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Clinical Observation and Research on the Treatment of Knee Osteoarthritis of Damp-heat Arthralgia Type with Intelligent Temperature Control and Cold Needle

注册号：

Registration number：

ITMCTR2000003611

最近更新日期：

Date of Last Refreshed on：

2020-08-21

注册时间：

Date of Registration：

2020-08-21

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

智能控温冷针治疗湿热痹阻型膝骨关节炎的临床观察研究

Public title：

Clinical Observation and Research on the Treatment of Knee Osteoarthritis of Damp-heat Arthralgia Type with Intelligent Temperature Control and Cold Needle

注册题目简写：

English Acronym：

研究课题的正式科学名称：

智能控温冷针治疗湿热痹阻型膝骨关节炎的临床观察研究

Scientific title：

Clinical Observation and Research on the Treatment of Knee Osteoarthritis of Damp-heat Arthralgia Type with Intelligent Temperature Control and Cold Needle

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：

ChiCTR2000036110 ; ChiMCTR2000003611

申请注册联系人：

蔡娲

研究负责人：

沈卫东

Applicant：

Wa Cai

Study leader：

Weidong Shen

申请注册联系人电话：

Applicant telephone：

+86 13671668310

研究负责人电话：

Study leader's telephone：

+86 13391019193

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：

408346323@qq.com

研究负责人电子邮件：

Study leader's E-mail：

shenweidong1018@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

研究负责人通讯地址：

上海市浦东新区张衡路528号

Applicant address：

528 Zhangheng Road, Pudong New Area, Shanghai

Study leader's address：

528 Zhangheng Road, Pudong New Area, 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：

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

Name of the ethic committee：

伦理委员会批准日期：

Date of approved by ethic committee：

2013/8/26 0:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

伦理委员会联系人电话：

Contact phone of the ethic committee：

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

Primary sponsor's address：

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：

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

经费或物资来源：

上海申康医院发展中心

Source(s) of funding：

Shanghai 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：

通过随机对照的临床研究，评价智能控温冷针治疗湿热痹阻型膝骨关节炎的有效性和安全性，为临床推广提供循证医学依据。

Objectives of Study：

Through randomized controlled clinical studies, the efficacy and safety of intelligent temperature-controlled cold needles in the treatment of damp-heat arthralgia knee osteoarthritis are evaluated, and evidence-based medicine is provided for clinical promotion.

药物成份或治疗方案详述：

1.基础治疗：两组均进行基础治疗，根据中华医学会骨科分会关节外科学组、吴阶平医学基金会骨科学专家委员会制定的《膝骨关节炎阶梯治疗专家共识( 2018 年版)》中基础治疗，包括： （1）患者教育：使患者了解本病的治疗原则、锻炼方法； （2）减轻关节负荷，保护关节功能：受累关节应避免过度负荷，可利用手杖、 步行器等协助活动，肥胖者减轻体重等。 2.试验组：采用智能控温冷针仪治疗，具体措施如下： （1）穴位处方：患肢内、外膝眼穴。 （2）穴位定位：参照《针灸学》，中国中医药出版社，主编：梁繁荣，王华，2016版。 内膝眼：屈膝，在膝部，髌骨与髌韧带内侧凹陷处。 外膝眼：屈膝，在膝部，髌骨与髌韧带外侧凹陷中。 （3）操作方法：使患者取仰卧位，用75%乙醇棉球进行穴位常规消毒，采用佳健牌一次性无菌针灸针，1.5寸毫针（0.25mm*40mm）垂直刺入，行手法得气后留针，针刺深度约为1寸。冷针操作方法：将智能冷针治疗仪固定在针灸针身，调节温度为10度。每次留针30min，隔日治疗1次，1周治疗3次，疗程为1周，随访1周。 3.对照组：采用常规针刺治疗，穴位处方、定位同试验组，操作方法如下： 操作方法：使患者取仰卧位，用75%乙醇棉球进行穴位常规消毒，采用佳健牌一次性无菌针灸针，1.5寸毫针（0.25mm*40mm）垂直刺入，行手法得气后留针，针刺深度约为1寸。每次留针30min，隔日治疗1次，1周治疗3次，疗程为1周，随访1周。

Description for medicine or protocol of treatment in detail：

1. Basic treatment: Both groups received basic treatment, based on the basic treatment in the "Expert Consensus on Knee Osteoarthritis Ladder Treatment (2018 Edition)" formulated by the Joint Surgery Group of the Orthopedic Branch of the Chinese Medical Association and the Orthopedic Expert Committee of the Wu Jieping Medical Foundation, include: (1) Patient education: enable patients to understand the treatment principles and exercise methods of this disease; (2) Reduce joint load and protect joint function: the affected joints should avoid excessive load, and cane, Walkers and other assist activities, obese people lose weight, etc. 2. Test group: use intelligent temperature control cold needle instrument for treatment, the specific measures are as follows: (1) Acupuncture point prescription: knee and eye acupoints inside and outside the affected limb. (2) Acupoint positioning: refer to "Acupuncture and Moxibustion", China Traditional Chinese Medicine Press, Editor-in-Chief: Liang Fanrong, Wang Hua, 2016 edition. Inner Knee Eye: Bend the knee, in the depression on the inner side of the patella and patellar ligament. External knee eye: knee bent, in the knee, patella and patellar ligament lateral depression. (3) Operation method: Make the patient take the supine position, use 75% ethanol cotton ball for routine disinfection of the acupoints, use Jiajian brand disposable sterile acupuncture needles, 1.5-inch milli needles (0.25mm*40mm) vertical piercing, and get it Keep the needle after air, the depth of needle penetration is about 1 inch. Cold needle operation method: Fix the smart cold needle treatment instrument on the acupuncture needle body and adjust the temperature to 10 degrees. The needles were retained for 30 minutes each time, treatment was performed every other day, 3 times a week, the course of treatment was 1 week, and the follow-up was 1 week. 3. Control group: conventional acupuncture treatment is used, and the prescription and location of acupoints are the same as those in the experimental group. The operation method is as follows: Operation method: Make the patient take the supine position, use 75% ethanol cotton ball for routine disinfection of the acupoints, use Jiajian brand disposable sterile acupuncture needles, pierce vertically with a 1.5-inch needle (0.25mm*40mm), and leave the needle after getting qi , Needle penetration depth is about 1 inch. The needles were retained for 30 minutes each time, treatment was performed every other day, 3 times a week, the course of treatment was 1 week, and the follow-up was 1 week.

