Clinical Application and Mechanical Effect of Tuina Intervention on Hip-Knee-Ankle Kinematic Chain in Lower Limbs of Knee Osteoarthritis

注册号:

Registration number:

ITMCTR2024000293

最近更新日期:

Date of Last Refreshed on:

2024-08-24

注册时间:

Date of Registration:

2024-08-24

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

中医推拿干预膝骨关节炎下肢运动链临床应用及力学效应研究

Public title:

Clinical Application and Mechanical Effect of Tuina Intervention on Hip-Knee-Ankle Kinematic Chain in Lower Limbs of Knee Osteoarthritis

注册题目简写:

English Acronym:

研究课题的正式科学名称:

中医推拿干预膝骨关节炎下肢运动链临床应用及力学效应研究

Scientific title:

Clinical Application and Mechanical Effect of Tuina Intervention on Hip-Knee-Ankle Kinematic Chain in Lower Limbs of Knee Osteoarthritis

研究课题的正式科学名称简写:

Scientific title acronym:

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:

温宗麟

研究负责人:

温宗麟

Applicant:

Wen Zonglin

Study leader:

Wen Zonglin

申请注册联系人电话:

Applicant telephone:

18818273239

研究负责人电话:

Study leader's telephone:

18818273239

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:

shuguangtuinawzl@163.com

研究负责人电子邮件:

Study leader's E-mail:

shuguangtuinawzl@163.com

申请单位网址(自愿提供):

Study leader's 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:

上海市浦东新区张衡路528号3号楼1楼北区推拿科106医生办公室

研究负责人通讯地址:

上海市浦东新区张衡路528号3号楼1楼北区推拿科106医生办公室

Applicant address:

Office 106, Department of Tuina, North Area, 1st Floor, Building 3, No. 528 Zhangheng Road, Pudong New Area, Shanghai

Study leader's address:

Office 106, Department of Tuina, North Area, 1st Floor, Building 3, No. 528 Zhangheng Road, Pudong New Area, Shanghai

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:

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2024-1560-143-01

伦理委员会批件附件:

Approved file of Ethical Committee:

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:

IRB of Shuguang Hospital afiliated to Shanghai University of TCM

伦理委员会批准日期:

Date of approved by ethic committee:

2024/8/6 0:00:00

伦理委员会联系人:

耿希

Contact Name of the ethic committee:

Geng Xi

伦理委员会联系地址:

上海市浦东新区张衡路528号

Contact Address of the ethic committee:

528 Zhangheng Road, Pudong New Area, 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:

sgyylywyh@126.com

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:

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

上海市浦东新区张衡路528号3号楼1楼北区推拿科106医生办公室

Primary sponsor's address:

Office 106, Department of Tuina, North Area, 1st Floor, Building 3, No. 528 Zhangheng Road, Pudong New Area, Shanghai

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

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

具体地址:

上海市浦东新区张衡路528号

Institution
hospital:

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine

Address:

528 Zhangheng Road, Pudong New Area, Shanghai

经费或物资来源:

上海申康医院发展中心

Source(s) of funding:

Shanghai Shenkang Hospital Development Center

研究疾病:

膝骨关节炎

研究疾病代码:

Target disease:

Knee Osteoarthritis

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

本研究的目的是为了评价推拿干预膝骨关节炎下肢运动链的有效性和安全性,其研究结果将用于提高推拿手法的疗效和操作安全性。

Objectives of Study:

The purpose of this study is to evaluate the efficacy and safety of massage intervention in the hip-knee-ankle Kinematic Chain of knee osteoarthritis, and the results will be used to improve the efficacy and safety of Tuina.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

KOA患者纳入标准如下: ①WOMAC评分中5项疼痛评估部分平均分≥4分; ②下肢全长X线显示存在下肢力线异常; ③年龄20-65周岁,男女不限; ④近4周未接受过其他可能干预本研究结果的治疗; ⑤符合上述条件的单侧KOA患者将被纳入。 健康志愿者纳入标准如下: ①年龄在20-65周岁之间,男女不限; ②身体健康,既往无下肢神经系统及肌肉骨骼系统等疾病史; ③能够正确理解研究人员要求,积极配合完成测试,并自愿签署知情同意书。

Inclusion criteria

Inclusion criteria for KOA patients were as follows: ①The average pain score in WOMAC was≥4; ②The lower limb length X-ray showed abnormal lower limb line; ③Age 20-65 years old male or female; ④No other treatment that may interfere with the results of this study has been received in the past 4 weeks; ⑤Accords with the above conditions will be included in patients with unilateral KOA. Inclusion criteria for healthy volunteers were as follows: ① Age between 20 and 65 years old male and female; ② healthy body no previous history of lower extremity nervous system and musculoskeletal system diseases; ③ correctly understand the requirements of the researchers actively cooperate to complete the test and voluntarily sign the informed consent.

