中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2400086205
最近更新日期： Date of Last Refreshed on：	2024-06-26 18:03:27
注册时间： Date of Registration：	2024-06-26 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	青少年颈痛颈部筋出槽骨错缝与手法调治的生物力学机制研究
Public title：	A Biomechanical Mechanism Study on the Missutures of Neck Tendon and Groovement in Teenagers with Cervical Pain and Manual Treatment
注册题目简写：
English Acronym：
研究课题的正式科学名称：	青少年颈痛颈部筋出槽骨错缝与手法调治的生物力学机制研究
Scientific title：	A Biomechanical Mechanism Study on the Missutures of Neck Tendon and Groovement in Teenagers with Cervical Pain and Manual Treatment
研究课题代号(代码)： Study subject ID：
在二级注册机构或其它机构的注册号： The registration number of the Partner Registry or other register：

申请注册联系人：	张明才	研究负责人：	张明才
Applicant：	Mingcai ZHANG	Study leader：	Mingcai ZHANG
申请注册联系人电话： Applicant telephone：	+86 135 2442 8805	研究负责人电话： Study leader's telephone：	+86 135 2442 8805
申请注册联系人传真： Applicant Fax：		研究负责人传真： Study leader's fax：
申请注册联系人电子邮件： Applicant E-mail：	zhangmc816@126.com	研究负责人电子邮件： Study leader's E-mail：	zhangmc816@126.com
申请单位网址(自愿提供)： Applicant website(voluntary supply)：		研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：
申请注册联系人通讯地址：	上海市张衡路528号	研究负责人通讯地址：	上海市张衡路528号
Applicant address：	Zhangheng Road 528,Shanghai City,China zhangheng	Study leader's address：	Zhangheng Road 528,Shanghai City,China zhangheng
申请注册联系人邮政编码： Applicant postcode：	201203	研究负责人邮政编码： Study leader's postcode：	201203
申请人所在单位：	上海中医药大学附属曙光医院
Applicant's institution：	Shanghai University of Traditional Chinese Medicine Affiliated Shuguang Hospital
研究负责人所在单位：	上海中医药大学附属曙光医院
Affiliation of the Leader：	Shanghai University of Traditional Chinese Medicine Affiliated Shuguang Hospital

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	2024-1421-004-01	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	上海中医药大学附属曙光医院伦理委员会
Name of the ethic committee：	Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
伦理委员会批准日期： Date of approved by ethic committee：	2024-02-27 00:00:00
伦理委员会联系人：	马俊坚
Contact Name of the ethic committee：	Junjian Ma
伦理委员会联系地址：	上海市张衡路528号
Contact Address of the ethic committee：	528 Zhangheng Road, Shanghai
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 21 2025 6070	伦理委员会联系人邮箱： Contact email of the ethic committee：

研究实施负责（组长）单位：

上海中医药大学附属曙光医院

Primary sponsor：

Shanghai University of Traditional Chinese Medicine Affiliated Shuguang Hospital

研究实施负责（组长）单位地址：

上海中医药大学附属曙光医院

Primary sponsor's address：

Shanghai University of Traditional Chinese Medicine Affiliated Shuguang Hospital

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	shanghai	市(区县)：	shanghai
Country：	China	Province：	shanghai	City：	shanghai
单位(医院)：	上海中医药大学附属曙光医院	具体地址：	上海市张衡路528号
Institution hospital：	Shanghai University of Traditional Chinese Medicine Affiliated Shuguang Hospital	Address：	Zhangheng Road 528,Shanghai City,China zhangheng

经费或物资来源：

国家自然基金委员会

Source(s) of funding：

National Natural Science Foundation of China

研究疾病：

青少年颈痛

Target disease：

Adolescent Neck Pain

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

I期临床试验

Study phase：

1

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

该试验的目是应用特定手法通过对颈部筋出槽骨错缝进行针对性治疗，与枕颌布托牵引法进行对比，观察青少年颈痛患者生物力学参数和临床病情的变化，比较分析他们之间的相关关系和影响因素。

Objectives of Study：

The purpose of this experiment is to apply specific techniques for targeted treatment of cervical tendon groove bone dislocation, and compare it with the occipital jaw cloth traction method to observe the changes in biomechanical parameters and clinical conditions of adolescent neck pain patients, and compare and analyze the correlation and influencing factors between them.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

排除标准：

排除标准：具有下列条件之一者不能纳入本项研究。 ①年龄＜12岁、或＞18岁者。②符合《骨与关节十年2000-2010战略任务中关于颈痛及其相关疾患分类》的III或IV级。③颈椎发生骨折、脱位、颈部肿瘤或结核者。④合并严重心脑血管和消化系统等疾病、自身免疫性疾病、精神病、急性或慢性感染者。⑤研究者认为不宜参加本项研究的其它情况。

Exclusion criteria：

Exclusion criteria: Those who meet one of the following conditions cannot be included in this study. ① Individuals under 12 years old or over 18 years old Level III or IV in accordance with the "Classification of Neck Pain and Related Diseases" in the "Bone and Joint Decade 2000-2010 Strategic Task" Patients with cervical fractures, dislocations, neck tumors or tuberculosis Patients with severe cardiovascular, cerebrovascular, digestive system diseases, autoimmune diseases, mental illness, acute or chronic infections Other situations where the researcher considers it inappropriate to participate in this study.

