ChiCTR2300072931 版本V1.0 版本创建时间2023/06/28 11:52:13 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：

 ChiCTR2300072931 

最近更新日期：

Date of Last Refreshed on：

 2023-06-28 11:51:51 

注册时间：

Date of Registration：

 2023-06-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

经穴蜂针散刺法与针刺法治疗膝骨关节炎的疗效对照研究

Public title：

The comparative study on the curative effect of bee-acupuncture scattered needling and acupuncture in the treatment of knee osteoarthritis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

经穴蜂针散刺法与针刺法治疗膝骨关节炎的疗效对照研究

Scientific title：

The comparative study on the curative effect of bee-acupuncture scattered needling and acupuncture in the treatment of knee osteoarthritis

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：

徐明 

研究负责人：

徐明 

Applicant：

Ming Xu 

Study leader：

Ming Xu 

申请注册联系人电话：

Applicant telephone：

 +86 155 1907 6960

研究负责人电话：

Study leader's
telephone：

+86 155 1907 6960

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：

 acupuncturegary@outlook.com

研究负责人电子邮件：

Study leader's E-mail：

 acupuncturegary@outlook.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：

贵州省贵阳市云岩区贵医路28号

研究负责人通讯地址：

贵州省贵阳市云岩区贵医路28号

Applicant address：

No. 28, Guiyi Road, Yunyan District, Guiyang City, Guizhou Province

Study leader's address：

No. 28, Guiyi Road, Yunyan District, Guiyang City, Guizhou 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：

贵州医科大学附属医院

Applicant's institution：

Affiliated Hospital of Guizhou Medical University

研究负责人所在单位：

贵州医科大学附属医院

Affiliation of the Leader：

Affiliated Hospital of Guizhou Medical University

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：

 2022伦审第546号

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：

贵州医科大学附属医院医学科学伦理委员会

Name of the ethic committee：

The Ethics Committee oft h e Affiliated Hospital of Guizhou Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-06-28 00:00:00

伦理委员会联系人：

李海洋

Contact Name of the ethic committee：

Li Haiyang

伦理委员会联系地址：

贵阳市云岩区费医街28 号

Contact Address of the ethic committee：

Affiliated Hospital of GuiZhou Medical University Guiyang Guizhou 550004 P. R. China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 851 8675 2685

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：

贵州医科大学附属医院

Primary sponsor：

Affiliated Hospital of Guizhou Medical University

研究实施负责（组长）单位地址：

贵阳市云岩区费医街28 号

Primary sponsor's address：

Affiliated Hospital of GuiZhou Medical University Guiyang Guizhou 550004 P. R. 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)：

贵州

市(区县)：

Country：

China

Province：

Guizhou

City：

单位(医院)：

贵州省中医药管理局

具体地址：

贵州省贵阳市云岩区中华北路242号

Institution
hospital：

Guizhou Provincial Administration of Traditional Chinese Medicine

Address：

No. 242, Zhonghua North Road, Yunyan District, Guiyang City, Guizhou Province

经费或物资来源：

贵州省中医药管理局

Source(s) of funding：

Guizhou Provincial Administration of Traditional Chinese Medicine

研究疾病：

膝关节骨性关节炎  

Target disease：

knee osteoarthritis

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：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

通过多年临床病例观察及对大量文献的研究，归纳出蜂针疗法治疗膝骨关节炎的研究进展和研究方 向，建立相关被研究对象的纳入、排除等标准。遵循循证医学、流行病学的基本概念原则，在贵州医科 大学附属医院、贵州大学医院选择符合纳入标准的膝骨性关节炎的患者为研究对象，本课题采取完全随 机化的方式进行分组，分成“试验组”(蜂针治疗组)及“对照组”(普通针刺组)，两组按照 1:1 的 比例进行组间分配。采用统计软件包做出随机分配的结果，并用其制作随机卡片，加信封密封保存。复 合纳入标准的病例投入试验时，依入组顺序按信封上的序号拆开信封，并依照随机卡片上的提示进行分 组。试验组的治疗方案中蜂针治疗取穴参考人民卫生出版社出版的《无痛蜂疗法》，以患侧取穴为主， 主穴:阿是穴、鹤顶、内外膝眼，对照组的治疗方案参照中国中医药出版社出版的《针灸治疗学》教材 第九版，主穴为:阿是穴、血海、梁丘、膝眼、阳陵泉;两组的配穴为:寒痹(关节剧痛)加肾俞、腰阳 关，热痹(关节红肿疼痛)加曲池、大椎，行痹(关节游走性 疼痛)加膈俞，湿痹(关节酸胀疼痛)加足三里、 阴陵泉。两组均采用标准化操作，进行 1 个疗程的治疗，并在治疗前、治疗 1 周后、治疗完成后和治疗 3 个月后，分别进行针对患者的 Lequesne 指数、HSS 评分、VAS 量表评分、膝关节滑液 IL-6 含量记录， 建立数据库，并利用统计学软件对统计数据进行统计分析及疗效评价。  

