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J型针刀推切法治疗屈指肌腱狭窄性腱鞘炎的临床疗效研究

注册号：

Registration number：

ITMCTR2100004232

最近更新日期：

Date of Last Refreshed on：

2020-10-10

注册时间：

Date of Registration：

2020-10-10

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

J型针刀推切法治疗屈指肌腱狭窄性腱鞘炎的临床疗效研究

Public title：

Clinical efficacy of J-type acupotomy in the treatment of flexor tendon stenosing tenosynovitis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

J型针刀推切法治疗屈指肌腱狭窄性腱鞘炎的临床疗效研究

Scientific title：

Clinical efficacy of J-type acupotomy in the treatment of flexor tendon stenosing tenosynovitis

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：

ChiCTR2000038935 ; ChiMCTR2100004232

申请注册联系人：

程凌

研究负责人：

熊伟

Applicant：

Cheng Ling

Study leader：

Xiong Wei

申请注册联系人电话：

Applicant telephone：

+86 15079095332

研究负责人电话：

Study leader's telephone：

+86 15979030828

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：

yongyicheng1991@163.com

研究负责人电子邮件：

Study leader's E-mail：

330754036@qq.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：

江西省南昌市东湖区民德路264号

研究负责人通讯地址：

江西省南昌市东湖区民德路264号

Applicant address：

264 Minde Road, Donghu District, Nanchang, Jiangxi, China

Study leader's address：

264 Minde Road, Donghu District, Nanchang, Jiangxi, China

申请注册联系人邮政编码：

Applicant postcode：

330000

研究负责人邮政编码：

Study leader's postcode：

330000

申请人所在单位：

南昌市洪都中医院

Applicant's institution：

Nanchang Hongdu Hospital of TCM

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：

KY-2020-005

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：

南昌市洪都中医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Nanchang Hongdu Hospital of TCM

伦理委员会批准日期：

Date of approved by ethic committee：

2020/8/20 0:00:00

伦理委员会联系人：

刘建芳

Contact Name of the ethic committee：

Liu Jianfang

伦理委员会联系地址：

江西省南昌市红谷滩区碟子湖大道1399号

Contact Address of the ethic committee：

1399 Diezihu Avenue, Honggutan District, Nanchang, Jiangxi, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 791-83863120

伦理委员会联系人邮箱：

Contact email of the ethic committee：

hongduiec@163.com

研究实施负责（组长）单位：

洪都中医院

Primary sponsor：

Nanchang Hongdu Hospital of TCM

研究实施负责（组长）单位地址：

江西省南昌市东湖区民德路264号

Primary sponsor's address：

264 Minde Road, Donghu District, Nanchang, Jiangxi, 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)：

江西

市(区县)：

南昌

Country：

China

Province：

Jiangxi

City：

Nanchang

单位(医院)：

洪都中医院

具体地址：

东湖区民德路264号

Institution
hospital：

Nanchang Hongdu Hospital of TCM

Address：

264 Minde Road, Donghu District

经费或物资来源：

江西省科技厅重点研发项目拨付；医院配套

Source(s) of funding：

Jiangxi Provincial Science and Technology Department allocated funds for key RESEARCH and development projects; Form a complete set of the hospital

研究疾病：

屈指肌腱狭窄性腱鞘炎

研究疾病代码：

Target disease：

Flexor tendon stenosing tenosynovitis

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

非随机对照试验

Non randomized control

研究所处阶段：

Study phase：

探索性研究/预试验

Pilot clinical trial

研究目的：

近年来随着手工劳动者及家庭妇女的屈指肌腱狭窄性腱鞘炎的发病率不断增高，课题组发明一种新型针刀工具（J型针刀）。为验证该工具的有效性性及安全性为目的而开展试验。方法：纳入我院2020年11月至2022年5月间的屈指肌腱狭窄性腱鞘炎患者，分为实验组及对照组开展队列研究，对比记录实验数据验证该新型针刀与传统针刀、封闭注射之间的优劣。

Objectives of Study：

In recent years, with the increasing incidence of flexor tendon stenosing tenosynovitis in manual workers and housewives, the research team has invented a new type of needle knife (J type needle knife). Experiments are carried out for the purpose of verifying the effectiveness and safety of the tool. Methods: The patients with flexor tendon stenosing tenosynovitis in our hospital from December 2019 to May 2022 were enrolled and divided into experimental group and control group to carry out a cohort study. The experimental data was compared and recorded to verify that the new type of needle knife and traditional needle knife, closed injection The pros and cons between.

