School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong SAR, N.T, China.
Institute of Chinese Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong SAR, N.T, China.
BMC Musculoskelet Disord. 2024 Jan 4;25(1):32. doi: 10.1186/s12891-023-07152-9.
BACKGROUND: Adolescent idiopathic scoliosis (AIS) is the most common developmental spine disorder among children. It is characterized by a lateral deviation of the spine that gives rise to the distinctive "S" or "C" shaped bending of the spine. The Lin School of Lingnan Region (LSLR), one of the prominent schools for bare-handed orthopaedic manipulation in southern China, provides preliminary evidences that the orthopaedic manipulation techniques help to correct deviations of the spine. Previous research found that Orthopaedic Manipulation Techniques of LSLR (OMT-LSLR) could reduce the Cobb's angles in patients with AIS. Therefore, the current study aims to investigate the effectiveness and safety of the OMT-LSLR in treating teenagers with AIS. METHODS: In this participant-and-assessor-blinded randomized controlled clinical trial, 50 participants identified AIS without surgical indications will be recruited and randomized into two groups to receive physiotherapy scoliosis-specific exercises training with either orthopaedic manipulation or sham manipulation treatment for 16 weeks, followed by post-treatment visits at week 24. Primary outcome measure is the change of Scoliosis Research Society-22 (SRS-22) questionnaire score. Secondary outcome measures include Traditional Chinese version of Spinal Appearance Questionnaire (TC-SAQ) score, Italian Spine Youth Quality of Life (ISYQOL) score, the change of Cobb's angle measured by Xray, and the change of Cobb's angle, spinal rotation and muscle volume measured by three-dimensional (3D) ultrasound. The trial will be conducted at the Chinese University of Hong Kong Chinese Medicine Specialty Clinic cum Clinical Teaching and Research Centre in Hong Kong (CUHK-CMSCTRC). DISCUSSION: The results of this study will establish comprehensive clinical evidence about the efficacy and safety of the Orthopaedic Manipulation Techniques of the Lin School of Lingnan Region in the Treatment of Adolescent Idiopathic Scoliosis. One of the characteristics of this trial is that it is a participant-and-assessor-blinded randomized controlled clinical trial with sham manipulation. The study would also apply three-dimensional (3D) ultrasound technology to investigate the relationship between the change of the muscle volume and the spinal curve. TRIAL REGISTRATION: The trial is registered on ClinicalTrials.gov (Identifier: NCT05639023 ) on December 6, 2022.
背景:青少年特发性脊柱侧凸(AIS)是儿童中最常见的发育性脊柱疾病。它的特征是脊柱的侧向偏移,导致脊柱呈现出独特的“S”或“C”形弯曲。岭南林氏流派(LSLR)整脊手法是中国南方徒手整脊的主要流派之一,其提供了初步证据表明整脊手法有助于矫正脊柱的偏移。先前的研究发现,LSLR 整脊手法(OMT-LSLR)可以减少 AIS 患者的 Cobb 角。因此,本研究旨在探讨 OMT-LSLR 治疗青少年 AIS 的有效性和安全性。
方法:在这项参与者和评估者盲法随机对照临床试验中,将招募 50 名符合 AIS 且无手术指征的参与者,并将他们随机分为两组,分别接受物理治疗脊柱侧弯特定运动训练加整脊手法或假手法治疗,治疗时间为 16 周,随后在治疗后第 24 周进行随访。主要观察指标是 SRS-22 问卷评分的变化。次要观察指标包括中医脊柱外观问卷(TC-SAQ)评分、意大利脊柱青年生活质量(ISYQOL)评分、X 射线测量的 Cobb 角变化,以及三维(3D)超声测量的 Cobb 角、脊柱旋转和肌肉体积变化。试验将在香港中文大学中医专科诊所暨临床教学及研究中心(CUHK-CMSCTRC)进行。
讨论:本研究的结果将为岭南林氏流派整脊手法治疗青少年特发性脊柱侧凸的疗效和安全性提供全面的临床证据。本试验的一个特点是,它是一项参与者和评估者盲法的随机对照临床试验,采用假手法。该研究还将应用三维(3D)超声技术来研究肌肉体积变化与脊柱曲线之间的关系。
试验注册:该试验于 2022 年 12 月 6 日在 ClinicalTrials.gov 上注册(标识符:NCT05639023)。
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