感觉运动训练联合核心力量训练对成人特发性脊柱侧凸腰痛的疗效:一项随机对照试验的研究方案。

IF 2.4 3区 医学 Q1 MEDICINE, GENERAL & INTERNAL
Xiangyue Zhou, Xin Li, Nan Chen, Zhengquan Chen, Hong Yu, Juping Liang, Qimeng Fan, Xiaoqing Zhu, Tongtong Zhang, Xuan Zhou, Qing Du
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引用次数: 0

摘要

简介:感觉运动训练(SoMT)是一种渐进式平衡训练技术,用于治疗各种慢性肌肉骨骼疼痛。核心力量训练(CST)是管理腰痛(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联合CST是否能显著降低腰痛,改善成人特发性脊柱侧凸(AdIS)患者脊柱侧凸相关结局和整体功能状态。方法与分析:从门诊共招募300例AdIS患者,根据脊柱侧凸曲线的严重程度,采用分层块随机分组,随机分为CST组、SoMT组或联合治疗组。所有组每周接受三次干预,持续12周。课程将在医院进行,不提供家庭课程。遵守和出勤将被监控和记录。CST组采用CST治疗,而SoMT组采用SoMT治疗,分为静态、动态和功能三个渐进阶段。参与者将进入下一阶段,在当前阶段实现骨盆稳定。联合治疗组采用CST和SoMT联合治疗。在整个研究过程中,评估人员和统计人员对参与者的分配情况不知情。评估将在干预开始12周后的基线和终点进行。主要结果将是自我报告的疼痛水平,使用视觉模拟量表测量。次要结果包括与疼痛相关的残疾(通过Oswestry残疾指数和Roland-Morris残疾问卷)、脊柱形态学指标(包括Cobb角、躯干旋转角和矢状指数)、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)和健康相关的生活质量(通过36项简短健康调查)。统计分析将遵循意向治疗原则,并辅以方案分析。为了比较SoMT与CST以及联合治疗与SoMT对主要和次要结果的影响,将应用线性混合效应模型或广义线性混合模型。伦理与传播: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。所有参与者均需获得书面知情同意。任何中期分析和完整结果将发表在国际同行评审期刊上。试验注册号:本方案已在中国临床试验注册中心注册(ChiCTR2400085370)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy of sensorimotor training combined with core strength training for low back pain in adult idiopathic scoliosis: a study protocol for a randomized controlled trial.

Introduction: 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.

Methods and analysis: 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.

Ethics and dissemination: 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.

Trial registration number: This protocol was registered in the Chinese Clinical Trial Registry (ChiCTR2400085370).

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来源期刊
BMJ Open
BMJ Open MEDICINE, GENERAL & INTERNAL-
CiteScore
4.40
自引率
3.40%
发文量
4510
审稿时长
2-3 weeks
期刊介绍: BMJ Open is an online, open access journal, dedicated to publishing medical research from all disciplines and therapeutic areas. The journal publishes all research study types, from study protocols to phase I trials to meta-analyses, including small or specialist studies. Publishing procedures are built around fully open peer review and continuous publication, publishing research online as soon as the article is ready.
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