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Based on the "long-distance treatment theory" the efficacy of moxibustion combined with exercise therapy on rapid recovery after TKA was observed

注册号：

Registration number：

ITMCTR2025001032

最近更新日期：

Date of Last Refreshed on：

2025-05-26

注册时间：

Date of Registration：

2025-05-26

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

基于“远治理论”探究隔六籽灸联合运动疗法对TKA术后快速康复的疗效

Public title：

Based on the "long-distance treatment theory" the efficacy of moxibustion combined with exercise therapy on rapid recovery after TKA was observed

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于“远治理论”探究隔六籽灸联合运动疗法对TKA术后快速康复的疗效

Scientific title：

Based on the "long-distance treatment theory" the efficacy of moxibustion combined with exercise therapy on rapid recovery after TKA was observed

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：

陈晓霞

研究负责人：

陈晓霞

Applicant：

Chen Xiaoxia

Study leader：

Chen Xiaoxia

申请注册联系人电话：

Applicant telephone：

13560227314

研究负责人电话：

Study leader's telephone：

13560227314

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：

1074168409@qq.com

研究负责人电子邮件：

Study leader's E-mail：

1074168409@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：

广东省广州市荔湾区龙溪大道261、263号

研究负责人通讯地址：

广东省广州市荔湾区龙溪大道261、263号

Applicant address：

Nos. 261 and 263 Longxi Avenue Liwan District Guangzhou City Guangdong Province

Study leader's address：

Nos. 261 and 263 Longxi Avenue Liwan 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：

广州中医药大学第三附属医院

Applicant's institution：

The Third Affiliated Hospital of Guangzhou 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：

PJ-KY-20250227-002

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：

广州中医药大学第三附属医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Third Affiliated Hospital of Guangzhou University of Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2025/3/6 0:00:00

伦理委员会联系人：

简焕玲

Contact Name of the ethic committee：

Jian Huanling

伦理委员会联系地址：

广东省广州市荔湾区龙溪大道261、263号

Contact Address of the ethic committee：

Nos. 261 and 263 Longxi Avenue Liwan District Guangzhou City Guangdong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

020-22292751

伦理委员会联系人邮箱：

Contact email of the ethic committee：

gzysyec@163.com

研究实施负责（组长）单位：

广州中医药大学第三附属医院

Primary sponsor：

The Third Affiliated Hospital of Guangzhou University of Chinese Medicine

研究实施负责（组长）单位地址：

广东省广州市荔湾区龙溪大道261、263号

Primary sponsor's address：

Nos. 261 and 263 Longxi Avenue Liwan District Guangzhou City Guangdong 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)：

广东省

市(区县)：

广州市

Country：

China

Province：

Guangdong Province

City：

Guangzhou

单位(医院)：

广州中医药大学第三附属医院

具体地址：

广东省广州市荔湾区龙溪大道261、263号

Institution
hospital：

The Third Affiliated Hospital of Guangzhou University of Chinese Medicine

Address：

Nos. 261 and 263 Longxi Avenue Liwan District Guangzhou City Guangdong Province

经费或物资来源：

广州中医药大学第三附属医院

Source(s) of funding：

The Third Affiliated Hospital of Guangzhou University of Chinese Medicine

研究疾病：

膝骨性关节炎

研究疾病代码：

Target disease：

knee osteoarthritis KOA

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“远治理论”隔六籽灸联合运动疗法观察TKA术后快速康复效果，为优化术后治疗与康复提供临床依据。减轻TKA术后膝部疼痛，促进功能恢复，提高生活质量，节省康复成本。同时，推广中西医结合的康复理念，帮助医务人员掌握新的中医药特色疗法，发扬中医药优势。

Objectives of Study：

The effect of rapid recovery after TKA was observed through the "long-term treatment theory" and the combination of moxibustion and exercise therapy so as to provide a clinical basis for optimizing postoperative treatment and rehabilitation. Reduce knee pain after TKA promote functional recovery improve quality of life and save rehabilitation costs. At the same time it promotes the rehabilitation concept of integrated traditional Chinese and Western medicine helps medical staff master new traditional Chinese medicine characteristic therapies and carries forward the advantages of traditional Chinese medicine.