Objectives of Study：

Through years of clinical case observation and research on a large number of literatures, the research progress and research direction of bee acupuncture therapy for knee osteoarthritis are summarized, and the inclusion and exclusion criteria of relevant research objects are established. Following the basic concepts and principles of evidence-based medicine and epidemiology, patients with knee osteoarthritis who meet the inclusion criteria were selected as research objects in the Affiliated Hospital of Guizhou Medical University and Guizhou University Hospital. They were divided into "experimental group" (bee acupuncture treatment group) and "control group" (common acupuncture group), and the two groups were allocated between groups according to the ratio of 1:1. Use statistical software package to make the results of random allocation, and use it to make random cards, and keep them in sealed envelopes. When the cases with multiple inclusion criteria are put into the trial, the envelopes will be opened according to the serial numbers on the envelopes according to the order of inclusion, and the groups will be grouped according to the prompts on the random cards. In the treatment plan of the experimental group, the acupoint selection for bee acupuncture treatment refers to "Painless Bee Therapy" published by People's Health Publishing House, and the acupoints are mainly selected on the affected side. The treatment plan refers to the ninth edition of the textbook "Acupuncture and Moxibustion Therapeutics" published by China Press of Traditional Chinese Medicine. The main points are: Ashi point, Xuehai, Liangqiu, knee eye, and Yanglingquan; the matching points of the two groups are: Hanbi (severe joint pain) plus Shenshu, Yaoyangguan, Rebi (joint swelling and pain) plus Quchi, Dazhui, Xingbi (joint migratory pain) plus Geshu, Shibi (joint soreness and pain) plus Zusanli , Yinling Spring. Both groups were treated with standardized operations for one course of treatment, and Lequesne index, HSS score, VAS scale score, The content of IL-6 in knee joint synovial fluid was recorded, a database was established, and statistical software was used to analyze the statistical data and evaluate the curative effect.

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)、与 KOA 的诊断相符; (2)、思维逻辑正常，可配合病史采集; (3)、愿意接受蜂针治疗者; (4)、病程在 3 年以内; (5)、治疗前 1 个月内无 KOA 相关治疗干预;

Inclusion criteria

(1), consistent with the diagnosis of KOA; (2), normal thinking logic, can cooperate with medical history collection; (3), willing to accept bee acupuncture treatment; (4), course of disease within 3 years; (5) No KOA-related therapeutic intervention within 1 month before treatment;

排除标准：

(1)、有食物、药物及接触过敏史者，蜂毒皮肤敏试验阳性或蜂毒过敏原检测阳性者; (2)、对蜂针治疗畏惧者; (3)、合并脏器衰竭者(如肝、肾功能检验检查结果严重异常者); (4)、合并有风湿、类风湿性关节炎者; (5)、膝关节先天发育不良者;(6)、妊娠期及哺乳期妇女; (7)、观察期内接受关节镜治疗、关节置换等手术治疗者; (8)、在观察期内因各种原因导致失访者;

Exclusion criteria：

(1) Those with a history of food, drug and contact allergies, positive bee venom skin sensitivity test or positive bee venom allergen test; (2) Those who are afraid of bee acupuncture treatment; (3) Those with organ failure ( Such as liver and kidney function test results are seriously abnormal); (4), combined with rheumatism, rheumatoid arthritis;(5) Congenital dysplasia of the knee joint; (6) Pregnant and breastfeeding women; (7) Patients who received arthroscopic treatment, joint replacement and other surgical treatment during the observation period; (8) During the observation period due to various Lost to follow-up due to various reasons;

研究实施时间：

Study execute time：

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

征募观察对象时间：

Recruiting time：

从 From 2023-06-28 00:00:00 至 To 2023-08-31 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 47

Group：

test group

Sample size：

干预措施：

蜂针疗法

干预措施代码：

Intervention：

Bee Acupuncture

Intervention code：

组别：

对照组

样本量：

 47

Group：

control group

Sample size：

干预措施：

针刺治疗

干预措施代码：

Intervention：

Acupuncture

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 贵州 

市(区县)：

  

Country：

China

Province：

Guizhou

City：

单位(医院)：

 贵州医科大学附属医院 

单位级别：

 三甲 

Institution
hospital：

Affiliated Hospital of Guizhou Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

Lequesne 指数

指标类型：

主要指标

Outcome：

Lequesne index

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

HSS 评分

指标类型：

主要指标

Outcome：

HSS score

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 评分

指标类型：

主要指标

Outcome：

VAS scale score

Type：

Primary 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：

膝关节腔滑液

组织：

Sample Name：

synovial fluid of knee joint

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 20 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）：

由课题组护士采取完全随机化方法分组，分为试验组、对照组，两组以 1:1 的对等比例进行分组。根据拟定的样 本含量，利用统计软件包做出随机分拨的结果，并将结果以随机卡片的形式进行制作，密封于信封之内， 并对信封进行序号标记。符合要求的病例投入该研究时，依接诊次序拆开信封，按照提示进行分组。

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

The nurses in the research group adopted a completely randomized method and divided them into the experimental group and the control group, and the two groups were grouped in an equal ratio of 1:1. According to the proposed sample content, use the statistical software package to make the results of random allocation, and make the results in the form of random cards, seal them in envelopes, and mark the envelopes with serial numbers. When eligible cases were put into the study, the envelopes were opened according to the order of admission, and grouped according to the prompts.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

未说明

Blinding：

Not stated

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）：

无

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

none

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：

由课题组成员采集数据并由护士进行数据统计录入整理，并归档原始数据

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

The data is collected by the members of the research team, and the nurses carry out statistical entry and sorting of the data, and archive the original data

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：

  2023-06-28 11:51:51