药物成份或治疗方案详述：

以针刀理论为指导，在前期针刀治疗屈指肌腱狭窄性腱鞘炎相关研究的基 础上，开展“J 型针刀推切法治疗屈指肌腱狭窄性腱鞘炎的临床疗效研究”疗法 的临床试验研究，本课题采用病例系列观察设计，纳入 50 例合格病例，以 J 型 针刀推切法治疗屈指肌腱狭窄性腱鞘炎为干预措施，观察屈指肌腱狭窄性腱鞘 炎治疗的效果，以期为屈指肌腱狭窄性腱鞘炎的中西医结合防治研究提供一种 可借鉴的思路和方法。主要内容如下： 2.1.1.1 发明 J 型针刀刀具、针刀操作台、治疗床及配套设备的改良研究本 课题组经长期研究发现，拥有弧刃的 J 型针刀通过推切法对腱鞘的松解 力度更大，更易操作且复发概率更低，因此发明了 J 型针刀，该型针刀采用进 口钢材，其针刃呈 J 型，采用一次性铸造工艺加工而成；同时拟对针刀操作台、治 疗床及配套设备进行改良：进行该项治疗时采用本院自制的特制针刀操作台、治 疗床及配套设备，该治疗床选用坚固、耐用的铝合金材料，采用常规焊接工艺 制成，患者平卧时可云操作台上摆放患肢，可使患者在平卧状态下舒适的完成 治疗，减轻患者不适感。 2.1.1.2 屈指肌腱狭窄性腱鞘炎治疗的新技术研究 本课题组首次将 J 型针刀用于治疗屈指肌腱狭窄性腱鞘炎，课题组突破传 统思维发明了 J 型针刀，并研究运用 J 型针刀推切技术探索屈指肌腱狭窄性腱 鞘炎的新技术。 2.1.1.3 归类并整理屈指肌腱狭窄性腱鞘炎的诊断标准 目前国内对于腱鞘炎的诊断过于笼统，课题组经过研究发现，狭窄性腱鞘 炎同时也有不同种类的分型，通过临床研究课题组将逐步总结归纳。 2.1.1.4 J 型针刀治疗操作规范研究 课题组拟设计一套规范的 J 型针刀治疗操作方案，具体方案如下：患者取卧 位，患手放在操作台上，用碘伏消毒后，铺无菌洞巾，术者带无菌手套，左手拇 指按压痛性结节处，右手持注射器注入 2%盐酸利多卡因 1ml 和 0.9%氯化钠注射液 4ml 的混合液，进行局部浸润麻醉，稍停，当麻醉生效后。右手更换手持 J 型针 刀尖部对准痛性结节顶点皮肤，右手食指按压 J 型针刀，将针刀刺入皮下，深度 达屈指肌腱表面，沿屈指肌腱走形方向用 J 型针刀提拉松解 3～5 次， 感针刀下无 阻力，即松解充分后，拔出 J 型针刀，拔出 J 型针刀用左手拇指按压针孔防止出 血，并做被动关节屈伸活动，此时病人感觉无疼痛，屈伸无阻力， 进针处贴创可 贴，手术完毕。每周 1 次，2 次为一个疗程，连续治疗 1 个疗程。 2.1.1.5J 型针刀治疗屈指肌腱狭窄性腱鞘炎临床效果及安全性研究 课题组拟采用拟采用屈指肌腱狭窄性腱鞘炎患者的发病指关节的活动度及 VAS 评分作为观察指标；随访研究对象治疗后 6 个月及 1 年后复发次数及疼痛改 善情况；采用研究对象自身前后对比，观察研究对象的症状、VAS 评分变化，客 观评价“J 型针刀治疗” 疗法在屈指肌腱狭窄性腱鞘炎的临床疗效。

