基于内外兼治、筋骨并重治疗原则指导下应用中药干预结合物理因子和康复训练对肌少-骨质疏松症的基础与临床观察研究

注册号:

Registration number:

ITMCTR2200005723

最近更新日期:

Date of Last Refreshed on:

2022-03-15

注册时间:

Date of Registration:

2022-03-15

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

基于内外兼治、筋骨并重治疗原则指导下应用中药干预结合物理因子和康复训练对肌少-骨质疏松症的基础与临床观察研究

Public title:

Based on the principle of internal and external treatment and equal treatment of muscles and bones, the basic and clinical observation and study of the application of Traditional Chinese medicine intervention combined with physical factors and rehabilitation training in the treatment of sarcopenia-osteoporosis

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于内外兼治、筋骨并重治疗原则指导下应用中药干预结合物理因子和康复训练对肌少-骨质疏松症的基础与临床观察研究

Scientific title:

Based on the principle of internal and external treatment and equal treatment of muscles and bones, the basic and clinical observation and study of the application of Traditional Chinese medicine intervention combined with physical factors and rehabilitation training in the treatment of sarcopenia-osteoporosis

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:

ChiCTR2200057669 ; ChiMCTR2200005723

申请注册联系人:

荆科

研究负责人:

刘西纺

Applicant:

Ke jing

Study leader:

Xi fang Liu

申请注册联系人电话:

Applicant telephone:

18434161543

研究负责人电话:

Study leader's telephone:

18821792256

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:

jk20180414@163.com

研究负责人电子邮件:

Study leader's E-mail:

lxfyg2006@126.com

申请单位网址(自愿提供):

Study leader's website(voluntary supply):

www.xahhyy.com

研究负责人网址(自愿提供):

Study leader's website
(voluntary supply):

www.xahhyy.com

申请注册联系人通讯地址:

陕西省西安市碑林区南稍门友谊东路555号

研究负责人通讯地址:

陕西省西安市碑林区南稍门友谊东路555号

Applicant address:

555 Nanshaomen Dong Lu, Beilin District, Xi 'an city, Shaanxi Province, China

Study leader's address:

555 Nanshaomen Youyi Dong Lu, Beilin District, Xi 'an city, Shaanxi Province, China

申请注册联系人邮政编码:

Applicant postcode:

710054

研究负责人邮政编码:

Study leader's postcode:

710054

申请人所在单位:

西安交通大学附属红会医院

Applicant's institution:

Red Union Hospital affiliated to Xi 'an Jiaotong University

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:

202202003

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

西安交通大学附属红会医院伦理委员会

Name of the ethic committee:

Ethics Committee of Honghui Hospital affiliated to Xi 'an Jiaotong University

伦理委员会批准日期:

Date of approved by ethic committee:

2022/2/15 0:00:00

伦理委员会联系人:

宁宁

Contact Name of the ethic committee:

Ning ning

伦理委员会联系地址:

陕西省西安市碑林区南稍门友谊东路555号

Contact Address of the ethic committee:

陕西省西安市碑林区南稍门友谊东路555号

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:

西安交通大学附属红会医院

Primary sponsor:

Red Union Hospital affiliated to Xi 'an Jiaotong University

研究实施负责(组长)单位地址:

陕西省西安市碑林区南稍门友谊东路555号

Primary sponsor's address:

555 Nanshaomen Youyi Dong Lu, Beilin District, Xi 'an city, Shaanxi Province, 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):

陕西省

市(区县):

西安市

Country:

China

Province:

Shaanxi Province

City:

Xi’an city

单位(医院):

西安交通大学附属红会医院

具体地址:

陕西省西安市碑林区南稍门友谊东路555号

Institution
hospital:

Red Union Hospital affiliated to Xi 'an Jiaotong University

Address:

555 Nanshaomen Youyi Dong Lu, Beilin District, Xi 'an city, Shaanxi Province, China

经费或物资来源:

