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Effect of fumigation with traditional Chinese medicine combined with functional exercise on postoperative rehabilitation and quality of life of senile hip fracture patients

注册号：

Registration number：

ITMCTR2000003968

最近更新日期：

Date of Last Refreshed on：

2020-09-23

注册时间：

Date of Registration：

2020-09-23

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

使用中药熏蒸配合功能锻炼对老年髋部骨折术后康复及生活质量的影响

Public title：

Effect of fumigation with traditional Chinese medicine combined with functional exercise on postoperative rehabilitation and quality of life of senile hip fracture patients

注册题目简写：

English Acronym：

研究课题的正式科学名称：

使用中药熏蒸配合功能锻炼对老年髋部骨折术后康复及生活质量的影响

Scientific title：

Effect of fumigation with traditional Chinese medicine combined with functional exercise on postoperative rehabilitation and quality of life of senile hip fracture patients

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：

ChiCTR2000038487 ; ChiMCTR2000003968

申请注册联系人：

王斌

研究负责人：

王斌

Applicant：

Wang Bin

Study leader：

Wang Bin

申请注册联系人电话：

Applicant telephone：

+86 13862558230

研究负责人电话：

Study leader's telephone：

+86 13862558230

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：

34945954@qq.com

研究负责人电子邮件：

Study leader's E-mail：

34945954@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：

江苏省苏州市张家港市金港镇同济路2号

研究负责人通讯地址：

江苏省苏州市张家港市金港镇同济路2号

Applicant address：

2 Tongji Road, Jin'gang Town, Zhangjiagang, Suzhou, Jiangsu, China

Study leader's address：

2 Tongji Road, Jin'gang Town, Zhangjiagang, Suzhou, Jiangsu, China

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：

张家港市第二人民医院

Applicant's institution：

Zhangjiagang Second People's Hospital

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：

ZEY-2020008

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：

张家港市第二人民医院 医学伦理委员

Name of the ethic committee：

Medical Ethics Committee of Zhangjiagang Second People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2020/9/19 0:00:00

伦理委员会联系人：

强胜

Contact Name of the ethic committee：

Qiang Sheng

伦理委员会联系地址：

江苏省苏州市张家港市金港镇同济路2号

Contact Address of the ethic committee：

2 Tongji Road, Jin'gang Town, Zhangjiagang, Suzhou, Jiangsu, China

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：

张家港市第二人民医院

Primary sponsor：

Zhangjiagang Second People's Hospital

研究实施负责（组长）单位地址：

江苏省苏州市张家港市金港镇同济路2号

Primary sponsor's address：

2 Tongji Road, Jin'gang Town, Zhangjiagang, Suzhou, Jiangsu, 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)：

江苏

市(区县)：

苏州

Country：

China

Province：

Jiangsu

City：

Suzhou

单位(医院)：

张家港市第二人民医院

具体地址：

张家港市金港镇同济路2号

Institution
hospital：

Zhangjiagang Second People's Hospital

Address：

2 Tongji Road, Jin'gang Town, Zhangjiagang

经费或物资来源：

单位自筹及政府补助

Source(s) of funding：

Self-raised by the unit and government subsidies

研究疾病：

髋部骨折

研究疾病代码：

Target disease：

Hip fracture

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：

髋部骨折致残率及致死率较高，以往有学者称为“人生中最后一次骨折”，骨折后出现多种并发症，会从很大程度上影响患者身体及心理，导致负面心态加重，包括焦虑、抑郁等，降低了患者日常生活的质量。而中药熏蒸有活血化瘀、通经络血、祛寒消炎、排除风湿、调节植物神、缓解压力经等好处，本研究旨在观察使用中药熏蒸配合功能锻炼，与常规功能锻炼相比较，通过研究对比，总结出增强老年髋部骨折术后康复锻炼的系统及个体化方法，降低老年髋部骨折的致残率及致死率，提高术后康复效率及生活质量，促进患者快速康复，并推广应用该方法到全省乃至全国范围内使用。

Objectives of Study：

The disability rate and fatality rate of hip fracture are relatively high, which is called "the last fracture in life" by some scholars in the past. The occurrence of multiple complications after the fracture will greatly affect the patient's body and mind, leading to aggravation of negative mentality, including anxiety and depression, and reducing the quality of the patient's daily life. And Chinese medicine fumigation with promoting blood circulation to remove blood stasis, blood meridian, remove cold diminish inflammation, eliminate rheumatism, plant god to adjust, and stress the advantage, this study was to observe the use of traditional Chinese medicine fumigation cooperating with functional exercise, compared with conventional functional exercise, through the comparison, the study concluded that enhance the postoperative rehabilitation exercise of hip fracture system and individualized method, reduce the morbidity and mortality rates of hip fracture, improve the efficiency of postoperative rehabilitation and quality of life, promote the patients' rapid recovery, and applied this method to the province and across the country.