Description for medicine or protocol of treatment in detail：

Guided by the acupotomy theory, and on the basis of the previous research related to the treatment of flexor flexor tendon stenosing tenosynovitis with acupotomy, the clinical trial study of the treatment of "J-shaped needle knife pushing method in the treatment of flexor tendon stenosing tenosynovitis" was carried out. The subject adopts a case series observation design, and 50 qualified cases are included. The J-type needle knife push method is used to treat flexor tendon stenosing tenosynovitis as an intervention measure to observe the effect of the treatment of flexor tendon stenosing tenosynovitis. The prevention and treatment research of integrated western medicine provides a way of thinking and methods for reference. The main contents are as follows: 2.1.1.1 Inventing the improvement of the J-shaped needle knife, needle knife operating table, treatment bed and supporting equipment After long-term research, the research group found that the J-shaped needle knife with arc blade can release the tendon sheath more forcefully by pushing and cutting. It is larger, easier to operate and has a lower probability of recurrence. Therefore, the J-type needle knife was invented. This type of needle knife is made of imported steel, and its needle blade is J-shaped. It is processed by a one-time casting process; at the same time, it is planned to align the needle knife operating table, The treatment bed and supporting equipment are improved: the special needle knife operating table, treatment bed and supporting equipment made by our hospital are used for this treatment. The treatment bed is made of strong and durable aluminum alloy material and is made by conventional welding technology. When lying supine, the affected limb can be placed on the cloud operating table, so that the patient can complete the treatment comfortably in the supine state and reduce the patient's discomfort. 2.1.1.2 Research on new technology for the treatment of flexor tendon stenosing tenosynovitis This research group used the J-type needle knife for the treatment of flexor tendon stenosing tenosynovitis for the first time. The research group broke through traditional thinking and invented the J-type needle knife, and studied the use of the J-type needle knife. Push-cut technique to explore new techniques for stenosing tenosynovitis of the flexor tendon. 2.1.1.3 Categorize and sort out the diagnostic criteria for flexor tendon stenosing tenosynovitis. At present, the diagnosis of tenosynovitis in China is too general. The research team found that there are also different types of stenosing tenosynovitis, which will be gradually summarized and summarized by the clinical research team. . 2.1.1.4 The research group of J-type needle-knife treatment operation specifications plans to design a standard J-type needle-knife treatment operation plan. The specific plan is as follows: the patient is placed in a lying position, the affected hand is placed on the operating table, and after disinfection with iodophor, Spread a sterile hole towel, the surgeon wears sterile gloves, press the painful nodule with the left thumb, and inject a mixture of 1ml 2% lidocaine hydrochloride and 4ml 0.9% sodium chloride injection with the right hand syringe for local infiltration anesthesia , Pause, when the anesthesia takes effect. Replace the tip of the J-shaped needle knife with the right hand and aim at the skin of the apex of the painful nodule, press the J-shaped needle knife with the index finger of the right hand, and pierce the needle knife into the skin, reaching the surface of the flexor digitorum tendon, and use the J-shaped needle knife along the direction of the flexor digitorum tendon. Lift and loosen 3 to 5 times, and feel no resistance under the needle knife, that is, when the needle knife is fully loosened, pull out the J needle knife, pull out the J needle knife, press the needle hole with the left thumb to prevent bleeding, and do passive joint flexion and extension activities At this time, the patient feels no pain, no resistance to flexion and extension, a band-aid is applied to the needle entry point, and the operation is completed. 1 time a week, 2 times as a course of treatment, continuous treatment for 1 course. 2.1.1.5 The clinical effect and safety of J-type needle-knife in the treatment of flexor tendon stenosing tenosynovitis The research group intends to use the range of motion and VAS score of the onset finger joints of patients with flexor tendon stenosing tenosynovitis as observation indicators; follow-up study subjects after treatment The number of recurrences and pain improvement after 6 months and 1 year; before and after comparison of the subjects themselves, the subjects symptoms and VAS score changes were observed to objectively evaluate the clinical efficacy of "J-type needle knife treatment" in flexor tendon stenosing tenosynovitis .

纳入标准：

1.患者符合中屈肌腱狭窄性腱鞘炎的诊断标准； 2.年龄在 18～ 60 岁的患者，男女不限； 3.患者均知情同意。

Inclusion criteria

1. The patient meets the diagnostic criteria for stenosing tenosynovitis of the middle flexor tendon; 2. Patients aged 18 to 60 years, regardless of gender; 3. All patients have informed consent.

