Effect of acupuncture on the Myofascial trigger point of pain in patients with knee osteoarthritis

注册号:

Registration number:

ITMCTR2000004098

最近更新日期:

Date of Last Refreshed on:

2020-11-28

注册时间:

Date of Registration:

2020-11-28

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

针刺肌筋膜疼痛触发点对膝骨关节炎患者的疗效研究

Public title:

Effect of acupuncture on the Myofascial trigger point of pain in patients with knee osteoarthritis

注册题目简写:

English Acronym:

研究课题的正式科学名称:

LED 治疗神经损伤性疼痛的机理研究和临床示范

Scientific title:

Mechanism research and clinical demonstration of LED therapy for nerve injury pain

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:

ChiCTR2000040399 ; ChiMCTR2000004098

申请注册联系人:

宁秀娟

研究负责人:

郑拥军

Applicant:

Xiujuan Ning

Study leader:

Yongjun Zheng

申请注册联系人电话:

Applicant telephone:

+86 18817865086

研究负责人电话:

Study leader's telephone:

+86 18116267895

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:

18263832683@163.com

研究负责人电子邮件:

Study leader's E-mail:

zhengyongjun1971@126.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:

上海市静安区延安西路221号

研究负责人通讯地址:

上海市静安区延安西路221号复旦大学附属华东医院

Applicant address:

221 Yan'an Road West, Jing'an District, Shanghai, China

Study leader's address:

221 Yan'an Road West, Jing'an District, Shanghai, 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:

复旦大学附属华东医院

Applicant's institution:

Huadong Hospital affiliated to Fudan 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:

2020K188

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:

复旦大学附属华东医院伦理委员会

Name of the ethic committee:

Ethics Committee of Huadong Hospital affiliated to Fudan University

伦理委员会批准日期:

Date of approved by ethic committee:

2020/11/23 0:00:00

伦理委员会联系人:

沙颖豪

Contact Name of the ethic committee:

Haoying Sha

伦理委员会联系地址:

上海市静安区延安西路168号复旦大学附属华东医院伦理委员会

Contact Address of the ethic committee:

Ethics Committee of Huadong Hospital affiliated to Fudan University, 221 Yan'an Road West, Jing'an District, Shanghai, 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:

复旦大学附属华东医院

Primary sponsor:

Huadong Hospital affiliated to Fudan University

研究实施负责(组长)单位地址:

上海市静安区延安西路221号复旦大学附属华东医院

Primary sponsor's address:

221 Yan'an Road West, Jing'an District, Shanghai, 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):

上海市

市(区县):

静安区

Country:

China

Province:

Shanghai

City:

单位(医院):

复旦大学附属华东医院

具体地址:

上海市静安区延安西路221号复旦大学附属华东医院

Institution
hospital:

Huadong Hospital affiliated to Fudan University

Address:

221 Yan'an Road West, Jing'an District

经费或物资来源:

LED 治疗神经损伤性疼痛的机理研究和临床示范

Source(s) of funding:

Mechanism research and clinical demonstration of LED therapy for nerve injury pain

研究疾病:

膝骨关节炎

研究疾病代码:

Target disease:

Knee osteoarthritis

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:

观察针刺触发点治疗膝骨关节炎效果,并对其进行随访。

Objectives of Study:

To observe the effect of acupuncture trigger point on knee osteoarthritis and follow up.

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)符合本试验研宄中的疾病诊断标准; (2)年龄≥50岁; (3)Kellgren-Lawrence(放射学标准)评分至少Ⅱ级; (4)纳入前3个月未进行膝关节炎手术治疗; (5)纳入前1个月未接受针灸的治疗; (6)自愿签署知情同意书。

Inclusion criteria

(1) Meet the disease diagnostic criteria in this study;  (2) Aged >=50 years; (3) Kellgren - Lawrence (standard radiology) score at least level II; (4) No surgical treatment of knee arthritis was performed in the first 3 months; (5) Patients who had not received acupuncture and moxibustion treatment in the previous month were included; (6) Sign informed consent voluntarily.

