针刺激痛点对腰背筋膜炎的镇痛的效应机制探讨和临床研究

注册号:

Registration number:

ITMCTR2025000258

最近更新日期:

Date of Last Refreshed on:

2025-02-13

注册时间:

Date of Registration:

2025-02-13

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

针刺激痛点对腰背筋膜炎的镇痛的效应机制探讨和临床研究

Public title:

The mechanism and clinical study of analgesic effect of acupuncture stimulation of myofascial trigger points on lumbar and dorsal fasciitis

注册题目简写:

English Acronym:

研究课题的正式科学名称:

针刺激痛点对腰背筋膜炎的镇痛的效应机制探讨和临床研究

Scientific title:

The mechanism and clinical study of analgesic effect of acupuncture stimulation of myofascial trigger points on lumbar and dorsal fasciitis

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:

申请注册联系人:

陈子杰

研究负责人:

王俊英

Applicant:

Zijie Chen

Study leader:

Junying Wang

申请注册联系人电话:

Applicant telephone:

18988947603

研究负责人电话:

Study leader's telephone:

13811526126

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:

kittotsuen@163.com

研究负责人电子邮件:

Study leader's E-mail:

wjyanguning@aliyun.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:

中国北京市东城区东直门内南小街16号

研究负责人通讯地址:

中国北京市东城区东直门内南小街16号

Applicant address:

No. 16, Dongzhimen Nei Nan Xiaojie, Dongcheng District, Beijing, China

Study leader's address:

No. 16, Dongzhimen Nei Nan Xiaojie, Dongcheng District, Beijing, 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:

中国中医科学院针灸研究所

Applicant's institution:

Institute of Acupuncture and Moxibustion,CACMS

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:

2024XLW007-2

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:

中国中医科学院西苑医院医学伦理委员会

Name of the ethic committee:

Xi Yuan Hospital Ethic Committee, Xiyuan Hospital, CACMS

伦理委员会批准日期:

Date of approved by ethic committee:

2025/1/1 0:00:00

伦理委员会联系人:

贾敏

Contact Name of the ethic committee:

Min Jia

伦理委员会联系地址:

北京市海淀区西苑操场1号

Contact Address of the ethic committee:

1 Xiyuan Caochang, Haidian District, Beijing, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

010-62835646

伦理委员会联系人邮箱:

Contact email of the ethic committee:

drzimingjie@126.com

研究实施负责(组长)单位:

中国中医科学院针灸研究所

Primary sponsor:

Institute of Acupuncture and Moxibustion,CACMS

研究实施负责(组长)单位地址:

中国北京市东城区东直门内南小街16号

Primary sponsor's address:

No. 16, Dongzhimen South Xiaojie, Dongcheng District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院针灸研究所针灸医院

具体地址:

东直门内南小街16号北新仓胡同 ,中国中医科学院北门西侧50米

Institution
hospital:

Acupuncture and Moxibustion Hospital of CACMS

Address:

No. 16, Dongzhimen Nei Nan Xiaojie, Dongcheng District, Beijing, China, 50 meters west of the north gate of China Academy of Chinese Medical Sciences

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院针灸研究所

具体地址:

中国北京市东城区东直门内南小街16号

Institution
hospital:

Institute of Acupuncture and Moxibustion,CACMS

Address:

No. 16, Dongzhimen Nei Nan Xiaojie, Dongcheng District, Beijing, China

经费或物资来源:

中国中医科学院针灸研究所基本科研业务费自主选题

Source(s) of funding:

Self - selected topics funded by the basic scientific research and operation expenses of the Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences

研究疾病:

腰背筋膜炎

研究疾病代码:

Target disease:

lumbar and dorsal fasciitis

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:

治疗新技术临床试验

New Treatment Measure Clinical Study

研究目的:

本研究拟观察腰部肌筋膜炎患者在针刺激痛点组和常规针刺组两种不同的针刺手法干预前后疼痛视觉模拟量表和压力疼痛阈值变化,观察评估其疗效;同时观察其激痛点数量、超声下评估针刺前后激痛点大小变化,激痛点的平均温度值,探索针刺激痛点镇痛与肌筋膜-肌肉及其周围血管可能的干预作用,明确针刺激痛点镇痛的可能机制。

Objectives of Study:

This study aims to observe the changes in the Visual Analogue Scale (VAS) for pain and pressure pain threshold in patients with lumbar myofasciitis before and after intervention with two different acupuncture techniques, namely the trigger - point acupuncture group and the conventional acupuncture group, and to evaluate the therapeutic effects. Meanwhile, the number of trigger points, the changes in the size of trigger points before and after acupuncture evaluated by ultrasound, and the average temperature value of trigger points will be observed. This is to explore the possible intervention effects of trigger - point acupuncture on analgesia and myofascia - muscle and its surrounding blood vessels, and to clarify the possible mechanisms of analgesia by trigger - point acupuncture.

