ChiCTR2300072739 版本V1.1 版本创建时间2023/08/17 12:36:55 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2300072739 

最近更新日期：

Date of Last Refreshed on：

 2023-06-25 08:57:08 

注册时间：

Date of Registration：

 2023-06-25 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

巨刺电针治疗全膝关节置换术后急性疼痛的临床研究

Public title：

Opposing needling electroacupuncture for clinical study on the treatment of acute pain after total knee arthroplasty

注册题目简写：

English Acronym：

研究课题的正式科学名称：

巨刺电针治疗全膝关节置换术后急性疼痛的临床研究

Scientific title：

Opposing needling electroacupuncture for clinical study on the treatment of acute pain after total knee arthroplasty

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：

王建业 

研究负责人：

王建业 

Applicant：

Jianye Wang 

Study leader：

Jianye Wang 

申请注册联系人电话：

Applicant telephone：

 +86 157 5512 7012

研究负责人电话：

Study leader's
telephone：

+86 157 5512 7012

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：

 wangjianye1006@163.com

研究负责人电子邮件：

Study leader's E-mail：

 wangjianye1006@163.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：

上海市光华中西医结合医院延安西路1474号

研究负责人通讯地址：

上海市光华中西医结合医院延安西路1474号

Applicant address：

1474 Yan 'an West Road, Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai

Study leader's address：

1474 Yan 'an West Road, Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai

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：

上海市光华中西医结合医院

Applicant's institution：

Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

研究负责人所在单位：

上海市光华中西医结合医院

Affiliation of the Leader：

Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

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：

 2023-K-39

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：

上海市光华中西医结合医院伦理委员会

Name of the ethic committee：

Ethics Committee of Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-05-12 00:00:00

伦理委员会联系人：

朱丹

Contact Name of the ethic committee：

Dan Zhu

伦理委员会联系地址：

上海市长宁区延安西路1474号

Contact Address of the ethic committee：

1474 Yan'an Road West, Changning District, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 157 5512 7012

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：

上海市光华中西医结合医院

Primary sponsor：

Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

研究实施负责（组长）单位地址：

上海市长宁区延安西路1474号

Primary sponsor's address：

No. 1474 Yan'an West Road, Changning District, 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)：

上海市光华中西医结合医院

具体地址：

上海市长宁区延安西路1474号

Institution
hospital：

Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

Address：

1474 Yan'an Road West, Changning District, Shanghai

经费或物资来源：

市级（上海市科委医学创新研究专项）

Source(s) of funding：

Shanghai Science and Technology Commission medical Innovation Research Program

研究疾病：

急性术后疼痛  

Target disease：

Acute Postoperative pain

研究疾病代码：

MG31.2

Target disease code：

MG31.2

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

电针对于TKA术后急性疼痛的研究具有重要的意义和价值。通过深入探讨电针的治疗机制、优化治疗方案、提高安全性等方面的研究，可以为临床医生提供更加有效、安全、便捷的疼痛管理方式，为患者提供更好的医疗服务和生活质量。  

Objectives of Study：

Electroacupuncture is of great significance and value in the study of acute pain after TKA. Through in-depth exploration of the treatment mechanism of electroacupuncture, optimization of treatment plan and improvement of safety, we can provide clinicians with more effective, safe and convenient pain management methods, and provide better medical services and quality of life for patients.

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60岁-80岁之间 2: 了解试验全过程，自愿参加并签署知情同意书 3: 符合中华医学会2018年提出的《膝骨关节炎诊断标准》，住院择期在全麻下行单侧膝关节置换手术病例，无手术禁忌证 4: 美国麻醉医师协会(ASA)分级为Ⅰ 或 Ⅱ 级

Inclusion criteria

1: Between 60 and 80 years of age 2: Understand the whole process of the trial, voluntarily participate in and sign the informed consent 3: Patients who met the Diagnostic criteria for knee Osteoarthritis proposed by the Chinese Medical Association in 2018, and were scheduled for unilateral knee arthroplasty under general anesthesia, had no surgical contraindications 4: The patients were classified as American Society of Anesthesiologists (ASA) grade Ⅰ or Ⅱ

排除标准：

1: 严重心律失常、心力衰竭、慢性阻塞性肺疾病、精神病、妊娠妇女或哺乳期妇女 2: 存在电针使用禁忌者（如心脏起搏器植入，操作穴位处有皮肤破溃等） 3: 一月内曾行针刺治疗 4: 正在参加其他临床试验者，具有其他各种研究者认为不能加入此临床试验的情况

Exclusion criteria：

1: Severe cardiac arrhythmias, heart failure, chronic obstructive pulmonary disease, psychiatric disorders, pregnant or lactating women 2: There are contraindications to the use of electroacupuncture (such as cardiac pacemaker implantation, skin ulceration at the operating point, etc.) 3: She had received acupuncture treatment within one month 4: Persons who are enrolled in other clinical trials and have various other conditions that the investigators deem impossible to participate in this clinical trial

