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三维综合运动对青少年特发性脊柱侧凸患者脊柱侧凸的疗效:一项随机对照试验的研究方案

Efficacy of three-dimensionally integrated exercise for scoliosis in patients with adolescent idiopathic scoliosis: study protocol for a randomized controlled trial.

作者信息

Liang Juping, Zhou Xuan, Chen Nan, Li Xin, Yu Hong, Yang Yuqi, Song Yuanyuan, Du Qing

机构信息

Department of Rehabilitation Medicine, Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200092, China.

School of Nursing and Health Management, Shanghai University of Medicine & Health Sciences, Shanghai, 201318, China.

出版信息

Trials. 2018 Sep 10;19(1):485. doi: 10.1186/s13063-018-2834-x.

Abstract

BACKGROUND

Adolescent idiopathic scoliosis (AIS) is one of the most prevalent spinal deformities that may progress sharply during growth. The aim of this study will be to evaluate the efficacy of three-dimensionally integrated exercise on the Cobb angle, angle of trunk rotation, sagittal profile, and quality of life in patients with AIS.

METHODS/DESIGN: The study is designed as a randomized controlled trial. Participants include 42 patients with AIS aged 10-16 years. Randomly assigned patients will follow a 6-month treatment, either in a control group with standard care of observation following the Scoliosis Research Society criteria or in an experimental group with three-dimensionally integrated exercise for scoliosis. Blinded assessments at baseline and immediately after intervention will include the change of Cobb angle, angle of trunk rotation, sagittal index, and quality of life.

DISCUSSION

If we find that the intervention is effective in improving Cobb angle, angle of trunk rotation, sagittal profile, and quality of life in patients with AIS, this trial will have a positive impact and warrant a change in clinical practice.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT03427970 . Registered on February 9, 2018, and revised on July 24, 2018.

摘要

背景

青少年特发性脊柱侧弯(AIS)是最常见的脊柱畸形之一,在生长过程中可能会急剧进展。本研究的目的是评估三维综合运动对AIS患者的Cobb角、躯干旋转角度、矢状面形态和生活质量的疗效。

方法/设计:本研究设计为随机对照试验。参与者包括42名年龄在10至16岁的AIS患者。随机分配的患者将接受为期6个月的治疗,对照组按照脊柱侧弯研究学会标准进行标准护理观察,试验组进行脊柱侧弯三维综合运动。在基线和干预后立即进行的盲法评估将包括Cobb角、躯干旋转角度、矢状指数和生活质量的变化。

讨论

如果我们发现该干预措施对改善AIS患者的Cobb角、躯干旋转角度、矢状面形态和生活质量有效,那么本试验将产生积极影响,并值得改变临床实践。

试验注册

ClinicalTrials.gov,NCT03427970。于2018年2月9日注册,并于2018年7月24日修订。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5a16/6131734/eaabcaef4b3e/13063_2018_2834_Fig1_HTML.jpg

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