排除标准:

(1)伴有严重的膝关节畸形(膝关节间隙严重减小甚至消失者或关节间形成骨桥连接而呈骨性强直者)、急性创伤、膝关节感染性炎症患者。 (2)患有风湿免疫性疾病及代谢疾病者,如痛风、类风湿性关节炎、糖尿病等。 (3)合并有严重的心、脑、肝、肾和血液系统等原发性疾病,精神病患者。 (4)有出血性疾病者或凝血功能障碍者; (5)妇女妊娠期及哺乳期。 (6)依从性差,不积极配合检查及治疗者。

Exclusion criteria:

(1) Patients with severe knee malformation (severe reduction or even disappearance of the knee space or osteorigidity due to the formation of osteobridge connections between the joints), acute trauma, and infectious inflammation of the knee joint; (2) Patients with rheumatic immune diseases and metabolic diseases, such as gout, rheumatoid arthritis, diabetes, etc.; (3) Patients with severe primary diseases of the heart, brain, liver, kidney and blood system, and psychosis; (4) patients with hemorrhagic diseases or clotting dysfunction; (5) Pregnancy and lactation;  (6) Poor compliance, do not actively cooperation.

研究实施时间:

Study execute time:

From 2020-12-01

To      2021-12-01

征募观察对象时间:

Recruiting time:

From 2020-12-01

To      2021-02-01

干预措施:

Interventions:

组别:

对照组

样本量:

30

Group:

Control group

Sample size:

干预措施:

穴位埋针

干预措施代码:

Intervention:

embedding needle

Intervention code:

组别:

实验组

样本量:

30

Group:

Experimental group

Sample size:

干预措施:

针刺

干预措施代码:

Intervention:

needle

Intervention code:

样本总量 Total sample size : 60

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

上海

市(区县):

静安区

Country:

China

Province:

Shanghai

City:

Jing'an

单位(医院):

复旦大学附属华东医院

单位级别:

三甲医院

Institution/hospital:

Huadong Hospital affiliated to Fudan University

Level of the institution:

T

测量指标:

Outcomes:

指标中文名:

医院焦虑抑郁量表

指标类型:

主要指标

Outcome:

Hospital Anxiety and Depression Scale

Type:

Primary indicator

测量时间点:

治疗前,治疗后

测量方法:

开始治疗前,跟患者讲明具体情况,患者真实填写。

Measure time point of outcome:

pro-treat, post-treat

Measure method:

Before starting the treatment, explain the specific situation to the patient, and the patient fill in the information truthfully

指标中文名:

36项简明健康调查量表

指标类型:

主要指标

Outcome:

36-Item ShortForm Health Survey

Type:

Primary indicator

测量时间点:

治疗前,治疗后

测量方法:

开始治疗前,跟患者讲明具体情况,患者真实填写。

Measure time point of outcome:

pro-treat, post-treat

Measure method:

Before starting the treatment, explain the specific situation to the patient, and the patient fill in the information truthfully

指标中文名:

简式McGill疼痛问卷

指标类型:

主要指标

Outcome:

short form McGill pain questionnaire

Type:

Primary indicator

测量时间点:

治疗前,治疗后

测量方法:

开始治疗前,跟患者讲明具体情况,患者真实填写。

Measure time point of outcome:

pro-treat, post-treat

Measure method:

Before starting the treatment, explain the specific situation to the patient, and the patient fill in the information truthfully

指标中文名:

膝关节损伤和骨关节炎结局评分

指标类型:

主要指标

Outcome:

Knee Injury and Osteoarthritis Outcome Score

Type:

Primary indicator

测量时间点:

治疗前,治疗后

测量方法:

开始治疗前,跟患者讲明具体情况,患者真实填写。

Measure time point of outcome:

pro-treat, post-treat

Measure method:

