ChiCTR2300077138 版本V1.0 版本创建时间2023/10/31 16:13:17 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：

ChiCTR2300077138 

最近更新日期：

Date of Last Refreshed on：

2023-10-31 16:12:53 

注册时间：

Date of Registration：

2023-10-31 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

倍他米松联合中药冷敷治疗TKA患者康复期疼痛与肤温异常的临床研究

Public title：

Clinical study on the combination of betamethasone and traditional Chinese medicine cold compress in the treatment of pain and abnormal skin temperature in TKA patients during rehabilitation period

注册题目简写：

English Acronym：

研究课题的正式科学名称：

倍他米松联合中药冷敷治疗TKA患者康复期疼痛与肤温异常的临床研究

Scientific title：

Clinical study on the combination of betamethasone and traditional Chinese medicine cold compress in the treatment of pain and abnormal skin temperature in TKA patients during rehabilitation period

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：

肖俊强 

研究负责人：

黄永明 

Applicant：

Xiao Junqiang 

Study leader：

Huang Yongming 

申请注册联系人电话：

Applicant telephone：

+86 185 2397 1844

研究负责人电话：

Study leader's telephone：

+86 136 6000 3369

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：

980749272@qq.com

研究负责人电子邮件：

Study leader's E-mail：

huang163huang@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：

广东省广州市越秀区大德路111号

研究负责人通讯地址：

广东省广州市越秀区大德路111号

Applicant address：

111 Dade Road, Yuexiu District, Guangzhou City, Guangdong Province

Study leader's address：

111 Dade Road, Yuexiu District, Guangzhou City, Guangdong Province

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：

广州中医药大学

Applicant's institution：

Guangzhou University of Chinese Medicine

研究负责人所在单位：

广东省中医院

Affiliation of the Leader：

Guangdong Provincial Hospital of Traditional Chinese Medicine

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

YF2023-305-01

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：

广东省中医院伦理委员会

Name of the ethic committee：

Ethics Committee of Guangdong Provincial Hospital of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2023-09-15 00:00:00

伦理委员会联系人：

李晓彦

Contact Name of the ethic committee：

Li Xiaoyan

伦理委员会联系地址：

广东省广州市大德路111号广东省中医院研修楼18楼1803房

Contact Address of the ethic committee：

Room 1803, 18th Floor, Research Building, Guangdong Traditional Chinese Medicine Hospital, No. 111 Dade Road, Guangzhou, Guangdong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 20 8188 7233

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：

广东省中医院（大学城骨科）

Primary sponsor：

Guangdong Provincial Hospital of Traditional Chinese Medicine (Orthopedics of Guangzhou campus city hospital)

研究实施负责（组长）单位地址：

广东省中医院（大学城骨科）

Primary sponsor's address：

Guangdong Provincial Hospital of Traditional Chinese Medicine (Orthopedics of Guangzhou campus city 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)：

广东省

市(区县)：

Country：

China

Province：

Guangdong Province

City：

单位(医院)：

广东省中医院

具体地址：

广东省广州市越秀区大德路111号

Institution
hospital：

Guangdong Provincial Hospital of Traditional Chinese Medicine

Address：

111 Dade Road, Yuexiu District, Guangzhou City, Guangdong Province

经费或物资来源：

广东省中医院（大学城骨科）

Source(s) of funding：

Guangdong Provincial Hospital of Traditional Chinese Medicine (Orthopedics of Guangzhou campus city hospital)

Target disease：

pain and abnormal skin temperature in TKA patients during rehabilitation period

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 上市后药物 

Study phase：

4

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

（1） 评估倍他米松联合中药冷敷应用于TKA（全部膝关节置换术）术后康复期以缓解患者疼痛和皮温升高问题的效果，提供一种快捷有效的治疗手段。 （2）探究倍他米松针对TKA康复期出现疼痛与肤温升高患者疗效情况，并与倍他米松联合中药冷敷的治疗方式进行比较，寻找一种对患者生存质量具有更好影响的治疗方式。  

