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Efficacy evaluation of blade acupuncture in the treatment of fasciitis of the back of the nape based on the theory of fascial release

注册号：

Registration number：

ITMCTR2200006468

最近更新日期：

Date of Last Refreshed on：

2022-08-13

注册时间：

Date of Registration：

2022-08-13

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

基于筋膜松解理论刃针治疗项背肌筋膜炎的疗效评价

Public title：

Efficacy evaluation of blade acupuncture in the treatment of fasciitis of the back of the nape based on the theory of fascial release

注册题目简写：

基于筋膜松解理论刃针治疗项背肌筋膜炎的疗效评价

English Acronym：

Evaluation of the efficacy of fascial release theory based on sharpened needling in the treatment of fasciitis of the collar dorsalis muscle

研究课题的正式科学名称：

中医学-针灸推拿学

Scientific title：

Chinese Medicine -Acupuncture, Moxibustion and Tuina

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：

ChiCTR2200062603 ; ChiMCTR2200006468

申请注册联系人：

张军

研究负责人：

张军

Applicant：

张军

Study leader：

张军

申请注册联系人电话：

Applicant telephone：

18201692535

研究负责人电话：

Study leader's telephone：

18201692535

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：

853538582@qq.com

研究负责人电子邮件：

Study leader's E-mail：

853538582@qq.com

申请单位网址(自愿提供)：

Study leader's website(voluntary supply)：

北京小汤山医院

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：

北京市昌平区北京小汤山医院

研究负责人通讯地址：

北京市昌平区北京小汤山医院

Applicant address：

Beijing Xiaotangshan Hospital, Changping District, Beijing

Study leader's address：

/

申请注册联系人邮政编码：

Applicant postcode：

102200

研究负责人邮政编码：

Study leader's postcode：

102200

申请人所在单位：

北京小汤山医院

Applicant's institution：

Beijing Xiaotangshan Hospital

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：

[2022]伦审第（03）号

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

北京小汤山医院医学伦理委员会

Name of the ethic committee：

Beijing Xiaotangshan Hospital Medical Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2022/2/21 0:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

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：

北京小汤山医院

Primary sponsor：

Beijing Xiaotangshan Hospital

研究实施负责（组长）单位地址：

北京市昌平区北京小汤山医院

Primary sponsor's address：

Beijing Xiaotangshan Hospital, Changping District, Beijing

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

市(区县)：

北京市

Country：

China

Province：

Beijing

City：

Beijing

单位(医院)：

北京小汤山医院

具体地址：

北京市昌平区北京小汤山医院

Institution
hospital：

Beijing Xiaotangshan Hospital

Address：

Beijing Xiaotangshan Hospital, Changping District, Beijing

经费或物资来源：

北京小汤山医院

Source(s) of funding：

Beijing Xiaotangshan Hospital

研究疾病：

项背痛

研究疾病代码：

/

Target disease：

Neck and back pain

Target disease code：

研究类型：

Study type：

治疗研究

Treatment 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：

本研究基于筋膜松解理论，采用刃针干预，观察其对项背肌筋膜炎患者VAS值、压痛积分评定及表面肌电图信号检测、肌骨超声检测的影响，探讨筋膜松解理论指导下刃针治疗项背肌筋膜炎的疗效评价及其作用机制，为今后优化肌筋膜炎的临床诊疗方案及其推广应用提供试验依据和研究思路。 (1) 采用刃针作为干预手段，通过观察干预前后VAS值、表面肌电图信号检测、肌骨超声及压痛积分评定等指标的变化； (2) 明确并探讨筋膜松解理论刃针治疗项背肌筋膜炎的疗效及可能机制； (3) 为今后临床推广应用提供试验依据和研究思路。

Objectives of Study：

In this study, based on the fascial release theory, we used sharpened needle intervention to observe its effects on VAS values, pressure pain score assessment, surface EMG signal detection and musculoskeletal ultrasound detection in patients with myofasciitis, to investigate the efficacy evaluation of sharpened needle treatment of myofasciitis under the guidance of fascial release theory and its mechanism of action, and to provide experimental basis and research ideas for optimizing the clinical treatment plan of myofasciitis and its promotion. (1) To observe the changes of VAS value, surface EMG signal detection, musculoskeletal ultrasound and pressure pain score assessment before and after the intervention by using sharpened needle as an intervention tool. (2) To clarify and explore the efficacy and possible mechanisms of the fascial release theory of sharpened needling in the treatment of collar dorsal myofasciitis. (3) To provide a test basis and research ideas for future clinical promotion and application.