研究实施时间：

Study execute time：

从 From 2024-07-01 00:00:00至 To 2027-12-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-07-01 00:00:00 至 To 2027-05-01 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	60
Group：	Test Group	Sample size：	60
干预措施：	进行颈部筋出槽骨错缝手法治疗，主要采用本课题组“十·五”期间国家中医药管理局授权全国中医院范围内推广的“颈椎仰卧位拔伸整复手法”技术进行治疗，具体操作如下：具体操作步骤：a患者取俯卧位，以一指禅推法、滚法和按揉法在颈项、肩及上背部常规操作10min；b 患者取仰卧位，术者立其头端，双手重叠自第3、4颈椎下将颈部稍微托起，与水平方向呈15～2O°角拔伸，着力点位于棘突之间，持续时问不少于lmin，反复5遍；c 以食、中、环三指指腹着力，由下而上沿直线平推，两手协同，交替进行，包括督脉和两侧膀胱经的颈段，每条线各6遍，共12遍；d 以中指指腹着力，以中等强度力量沿项韧带及其两旁自下而上弹拨，两手交替进行，反复5遍；e 以中等强度力量勾揉风池、风府穴、阿是穴，按揉肩井穴各2min；f 在拔伸状态下左右旋转颈椎至极限位(约45°左右)，不做扳法，反复5遍；g 自颈根部将颈椎微微托起，然后边拔伸，两手边向头部滑移至发际，反复5遍；h 患者仰卧，术者立其头端，矫正手的接触点（食指末节桡侧缘）顶在关节错缝椎体的横突（关节突发生错缝的一侧）后，稳定手扶住患者对侧耳后枕骨，将头慢慢抬起前屈，颈后的肌群被拉紧的感觉达到食指时，停止前屈；矫正手的接触点用力向右侧推患椎，与稳定手形成相对力，使颈椎形成向左的侧弯，当矫正手的接触点感觉到阻力时，侧弯停止，将患者的头向右侧旋转到极限，锁定关节突关节，然后矫正手接触点朝矫正手大拇指的方向快速发闪动力，听到关节突关节弹响声，则矫正手法完成。	干预措施代码：
Intervention：	The treatment of cervical tendon and groove bone dislocation is mainly carried out using the "cervical spine supine position extension and reduction technique" authorized by the National Administration of Traditional Chinese Medicine during the "10th Five Year Plan" period, which is promoted nationwide in traditional Chinese medicine hospitals. The specific operation steps are as follows: a patient takes a prone position and uses one finger Zen push method, rolling method, and massage method to perform routine operations on the neck, shoulder, and upper back for 10 minutes; Patient B is placed in a supine position, with the surgeon standing on their head and overlapping their hands under the 3rd and 4th cervical vertebrae to slightly lift the neck and extend it at an angle of 15-20 ° to the horizontal. The focus is located between the spinous processes, lasting for no less than 1 minute and repeated 5 times; Using the three fingertips of food, middle, and ring, push horizontally from bottom to top in a straight line, with both hands working together and alternating, including the neck segments of the governor meridian and bladder meridians on both sides. Each line is repeated 6 times, a total of 12 times; Using the middle finger pulp to exert force, use moderate strength to bounce along the nuchal ligament and its sides from bottom to top, alternating with both hands, repeating 5 times; Use moderate strength to knead the Fengchi, Fengfu, and Ashi acupoints, and press and knead the Jianjing acupoints for 2 minutes each; Rotate the cervical spine left and right to the limit position (about 45 °) in the state of extension, without pulling, repeat 5 times; Lift the cervical spine slightly from the base of the neck, then pull and extend it, sliding both hands towards the head to the hairline, repeating 5 times; The patient is lying on their back, with the surgeon standing on their head. The contact point of the corrective hand (the radial edge of the distal segment of the index finger) is pressed against the transverse process of the joint dislocation vertebral body (the side where the joint process occurs), and the stable hand is supported by the patient's opposite ear occipital bone. The head is slowly lifted and bent forward. When the feeling of tension on the muscles behind the neck reaches the index finger, the forward bending stops; The contact point of the corrective hand forcefully pushes the affected vertebra to the right, forming a relative force with the stable hand, causing the cervical spine to form a left lateral bend. When resistance is felt at the contact point of the corrective hand, the lateral bend stops, and the patient's head is rotated to the right to the limit, locking the articular process joint. Then, the contact point of the corrective hand quickly flashes in the direction of the corrective hand's thumb. When the sound of the articular process joint bouncing is heard, the corrective technique is completed.	Intervention code：