药物成份或治疗方案详述：

选择180例TKA术后患者，随机分为1、常规治疗对照组 2、隔六籽灸组 3、运动疗法组 4、隔六籽灸配合运动疗法组，各45例。对照组采用常规康复治疗，隔六籽灸组即常规康复治疗+远治理论隔六籽灸治疗；运动疗法组即常规康复治疗+运动疗法治疗；隔六籽灸配合运动疗法组即常规康复治疗+远治理论隔六籽灸治疗+运动疗法治疗。通过对比4组患者的:①VAS评分，②膝关节HSS评分③肿胀值④肌力测试级别，⑤Barthel生活自理能力评估量表⑥4组患者不同时间点患者依从性评分比较。采用统计方法分析四组的差异。着重探讨基于“远治理论”隔六籽灸联合运动疗法对TKA术后快速康复的疗效观察。

Description for medicine or protocol of treatment in detail：

A total of 180 patients with TKA were randomly divided into 1 conventional treatment control group 2 6-seed moxibustion group 3 exercise therapy group 4 and 45 cases in each group. The control group was treated with conventional rehabilitation and the group was treated with conventional rehabilitation and the theory of distance treatment. The exercise therapy group is conventional rehabilitation therapy Exercise therapy treatment; Interval six seed moxibustion combined with exercise therapy group that is conventional rehabilitation treatment distance treatment theory interval six seed moxibustion treatment exercise therapy treatment. By comparing the following scores of 4 groups of patients: (1) VAS score (2) knee HSS score (3) swelling value (4) muscle strength test level (5) Barthel self-care ability assessment scale and (6) patient compliance scores at different time points in 4 groups. Statistical methods were used to analyze the differences between the four groups. This paper focuses on the efficacy of moxibustion combined with exercise therapy based on the "long-term treatment theory" on rapid recovery after TKA.

纳入标准：

①年龄在60-85岁的患者； ②符合膝骨关节炎诊断且有手术指征； ③同意并接受全膝人工关节置换手术治疗 ； ④智力无异常，可正常进行语言交流，可配合医师有效完成整个术后疼痛分级评分过程； ⑤签署知情同意书。

Inclusion criteria

(1) Patients aged 60-85 years; (2) Consistent with the diagnosis of knee osteoarthritis and indicated for surgery; (3) Agree to and accept the surgical treatment of total knee artificial joint replacement; (4) There is no abnormality in intelligence can communicate normally and can cooperate with the physician to effectively complete the whole postoperative pain grading and scoring process; (5) Sign the informed consent form.

排除标准：

①合并有其他膝关节疾病； ②影响全膝关节置换术后疼痛程度的患者； ③伴发心脑血管病变，肝肾机能减弱下、造血系统病变等重度原发性内科病变的人员； ④因自身原因不能配合医生完成试验研究的患者； ⑤术后合并有感染性疾病的患者，免疫系统缺陷或低下、重度过敏性体质病人，对药方所含任一味中药存在变态反应人员 ⑥不同意参加本次试验观察的患者，不符合试验对象纳入标准的患者。

Exclusion criteria：

(1) Combined with other knee joint diseases; (2) patients who affect the degree of pain after total knee arthroplasty; (3) Persons with severe primary medical diseases such as cardiovascular and cerebrovascular lesions weakened liver and kidney function and hematopoietic system lesions; (4) Patients who cannot cooperate with the doctor to complete the experimental study due to their own reasons; (5) Patients with infectious diseases after surgery patients with immune system deficiency or low or severe allergic constitution and those who have allergic reactions to any of the traditional Chinese medicines contained in the prescription (6) Patients who do not agree to participate in the observation of this trial and patients who do not meet the inclusion criteria of the test subjects.

研究实施时间：

Study execute time：

从From 2025-03-15

至To      2026-12-31

征募观察对象时间：

Recruiting time：

从From 2025-03-15

至To      2026-12-31

干预措施：

Interventions：

组别：

隔六籽灸配合运动疗法组

样本量：

45

Group：

Moxibustion combined with exercise therapy group

Sample size：

干预措施：

隔六籽灸配合运动疗法组即常规康复治疗+远治理论隔六籽灸治疗+运动疗法治疗。隔六籽灸治疗时间20min，每日2次，治疗疗程为1周。运动疗法每日2次，每次总时间30～35min，治疗疗程为1周。

干预措施代码：

Intervention：

Interval six seed moxibustion combined with exercise therapy group that is conventional rehabilitation treatment distance treatment theory interval six seed moxibustion treatment exercise therapy treatment. The treatment time of moxibustion is 20min 2 times a day and the course of treatment is 1 week. Exercise therapy is 2 times a day the total time of each time is 30~35min and the course of treatment is 1 week.

Intervention code：

组别：

常规治疗对照组

样本量：

45

Group：

Conventional treatment control group

Sample size：

干预措施：

常规治疗对照组采用常规康复治疗。

干预措施代码：

Intervention：

The conventional treatment control group was treated with conventional rehabilitation.