Before starting the treatment, explain the specific situation to the patient, and the patient fill in the information truthfully

指标中文名:

数字疼痛评分

指标类型:

主要指标

Outcome:

Numeric Rating scale

Type:

Primary indicator

测量时间点:

每次治疗前,随访

测量方法:

将一条直线平均分为10份,在每个点标记数字0~10,让患者圈出自己的疼痛程度

Measure time point of outcome:

pro-treating,follow

Measure method:

Divide the line into 10 parts on average, mark the number 0~10 at each point, and let the patient circle their pain degree

指标中文名:

超声下触发点部位肌肉厚度

指标类型:

主要指标

Outcome:

The muscle thickness at the triggering point under ultrasound

Type:

Primary indicator

测量时间点:

治疗前,治疗后

测量方法:

触发点定位之后,用标记笔进行标记,借助超声观察厚度变化,按freeze,点击存储。

Measure time point of outcome:

pro-treat, post-treat

Measure method:

After the trigger point is located, mark it with a marker pen, observe the thickness change with ultrasound, press freeze and click store。

指标中文名:

超声下触发点对应肌肉的筋膜厚度

指标类型:

主要指标

Outcome:

he trigger point under ultrasound corresponds to the fascia thickness of the muscle

Type:

Primary indicator

测量时间点:

治疗前,治疗后

测量方法:

触发点定位之后,用标记笔进行标记,借助超声观察厚度变化,按freeze,点击存储。

Measure time point of outcome:

pro-treat, post-treat

Measure method:

After the trigger point is located, mark it with a marker pen, observe the thickness change with ultrasound, press freeze and click store。

指标中文名:

心率变化率

指标类型:

主要指标

Outcome:

Heart Rate Variability

Type:

Primary indicator

测量时间点:

治疗前,治疗后

测量方法:

患者端坐位,待准备好后将设备连接,点击开始,患者在整个过程中保持安静,但不能睡着。

Measure time point of outcome:

pro-treat, post-treat

Measure method:

The patient sits up, connects the device when ready, and clicks start. The patient stays quiet throughout the procedure, but does not fall asleep.

指标中文名:

骨关节炎严重性指数

指标类型:

主要指标

Outcome:

Index of severity for osteoarthritis

Type:

Primary indicator

测量时间点:

治疗前,治疗后

测量方法:

开始治疗前,跟患者讲明具体情况,患者真实填写。

Measure time point of outcome:

pro-treat, post-treat

Measure method:

Before starting the treatment, explain the specific situation to the patient, and the patient fill in the information truthfully

指标中文名:

关节活动度

指标类型:

主要指标

Outcome:

Range of motition

Type:

Primary indicator

测量时间点:

每次治疗前,随访

测量方法:

将一条直线平均分为10份,在每个点标记数字0~10,让患者圈出自己的疼痛程度

Measure time point of outcome:

pro-treating, follow

Measure method:

Divide the line into 10 parts on average, mark the number 0~10 at each point, and let the patient circle their pain degree

指标中文名:

匹兹堡睡眠指数量表

指标类型:

主要指标

Outcome:

Pittsburgh Sleep Index Quality scale

Type:

Primary indicator

测量时间点:

治疗前,治疗后

测量方法:

开始治疗前,跟患者讲明具体情况,患者真实填写。

Measure time point of outcome:

pro-treat, post-treat

Measure method:

Before starting the treatment, explain the specific situation to the patient, and the patient fill in the information truthfully

采集人体标本:

Collecting sample(s)
from participants:

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 70
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):

使用Gpower软件,α=0.05,β=80%,得出每组30人,因此每组纳入30名OA患者。(未说明随机方法)

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

Using Gpower software, =0.05, =80%, 30 people in each group were obtained, so 30 OA patients were included in each group.

盲法:

未说明

Blinding:

Not stated

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):

网络平台

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

network 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:

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

数据管理委员会:

Data Managemen Committee:

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):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above