纳入标准：

（1）年龄50～80岁； （2）符合西医膝骨关节炎诊断标准； （3）符合中医湿热痹阻证辨证标准者； （4）膝骨关节炎 Kellgren-Lawrence分级0-Ⅲ级； （5）至少停服 NSAIDs（非甾体类抗炎药）7天及以上的患者； （6）如果使用改善病情药（双醋瑞因及同类药物），需停药1个月及以上； （7）患者及家属依从性好，签署知情同意书。

Inclusion criteria

(1) Aged 50-80 years; (2) Meet the diagnostic criteria of western medicine for knee osteoarthritis; (3) Those who meet the standard of TCM damp-heat arthralgia syndrome differentiation; (4) Kellgren-Lawrence grade 0-III for knee osteoarthritis; (5) Patients who have stopped taking NSAIDs (non-steroidal anti-inflammatory drugs) for at least 7 days; (6) If you use disease-improving drugs (diacerein and similar drugs), you need to stop the drug for 1 month or more; (7) Patients and their families have good compliance and signed informed consent.

排除标准：

（1）重叠其他风湿病如系统性红斑狼疮、干燥综合征、类风湿关节炎等患者； （2）合并心、脑、肝、肾和造血系统等严重疾病者； （3）妊娠或哺乳期妇女，精神病患者； （4）近四周内参加过其它临床试验的病人。

Exclusion criteria：

(1) Overlap patients with other rheumatic diseases such as systemic lupus erythematosus, Sjogrens syndrome, rheumatoid arthritis, etc.; (2) Patients with serious diseases on heart, brain, liver, kidney and hematopoietic system; (3) Pregnant or breastfeeding women, mental patients; (4) Patients who have participated in other clinical trials within the past four weeks.

研究实施时间：

Study execute time：

从From 2020-10-01

至To      2022-09-30

征募观察对象时间：

Recruiting time：

从From 2020-10-01

至To      2022-09-30

干预措施：

Interventions：

组别：

试验组

样本量：

50

Group：

experimental group

Sample size：

干预措施：

智能控温冷针治疗+基础治疗

干预措施代码：

Intervention：

Intelligent temperature control cold needle therapy + Basic treatment

Intervention code：

组别：

对照组

样本量：

50

Group：

control group

Sample size：

干预措施：

常规针刺治疗+基础治疗

干预措施代码：

Intervention：

Conventional acupuncture treatment + Basic treatment

Intervention code：

样本总量 Total sample size ： 100

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：

WOMAC 骨关节炎评分

指标类型：

次要指标

Outcome：

Western Ontario McMaster Universities Osteoarthritis Index

Type：

Secondary indicator

测量时间点：

首次治疗前后、末次治疗后、随访1周后

测量方法：

医生评价

Measure time point of outcome：

Before and after the first treatment, after the last treatment, and after 1 week of follow-up

Measure method：

Doctor evaluation

指标中文名：

视觉模拟评分法

指标类型：

主要指标

Outcome：

VAS

Type：

Primary indicator

测量时间点：

首次治疗前后、末次治疗后、随访1周后

测量方法：

患者自评

Measure time point of outcome：

Before and after the first treatment, after the last treatment, and after 1 week of follow-up

Measure method：

Patient self-assessment

指标中文名：

Michel Lequesen 膝OA严重指数

指标类型：

次要指标

Outcome：

Michel Lequesen knee OA severity index

Type：

Secondary indicator

测量时间点：

首次治疗前后、末次治疗后、随访1周后

测量方法：

医生评价

Measure time point of outcome：

Before and after the first treatment, after the last treatment, and after 1 week of follow-up

Measure method：

Doctor evaluation

指标中文名：

健康评定调查量表

指标类型：

次要指标

Outcome：

Health assessment questionnaire

Type：

Secondary indicator

测量时间点：

治疗前、治疗1周后及随访1周

测量方法：

医生评价

Measure time point of outcome：

Before treatment, after 1 week of treatment and 1 week of follow-up

Measure method：

Doctor evaluation

指标中文名：

中医证候积分

指标类型：

次要指标

Outcome：

TCM Syndrome Points

Type：

Secondary indicator

测量时间点：

治疗前、治疗1周后及随访1周

测量方法：

医生评价

Measure time point of outcome：

Before treatment, after 1 week of treatment and 1 week of follow-up

Measure method：

Doctor evaluation

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

尿液

组织：

Sample Name：

Urine

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

标本中文名：

血液

组织：

静脉

Sample Name：

Blood

Tissue：

Vein

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 50 岁
Min age years
最大 80 岁
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）：

随机数字表法

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

Random number table

盲法：

开放

Blinding：

open-label

是否共享原始数据：

IPD sharing：

是

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）：

http://www.chictr.org.cn

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

http://www.chictr.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：

CRF表

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：

有

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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