Objectives of Study：

(1) Evaluate the effectiveness of betamethasone combined with traditional Chinese medicine cold compress in the postoperative rehabilitation period of TKA (total knee arthroplasty) to alleviate patients' pain and elevated skin temperature, and provide a fast and effective treatment method. (2) Explore the efficacy of betamethasone in treating patients with pain and elevated skin temperature during TKA rehabilitation, and compare it with the treatment method of betamethasone combined with traditional Chinese medicine cold compress, in order to find a treatment method that has a better impact on the quality of life of 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符合全膝关节置换术手术指征，在广东省中医院大学城院区行全膝关节置换术者（假体器材型号及提供公司均相同）；②年龄在60~80岁之间的中老年患者，性别不限；③术后三周复诊时自诉有膝关节疼痛、经测量膝关节手术区域皮肤温度高于对侧膝关节者；④精神意识状态良好，能够配合查体及问卷调查；⑤住院病历及门诊病历资料完善；⑥自愿参加研究，并签署知情同意书 。

Inclusion criteria

① Those who meet the surgical indications for total knee arthroplasty and undergo total knee arthroplasty in the university town area of Guangdong Provincial Hospital of Traditional Chinese Medicine (with the same model and provider of prosthetic equipment); ② Middle aged and elderly patients aged between 60 and 80, regardless of gender; ③ Those who reported knee joint pain during follow-up three weeks after surgery, and whose skin temperature in the surgical area of the knee joint was measured to be higher than that of the contralateral knee joint; ④ Good mental and conscious state, able to cooperate with physical examinations and questionnaire surveys; ⑤ Complete inpatient and outpatient medical records; ⑥ Volunteer to participate in the study and sign an informed consent form.

排除标准：

①凝血、肝肾功能异常患者；②既往有中风、神经系统疾病影响术后康复及有沟通障碍者；③不能配合接受本研究治疗方案者；④患糖尿病或其他代谢性疾病需要长期服用激素者；⑤患有骨质疏松或其他代谢性骨病；⑥膝关节皮肤温度测量部位及中药冷敷部位有皮损、皮肤等不适本研究治疗方法者；⑦患有消化道疾病或其他不能服用非甾体抗炎药物疾病者；⑧患者双膝既往有开放性外伤史、骨折病史。

Exclusion criteria：

① Patients with abnormal coagulation, liver and kidney function; ② Individuals with previous stroke, neurological disorders that affect postoperative recovery, and communication difficulties; ③ Those who cannot cooperate with the treatment plan of this study; ④ Those suffering from diabetes or other metabolic diseases who need to take hormones for a long time; ⑤ Suffering from osteoporosis or other metabolic bone diseases; ⑥ Patients with discomfort such as skin damage or skin discomfort at the measurement site of knee joint skin temperature and the cold compress site of traditional Chinese medicine in this study; ⑦ Individuals with digestive tract diseases or other diseases that cannot take non-steroidal anti-inflammatory drugs; ⑧ The patient has a history of open trauma and fractures in both knees.

研究实施时间：

Study execute time：

从 From 2023-09-15 00:00:00至 To 2025-09-15 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2023-11-01 00:00:00 至 To 2024-12-31 00:00:00  

干预措施：

Interventions：

组别：

实验组1

样本量：

30

Group：

Experimental group one

Sample size：

干预措施：

对TKA术后3周复诊时出现疼痛与膝关节手术区域皮肤温度升高的患者，在纳入研究的第1、2、3周予以肌肉注射2mg得宝松（复方倍他米松注射液），疗程共3周，并给予依托考昔片（安康信），30mg/天，疗程8周，嘱患者按时使用药物。

干预措施代码：

Intervention：

For patients who experienced pain and increased skin temperature in the knee joint surgery area during the 3-week follow-up after TKA surgery, 2mg of dexamethasone (compound betamethasone injection) was intramuscularly injected for a total of 3 weeks in the first, second, and third weeks of inclusion in the study. The patients were also given etocoxib tablets (Ankanxin) at 30mg/day for 8 weeks, and were advised to use the medication on time.