药物成份或治疗方案详述：

对照组：对照组采用常规取穴，参照全国中医药行业高等教育“十二五”规划教材《针灸治疗学》第9版，颈部取双侧完骨、天柱、C3~C5颈夹脊穴、肩胛骨内上角阿是穴。选用一次性东邦针灸针0.25 mm×40mm毫针常规针刺。患者取俯卧位或坐位, 用75%酒精棉球穴位常规消毒, 完骨、天柱均向鼻根方向斜刺；肩胛部内上角阿是穴与皮肤呈15°、夹角进针5~10 mm, 持续捻转1 min；颈夹脊穴向脊柱方向斜刺10 mm，穴位先行提插法获得酸麻或者重胀感后，行平补平泻捻转手法，留针20 分钟，3次/周，2周为一疗程。 针刺腧穴定位参照2006年中华人民共和国国家标准(GB/T 12346-2006)《腧穴名称与定位》。针刺操作参照新世纪全国中医药院校规划教材《针灸学》中的操作方法。 试验组 基于筋膜松解理论指导刃针治疗项背肌筋膜炎操作方法：患者俯卧位， 在患者的肩背部触诊寻找到有结节、按压硬、痛处作为阳性点，根据患者体征选取患病肌肉、筋膜起止点及循行部位粘连、挛缩疼痛点（主要以斜方肌、肩胛提肌、大小菱形肌等起止点及走行选取压痛点），用龙胆紫笔标记定位， 局部常规消毒， 铺无菌洞巾，戴无菌手套，予1%利多卡因适量局麻，起效后施术，采用刃针为汉章牌0.6×50mm针具，刃口方向与肌肉走向一致，针体与皮肤呈90°垂直，严格按照四步进针法，即定点、定位、加压分离、刺入进行操作。术后处置及护理:出刃针后针孔如有出血用无菌棉球按压2~3 min止血；操作结束后用75%酒精常规消毒术区，然后用无菌纱布覆盖或创可贴覆盖术口， 嘱患者保持术口清洁干燥，24小时后去除，3天内勿使术口湿水或污染。每周治疗1次，治疗1~2周，观察2周。 （操作、治疗点选取参照中国中医药出版社中国针灸学会微创针刀委员会制订《针刀医学临床诊疗与操作规范》）

Description for medicine or protocol of treatment in detail：

Control group: In the control group, conventional acupuncture points were taken, referring to the "12th Five-Year Plan" textbook for higher education in Chinese medicine, "Acupuncture and Moxibustion Therapeutics", 9th edition. Disposable Dongbang acupuncture needles 0.25 mm×40 mm milli needles were selected for conventional acupuncture. The patient was placed in a prone or seated position, and the acupuncture points were disinfected with 75% alcohol cotton balls, and the end bone and tianzhu were stabbed obliquely in the direction of the nasal root; the acupuncture point at the upper inner corner of the scapula was stabbed at an angle of 15° to the skin for 5-10 mm, with continuous twisting for 1 min; the cervical spine point was stabbed obliquely in the direction of the spine for 10 mm. The acupuncture point was first lifted and inserted to obtain a feeling of soreness and numbness or heavy distension. The acupuncture points were positioned with reference to the 2006 National Standard of the People's Republic of China (GB/T 12346-2006) "Name and Positioning of Acupuncture Points". The acupuncture operation referred to the operation method in the new century national Chinese medicine college planning textbook "Acupuncture and Moxibustion". Experimental group Based on the theory of fascial release to guide the treatment of fasciitis of the collateral dorsal muscles, the patient was placed in a prone position, and the patient's back shoulder was palpated to find the nodules, hard and painful areas as positive points. Localization, routine local disinfection, sterile towel, sterile gloves, appropriate amount of 1% lidocaine local anesthesia, after the onset of effect, the operation was performed with a Hanzhang 0.6×50mm needle, the direction of the blade was in line with the direction of the muscle, the needle body was 90° perpendicular to the skin, and the operation was performed in strict accordance with the four-step needle method, i.e., pointing, positioning, pressure separation, and piercing. Postoperative disposal and care: If there is bleeding in the needle hole after the blade needle is removed, press the sterile cotton ball for 2~3 min to stop the bleeding; after the operation, disinfect the operation area with 75% alcohol routinely, then cover the operation opening with sterile gauze or band-aid, instruct the patient to keep the operation opening clean and dry, remove it after 24 hours, and do not make the operation opening wet or contaminated within 3 days. The treatment was performed once a week for 1~2 weeks and observed for 2 weeks. (Operation and selection of treatment points refer to the "Clinical Diagnosis and Operation Specification of Acupuncture Medicine" developed by the Minimally Invasive Acupuncture Committee of the Chinese Academy of Acupuncture and Moxibustion of the Chinese Medicine Press)

纳入标准：

(1)年龄18～75岁。 (2)符合项背肌筋膜疼痛综合征诊断标准。 (3)项背肌筋膜炎非急性期。 (4)自愿参与临床观察，服从医生安排，配合治疗，意识清楚，能配合检查及治疗； （5）病人及家属知情同意接受本临床试验，自愿参与研究签署知情同意书。

Inclusion criteria

(1)Age 18-75 years (2)Meet the diagnostic criteria of the myofascial pain syndrome of the collar and dorsal muscles (3) Non-acute stage of myofasciitis of the collar and back (4) Voluntary participation in clinical observation and obedience to the doctor's arrangement and cooperation with treatment. (5) Patients and their families gave informed consent to accept the clinical trial and voluntarily participated in the study by signing the informed consent form.

