滞动针针刺肌筋膜激痛点治疗原发性冻结肩的临床研究方案

注册号:

Registration number:

AMCTR-IPR-19000311 

注册号获得时间:

Date of releasing the registration number:

2019/12/21 20:21:57 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

滞动针针刺肌筋膜激痛点治疗原发性冻结肩的临床研究方案 

Public title:

Clinical Study of Stuck-moving Needle acupuncture the Myofascial Triggers Point to treat Idiopathic Frozen Shoulders 

研究课题的正式科学名称:

滞动针针刺肌筋膜激痛点治疗原发性冻结肩的临床研究方案 

Scientific title:

Clinical Study of Stuck-moving Needle acupuncture the Myofascial Triggers Point to treat Idiopathic Frozen Shoulders 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

白杨 

研究负责人:

杜元灏 

Applicant:

BAI-Yang 

Study leader:

DU-Yuanhao 

申请注册联系人电话:

Applicant telephone:

18093468811 

研究负责人电话:

Study leader's telephone:

13821820885 

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:

314937471@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

jpjs_cn@sina.com 

申请单位网址(自愿提供):

Applicant 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:

甘肃省庆阳市西峰区古象西路10号 

研究负责人通讯地址:

No. 88, Changling Road, Xiqing District, Tianjin 300391, China 

Applicant address:

No. 10, Guxiang West Road, Qingyang City, Gansu 745000, China 

Study leader's address:

天津市西青区昌凌路88号 

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:

庆阳市中医医院 

Applicant's institution:

Qingyang Hospital of Traditional Chinese Medicine 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

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:

2013-08-26 

研究实施负责(组长)单位:

庆阳市中医医院 

Primary sponsor:

Qingyang Hospital of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

甘肃省庆阳市西峰区古象西路10号 

Primary sponsor's address:

No. 10, Guxiang West Road, Qingyang City, Gansu 745000, 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):

甘肃省

市(区县):

庆阳市

Country:

China

Province:

Gansu

City:

Qingyangq

单位(医院):

庆阳市中医医院

具体地址:

甘肃省庆阳市西峰区古象西路10号

Institution
hospital:

Qingyang Hospital of Traditional Chinese Medicine

Address:

No. 10, Guxiang West Road, Qingyang City, Gansu 745000, China

经费或物资来源:

自筹以及庆阳市中医医院科研基金资助 

Source(s) of funding:

Self-raised and qingyang hospital of traditional Chinese medicine scientific research funds 

研究疾病:

原发性冻结肩 

Target disease:

Idiopathic Frozen Shoulders 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

I期临床试验 

Study phase:

Phase I 

研究目的:

1.1主要研究目标 评估滞动针针刺肌筋膜激痛点改善原发性冻结肩患者疼痛和关节活动度以及生活质量的有效性和安全性。 1.2次要研究目标 对比滞动针针刺肌筋膜激痛点及传统针刺在改善原发性冻结肩患者疼痛和关节活动度以及生活质量的疗效差异。 

Objectives of Study:

1.1 Main Research Objective To evaluate the efficacy and safety of stuck-moving needle acupuncture the myofascial triggers points in improving pain , range of motion and quality of life in patients with idiopathic frozen shoulder. 1.2 Secondary research objectives To compare the effect of stuck-moving needle acupuncture the myofascial triggers points and traditional acupuncture on the improvement of pain, range of motion and quality of life in patients with idiopathic frozen shoulder. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

(1)年龄处于40~70岁之间; (2)自诉肩部疼痛,疼痛范围向肩内侧延伸至肱二头肌区域或向外侧延伸至三角肌后部。VAS评分在7-8分之间。 (3)疼痛发作至少持续3个月。 (4)肩部僵硬疼痛呈自发性发作,且肩部上举、外旋、后伸、外展功能丧失50%以上,OSS评分在50-60分之间。 (5)能够与医生积极配合,并签署知情同意书自愿接受针刺治疗。 

Inclusion criteria

(1) The age is between 40 and 70 years old. (2) Self-reported shoulder pain, the pain range extends from the medial side of the shoulder to the biceps area or to the outside of the deltoid muscle.The VAS score is between 7-8 points. (3) The onset of pain lasts for at least 3 months. (4) The stiff shoulder pain is a spontaneous attack, and the shoulder lifting or external rotation or backward extension or abduction function is lost by 50%, and the OSS score is between 50-60 points. (5) Being able to actively cooperate with the doctor and sign the informed 

排除标准:

(1)患者已接受其它治疗,而其它治疗可能会对本研究的效应指标带来影响,包括近3月内口服止痛药物,进行针刺,推拿等物理治疗等; (2)患者合并有严重的肝肾心脑血管等危及生命的原发性疾病精神病患者; (3)妊娠或哺乳期患者,不符纳入标准。 (4)需排除与具体研究病种有关的其它因素,如: 肩部外伤史及手术史;肩部结核和肿瘤;类风湿性关节炎和风湿性关节炎以及痛风性关节炎;中风后遗症肩关节半脱位;颈椎病导致的肩部疼痛;心或胆道疾患导致的反射性肩痛等。 注:符合以上任何一条的患者,立即排除。 

Exclusion criteria:

(1) The patient has received other treatments that may affect the effect indicators of this study, including oral painkillers for nearly 3 months, physical therapy such as acupuncture and massage. (2) The patient has severe life-threatening primary diseases such as liver and kidney, cardiovascular and cerebrovascular diseases, and mental illness. (3) Patients who are pregnant or breast-feeding do not meet the inclusion criteria. (4) Exclude other factors related to the study of the disease, such as: history of shoulder trauma , shoulder tuberculosis and tumor, rheumatoid arthritis and rheumatic arthritis and gouty arthritis, shoulder subluxation of stroke sequelae,shoulder pain caused by cervical spondylosis,reflex shoulder pain caused by heart or biliary tract disease. Note: Patients who meet any of the above are excluded immediately. 