Intervention code：

组别：

实验组2

样本量：

30

Group：

Experimental group two

Sample size：

干预措施：

对TKA术后3周复诊时出现疼痛与膝关节手术区域皮肤温度升高的患者，在纳入研究的第1、2、3周予以肌肉注射2mg得宝松（复方倍他米松注射液），疗程共3周，并予患者中药（双柏膏）冷敷，冷敷方法为：先将双柏膏药帖放于-2℃~-6℃环境下（即家用冰箱冷冻区）至少5小时，取出后于每日中午在术侧区域使用1贴，持续15分钟~30分钟，疗程为8周，开具依托考昔片（安康信），30mg/天，疗程8周，嘱患者按时使用药物。

干预措施代码：

Intervention：

For patients who experienced pain and increased skin temperature in the knee joint surgery area during the follow-up visit 3 weeks after TKA surgery, 2mg of dexamethasone (compound betamethasone injection) was intramuscularly injected for a total of 3 weeks during the first, second, and third weeks of inclusion in the study. The patient was also given cold compress with traditional Chinese medicine (Shuangbai ointment). The cold compress method was to first place the Shuangbai ointment in an environment of -2 ℃ to -6 ℃ (i.e., in the freezer area of a household refrigerator) for at least 5 hours, After removal, apply one patch daily at noon in the surgical area for 15 to 30 minutes, with a treatment period of 8 weeks. prescribe etocoxib tablets (Ankanxin) at a dose of 30mg/day for 8 weeks, and instruct the patient to use the medication on time.

Intervention code：

组别：

对照组

样本量：

30

Group：

Control group

Sample size：

干预措施：

对TKA术后3周复诊时出现疼痛与膝关节手术区域皮肤温度升高的患者给予依托考昔片（安康信），30mg/天，疗程8周，嘱患者按时使用药物。

干预措施代码：

Intervention：

For patients who experience pain and elevated skin temperature in the knee joint surgery area during the follow-up visit 3 weeks after TKA surgery, etocoxib tablets (Ankanxin) are given at a dose of 30mg/day for 8 weeks. Patients are advised to use the medication on time.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

  

Country：

China 

Province：

Guangdong Province 

City：

 

单位(医院)：

广东省中医院（大学城骨科） 

单位级别：

三甲 

Institution
hospital：

Guangdong Provincial Hospital of Traditional Chinese Medicine (Orthopedics of Guangzhou campus city hospital)

Level of the institution：

Tertiary, Tertiary A

测量指标：

Outcomes：

指标中文名：

两侧膝关节指定区域的皮肤温度

指标类型：

主要指标

Outcome：

Skin temperature in designated areas of both knee joints

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

VAS疼痛评分标准

指标类型：

次要指标

Outcome：

Visual analogue scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

改良EQ-5D-3L量表

指标类型：

次要指标

Outcome：

Improved EQ-5D-3L scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

实验室指标

指标类型：

次要指标

Outcome：

Laboratory indicators

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：

Sample Name：

Blood

Tissue：

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：

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）：

随机方法通过应用PEMS3.1软件，根据样本含量:90，分组3，产生随机数字及对应分组信息，并将每一组的信息制作好卡片并用不透光的信封进行保存。当符合条件的患者进入研究时，研究负责人随机抽取一枚信封拆开，按照信封内的信息岁患者进行随机分组。

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

The random method uses PEMS3.1 software to generate random numbers and corresponding grouping information based on the sample size of 90 and group 3. Each group's information is then made into a card and stored in an opaque envelope. When eligible patients enter the study, the study leader randomly selects an envelope and opens it, and randomly groups the patients according to the information inside the envelope.

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：

未说明

Blinding：

Not stated

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

Yes

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）：

ResMan, http://www.medresman.org.cn

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

ResMan, http://www.medresman.org.cn

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：

通过病历记录表完成数据采集，病例记录表将作为研究方案附件；数据管理则通过ResMan进行

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

Data collection will be completed via case record forms, which will serve as study protocol attachments; data management will be performed via ResMan

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2023-10-31 16:12:53