排除标准：

(1)有刃针禁忌证，如皮肤感染、溃疡、瘢痕或肿瘤部位等。 (2)排除非软组织源性疾病，包括合并急性软组织损伤、严重胸椎疾病、风湿病等。 (3)合并有其他影响研究结果的疾病，如严重的循环、内分泌、血液、免疫系统等原发性疾病或精神病患者。 （4）不能理解量表内容及检查，有困难或无法判断自身疼痛程度者。

Exclusion criteria：

(1) Contraindications to sharpening needles such as skin infections ulcers scars or tumor sites (2) exclude diseases of non-soft tissue origin including combined acute soft tissue injury severe thoracic spine disease rheumatism, etc. (3) Combination of other diseases that affect the study results, such as severe primary diseases of the circulatory, endocrine, hematological, immune system, or psychiatric patients. (4) Those who cannot understand the content of the scale and examination, have difficulty or cannot judge the degree of their own pain.

研究实施时间：

Study execute time：

从From 2022-01-01

至To      2023-12-31

征募观察对象时间：

Recruiting time：

从From 2022-08-15

至To      2023-12-31

干预措施：

Interventions：

组别：

试验组

样本量：

31

Group：

Test group

Sample size：

干预措施：

刃针+针灸

干预措施代码：

/

Intervention：

Blade Needle + Acupuncture

Intervention code：

组别：

对照组

样本量：

31

Group：

Control group

Sample size：

干预措施：

针灸

干预措施代码：

/

Intervention：

Acupuncture

Intervention code：

样本总量 Total sample size ： 62

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)：

北京

Country：

China

Province：

Beijing

City：

Beijing

单位(医院)：

北京小汤山医院

单位级别：

三级医院

Institution/hospital：

Beijing Xiaotangshan Hospital

Level of the institution：

Tertiary Hospital

测量指标：

Outcomes：

指标中文名：

疼痛视觉模拟评分

指标类型：

主要指标

Outcome：

Pain visual simulation score

Type：

Primary indicator

测量时间点：

治疗前、治疗后

测量方法：

量表

Measure time point of outcome：

Measured before treatment, 2 weeks after treatment

Measure method：

Scale

指标中文名：

压痛积分评定

指标类型：

次要指标

Outcome：

Pressure pain score assessment

Type：

Secondary indicator

测量时间点：

治疗前、治疗2周后测量

测量方法：

量表

Measure time point of outcome：

Measured before treatment, 2 weeks after treatment

Measure method：

Scale

指标中文名：

表面肌电图信号检测

指标类型：

次要指标

Outcome：

Surface electromyography signal detection

Type：

Secondary indicator

测量时间点：

治疗前、治疗2周后测量

测量方法：

仪器测评

Measure time point of outcome：

Measured before treatment, 2 weeks after treatment

Measure method：

Instrument Evaluation

指标中文名：

肌骨超声测量

指标类型：

次要指标

Outcome：

Musculoskeletal ultrasound measurements

Type：

Secondary indicator

测量时间点：

治疗前、治疗2周后测量

测量方法：

仪器测评

Measure time point of outcome：

Measured before treatment, 2 weeks after treatment

Measure method：

Instrument Evaluation

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 18 岁
Min age years
最大 75 岁
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）：

一名不参与治疗和数据分析的研究者按照随机数字表法随机的原则将入选患者分为试验组、对照组。随机数字隐藏在不透光的信封里，所有的随机信封由一名不参与治疗和数据分析的研究者保存。在基线评价和签署知情同意书后，研究者根据患者入组顺序拆开一个信封取得患者随机号，得到随机号的患者被带到临床医生处。随机信封有2套，以避免研究者随意调整分组情况。

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

An investigator not involved in treatment and data analysis divided the enrolled patients into trial and control groups according to the randomization principle of the random number table method. The random numbers were concealed in opaque envelopes, and all randomization envelopes were kept by an investigator who&

盲法：

非盲法

Blinding：

Non-blind method

是否共享原始数据：

IPD sharing：

否

No

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）：

非共享

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

Non-shared

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：

设置有CRF表，并录入EXCEL进行统计分析

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

Set up with CRF table and enter into EXCEL for statistical analysis

数据管理委员会：

Data Managemen Committee：

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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