研究实施时间：

Study execute time：

从 From 2023-06-20 00:00:00至 To 2024-06-20 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-06-25 00:00:00 至 To 2024-05-30 00:00:00

干预措施：

Interventions：

组别：

安慰针组

样本量：

 33

Group：

Control Group

Sample size：

干预措施：

分别于术后24h，48h，72h干预治疗一次。用改良安慰针，针头钝化，针尖不刺入皮肤，仅对皮肤有挤压感来模拟针刺，同时穴位周围使用可粘胶垫固定，接“安慰电针仪” （外观与普通电针仪无差异，内部导线已切断，实际无电流通过）留置20min。

干预措施代码：

Intervention：

The intervention was performed at 24h, 48h and 72h after operation. The modified placebo acupuncture was used, the needle tip was passivated, and the needle tip did not penetrate the skin, only the skin had a pressing sensation to simulate acupuncture. At the same time, the surrounding of the acupoints was fixed with viscose pads, and the "comfort electroacupuncture apparatus" (there was no difference in appearance between the ordinary electroacupuncture apparatus and the comfort electroacupuncture apparatus, and the internal lead had been cut off, and no actual current passed through) was retained for 20 minutes.

Intervention code：

组别：

连续波组

样本量：

 33

Group：

Treatment Group

Sample size：

干预措施：

分别于术后24h，48h，72h干预治疗一次。使用0.25×50mm无菌针灸针，行针刺，进针约12-25mm，在穴位周围粘贴胶垫固定，接电针仪留置20min，电流为连续波，2mA，频率2Hz，强度2级。

干预措施代码：

Intervention：

The intervention was performed at 24h, 48h and 72h after operation. A 0.25×50mm sterile acupuncture needle was used for acupuncture, and the insertion of the needle was about 12-25mm. The adhesive pad was fixed around the acupoints, and the electroacupuncture apparatus was retained for 20min. The current was continuous wave, 2mA, frequency was 2Hz, and the intensity was 2 grade.

Intervention code：

组别：

疏密波组

样本量：

 33

Group：

Treatment Group

Sample size：

干预措施：

分别于术后24h，48h，72h干预治疗一次。使用0.25×50mm无菌针灸针，进针约12-25mm，在穴位周围粘贴胶垫固定，接电针仪留置20min，电流为疏密波，2mA，频率2Hz/100Hz，强度2级。

干预措施代码：

Intervention：

The intervention was performed at 24h, 48h and 72h after operation. The 0.25×50mm sterile acupuncture needle was used, and the insertion of the needle was about 12-25mm. The adhesive pad was fixed around the acupoints, and the electroacupuncture apparatus was retained for 20min. The current was disperse-dense wave, 2mA, the frequency was 2Hz/100Hz, and the intensity was 2 grade.

Intervention code：

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)：

  

Country：

China

Province：

Shanghai

City：

单位(医院)：

 上海市光华中西医结合医院 

单位级别：

 三级甲等 

Institution
hospital：

Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

NRS评分

指标类型：

主要指标

Outcome：

NRS score

Type：

Primary indicator

测量时间点：

术前；术后24h；术后48h；术后72h

测量方法：

Measure time point of outcome：

Preoperative; 24 hours after operation; 48 hours after operation; 72 hours after operation

Measure method：

指标中文名：

BNDF/TrkB蛋白

指标类型：

次要指标

Outcome：

BNDF/TrkB protein

Type：

Secondary indicator

测量时间点：

术前；术后72h

测量方法：

Measure time point of outcome：

Preoperative;72 hours after operation

Measure method：

指标中文名：

压力痛阈测试

指标类型：

次要指标

Outcome：

Stress pain threshold test

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

膝关节轴径

指标类型：

次要指标

Outcome：

Knee joint axis diameter

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：

血清

组织：

Sample Name：

serum

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 60 岁 years
最大 Max age 80 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）：

由王建业按照完全随机原则，观察病例从1～99编号，应用SAS软件由计算机随机分为三组，随机选取安慰针组、连续波组和疏密波组，按就诊先后顺序分配盲号。

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

According to the principle of complete randomization, the cases were numbered from 1 to 99 and randomly divided into three groups by computer using SAS software. The placebo group, continuous wave group and disperse-dense wave group were randomly selected, and the blind number was assigned according to the order of treatment.

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：

单盲（对受试者隐藏分组），对评估者不隐藏分组

Blinding：

Single-blind (grouping was concealed from subjects), and grouping was not concealed from assessors

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

请邮件联系项目负责人

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

Please contact the project leader by email.

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：

采用CRF表采集临床资料，通过EDC系统管理病例

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

CRF and EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-06-25 08:56:35