国家自然科学基金(11872297)(31670954)和自筹

Source(s) of funding:

National Natural Science Foundation of China (11872297)(31670954)

研究疾病:

肌少-骨质疏松症

研究疾病代码:

Target disease:

Weak muscle mass - Osteoporosis

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:

基于中医健脾补肾相关中医基础理论指导,遵从中医骨伤学内外兼治、筋骨并重治疗原则,探讨中药内服及康复运动疗法外治应用于脊柱骨质疏松性骨折术后患者的中远期疗效。通过临床观察脊柱骨质疏松性骨折术后患者内服健脾补肾中药,结合康复运动疗法外治,对骨质疏松疾病治疗及患者机体功能改善的有效性,探索符合当下人口渐进式老龄化国情的新型抗骨质疏松治疗方案。 对比研究全身振动训练结合低频脉冲电磁场辅助治疗肌少-骨质疏松症,与单独全身振动训练和单独低频脉冲电磁场治疗的疗效,是否联合治疗优于单独治疗,进一步验证二者对促进成骨和增加骨强度的协同作用。将全身振动训练结合低频脉冲电磁场首次应用于临床辅助治疗肌少-骨质疏松症,观察二者对于在促进成骨和增强骨强度协同作用,为肌少-骨质疏松症的治疗提供新的思路和方法。 通过对比两组治疗前后肌力、生活质量及骨折发生率等的变化, 评价抗骨质疏松药联合八段锦防治肌少-骨质疏松性中的疗效。构建疗效好、可行性强的防治骨质疏松症、提高生活质量的中医综合疗法方案,并向更多的社区进行推广。

Objectives of Study:

Based on the guidance of TCM basic theories related to spleen-tonifying and kidney tonifying, and in accordance with the principles of both internal and external treatment and equal treatment of muscles and bones in TRADITIONAL Chinese orthopedics, this paper discusses the medium and long-term effects of internal administration of TRADITIONAL Chinese medicine and rehabilitation exercise therapy for external treatment in patients with osteoporotic fractures of the spine. Through clinical observation of the effectiveness of internal administration of spleen-strengthening and kidney-tonifying Traditional Chinese medicine combined with external treatment of rehabilitation exercise therapy in the treatment of osteoporosis and the improvement of patients' body function after spinal osteoporotic fracture, a new anti-osteoporosis treatment scheme in line with the current situation of gradually aging population was explored. A comparative study was conducted on the efficacy of whole body vibration training combined with low frequency pulsed electromagnetic field in the treatment of sarcoma osteoporosis, and the efficacy of whole body vibration training and low frequency pulsed electromagnetic field alone, whether the combined treatment is superior to the single treatment, to further verify the synergistic effect of the two on promoting osteogenesis and increasing bone strength. The whole body vibration training combined with low-frequency pulsed electromagnetic field was applied for the first time in the clinical adjuvant treatment of myosiness-osteoporosis, to observe the synergistic effect of the two on promoting osteogenesis and enhancing bone strength, and to provide a new idea and method for the treatment of myosiness-osteoporosis. By comparing the changes of muscle strength, quality of life and fracture rate between the two groups before and after treatment, the efficacy of anti-osteoporosis drugs combined with Baduanjin in the prevention and treatment of sarcoma and osteoporosis was evaluated. To construct a comprehensive TCM therapy program with good curative effect and strong feasibility to prevent and cure osteoporosis and improve the quality of life, and popularize it to more communities.