药物成份或治疗方案详述：

1.1自拟药方 伸筋草10g，透骨草10g，木瓜10g，红花10g，海桐皮10g，桑寄生10g，防风10g，桂枝10g，骨碎补10g，片姜黄10g，蜈蚣2条，蕲蛇3g。 1.2中药熏蒸的方法 将配好的一份中药用纱布包好，放置于药锅内，用水浸泡没过药，浸泡10 min后，武火煎煮至沸腾，10 min后以文火煎煮20 min，然后倒出药液放入骨伤科专用熏蒸床进行治疗，控制熏蒸温度为50℃, 熏蒸30 min/次。局部症状明显者，对局部强化熏蒸30~40 min， 1~2次/d。14 d为1个疗程。

Description for medicine or protocol of treatment in detail：

1. Self made prescription The results showed that there were 10 g Hypericum, 10 g Tougu grass, 10 g papaya, 10 g safflower, 10 g Pittosporum, 10 g sangjisheng, 10 g Fangfeng, 10 g Cinnamomum fragrans, 10 g turmeric, 2 centipedes and 3 G Agkistrodon acutus. 2. Fumigation of traditional Chinese Medicine Wrap a portion of Chinese medicine with gauze and place it in a medicine pot. Soak it in water for 10 minutes. After soaking for 10 minutes, boil it with fire. After 10 minutes, boil it with slow fire for 20 minutes. Then pour out the liquid medicine and put it into a special fumigation bed for orthopedics and traumatology. The fumigation temperature is controlled at 50 ℃ and fumigated for 30 minutes per time. For patients with obvious local symptoms, local intensive fumigation should be carried out for 30-40 min, 1-2 times a day. 14 days was a course of treatment.

纳入标准：

（1）符合《老年髋部骨折诊疗专家共识(2017)》中的相关诊断标准； （2）年龄≥65岁； （3）近4周内未接受中医药制剂治疗； （4）术后患生命体征平稳患者。

Inclusion criteria

1. Patients who meet the relevant diagnostic criteria of "expert consensus on diagnosis and treatment of hip fracture in the elderly (2017)"; 2. Patients with age >= 65 years old; 3. Patients who did not receive TCM preparation treatment in recent 4 weeks; 4. Patients with stable vital signs after operation.

排除标准：

（1）合并重症高血压、心脏病、急慢性心功能不全者； （2）合并肝肾及其他器官严重功能障碍者； （3）合并重度贫血、动脉硬化症、心绞痛、青光眼等疾病者； （4）患有精神疾病者； （5）患有急性传染病者； （6）妇女妊娠及月经期； （7）开放性伤口、感染性病灶年龄过大或者体质特别虚弱者； （8）对本研究依从性差及数据不全。

Exclusion criteria：

1. Patients with severe hypertension, heart disease or acute or chronic cardiac insufficiency; 2. Patients with severe dysfunction of liver, kidney and other organs; 3. Patients with severe anemia, arteriosclerosis, angina pectoris, glaucoma and other diseases; 4. Persons suffering from mental illness; 5. Persons suffering from acute infectious diseases; 6. Pregnant and menstrual women; 7. Patients with open wounds, infectious lesions, who are too old or physically weak; 8. Patients with poor compliance and incomplete data in this study.

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 2020-10-31

至To      2022-09-30

干预措施：

Interventions：

组别：

对照组

样本量：

50

Group：

control group

Sample size：

干预措施：

常规功能锻炼

干预措施代码：

Intervention：

functional exercise

Intervention code：

组别：

试验组

样本量：

50

Group：

experimental group

Sample size：

干预措施：

中药熏蒸配合功能锻炼

干预措施代码：

Intervention：

Chinese medicine fumigation with functional exercise

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)：

江苏

市(区县)：

张家港

Country：

China

Province：

Jiangsu

City：

Zhangjiagang

单位(医院)：

张家港市第二人民医院

单位级别：

二级乙等

Institution/hospital：

Zhangjiagang Second People's Hospital

Level of the institution：

Secondary B

测量指标：

Outcomes：

指标中文名：

自理能力

指标类型：

主要指标

Outcome：

Ability to care for

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

髋关节活动度

指标类型：

主要指标

Outcome：

Hip range of motion

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

生活质量

指标类型：

主要指标

Outcome：

The quality of life

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：

没有标本

组织：

Sample Name：

No specimens

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：

尚未开始

Not yet recruiting

年龄范围：

最小 岁
Min age years
最大 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）：

由我院一位不参与此项研究的医师采用随机序列发生器生成1～100个随机序列数。因预设的患者年龄分布范围较大（60～90岁），对研究结果可能有影响，由指定医师采用平衡随机入组方法，按照单数入观察组，双数入对照组的方式将患者分配给干预实施者。当其中一组入组人数率先完成约85%时开始统计两组已入组人数的年龄均值，后续入组按年龄大的（≥75岁）入年龄均值较低的组，年龄小的（＜75岁）入另一组，直至152例患者全部完成入组。

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

A random sequence generator is used to generate 1 - 100 random sequence numbers by a physician in our hospital who is not involved in this study

盲法：

未说明

Blinding：

Not stated

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）：

原始数据在试验完成后6个月内公开，原始数据和研究计划可在临床试验公共管理平台ResMan （网址：www.medresman.org.cn）上查询。

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

The original data will be available within six months of completion of the trial, and the original data and study plan can be accessed at ResMan (www.medresman.org.cn), the public management pla

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：

1.数据采集由我院经过统计培训的曹雯萍医师采用盲法进行，数据录入与管理由我院范理强医师负责。临床试验启动前的数据监察一般在现场核察，所有数据采集准备工作完成后书面报告课题负责人王斌及我院数据安全与监察委员会（DSMB）。 2.试验进行中的数据监察根据数据库不同采用不同的方法，主要采用计算机本机数据库录入，数据库须能追溯任何更改。数据监察定期在现场进行，试验进行中期分析时，一般是纳入参试者一半时进行。中期分析前要先截止数据录入，再进行数据监察并编制监察结果清单。 3.试验数据收集完成后要进行最后的数据监察，在现场对外部数据材料等进行审核验收。数据监察中发现的问题数据应及时汇总分类，分别向不同数据来源的责任人发出质询函，经核对无误后由数据录人员或数据库管理员进行更正 。 4.临床试验中期分析和试验结束的数据监察完成后，为了防止意外或未授权的更改，均需要将数据库锁定，即取消所有人员的编辑权限。锁定数据库前必须向DSMB、课题负责人报告，并附数据监察清单，在获得书面签字批准后锁定数据库 。 5.数据库锁定后，如需要重新开锁继续录入数据或对错误数据进行修正，均需获得DSMB的批准并详细记录。重新开锁的条件和操作流程：中期分析完成后继续开始后半程试验； 数据库锁定后新发现遗漏数据或错误。由DSMB批准授权后，数据库管理员和监察员实施重新开锁，修改完成后除数据库自动记录修改操作外，还需将纸质授权批件和执行情况记录归档保存。

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

Cao Wenqiang and our hospital doctors will be responsible for data collection and management. The data monitoring before the start of clinical trials is generally carried out on the spot. After all the data collection preparations are completed, a written report will be submitted to the project leader Wang Bin and the data security and Supervision Committee (DSMB) of our hospital. 2. The data monitoring during the test will adopt different methods according to different databases, mainly using the computer local database input, and the database must be able to trace any changes. Data monitoring is carried out on site regularly, and the mid-term analysis of the trial is generally carried out when half of the participants are included. Before the mid-term analysis, the data entry should be cut off, then the data monitoring should be carried out, and the list of monitoring results should be compiled. 3. After the test data collection is completed, the final data monitoring shall be carried out, and the external data materials shall be checked and accepted on site. The problem data found in the data monitoring shall be summarized and classified in time, and the inquiry letters shall be sent to the responsible persons of different data sources respectively. After verification, the data recorder or database administrator shall correct it. 4. After the interim analysis of clinical trial and data monitoring at the end of the trial, in order to prevent accidental or unauthorized changes, the database should be locked, that is, to cancel the editing authority of all personnel. Before locking the database, it is necessary to report to DSMB and the project leader, and attach the data monitoring list, and lock the database after obtaining the written signature and approval. 5. After the database is locked, if it is necessary to re unlock, continue to input data or correct the wrong data, it is required to obtain the approval of DSMB and make detailed records. The conditions and operation process of re unlocking: after the completion of the mid-term analysis, the second half of the test should be continued; after the database is locked, new missing data or errors are found. After the authorization is approved by DSMB, the database administrator and the supervisor implement the re unlocking. After the modification, in addition to the automatic record of the modification operation in the database, the paper authorization approval documents and the implementation records need to be filed and saved.

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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