注册号: Registration number: |
ChiCTR1900028452 |
最近更新日期: Date of Last Refreshed on: |
2019-12-22 |
注册时间: Date of Registration: |
2019-12-22 |
注册号状态: |
预注册 |
Registration Status: |
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 for Stuck-Moving Needle Acupuncture the Myofascial Triggers Point to Treat Idiopathic Frozen Shoulders |
注册题目简写: |
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English Acronym: |
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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 for Stuck-Moving Needle Acupuncture the Myofascial Triggers Point to Treat Idiopathic Frozen Shoulders |
研究课题代号(代码): Study subject ID: |
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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: |
ChiMCTR1900002862 |
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: |
+86 18093468811 |
研究负责人电话: Study leader's telephone: |
+86 13821820885 |
申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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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): |
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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: |
天津市西青区昌凌路88号 |
Applicant address: |
10 Guxiang Road West, Xifeng District, Qingyang, Gansu, China |
Study leader's address: |
88 Changling Road, Xiqing District, Tianjin, China |
申请注册联系人邮政编码: Applicant postcode: |
745000 |
研究负责人邮政编码: Study leader's postcode: |
300391 |
申请人所在单位: |
庆阳市中医医院 |
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Applicant's institution: |
Qingyang Hospital of Traditional Chinese Medicine |
是否获伦理委员会批准: |
否 |
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Approved by ethic committee: |
NO |
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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: |
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批准本研究的伦理委员会名称: |
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Name of the ethic committee: |
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伦理委员会批准日期: Date of approved by ethic committee: |
2013-08-26 | ||
伦理委员会联系人: |
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Contact Name of the ethic committee: |
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伦理委员会联系地址: |
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Contact Address of the ethic committee: |
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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: |
庆阳市中医医院 |
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Primary sponsor: |
Qingyang Hospital of Traditional Chinese Medicine |
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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 |
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Primary sponsor's address: |
10 Guxiang Road West, Xifeng District, Qingyang, Gansu, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
自筹以及庆阳市中医医院科研基金资助 |
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Source(s) of funding: |
Self-raised and qingyang hospital of traditional Chinese medicine scientific research funds |
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研究疾病: |
原发性冻结肩 |
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Target disease: |
Idiopathic Frozen Shoulders |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
探索性研究/预试验 | ||||||||||||||||||||||
Study phase: |
0 |
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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。 |
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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. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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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。 |
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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 |
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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; (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。 |
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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. (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: |
从From2020-01-01至To 2021-01-31 |
征募观察对象时间: Recruiting time: |
从From2020-01-01至To 2021-01-31 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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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。 |
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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 |
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(上传文件): |
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Calculated Results after
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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): |
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-based public database, please provide the url): |
by publication |
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: |
CRF表采集数据,数据电子存档管理 |
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
collect data by CRF,and manage data via computer |
数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |