Department of Orthopedics & Traumatology, Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, China.
Department of Orthopedics & Traumatology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
JMIR Res Protoc. 2024 Aug 13;13:e57865. doi: 10.2196/57865.
The clinical diagnosis of atlantoaxial joint subluxation (AJS) in traditional Chinese medicine (TCM) is characterized by an unequal distance between the lateral mass of the atlas and the odontoid process on imaging, resulting in neck pain accompanied by symptoms such as dizziness, headache, and limited cervical mobility. In Shanghai, Shi cervical rotational manipulation (SCRM) is a commonly employed TCM manual therapy for treating this condition. Nevertheless, there is a lack of evidence-based medical information regarding the clinical efficacy and safety of this technique.
The principal aim of this study is to evaluate the efficacy and safety of SCRM in patients diagnosed with AJS.
This study is a prospective randomized controlled clinical trial that will be conducted at a single center and that has a follow-up period of 24 weeks. A total of 96 patients diagnosed with AJS will be recruited from outpatient and inpatient clinics at Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine. These patients will be randomly assigned to either the experimental group (SCRM) or the comparison group (basic cervical manipulation [BCM]). Treatment sessions consisting of SCRM or BCM will be administered twice a week for a duration of 4 weeks. Clinical monitoring indicators include the presence or absence of clinical symptoms as recorded on a symptom recording form, cervical imaging examination findings using cervical computed tomography, degree of neck pain measured by a visual analog scale (VAS), cervical range of motion assessed through cervical mobility measurement, degree of vertigo evaluated using the Vertigo Symptoms Scale-Chinese Version (VSS-C), and adverse events that may occur during the follow-up period. The time points for data collection and follow-up are baseline and postintervention (weeks 4, 8, 12, 16, 20, and 24).
This paper presents an overview of the reasoning and structure of a prospective randomized controlled trial with the objective of investigating the clinical efficacy and safety of SCRM in patients with AJS by assessing improvements in clinical symptoms, neck pain severity, and vertigo severity and evaluating changes in cervical imaging findings. Recruitment was started in March 2023. By the end of May 2024, 76 patients were included in this project. The last follow-up data are predicted to be collected by the end of February 2025.
This investigation will yield dependable evidence regarding the efficacy and safety of SCRM in patients with AJS.
Chinese Clinical Trial Registry ChiCTR2300068510; https://www.chictr.org.cn/showprojEN.html?proj=186883.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/57865.
中医（TCM）对寰枢关节半脱位（AJS）的临床诊断特征是影像学上寰椎侧块与齿状突之间的距离不等，导致颈部疼痛，并伴有头晕、头痛和颈部活动受限等症状。在上海，Shi 颈椎旋转手法（SCRM）是一种常用于治疗这种疾病的 TCM 手法治疗。然而，关于该技术的临床疗效和安全性，缺乏基于证据的医学信息。
本研究的主要目的是评估 SCRM 治疗 AJS 患者的疗效和安全性。
这是一项在单中心进行的前瞻性随机对照临床试验，随访期为 24 周。将从上海宝山区中西医结合医院的门诊和住院患者中招募 96 例 AJS 患者。这些患者将被随机分配到实验组（SCRM）或对照组（基础颈椎手法[BCM]）。SCRM 或 BCM 治疗疗程为每周 2 次，共 4 周。临床监测指标包括症状记录表上记录的临床症状的有无、颈椎 CT 影像学检查结果、视觉模拟量表（VAS）测量的颈部疼痛程度、颈椎活动度测量的颈椎活动度、中文版眩晕症状量表（VSS-C）评估的眩晕程度以及随访期间可能发生的不良事件。数据收集和随访的时间点为基线和干预后（第 4、8、12、16、20 和 24 周）。
本文概述了一项前瞻性随机对照临床试验的推理和结构，旨在通过评估临床症状、颈部疼痛严重程度和眩晕严重程度的改善，以及评估颈椎影像学发现的变化，来研究 SCRM 治疗 AJS 患者的临床疗效和安全性。招募工作于 2023 年 3 月开始。到 2024 年 5 月底，有 76 名患者参与了该项目。预计最后一次随访数据将于 2025 年 2 月底收集。
这项研究将为 SCRM 治疗 AJS 患者的疗效和安全性提供可靠的证据。
中国临床试验注册中心 ChiCTR2300068510；https://www.chictr.org.cn/showprojEN.html?proj=186883。
国际注册报告标识符（IRRID）：DERR1-10.2196/57865。
