Zhou Xiangyue, Li Xin, Chen Nan, Chen Zhengquan, Yu Hong, Liang Juping, Fan Qimeng, Zhu Xiaoqing, Zhang Tongtong, Zhou Xuan, Du Qing
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.
Children's Rehabilitation Innovation and Transformation Research Center of Yuanshen Rehabilitation Institute, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
BMJ Open. 2025 May 23;15(5):e091476. doi: 10.1136/bmjopen-2024-091476.
Sensorimotor training (SoMT) is a gradual balance training technique employed to treat various chronic musculoskeletal pain. Core strength training (CST) is one of the most commonly used interventions for managing low back pain (LBP). This randomied controlled trial protocol aims to determine whether the combination of SoMT and CST can significantly reduce LBP, and improve scoliosis-related outcomes and overall functional status in adult idiopathic scoliosis (AdIS) patients.
A total of 300 AdIS patients will be recruited from the outpatient clinic and randomly assigned to one of three groups: CST group, SoMT group or the combined therapy group, using stratified block randomization based on the severity of scoliosis curve. All groups will receive the intervention three times a week for 12 weeks. Sessions will be conducted in the hospital, and no home programme will be provided. Adherence and attendance will be monitored and recorded. The CST group will receive CST therapy, while the SoMT group will receive SoMT therapy, which consists of three progressive phases: static, dynamic and functional. Participants will progress to the next phase on achieving pelvic stability in the current phase. The combined therapy group will receive both CST and SoMT. Assessors and statisticians will remain blinded to participant allocation throughout the study. Assessments will be performed at baseline and at the endpoint, 12 weeks after the initiation of the intervention. The primary outcome will be the self-reported pain level, measured using the visual analogue scale. Secondary outcomes will include pain-related disability (by the Oswestry Disability Index and the Roland-Morris Disability Questionnaire), spinal morphology indicators (including Cobb angle, the angle of trunk rotation and the Sagittal Index), postural control ability (by the Tetrax IBSTM), proprioceptive sensitivity (by the repositioning error test) and health-related quality of life (by the 36-Item Short Form Health Survey). Statistical analysis will adhere to the intention-to-treat principle and will be complemented by per-protocol analysis. To compare the effects of SoMT versus CST and combined therapy versus SoMT on both primary and secondary outcomes, a linear mixed-effects model or generalised linear mixed model will be applied.
The current study received ethical approval from the Xinhua Hospital Ethics Committee Affiliated to Shanghai Jiao Tong University School of Medicine (XHEC-C-2024-080-3). Written informed consent will be obtained from all participants. Any interim analysis and full results will be published in an international peer-reviewed journal.
This protocol was registered in the Chinese Clinical Trial Registry (ChiCTR2400085370).
感觉运动训练（SoMT）是一种渐进性平衡训练技术，用于治疗各种慢性肌肉骨骼疼痛。核心力量训练（CST）是治疗腰痛（LBP）最常用的干预措施之一。本随机对照试验方案旨在确定SoMT与CST相结合是否能显著减轻成年特发性脊柱侧凸（AdIS）患者的腰痛，改善脊柱侧凸相关结局和整体功能状态。
将从门诊招募300例AdIS患者，根据脊柱侧凸曲线的严重程度，采用分层区组随机化方法将其随机分为三组之一：CST组、SoMT组或联合治疗组。所有组将每周接受3次干预，共12周。治疗将在医院进行，不提供家庭训练计划。将监测并记录依从性和出勤率。CST组将接受CST治疗，而SoMT组将接受SoMT治疗，SoMT治疗包括三个渐进阶段：静态、动态和功能阶段。参与者在当前阶段实现骨盆稳定后将进入下一阶段。联合治疗组将接受CST和SoMT治疗。在整个研究过程中，评估者和统计人员将对参与者的分组情况保持盲态。将在基线和干预开始12周后的终点进行评估。主要结局将是使用视觉模拟量表测量的自我报告疼痛水平。次要结局将包括疼痛相关残疾（通过Oswestry残疾指数和Roland-Morris残疾问卷）、脊柱形态指标（包括Cobb角、躯干旋转角度和矢状指数）、姿势控制能力（通过Tetrax IBSTM）、本体感觉敏感性（通过重新定位误差测试）和健康相关生活质量（通过36项简短健康调查）。统计分析将遵循意向性分析原则，并辅以符合方案分析。为了比较SoMT与CST以及联合治疗与SoMT对主要和次要结局的影响，将应用线性混合效应模型或广义线性混合模型。
本研究获得了上海交通大学医学院附属新华医院伦理委员会（XHEC-C-2024-080-3）的伦理批准。将获得所有参与者的书面知情同意书。任何中期分析和完整结果将发表在国际同行评审期刊上。
本方案已在中国临床试验注册中心（ChiCTR2400085370）注册。
