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This study investigated the dynamic effects of acupuncture on sensitized acupoints in relation to knee osteoarthritis grounded in the theory of acupoint sensitization.

注册号：

Registration number：

ITMCTR2025000631

最近更新日期：

Date of Last Refreshed on：

2025-04-02

注册时间：

Date of Registration：

2025-04-02

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

基于穴位敏化探讨针刺敏态穴位对膝骨性关节炎的动态效应规律

Public title：

This study investigated the dynamic effects of acupuncture on sensitized acupoints in relation to knee osteoarthritis grounded in the theory of acupoint sensitization.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于穴位敏化探讨针刺敏态穴位对膝骨性关节炎的动态效应规律

Scientific title：

This study investigated the dynamic effects of acupuncture on sensitized acupoints in relation to knee osteoarthritis grounded in the theory of acupoint sensitization.

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：

魏艳蓉

研究负责人：

魏艳蓉

Applicant：

Wei Yanrong

Study leader：

Wei Yanrong

申请注册联系人电话：

Applicant telephone：

13974977516

研究负责人电话：

Study leader's telephone：

13974977516

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：

1309977278@qq.com

研究负责人电子邮件：

Study leader's E-mail：

1309977278@qq.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：

长沙市韶山中路95号

研究负责人通讯地址：

长沙市韶山中路95号

Applicant address：

No.95 Shaoshan Middle Road Changsha City

Study leader's address：

No.95 Shaoshan Middle Road Changsha City

申请注册联系人邮政编码：

Applicant postcode：

410007

研究负责人邮政编码：

Study leader's postcode：

410007

申请人所在单位：

湖南中医药大学第一附属医院

Applicant's institution：

The First Affiliated Hospital of Hunan University of 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：

HN-LL-KY-2024-075-01

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：

湖南中医药大学第一附属医院伦理审查委员会

Name of the ethic committee：

Ethics Review Committee of the First Affiliated Hospital of Hunan University of Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2024/7/7 0:00:00

伦理委员会联系人：

唐玲

Contact Name of the ethic committee：

Tang Ling

伦理委员会联系地址：

长沙市韶山中路95号

Contact Address of the ethic committee：

No.95 Shaoshan Middle Road Changsha City

伦理委员会联系人电话：

Contact phone of the ethic committee：

0731-85600515

伦理委员会联系人邮箱：

Contact email of the ethic committee：

190043756@qq.com

研究实施负责（组长）单位：

湖南中医药大学第一附属医院

Primary sponsor：

The First Affiliated Hospital of Hunan University of Chinese Medicine

研究实施负责（组长）单位地址：

湖南省长沙市韶山中路95号

Primary sponsor's address：

95 Shaoshan Middle Road Changsha City Hunan Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

市(区县)：

长沙市

Country：

china

Province：

Changsha Hunan

City：

单位(医院)：

湖南中医药大学第一附属医院

具体地址：

长沙市韶山中路95号

Institution
hospital：

The First Affiliated Hospital of Hunan University of Chinese Medicine

Address：

No.95 Shaoshan Middle Road Changsha CityA qs9j. nn

经费或物资来源：

湖南省中医药管理局课题

Source(s) of funding：

Subject of Hunan Provincial Administration of Chinese Medicine

研究疾病：

膝骨性关节炎

研究疾病代码：

Target disease：

Osteoarthritis of the knee

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. 验证针刺干预KOA患者压痛敏态穴位的临床疗效 2 .探究针刺干预KOA患者压痛敏态穴位的效应规律

Objectives of Study：

1. To verify the clinical efficacy of acupuncture intervention in the tender sensitive acupoints of KOA patients 2. To explore the effect rule of acupuncture intervention on acupoints sensitive to pain in KOA patients

药物成份或治疗方案详述：

高敏针刺组、低敏针刺组、等待治疗组患者均取一侧患膝，高敏针刺组根据穴位检测结果选出阈值最低的5组穴位，低敏针刺组根据穴位检测结果选出阈值最高的5组穴位，针刺治疗，每次留针30 min，每日1次，治疗5天后休息2天，连续治疗4周。等待治疗组不接受任何治疗。

Description for medicine or protocol of treatment in detail：

Patients in hypersensitive acupuncture group hyposensitive acupuncture group and waiting for treatment group were treated on one side of the affected knee. The five groups of acupoints with the lowest threshold were selected for the hypersensitive acupuncture group according to the results of acupoint detection and the five groups of acupoints with the highest threshold were selected for acupuncture treatment leaving needles for 30 minutes each time once a day and resting for 2 days after 5 days of treatment for 4 weeks. The waiting group did not receive any treatment.