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.年龄介于55岁-75岁之间,视力正常 2.符合肌少症、骨质疏松症的临床诊断且不合并其他疾病。 3.了解研究方案,同意并签署知情同意书 4.接受随访

Inclusion criteria

1. The age ranges from 55 to 75 years old with normal vision 2. It conforms to the clinical diagnosis of sarcopenia and osteoporosis and is not complicated with other diseases. 3. Understand the research proposal, agree and sign the informed consent 4. Follow up

排除标准:

1.严重高血压、低血压、心脏病、血管病及癫痫 2.血栓或近6个月内有血栓史 3.各种手术未愈 4.关节外伤、骨折、肌肉拉伤未愈,关节严重变形、下蹲困难 5.有影响活动、行走的骨关节疾病有严重躯体疾病; 6.体弱多病、严重平衡障碍或眩晕,患有精神疾病或精神疾病家族史痴呆和认知功能障碍者等 7.体内有植入物 8.患有痛风、类风湿、糖尿病血糖控制欠佳,或其他严重影响骨代谢的疾病 9.腰椎间盘突出或滑脱、腰椎神经管狭窄或压迫。

Exclusion criteria:

1. Severe hypertension, hypotension, heart disease, vascular disease and epilepsy 2. Thrombosis or a history of thrombosis in the last 6 months 3. Various operations are not recovered 4. Joint trauma, fracture, muscle strain, serious joint deformation, difficult squatting 5. Bone and joint diseases affecting movement and walking have serious physical diseases; 6. Patients with weak health, severe balance disorder or vertigo, mental illness or family history of mental illness dementia and cognitive dysfunction 7. You have an implant 8. Suffering from gout, rheumatoid disease, poor glycemic control in diabetes, or other diseases that seriously affect bone metabolism 9. Lumbar disc herniation or slip, lumbar nerve tube stenosis or compression.

研究实施时间:

Study execute time:

From 2022-03-20

To      2023-01-20

征募观察对象时间:

Recruiting time:

From 2022-03-20

To      2023-01-20

干预措施:

Interventions:

组别:

实验组8

样本量:

15

Group:

The experimental group 8

Sample size:

干预措施:

药物联合运动处方

干预措施代码:

Intervention:

Drug combination exercise prescription

Intervention code:

组别:

实验组9

样本量:

15

Group:

The experimental group 9

Sample size:

干预措施:

药物联合运动处方和赢体生骨方

干预措施代码:

Intervention:

Medicine combined with exercise prescription and winning body sheng Bone prescription

Intervention code:

组别:

实验组2

样本量:

15

Group:

The experimental group 2

Sample size:

干预措施:

药物治疗联合低频脉冲电磁场

干预措施代码:

Intervention:

Drug therapy combined with low frequency pulsed electromagnetic fields

Intervention code:

组别:

实验组1

样本量:

15

Group:

The experimental group 1

Sample size:

干预措施:

药物治疗联合全身振动训练

干预措施代码:

Intervention:

Drug therapy combined with whole body vibration training

Intervention code:

组别:

常规治疗组1

样本量:

15

Group:

Conventional treatment group1

Sample size:

干预措施:

口服钙尔奇、阿法骨化醇胶囊和阿伦磷酸钠片

干预措施代码:

Intervention:

Oral calcitol, alfacalccitol capsules and alendronate tablets

Intervention code:

组别:

药物治疗组

样本量:

50

Group:

Pharmacotherapy group

Sample size:

干预措施:

口服抗骨质疏松药物

干预措施代码:

Intervention:

Oral anti-osteoporosis drugs

Intervention code:

组别:

实验组7

样本量:

15

Group:

The experimental group 7

Sample size:

干预措施:

药物联合赢体生骨方

干预措施代码:

Intervention:

Combination of drugs and winning body sheng Gu fang

Intervention code:

组别:

实验组6

样本量:

15

Group:

The experimental group 6

Sample size:

干预措施:

药物治疗联合全身振动训练和低频脉冲电磁场

干预措施代码:

Intervention:

Drug therapy combined with whole body vibration training and low frequency pulsed electromagnetic fields

Intervention code:

组别:

药物联合八段锦组

样本量:

50

Group:

Drugs combined with baduanjin group

Sample size:

干预措施:

口服抗骨质疏松药物联合八段锦

干预措施代码:

Intervention:

Oral anti-osteoporosis drugs combined with baduanjin

Intervention code:

组别:

实验组3

样本量:

