Negrini 2008a.
Methods | Prospective controlled cohort study. | |
Participants | 74 adolescents with idiopathic scoliosis; mean age: 12.4 years, females: 52. mean Cobb angle at the start of treatment was 15° (SD 6°), while the mean ATR was 7° (SD 2°). Inclusion criteria were: adolescent idiopathic scoliosis not previously treated, and diagnosed as at risk of bracing according to the Italian Clinical Guidelines and expert medical judgment: (i) proven radiographic progression; (ii) Cobb angle exceeding 15° or Bunnell Angle of Trunk Rotation (ATR) exceeding 7°, first signs of puberty, pre‐menarchal and Risser value 0–1; (iii) Cobb angle exceeding 20° and Risser value of 2 or 3. Exclusion criteria : secondary scoliosis and pathologies known as possible causes of scoliosis, neurological deficits, a difference in inferior limb length exceeding 10 mm, previous treatment for scoliosis (brace, exercises or surgery) and Risser value exceeding 3. |
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Interventions | Experimental: N = 35: SEAS exercises according to the Italian Scientific Spine Institute (ISICO) approach; The SEAS (Scientific Exercise Approah to Scoliosis) protocol consists of an individual education session at specialized ISICO Center (1.5 hours session every 2‐3 months) and exercises are then performed by the patient twice a week at home or at a gym. Main elements of SEAS Approach are Active Self‐Correction, a complex movement to obtain the best three dimensional alignment of scoliotic spine associated with “distracting” elements (imbalance, external weight, co‐ordination task) for improvement of spine stabilisation and to obtain the neuromotor rehabilitation. Control: N = 39: Usual physiotherapy group: many different exercise protocols at a local facility according to the preferences of their single therapist. In most cases the exercises were performed in a group context, while in all cases they lasted 45 to 90 min and were performed 2 or 3 times per week. In some cases, the patients were required to repeat their exercises daily at home. |
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Outcomes | Progression of scoliosis as measured by Cobbs angle progression and ATR. Progression of scoliosis as measured by number of braces patients within one‐year follow‐up. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Prospective controlled cohort study. |
Allocation concealment (selection bias) | High risk | Prospective controlled cohort study "The patients themselves decided whether they preferred to be treated according to our exercise protocol (the SEAS group) or by a rehabilitation centre or single physiotherapist of their choice (the usual physiotherapy (UP) group). They were thus divided into 2 groups through self‐selection". |
Blinding (performance bias and detection bias) All outcomes ‐ patients | High risk | Blinding of patients not possible for the kind of intervention. |
Blinding (performance bias and detection bias) All outcomes‐ providers | High risk | Blinding of providers not possible for the kind of intervention. |
Blinding (performance bias and detection bias) All outcomes‐.outcome assessors | High risk | "physicians were neutral observers because they were not aware of the study being performed and they were focused only on the patients’ needs, although they were not blinded to the treatment applied". |
Incomplete outcome data (attrition bias) Were drop out reported and equal between groups? | Low risk | There were 5 drop‐outs: 2 in the SEAS group and 3 in the UP group. |
Incomplete outcome data (attrition bias) Were all randomised participants analysed in the group to which they were allocated? | Low risk | The 5 patients who dropped out were included in the worst‐case analysis. |
Selective reporting (reporting bias) | Low risk | |
Group similar at baseline | Low risk | No difference in mean age. No statistically significant difference was found between the 2 groups at baseline for any of the scoliosis parameters. |
Co‐intervention | Low risk | Patients were required to perform sport activities. No other intervention was provided. |
Compliance with interventions | Low risk | " The number of sessions per week was 2.0, min per session were 48, and compliance rate 95%. In addition, no differences were found between the 2 groups with respect to these parameters". |
Similar outcome timing | Low risk | |
Representativeness of the exposed cohort | Low risk | The sample is truly representative of the average adolescent with scoliosis. |
Selection of the non exposed cohort | Low risk | The sample has been drawn from the same community as the exposed cohort. |
Ascertainment of exposure | Low risk | Clinical records. |