排除标准：

1.屈肌腱狭窄性腱鞘炎而无弹响和绞锁症状者； 2 合并严重的肝、肾、造血系统、内分泌系统疾病，骨质疏松症、恶性肿瘤、严重外伤、心肌梗死、脑出血后遗症等严重原发性疾病及精神病患者； 3.近 1 个月内接受过或正在接 受其他治疗方法，可能对治疗效果造成影响者； 4.不能配合针刀治疗者； 5.存在出血倾向等不宜用针刀治疗者； 6.对利多卡因过敏者；

Exclusion criteria：

1. Patients with flexor tendon stenosing tenosynovitis without snapping and locking symptoms; 2. With severe liver, kidney, hematopoietic system, endocrine system diseases, osteoporosis, malignant tumors, severe trauma, myocardial infarction, sequelae of cerebral hemorrhage or other severe primary diseases and mental illness; 3. Those who have received or are receiving other treatments in the past month, which may affect the treatment effect; 4. Those who cannot cooperate with needle knife treatment; 5. Those who have bleeding tendency, etc. are not suitable for use needle knife therapy; 6. Allergic to lidocaine.

研究实施时间：

Study execute time：

从From 2020-01-01

至To      2022-06-30

征募观察对象时间：

Recruiting time：

从From 2020-11-01

至To      2022-05-31

干预措施：

Interventions：

组别：

B组

样本量：

26

Group：

Group B

Sample size：

干预措施：

普通针刀

干预措施代码：

O

Intervention：

Ordinary needle knife

Intervention code：

组别：

C组

样本量：

26

Group：

Group C

Sample size：

干预措施：

J型针刀

干预措施代码：

J

Intervention：

J type needle knife

Intervention code：

组别：

A组

样本量：

26

Group：

Group A

Sample size：

干预措施：

局部封闭

干预措施代码：

P

Intervention：

Partially closed

Intervention code：

样本总量 Total sample size ： 78

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

江西

市(区县)：

南昌

Country：

china

Province：

Jiangxi

City：

Nanchang

单位(医院)：

南昌市洪都中医院

单位级别：

三级甲等

Institution/hospital：

Nanchang Hongdu Hospital of TCM

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

视觉模拟评分

指标类型：

次要指标

Outcome：

Visual analog scale

Type：

Secondary indicator

测量时间点：

术前、术后、1周、2周

测量方法：

测试表

Measure time point of outcome：

Before operation, after operation, 1 week, 2 weeks

Measure method：

Test shteet

指标中文名：

肌腱功能评定标准

指标类型：

主要指标

Outcome：

Tendon function evaluation standard

Type：

Primary indicator

测量时间点：

术前、术后、1周、2周

测量方法：

测试表

Measure time point of outcome：

Before operation, after operation, 1 week, 2 weeks

Measure method：

Test sheet

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

N/A

Tissue：

人体标本去向

其它

说明

Fate of sample 

Others

Note：

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 60 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）：

根据患者的就诊门诊号码进行随机分组。A组的尾数为0、1、2和3，B组的尾数为4、5和6，C组的尾数为7、8和9。

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

Randomized grouping according to the outpatient number of patients.The mantissas of group A are 0, 1, 2, and 3, the mantissas of group B are 4, 5, and 6, and the mantissas of group C are 7, 8, and 9.

盲法：

未说明

Blinding：

Not stated

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）：

2023年01月01日，U.S. National Library of Medicine，https://clinicaltrials.gov/

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

January 1, 2023, U.S. National Library of Medicine, https://clinicaltrials.gov/

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：

计量资料采用 t 检验,计数资料采用χ2 检验, 等级资料用 Ridit 分析，所 用计量资料采用平均数±标准差表示。所有统计计算用 SPSS22.0 统计软件进行 分析，P≤0.05 作为有统计学意义，以 P≤0.01 作为有显著性统计学意义。

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

The measurement data is measured by t test, the count data is by the χ2 test, the rank data is analyzed by Ridit, and the measurement data used is represented by the mean ± standard deviation. All statistical calculations are analyzed with SPSS22.0 statistical software, P≤0.05 is considered statistically significant, and P≤0.01 is considered statistically significant.

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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