15

Group:

The experimental group 3

Sample size:

干预措施:

药物治疗联合全身振动训练和低频脉冲电磁场

干预措施代码:

Intervention:

Drug therapy combined with whole body vibration training and low frequency pulsed electromagnetic fields

Intervention code:

组别:

实验组5

样本量:

15

Group:

The experimental group 5

Sample size:

干预措施:

药物治疗联合低频脉冲电磁场

干预措施代码:

Intervention:

Drug therapy combined with low frequency pulsed electromagnetic fields

Intervention code:

组别:

常规治疗组3

样本量:

15

Group:

Conventional treatment group3

Sample size:

干预措施:

钙剂、维生素D及NSAIDs类药物

干预措施代码:

Intervention:

Calcium, vitamin D and NSAIDs

Intervention code:

组别:

常规治疗组2

样本量:

15

Group:

Conventional treatment group2

Sample size:

干预措施:

口服钙尔奇、阿法骨化醇胶囊和阿伦磷酸钠片

干预措施代码:

Intervention:

Oral calcitol, alfacalccitol capsules and alendronate tablets

Intervention code:

组别:

实验组4

样本量:

15

Group:

The experimental group 4

Sample size:

干预措施:

药物治疗联合全身振动训练

干预措施代码:

Intervention:

Drug therapy combined with whole body vibration training

Intervention code:

样本总量 Total sample size : 280

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

陕西省

市(区县):

西安市

Country:

China

Province:

Shaanxi Province

City:

Xi’an city

单位(医院):

西安交通大学附属红会医院

单位级别:

三级甲等

Institution/hospital:

Red Union Hospital affiliated to Xi 'an Jiaotong University

Level of the institution:

Third rate

测量指标:

Outcomes:

指标中文名:

身高体重指数

指标类型:

主要指标

Outcome:

Body mass 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:

骨碱性磷酸酶

指标类型:

主要指标

Outcome:

bone alkaline phosphatase

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

坐起时间

指标类型:

主要指标

Outcome:

Sit up time

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

四肢肌肉力量

指标类型:

主要指标

Outcome:

Muscle strength of extremities

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

I型胶原C端肽

指标类型:

主要指标

Outcome:

C-terminal peptide of type I collagen

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

髋部骨密度

指标类型:

主要指标

Outcome:

Hip bone density

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

小腿围度

指标类型:

主要指标

Outcome:

Crus surrounds degrees

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量评估

指标类型:

主要指标

Outcome:

appraisal of life quality

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腰部骨密度

指标类型:

主要指标

Outcome:

Lumbar bone density

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

大腿围度

指标类型:

主要指标

Outcome:

Thigh circumference degrees

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Ⅰ型前胶原氨基端原肽

指标类型:

主要指标

Outcome:

Amino terminal propeptide of type ⅰ procollagen

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血磷浓度

指标类型:

主要指标

Outcome:

The blood concentration of phosphorus

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

握力

指标类型:

主要指标

Outcome:

grip

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血钙浓度

指标类型:

主要指标

Outcome:

Blood calcium concentration

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

日常生活活动能力

指标类型:

主要指标

Outcome:

activities of daily living

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

视觉模拟评分量表

指标类型:

主要指标

Outcome:

Visual analog rating Scale

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Ⅱ型胶原C端肽

指标类型:

主要指标

Outcome:

C-terminal peptide of type ⅱ collagen

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

6米步速

指标类型:

主要指标

Outcome:

6 m pace

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:

血液

组织:

Sample Name:

blood

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 45
Min age years
最大 75
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):

各分组由专门医师负责,采用随机数字表产生随机数列

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

Each grouping is responsible for by specialized physicians, and random number tables are used to generate random numbers

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

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):

试验结束后在本平台公开

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

After the test, it will be released on this platform

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:

Microsoft Office Access

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

Microsoft Office Access

数据管理委员会:

Data Managemen Committee:

暂未确定

Not yet

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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