Intervention code：

组别：

运动疗法组

样本量：

45

Group：

Exercise therapy group

Sample size：

干预措施：

运动疗法组即常规康复治疗+运动疗法治疗，运动疗法每日2次，每次总时间30～35min，治疗疗程为1周。

干预措施代码：

Intervention：

The exercise therapy group is the conventional rehabilitation therapy and exercise therapy treatment exercise therapy 2 times a day the total time of each time is 30~35min and the course of treatment is 1 week.

Intervention code：

组别：

隔六籽灸组

样本量：

45

Group：

Septum six seed moxibustion group

Sample size：

干预措施：

隔六籽灸组即常规康复治疗+远治理论隔六籽灸治疗，隔六籽灸治疗时间20min，每日2次，治疗疗程为1周。

干预措施代码：

Intervention：

The interval six seed moxibustion group is the conventional rehabilitation treatment of the theory of distance treatment the treatment time of the interval six seeds moxibustion is 20min twice a day and the treatment course is 1 week.

Intervention code：

样本总量 Total sample size ： 180

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)：

广州市

Country：

China

Province：

Guangdong Province

City：

Guangzhou

单位(医院)：

广州中医药大学第三附属医院

单位级别：

三级甲等医院

Institution/hospital：

The Third Affiliated Hospital of Guangzhou University of Chinese Medicine

Level of the institution：

tertiary hospital

测量指标：

Outcomes：

指标中文名：

VAS评分

指标类型：

主要指标

Outcome：

VAS score

Type：

Primary indicator

测量时间点：

治疗的第1天、第3天、第5天、第7天。

测量方法：

用疼痛视觉模拟量表（visualanaloguescaleVAS）测量。

Measure time point of outcome：

Day 1 Day 3 Day 5 Day 7 of treatment.

Measure method：

Measured with a visual analogue scale for pain (VAS).

指标中文名：

Barthel生活自理能力评估量表

指标类型：

次要指标

Outcome：

Barthel Assessment Scale for Self-Care Ability

Type：

Secondary indicator

测量时间点：

治疗的第1天、第3天、第5天、第7天。

测量方法：

用Barthel生活自理能力评估量表测量

Measure time point of outcome：

Day 1 Day 3 Day 5 Day 7 of treatment.

Measure method：

Measured with the Barthel Assessment Scale for Self-Care Ability

指标中文名：

两组患者不同时间点患者依从性评分比较

指标类型：

次要指标

Outcome：

Comparison of patient compliance scores at different time points between the two groups

Type：

Secondary indicator

测量时间点：

治疗的第1天、第3天、第5天、第7天。

测量方法：

用康复训练依从性量表测量

Measure time point of outcome：

Day 1 Day 3 Day 5 Day 7 of treatment.

Measure method：

Measured with the Rehabilitation Training Adherence Scale

指标中文名：

肿胀值

指标类型：

主要指标

Outcome：

Swelling value

Type：

Primary indicator

测量时间点：

治疗的第1天、第3天、第5天、第7天。

测量方法：

用肿胀评估表测量。

Measure time point of outcome：

Day 1 Day 3 Day 5 Day 7 of treatment.

Measure method：

Measured with a swelling assessment form.

指标中文名：

膝关节HSS评分

指标类型：

主要指标

Outcome：

HSS score of the knee joint

Type：

Primary indicator

测量时间点：

治疗的第1天、第3天、第5天、第7天。

测量方法：

用膝关节HSS评分表测量。

Measure time point of outcome：

Day 1 Day 3 Day 5 Day 7 of treatment.

Measure method：

Measured with the knee HSS score scale.

指标中文名：

肌力测试

指标类型：

次要指标

Outcome：

Muscle strength test

Type：

Secondary indicator

测量时间点：

治疗的第1天、第3天、第5天、第7天。

测量方法：

用肌力评估表测量

Measure time point of outcome：

Day 1 Day 3 Day 5 Day 7 of treatment.

Measure method：

Measured with a muscle strength assessment scale

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

none

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：

正在进行

Recruiting

年龄范围：

最小 60 岁
Min age years
最大 85 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）：

由研究者用随机数字表法产生随机数列

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

A random series of numbers is generated by the researcher using the random number table method

盲法：

单盲（对受试者隐藏分组），对评估者不隐藏分组

Blinding：

Single-blind (groups are hidden from subjects) groups are not hidden from evaluators

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）：

暂不共享

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

Not shared at this time

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：

病例记录表

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

Case Record Form CRF

数据管理委员会：

Data Managemen Committee：

无

No

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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