药物成份或治疗方案详述:

1. 试验组 针刺激痛点组 a. 针灸针:0.42×40mm 的一次性针灸针 b. 操作前准备:患者取俯卧位并用手指指认腰背部疼痛部位,医生通过触诊校对激痛点位置,然后有针对性地寻找压痛结节点,用记号笔标记,充分暴露操作 部位后予以常规消毒。 c. 操作方法:操作者固定其激痛点,使用腕部的力量将针快速穿过表皮,后尝试顺着肌纤维方向针刺,在超声引导下,用针找到激痛点,快速在激痛点上反复刺激,刺激时可观察到局部抽搐反应,直至肌肉跳动停止后,拔针。 d. 疗程:治疗 2 次/周,共治疗 2 周。 2. 对照组 常规针刺组 a. 针灸针:0.25×40mm 的一次性针灸针。 b. 操作:患者取俯卧位,选取肾俞、委中、大肠俞、腰阳关穴位,得气后留针 30min。 c. 疗程:治疗 2 次/周,共治疗 2 周。

Description for medicine or protocol of treatment in detail:

1.Experimental Group Trigger - Point Acupuncture Group a. Acupuncture needles: Disposable acupuncture needles with a size of 0.42×40mm. b. Preparation before operation: The patient takes a prone position and indicates the painful area on the back with fingers. The doctor checks the location of the trigger points through palpation then purposefully looks for the tender nodular points marks them with a marker pen. After fully exposing the operation area routine disinfection is carried out. c. Operation method: The operator fixes the trigger point quickly inserts the needle through the epidermis using the strength of the wrist. Then try to insert the needle along the direction of muscle fibers. Under the guidance of ultrasound find the trigger point with the needle and rapidly and repeatedly stimulate the trigger point. During the stimulation a local twitch response can be observed. After the muscle twitching stops withdraw the needle. d. Treatment course: Treat 2 times a week for a total of 2 weeks. 2.Control Group Conventional Acupuncture Group a. Acupuncture needles: Disposable acupuncture needles with a size of 0.25×40mm. b. Operation: The patient takes a prone position. Select acupoints such as Shenshu (BL23) Weizhong (BL40) Dachangshu (BL25) and Yaoyangguan (GV3). After obtaining qi retain the needles for 30 minutes. c. Treatment course: Treat 2 times a week for a total of 2 weeks.

纳入标准:

(1)急性或慢性腰背部疼痛史、劳损或外感风寒湿等病史; (2)腰背部弥漫性疼痛,皮肤发凉或酸胀麻木,肌肉痉挛,活动受限等; (3)疼痛特点是晨起或气候变化及受凉后症状加重,而活动和遇暖后则疼痛减轻,长时间不活动或活动过度均可诱发疼痛,常反复发作,病情缠绵; (4)检查局部可触及明显的扳机点或肌肉痉挛性痛性结节,用力压迫或捏 挤受累肌肉时可引发疼痛和放射感,还可在该肌稍远区域引发疼痛和肌紧张; (5)辅助检查:X 线检查无阳性体征,排除骨折、结核等疾病; (6)年龄为 18~65 岁; (7)近 1 月未口服治疗或者安慰作用的药物,未接受针刺或封闭、手术治疗; (8)患者自愿签署知情同意书。

Inclusion criteria

(1) History of acute or chronic low back pain, history of strain, or exposure to wind - cold - dampness. (2) Diffuse pain in the low back, cool skin, or a feeling of soreness, numbness, muscle spasm, and limited mobility. (3) The pain is characterized by aggravation in the morning, with changes in climate, or after getting cold. The pain eases with movement and warmth. Prolonged inactivity or excessive activity can both trigger the pain. The condition often recurs and persists. (4) During examination, obvious trigger points or spastic tender nodules in the muscles can be felt locally. Pressing or squeezing the affected muscles forcefully can cause pain and a radiating sensation, and can also trigger pain and muscle tension in an area slightly farther away from the muscle. (5) Auxiliary examinations: No positive signs are found in X - ray examinations, ruling out diseases such as fractures and tuberculosis. (6) Age ranges from 18 to 65 years old. (7) No oral medications with therapeutic or placebo effects have been taken in the past month, and no acupuncture, nerve - block, or surgical treatments have been received. (8) The patient voluntarily signs the informed consent form.

排除标准:

(1)妊娠、哺乳期妇女、精神病患者或计划妊娠者; (2)合并心血管、脑血管、肝、肾等严重原发性疾病者; (3)凝血功能障碍等血液系统疾病及糖尿病、严重腰椎间盘突出、骨折、骨结核等病变患者; (4)有针灸禁忌证,如皮肤感染、溃疡、瘢痕,或肿瘤,以及 1 年内有胸腰椎骨折及手术史者; (5)近期参加过其它药物临床试验者。

Exclusion criteria:

(1) Pregnant women, lactating women, patients with mental illness, or those planning to become pregnant. (2) Patients with severe primary diseases involving the cardiovascular system, cerebrovascular system, liver, kidneys, etc. (3) Patients with hematological diseases such as coagulation disorders, as well as those with diseases like diabetes, severe lumbar disc herniation, fractures, bone tuberculosis, etc. (4) Patients with contraindications to acupuncture, such as skin infections, ulcers, scars, or tumors, and those with a history of thoracolumbar fractures or surgeries within one year. (5) Those who have participated in other drug clinical trials recently.