排除标准:

①患有风湿/类风湿性关节炎、骨质疏松、痛风等较严重的骨关节疾病者;过去12个月内有膝关节活动性感染; ②合并心血管、脑血管、肝、肾、造血、消化系统等严重疾病或精神病者;其他身体疾病或状况,造成在坐下、站立、行走等活动中比KOA更受限或疼痛的; ③孕妇或哺乳期妇女等不能完成放射学检查者; ④不能正确理解并填写与研究相关的各种量表和知情同意者; ⑤不愿加入本试验者/研究者认为不宜参加本研究的其它情况者。

Exclusion criteria:

①Patients with severe bone and joint diseases, such as rheumatoid arthritis, rheumatoid arthritis, osteoporosis, gout, etc. An active knee infection in the past 12 months. ②Patients with cardiovascular, cerebrovascular, liver, kidney, hematopoietic, digestive or mental illness, or other conditions that cause more restriction or pain in activities such as sitting, standing, or walking than KOA. ③Pregnant and lactating women who could not complete the radiological examination. ④Patients who cannot correctly understand and complete research related to various scales and informed patient consent. ⑤Patients who do not wish to participate in the study/other conditions that the investigator considers inappropriate to participate in the study.

研究实施时间:

Study execute time:

From 2024-05-10

To      2026-05-10

征募观察对象时间:

Recruiting time:

From 2024-09-01

To      2026-01-31

干预措施:

Interventions:

组别:

对照组

样本量:

48

Group:

control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

conventional treatment

Intervention code:

组别:

干预组

样本量:

48

Group:

Intervention group

Sample size:

干预措施:

推拿联合常规治疗

干预措施代码:

Intervention:

Tuina combined with conventional treatment

Intervention code:

样本总量 Total sample size : 96

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

上海

市(区县):

浦东新区

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:

三级甲等

Institution/hospital:

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

坦帕运动恐惧症量表

指标类型:

次要指标

Outcome:

TSK-17

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

功能性运动测试

指标类型:

次要指标

Outcome:

Functional Movement Screen

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

KOA主要症状体征/中医证候分级量化评分

指标类型:

次要指标

Outcome:

Key Symptoms and Signs/TCM Syndrome Classification Quantitative Evaluation of KOA

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

西安大略和曼彻斯特大学骨性关节炎指数可视化量表

指标类型:

主要指标

Outcome:

WOMAC

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

起立行走测试

指标类型:

次要指标

Outcome:

the Timed Up and Go

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

负重弓步测试

指标类型:

次要指标

Outcome:

Weight Bearing Lunge Test

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:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 20
Min age years
最大 65
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

随机分组采用 IBM SPSS Statistics 27.0 统计软件及人工辅助完成,具体方法如下: 在研究开始前设置一个随机分组专门人员,由这个专门人员运用 IBM SPSS Statistics 27.0 统计软件根据编号1-96生成一组随机数,将编号按照随机数从小到大的顺序排序后,将96例病例随机分入观察组和对照组,并将编号和对应分组发送给研究者;研究者将招募到的符合入组标准的病例按入组先后顺序列入表格并编号,对照随机分组人员生成的分组情况,确定当前病例所属组别,将两个组别人员名单分别整理成表后发送给实际操作人员,告知操作人员每个组别的具体操作方式,如此操作可减少研究人员和分组专员在分组过程中的不必要交流,尽可能避免研究者在病例收入过程中的主观意愿对研究分组情况的影响。

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

Randomization will be performed using IBM SPSS Statistics 27.0 software and manual assistance as follows: Prior to the study, a randomization specialist will be assigned to generate a random set of numbers based on numbers 1-96 using IBM SPSS Statistics 27.0 software. After the numbers are sorted from small to large by random number, 96 cases will be randomly divided into intervention group and control group, and the numbers and corresponding groups will be sent to the researchers. Recruited patients who meet the inclusion criteria will be listed in a table and numbered in order of enrollment. The current caseload will be determined according to the grouping generated by randomly assigned personnel. The lists of the two groups will be sorted into tables and sent to the actual operators, and operators will be informed of the specific methods of operation of each group. This method can reduce unnecessary communication between researchers and randomization specialists in the grouping process, as far as possible to avoid researchers in income cases in the subjective willingness to study the effect of the grouping situation.

盲法:

单盲(评估者盲)

Blinding:

是否共享原始数据:

IPD sharing:

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):

不共享

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Not applicable

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:

CRF

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

CRF

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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