Acupoint catenary therapy for analgesia after knee arthroplasty: a single-center randomized controlled prospective clinical study

注册号:

Registration number:

ITMCTR2025000206

最近更新日期:

Date of Last Refreshed on:

2025-01-28

注册时间:

Date of Registration:

2025-01-28

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

穴位埋线治疗在膝关节置换术后镇痛的应用:一项单中心、随机、对照、前瞻性的临床研究

Public title:

Acupoint catenary therapy for analgesia after knee arthroplasty: a single-center randomized controlled prospective clinical study

注册题目简写:

English Acronym:

研究课题的正式科学名称:

穴位埋线治疗在膝关节置换术后镇痛的应用:一项单中心、随机、对照、前瞻性的临床研究

Scientific title:

Acupoint catenary therapy for analgesia after knee arthroplasty: a single-center randomized controlled prospective clinical study

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:

李成

研究负责人:

熊利泽

Applicant:

Li Cheng

Study leader:

Xiong Lize

申请注册联系人电话:

Applicant telephone:

+86 153 0170 5322

研究负责人电话:

Study leader's telephone:

+86 55603999

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:

marklisa@163.com

研究负责人电子邮件:

Study leader's E-mail:

marklisa@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:

上海市虹口区三门路1279号

研究负责人通讯地址:

上海市虹口区三门路1279号

Applicant address:

1279 Sanmen Road Hongkou District Shanghai China

Study leader's address:

1279 Sanmen Road Hongkou District Shanghai China

申请注册联系人邮政编码:

Applicant postcode:

研究负责人邮政编码:

Study leader's postcode:

申请人所在单位:

上海市第四人民医院

Applicant's institution:

Shanghai Fourth People's Hospital

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:

2025004-001

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:

上海市第四人民医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Shanghai Fourth People's Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2025/1/21 0:00:00

伦理委员会联系人:

盛夏,张其胜

Contact Name of the ethic committee:

Sheng XiaZhang Qisheng

伦理委员会联系地址:

上海市虹口区三门路1279号A727室

Contact Address of the ethic committee:

1279 Sanmen Road Hongkou District Shanghai China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 55603999

伦理委员会联系人邮箱:

Contact email of the ethic committee:

254743361@qq.com

研究实施负责(组长)单位:

上海市第四人民医院

Primary sponsor:

Shanghai Fourth People's Hospital

研究实施负责(组长)单位地址:

上海市虹口区三门路1279号

Primary sponsor's address:

1279 Sanmen Road Hongkou District Shanghai China

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

市(区县):

Country:

China

Province:

Shanghai Municipality

City:

单位(医院):

上海市第四人民医院

具体地址:

上海市虹口区三门路1279号

Institution
hospital:

Shanghai Fourth People's Hospital

Address:

1279 Sanmen Road Hongkou District Shanghai China

经费或物资来源:

自选课题(经费自筹)

Source(s) of funding:

Self-selected project (self-funded)

研究疾病:

膝关节疼痛

研究疾病代码:

Target disease:

Knee pain

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:

其它

Others

研究目的:

1. 验证穴位埋线对术后疼痛的缓解效果; 2. 评估穴位埋线对术后功能恢复的促进作用; 3. 系统分析穴位埋线的安全性,确保该技术的临床可行性。

Objectives of Study:

1. Evaluate the efficacy of acupuncture point embedding in alleviating postoperative pain; 2. Assess the efficacy of acupuncture point embedding in promoting postoperative functional recovery; 3. The safety profile of acupuncture point embedding was systematically evaluated to ensure the clinical viability and feasibility of this therapeutic technique.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

1、年龄18-80岁,性别不限; 2、BMI(体质量指数)为 18-30 kg/m^2; 3、美国麻醉师协会(ASA)分级 ASA I-II级; 4、计划接受膝关节置换术,且已签署知情同意书。

Inclusion criteria

1. Age 18-80 years old gender unlimited; 2. BMI (Body mass index) is 18-30 kg/m^2; 3. American Association of Anesthesiologists (ASA) grade ASA I-II; 4. Plan to undergo knee replacement and have signed informed consent.

排除标准:

1、冠心病、消化道溃疡患者; 2、对麻醉药物或缝线材料过敏; 3、长期服用阿片类药物或有药物依赖史; 4、皮肤局部感染、过敏或针灸晕厥病史; 5、语言或认知障碍,无法完成疼痛评分。

Exclusion criteria:

1. Patients with coronary heart disease and digestive tract ulcer; 2. Allergic to anesthetic drugs or suture materials; 3. Long-term use of opioids or a history of drug dependence; 4. History of local skin infections allergies or acupuncture syncope; 5. Speech or cognitive impairment inability to complete a pain score.

研究实施时间:

Study execute time:

From 2025-01-01

To      2025-12-31

征募观察对象时间:

Recruiting time:

From 2025-02-05

To      2025-12-31

干预措施:

Interventions:

组别:

实验组(穴位埋线组)

样本量:

14

Group:

Experimental group (acupoint embedding group)

Sample size:

干预措施:

穴位埋线

干预措施代码:

Intervention:

Point embedding

Intervention code:

组别:

对照组(模拟埋线组)

样本量:

14

Group:

Control group (simulated buried wire group)

Sample size:

干预措施:

模拟埋线

干预措施代码:

Intervention:

Simulated buried wire

Intervention code:

样本总量 Total sample size : 28

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

上海市

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市第四人民医院

单位级别:

二甲

Institution/hospital:

Shanghai Fourth People's Hospital

Level of the institution:

Secondary A

测量指标:

Outcomes:

指标中文名:

住院天数

指标类型:

次要指标

Outcome:

Length of stay

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后24小时时疼痛评分(VAS)

指标类型:

主要指标

Outcome:

Pain score 24 hours after surgery (VAS)

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后2周内额外使用的镇痛剂量

指标类型:

次要指标

Outcome:

Hospital special surgery knee joint score and postoperative nausea and vomiting (PONV) symptoms on the 3rd day after surgery

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后第3天医院特殊外科膝关节评分及术后恶心与呕吐(PONV)症状

指标类型:

次要指标

Outcome:

Hospital special surgery knee joint score and postoperative nausea and vomiting (PONV) symptoms on the 3rd day after surgery

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后1小时、10小时、48小时和72小时时疼痛评分(VAS)

指标类型:

次要指标

Outcome:

Pain score (VAS) at 1 10 48 and 72 hours after surgery

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术中阿片类药物的使用剂量

指标类型:

次要指标

Outcome:

Intraoperative doses of opioids

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

穴位埋线相关局部并发症:局部感染、过敏反应、穴位疼痛等

指标类型:

副作用指标

Outcome:

Local complications related to acupoint embedding: local infection, allergic reaction, acupoint pain, etc

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

全身不良反应:系统性过敏反应、阿片类药物相关副作用(如恶心、呕吐、便秘)

指标类型:

副作用指标

Outcome:

Safety of functional recovery: whether pain or discomfort interferes with postoperative mobility

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后72 h C反应蛋白

指标类型:

次要指标

Outcome:

C-reactive protein 72 h after surgery

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:

血液

组织:

血管

Sample Name:

blood

Tissue:

Blood vessel

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 80
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):

由程序员采用JAMA程序生成随机数列

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

A random sequence of numbers is generated by a programmer using a JAMA program

盲法:

对受试者设盲

Blinding:

Participants were blinded

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):

不共享原始数据

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

Raw data is not shared

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:

病历记录表(CRF)表格

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

Medical Record Form (CRF) form

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):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above