组别：	对照组	样本量：	60
Group：	Control Group	Sample size：	60
干预措施：	按照《中医骨伤科学》教材中的“枕颌布托”颈椎牵引法操作标准进行治疗。	干预措施代码：
Intervention：	Treat according to the operating standards of the cervical traction method of "occipital jaw cloth support" in the textbook "Traditional Chinese Medicine Orthopedics and Trauma Science".	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	shanghai	市(区县)：
Country：	China	Province：	shanghai	City：
单位(医院)：	上海中医药大学附属曙光医院	单位级别：	三甲
Institution hospital：	Shanghai University of Traditional Chinese Medicine Affiliated Shuguang Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	NRS量表	指标类型：	主要指标
Outcome：	NRS	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	NDI量表	指标类型：	主要指标
Outcome：	NDI	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	颈椎动静态触诊阳性率	指标类型：	主要指标
Outcome：	Positive rate of cervical dynamic and static palpation	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	颈椎曲度和关节间隙测量值	指标类型：	主要指标
Outcome：	Measurement of cervical curvature and joint clearance	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	关节应力值	指标类型：	主要指标
Outcome：	Joint stress value	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	基本信息	指标类型：	次要指标
Outcome：	General information	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	颈椎CT三维重建影像	指标类型：	次要指标
Outcome：	Cervical CT three-dimensional reconstruction imaging	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	无	组织：
Sample Name：	None	Tissue：
人体标本去向	使用后保存	说明
Fate of sample：	Preservation after use	Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age	12	岁 years
最大 Max age	18	岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

本项目研究采用临床随机对照试验设计，将符合试验研究标准的受试者按照1:1比例随机分为：石氏伤科手法治疗组为试验组，牵引组为对照组；随机数字表由具体负责统计专职人员应用SAS软件（9.4版，SAS公司，Cary，NC）按照严格随机规程产生，随机化列表由数据管理器存储在安全数据库（Microsoft Office Access 2007）上，相关病例观察医师或其他研究人员无法访问该随机化数字表，每位受试者只能注册和随机化一次，数据库中不得删除任何关于受试者的详细信息。

Randomization Procedure (please state who generates the random number sequence and by what method)：

The study of cervical spine CT three-dimensional reconstruction imaging adopts a clinical randomized controlled trial design. Subjects who meet the experimental research standards are randomly divided into a 1:1 ratio: the Shi's Traumatology Manual Treatment Group is the experimental group, and the traction group is the control group; The random number table is generated by dedicated personnel responsible for statistical analysis using SAS software (version 9.4, SAS company, Cary, NC) in accordance with strict randomization procedures. The randomized list is stored in a secure database (Microsoft Office Access 2007) by a data manager, and cannot be accessed by relevant case observation physicians or other researchers. Each subject can only register and randomize once, No detailed information about the subjects should be deleted from the database.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：	本项目的随机分组及干预方案等信息均对受试者和数据统计分析人员采取盲法设置。编盲过程，编盲过程按照单盲临床试验编盲操作规范要求进行，并形成编盲过程记录文件；盲底保存采用两级盲法设汁，第一级为两个处理组所对应的代码（随机指定为Ａ、Ｂ），第二级为各代码对应的处理。两级盲底分别单独密封，各一式两份，分别存放于骨伤科研究所由专职人员（不直接参与本项目研究工作）保管。
Blinding：	The random grouping and intervention plan information of this project were blinded to the subjects and data analysts. The blinding process is carried out in accordance with the requirements of the single blind clinical trial blinding operation specifications, and a blinding process record file is formed; Blind bottom preservation adopts a two-level blind method for juice design. The first level is the code corresponding to the two processing groups (randomly designated as A and B), and the second level is the processing corresponding to each code. The two-level blind bottoms are sealed separately, with two copies each, stored separately in the orthopedic research institute and kept by dedicated personnel (who do not directly participate in the research work of this project).
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	否No
共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：	于2027年12月1日前发表学术论文及病例报告表
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Published article and case report form on December 1, 2027
数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：	病例记录表
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Case Record Form, CRF
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2024-06-26 18:02:57