纳入标准：

1)符合西医诊断标准膝骨性关节炎的患者； (2)年龄40-70 周岁(含40及70)，男女不限； (3)VAS评分≥3、≤8 分； (4)受试者知情，自愿签署知情同意书。

Inclusion criteria

1) Patients with knee osteoarthritis who meet the diagnostic criteria of Western medicine; (2) Age 40-70 years old (including 40 and 70) male and female; (3)VAS score ≥3 ≤8 points; (4) The subject is informed and signs the informed consent voluntarily.

排除标准：

(1) 膝关节的其它炎性疼痛性疾病，如类风湿关节炎、银屑病关节炎、痛风、肿瘤、绒毛结节性滑膜炎、关节创伤、化脓性关节炎、结核性关节炎者； (2) 由骨髓炎、骨肿瘤及骨结核引起的骨性关节炎者； (3) 伴有化脓性、非特异性等感染性膝关节炎患者； (4) 晚期关节畸形或残废者； (5) 合并髋膝踝多个下肢骨性关节炎者、因腰椎退行性疾病发作期引发下肢痹痛； (6) 研究者判断能够影响治疗疗效和安全性判定的合并严重的心脑血管(如心肌梗塞、卒中等)、血液系统(如出血倾向、凝血功能障碍等)、肝脏、胃肠道、肾脏疾病、糖尿病患者； (7) 精神病患者； (8) 筛选时存在全身性感染或处于传染性疾病治疗期患者； (9) 筛选前 3 个月内进行过关节腔内治疗，包括关节内注射药物、关节腔冲洗及关节镜手术等； (10) 筛选前一个月内使用过激素治疗者； (11) 筛选前3周内使用过非甾体抗炎药、氨基葡萄糖、硫酸软骨素，或其他治疗膝骨关节炎的药物及相关中药者； (12) 妊娠或哺乳期妇女； (13) 过敏体质者； (14) 筛选前三个月内参加过其他临床试验的患者； (15) 研究者认为不宜入选本试验者。

Exclusion criteria：

(1) Other inflammatory painful diseases of the knee joint such as rheumatoid arthritis psoriatic arthritis gout tumor villonodular synovitis joint trauma suppurative arthritis tuberculous arthritis; (2) Osteoarthritis caused by osteomyelitis bone tumor and bone tuberculosis; (3) Patients with suppurative non-specific and other infectious knee arthritis; (4) late joint deformity or disability; (5) Patients with multiple lower limb osteoarthritis combined with hip knee and ankle and lower limb arthralgia caused by the onset of lumbar degenerative diseases; (6) Patients with severe cardiovascular and cerebrovascular diseases (such as myocardial infarction stroke etc.) blood system (such as bleeding tendency coagulation dysfunction etc.) liver gastrointestinal kidney diseases and diabetes that researchers judge can affect treatment efficacy and safety; (7) Mentally ill persons; (8) Patients with systemic infection or in the treatment period of infectious diseases at the time of screening; (9) Intra-articular treatment including intra-articular drug injection joint cavity irrigation and arthroscopic surgery was performed within 3 months before screening; (10) Patients who had used hormone therapy within one month before screening; (11) Patients who had used non-steroidal anti-inflammatory drugs glucosamine chondroitin sulfate or other drugs for the treatment of knee osteoarthritis and related Chinese medicines within 3 weeks before screening; (12) Pregnant or lactating women; (13) People with allergies; (14) Patients who had participated in other clinical trials within three months prior to screening; (15) The researchers considered that the candidates should not be included in this study.