研究实施时间:

Study execute time:

From 2023-12-01

To      2025-12-31

征募观察对象时间:

Recruiting time:

From 2025-02-17

To      2025-12-31

干预措施:

Interventions:

组别:

常规针刺组

样本量:

30

Group:

Conventional Acupuncture Group

Sample size:

干预措施:

针刺穴位

干预措施代码:

2

Intervention:

Acupuncture at Acupoints

Intervention code:

组别:

针刺激痛点组

样本量:

30

Group:

Trigger-Point Acupuncture Group

Sample size:

干预措施:

针刺激痛点

干预措施代码:

1

Intervention:

Trigger - point acupuncture

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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院针灸研究所针灸医院

单位级别:

一级甲等

Institution/hospital:

Acupuncture and Moxibustion Hospital of CACMS

Level of the institution:

Grade I Grade A

测量指标:

Outcomes:

指标中文名:

激痛点数量

指标类型:

次要指标

Outcome:

The number of trigger points

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

RDQ 功能障碍评分

指标类型:

次要指标

Outcome:

Roland-Morris Disability Questionnaire

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疼痛视觉模拟量表

指标类型:

主要指标

Outcome:

Visual Analogue 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:

红外热成像

指标类型:

次要指标

Outcome:

Infrared Thermal Imaging

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

压痛阈值与疼痛耐受性

指标类型:

次要指标

Outcome:

Pressure Pain Threshold & Pressure Pain Tolerance

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

彩色多普勒显像

指标类型:

次要指标

Outcome:

Color Doppler Imaging

Type:

Secondary 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:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 65
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):

本研究采用中心随机方法。计算机产生的随机方案由专人负责,用不透光的信封密闭保管。随机方案除设计者及中心随机负责人之外,其他研究人员均不能知晓。将入组患者首先按就诊先后顺序编号,临床医师根据患者的入组序号向随机方案保管人索取该患者的随机号及该随机号所对应的治疗方案。将 60 例入组患者随机分为针刺激痛点组和常规针刺组。每组均为 30 例。

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

This study adopted the central randomization method. The randomization scheme generated by the computer was in the charge of a dedicated person and stored in opaque envelopes for secure custody. Except for the designer and the person in charge of central randomization other researchers were not privy to the randomization scheme. The enrolled patients were first numbered according to the order of their visits. The clinical physicians would request the random number of a patient and the corresponding treatment plan from the custodian of the randomization scheme based on the patient's enrollment serial number. A total of 60 enrolled patients were randomly divided into the trigger - point acupuncture group and the conventional acupuncture group with 30 patients in each group.

盲法:

本研究中针刺激痛点组和常规针刺组的治疗方式存在较大差异,因此无法采用双盲研究设计。为了克服这一弊端,我们采用了双人双录入方法,对录入的数据进行核对。

Blinding:

In this study, there were significant differences in the treatment methods between the trigger - point acupuncture group and the conventional acupuncture group. Therefore, a double - blind research design could not be adopted. To overcome this drawback, we employed a double - entry method by two individuals to check the entered data.

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):

公开时间:2030年1月1号;公开方式:联系试验执行人员

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

Publication time: January 1, 2030 Publication method: Contact the experiment executor

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)所有研究病例需按照上述方案进行观察记录,准确填写病例报告表(CRF表)。记录所有受试者的一般情况(如年龄、病程、BMI、生命体征等)和 VAS、RDQ 功能障碍评分、不良反应记录等内容。 2)CRF 表的记录要求:数据记录者(不清楚受试者组别及干预措施)必须在规定的时间填写 CRF 表。应确保数据的准确性、真实性和完整性。如需要对数据进行更正,可在原数据上划线(不可遮盖和涂擦)。随后在其旁边标注更正后的数据,并由记录者签名和标注日期。 3)CRF 表交由不参与本研究的第三方人员保管(不清楚受试者组别和干预措施)。

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

1) All research cases shall be observed and recorded in accordance with the above - mentioned protocol and the Case Report Form (CRF) shall be accurately filled out. Record the general information of all subjects (such as age disease duration BMI vital signs etc.) VAS RDQ disability scores adverse reaction records and other contents. 2) Requirements for recording in the CRF: The data recorder (who is unaware of the subject groups and intervention measures) must fill out the CRF within the specified time. Ensure the accuracy authenticity and integrity of the data. If data correction is required draw a line through the original data (do not cover or erase it). Then mark the corrected data next to it and the recorder shall sign and indicate the date. 3) The CRF shall be kept by a third - party person who is not involved in this study (and is unaware of the subject groups and intervention measures).

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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