研究实施时间:

Study execute time:

From2020-01-01To 2021-01-31 

干预措施:

Interventions:

组别:

肌筋膜激痛点滞动针针刺结合功能锻炼组

样本量:

36

Group:

stuck-moving needling myofascial triggers point combined physical training group,

Sample size:

干预措施:

滞动针针刺

干预措施代码:

Intervention:

stuck-moving needling

Intervention code:

组别:

普通针刺结合功能锻炼组

样本量:

36

Group:

common acupuncture combined physical training group,

Sample size:

干预措施:

毫针针刺

干预措施代码:

Intervention:

filiform needle

Intervention code:

组别:

普通针刺结合功能锻炼组

样本量:

36

Group:

common acupuncture combined physical training group,

Sample size:

干预措施:

毫针针刺

干预措施代码:

Intervention:

filiform needle

Intervention code:

组别:

功能锻炼组

样本量:

36

Group:

physical training group,

Sample size:

干预措施:

功能锻炼

干预措施代码:

Intervention:

physical training

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

China 

市(区县):

甘肃省 

Country:

Gansu 

Province:

庆阳市 

City:

 

单位(医院):

庆阳市中医医院 

单位级别:

Qingyang Hospital of Traditional Chinese Medicine 

Institution
hospital:

三级甲等  

Level of the institution:

Tertiary a hospital 

测量指标:

Outcomes:

指标中文名:

视觉模拟评分法

指标类型:

主要指标 

Outcome:

Visual Analogue Scale

Type:

Primary indicator 

指标中文名:

关节活动度测定

指标类型:

主要指标 

Outcome:

Range of joint motion

Type:

Primary indicator 

指标中文名:

(1)痛阈测定(PPT)和耐痛阈测定(PTT)

指标类型:

次要指标 

Outcome:

Pressure pain threshold (PPT) and Pressure pain tolerance (PTT):

Type:

Secondary indicator 

指标中文名:

牛津大学肩关节评分

指标类型:

次要指标 

Outcome:

Oxford shoulder score, OSS

Type:

Secondary indicator 

指标中文名:

生活质量评价

指标类型:

次要指标 

Outcome:

Quality of Life Evaluation

Type:

Secondary indicator 

指标中文名:

患者满意度

指标类型:

次要指标 

Outcome:

Patient satisfaction evaluation

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

其他

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:

Recruiting status:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 40 years
最大 Max age 70 years

随机方法(请说明由何人用什么方法产生随机序列):

采用中心区组随机化方法,依照各分中心实际情况分配观察病例数,将各中心观察病例数分次按照随机数字表分为 3 组,依次编好序列号(1、2、3、……N,此序列号为将来依次进入试验观察的入选患者的序列编号),随后在随机数字表上以任意一个数字开始,选取分中心所要观察的病例数目,将此随机数字表内截取的数字与前述序列号一一对应,并将其逐个被3除,余数为0的归入激痛点滞针结合功能锻炼组,余数为1的归入普通针刺结合功能锻炼组,余数为2的归入功能锻炼组。

性别:

男女均可

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

A method of?randomized block of the central is adopted. According to the actual situation of each center, the number of observed subjects is allocated. The subjects in each center were divided into 3 groups by random number table method, and make serial number ( such as 1, 2, 3, ..., N, this serial number is the ID of the subjects who entered the study),?then start from any number on the random number table, select the ?number of subjects in the sub-center, and the number intercepted in the rand

Gender:

Both

盲法:

本项目采用盲法评价,由不知分组情况的第三者进行疗效评价,所有参加评价的人员均接受统一培训,资料总结阶段采用盲法统计分析,统计分析人员不知道分组情况和内容,随机分组者、试验研究者、操作者、统计者三分离,保证受试者、评估者、统计者不了解分组情况。

Blinding:

This project uses a blind method for evaluation. Efficacy assessments were performed by third parties who did not know the grouping situation, and all participants in the assessment received uniform training.?Blind statistical analysis is used in the data summary stage, that is, statistical analysts do not know the grouping situation and content.?Randomized staff, study researchers, operators, and statisticians are blinded to ensure that subjects, evaluators, and statisticians do not understand the grouping situation.

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

通过发表期刊文章公布原始数据

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

by publication

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

CRF表采集数据,数据电子存档管理

The repository and management of the data(Please specify what repository will be used for management of the metadata):

collect data by CRF,and manage data via computer

创建人:

Creater Name:

 2019-12-05
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