研究实施时间：

Study execute time：

从From 2024-07-31

至To      2025-07-01

征募观察对象时间：

Recruiting time：

从From 2024-07-31

至To      2025-07-01

干预措施：

Interventions：

组别：

高敏针刺组

样本量：

30

Group：

High-sensitivity acupoint acupuncture group

Sample size：

干预措施：

针刺

干预措施代码：

Intervention：

Acupuncture point stimulation

Intervention code：

组别：

低敏针刺组

样本量：

30

Group：

Low-sensitivity acupoint acupuncture group

Sample size：

干预措施：

针刺

干预措施代码：

Intervention：

Acupuncture point stimulation

Intervention code：

组别：

等待治疗组

样本量：

30

Group：

Waiting group

Sample size：

干预措施：

不干预

干预措施代码：

Intervention：

nonintervention

Intervention code：

样本总量 Total sample size ： 90

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

湖南长沙

市(区县)：

长沙市

Country：

China

Province：

Changsha Hunan

City：

单位(医院)：

湖南中医药大学第一附属医院

单位级别：

三甲医院

Institution/hospital：

The First Affiliated Hospital of Hunan University of Chinese Medicine

Level of the institution：

The First Affiliated Hospital of Hunan University of Chinese Medicine

测量指标：

Outcomes：

指标中文名：

疼痛缓解时间

指标类型：

次要指标

Outcome：

Pain relief time

Type：

Secondary indicator

测量时间点：

针刺开始至针刺4周结束后

测量方法：

日记卡中VAS评分

Measure time point of outcome：

From the beginning to the end of 4 weeks of acupuncture

Measure method：

VAS score in diary card

指标中文名：

疼痛消失时间

指标类型：

次要指标

Outcome：

Pain removal time

Type：

Secondary indicator

测量时间点：

针刺开始至针刺4周结束后

测量方法：

日记卡中VAS评分

Measure time point of outcome：

From the beginning to the end of 4 weeks of acupuncture

Measure method：

VAS score in diary card

指标中文名：

SF-36

指标类型：

次要指标

Outcome：

SF-36

Type：

Secondary indicator

测量时间点：

针刺治疗前、针刺4周治疗后、随访3个月后

测量方法：

量表评分

Measure time point of outcome：

Before acupuncture treatment, 4 weeks after acupuncture treatment, 3 months after follow-up

Measure method：

Scale scoring

指标中文名：

WOMAC疼痛评分及总评分

指标类型：

主要指标

Outcome：

WOMAC pain score and total score

Type：

Primary indicator

测量时间点：

针刺治疗前、针刺4周治疗后、随访3个月后

测量方法：

量表评分

Measure time point of outcome：

Before acupuncture treatment, 4 weeks after acupuncture treatment, 3 months after follow-up

Measure method：

Scale scoring

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 40 岁
Min age years
最大 70 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）：

按照患者就诊顺序，根据随机种子数，将患者随机分为高敏针刺组、低敏针刺组、等待治疗组。

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

According to the order of treatment patients were randomly divided into hypersensitive acupuncture group hyposensitive acupuncture group and waiting for treatment group according to the random seed number.

盲法：

因本试验为研究者对受试者进行针灸操作的特殊性，因此本试验采用对研究医生和针刺操作者不设盲，对量表评价人员和受试者设盲的形式，试验分组研究者与针刺操作者以及量表评价人员由独立的3人执行。受试者、量表评价人员、统计人员对受试者接受的治疗类别不知情。由6名有执照有2年临床经验的针灸师提供治疗。并在招募前参加了集中培训。

Blinding：

Due to the particularity of the acupuncture operation performed by the researchers on the subjects, this experiment adopted the form of blind treatment for the research doctors and acupuncture operators, blind treatment for scale evaluators and subjects. The experiment was conducted by three independent investigators, acupuncture operators and scale evaluators. Subjects, scale evaluators, and statisticians were unaware of the type of treatment the subjects received. Treatment is provided by 6 licensed acupuncturists with 2 years of clinical experience. And participated in intensive training before recruitment.

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)：

No

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：

数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)纸质版采集，二为电子采集和管理系统(Electronic Data Capture, EDC)数据录入并导出

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

Data collection and management consists of two parts one is the collection of the paper version of the Case Record Form (CRF) the other is the data entry and export of the Electronic Data Capture and management system (EDC)

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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