |
5
|
Other conservative treatments | 0 | 0 | 0 | 0 | 1 | 2 |
3
|
Respiratory function and exercises | 0 | 0 | 0 | 2 | 1 | 0 |
3
|
Sports activities | 0 | 0 | 2 | 1 | 2 | 1 |
6
|
Assessment | 0 | 0 | 0 | 8 | 12 | 0 |
20
|
Total
|
0
|
2
|
7
|
20
|
26
|
10
|
65
|
A | B | C | D | Total | |
---|---|---|---|---|---|
Bracing | 4 | 15 | 1 | 0 |
20
|
Specific exercises to prevent scoliosis progression during growth | 0 | 8 | 0 | 0 |
8
|
Specific exercises during brace treatment and surgical therapy | 0 | 5 | 0 | 0 |
5
|
Other conservative treatments | 0 | 3 | 0 | 0 |
3
|
Respiratory function and exercises | 0 | 3 | 0 | 0 |
3
|
Sports activities | 0 | 4 | 2 | 0 |
6
|
Assessment | 9 | 11 | 0 | 0 |
20
|
Total
|
13
|
49
|
3
|
0
|
65
|