Schroth Physiotherapeutic Scoliosis-Specific Exercises Added to the Standard of Care Lead to Better Cobb Angle Outcomes in Adolescents with Idiopathic Scoliosis – an Assessor and Statistician Blinded Randomized Controlled Trial

Background
The North American non-surgical standard of care for adolescent idiopathic scoliosis (AIS) includes observation and bracing, but not exercises. Schroth physiotherapeutic scoliosis-specific exercises (PSSE) showed promise in several studies of suboptimal methodology. The Scoliosis Research Society calls for rigorous studies supporting the role of exercises before including it as a treatment recommendation for scoliosis.
Objectives
To determine the effect of a six-month Schroth PSSE intervention added to standard of care (Experimental group) on the Cobb angle compared to standard of care alone (Control group) in patients with AIS.
Methods
Fifty patients with AIS aged 10–18 years, with curves of 10°-45° and Risser grade 0–5 were recruited from a single pediatric scoliosis clinic and randomized to the Experimental or Control group. Outcomes included the change in the Cobb angles of the Largest Curve and Sum of Curves from baseline to six months. The intervention consisted of a 30–45 minute daily home program and weekly supervised sessions. Intention-to-treat and per protocol linear mixed effects model analyses are reported.
Results
In the intention-to-treat analysis, after six months, the Schroth group had significantly smaller Largest Curve than controls (-3.5°, 95% CI -1.1° to -5.9°, p = 0.006). Likewise, the between-group difference in the square root of the Sum of Curves was -0.40°, (95% CI -0.03° to -0.8°, p = 0.046), suggesting that an average patient with 51.2° at baseline, will have a 49.3° Sum of Curves at six months in the Schroth group, and 55.1° in the control group with the difference between groups increasing with severity. Per protocol analyses produced similar, but larger differences: Largest Curve = -4.1° (95% CI -1.7° to -6.5°, p = 0.002) and (95% CI -0.8 to 0.2, p = 0.006).
Conclusion
Schroth PSSE added to the standard of care were superior compared to standard of care alone for reducing the curve severity in patients with AIS.
Trial Registration
NCT01610908

背景
青少年特发性脊柱侧凸（Adolescent Idiopathic Scoliosis, AIS）的北美非手术治疗标准包含观察与支具治疗，但未纳入运动疗法。施罗特脊柱侧凸特异性物理治疗运动（Schroth physiotherapeutic scoliosis-specific exercises, PSSE）在多项方法学存在缺陷的研究中展现出应用前景。脊柱侧凸研究学会（Scoliosis Research Society）呼吁开展严谨的研究以证实运动疗法的作用，进而将其纳入脊柱侧凸的治疗推荐方案。

研究目的
对比在标准治疗基础上附加6个月施罗特PSSE干预的实验组（Experimental group）与仅接受标准治疗的对照组（Control group），评估该干预对青少年特发性脊柱侧凸患者Cobb角（Cobb angle）的影响。

研究方法
从单一儿童脊柱侧凸门诊招募50名年龄介于10~18岁的青少年特发性脊柱侧凸患者，其脊柱侧凸角度为10°~45°，Risser分级（Risser grade）为0~5级，将患者随机分配至实验组或对照组。研究结局指标包括从基线至6个月时，最大侧凸曲线Cobb角以及总曲线Cobb角之和的变化。干预方案为每日30~45分钟的家庭训练计划，辅以每周1次的督导训练。本研究采用意向性治疗（Intention-to-treat）方案与符合方案（per protocol）线性混合效应模型（linear mixed effects model）进行分析。

研究结果
意向性治疗分析结果显示，干预6个月后，施罗特组的最大侧凸曲线Cobb角显著小于对照组（-3.5°，95%置信区间[CI]：-1.1°~-5.9°，p=0.006）。同理，总曲线Cobb角之和的平方根组间差异为-0.40°（95%CI：-0.03°~-0.8°，p=0.046），这意味着对于基线时总曲线Cobb角为51.2°的平均患者，施罗特组在6个月时的总曲线Cobb角之和为49.3°，而对照组为55.1°，且组间差异随侧凸严重程度升高而增大。符合方案分析得到了相似但差异幅度更大的结果：最大侧凸曲线Cobb角变化为-4.1°（95%CI：-1.7°~-6.5°，p=0.002），总曲线Cobb角之和的平方根组间差异为（95%CI：-0.8°~0.2°，p=0.006）。

研究结论
相较于仅接受标准治疗的方案，在标准治疗基础上附加施罗特PSSE干预，可更有效地降低青少年特发性脊柱侧凸患者的脊柱侧凸严重程度。

临床试验注册
NCT01610908