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杵针配合一指禅推法治疗青少年假性近视的临床随机对照试验

注册号：

Registration number：

ITMCTR2025000916

最近更新日期：

Date of Last Refreshed on：

2025-05-07

注册时间：

Date of Registration：

2025-05-07

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

杵针配合一指禅推法治疗青少年假性近视的临床随机对照试验

Public title：

A randomized controlled trial of pestle needle Combined with One-Finger Pushing Manipulation in the treatment of juvenile pseudmyopia

注册题目简写：

English Acronym：

研究课题的正式科学名称：

杵针配合一指禅推法治疗青少年假性近视的临床随机对照试验

Scientific title：

A randomized controlled trial of pestle needle Combined with One-Finger Pushing Manipulation in the treatment of juvenile pseudmyopia

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：

史庆卫

研究负责人：

史庆卫

Applicant：

Qingwei Shi

Study leader：

Qingwei Shi

申请注册联系人电话：

Applicant telephone：

13540194152

研究负责人电话：

Study leader's telephone：

13540194152

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：

921275913@qq.com

研究负责人电子邮件：

Study leader's E-mail：

921275913@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：

四川省成都市温江区万春东路61号

研究负责人通讯地址：

四川省成都市温江区万春东路61号

Applicant address：

61 Wanchun East Road Wenjiang District Chengdu City Sichuan Province China

Study leader's address：

61 Wanchun East Road Wenjiang District Chengdu City Sichuan Province 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：

温江区中医医院

Applicant's institution：

Wenjiang district Hospital of traditional Chinese Medicine

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：

2023第01号

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：

温江区中医医院伦理委员会

Name of the ethic committee：

Ethics Committee of Wenjiang District Hospital of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2023/4/12 0:00:00

伦理委员会联系人：

叶晨霞

Contact Name of the ethic committee：

Chenxia Ye

伦理委员会联系地址：

四川省成都市温江区万春东路61号

Contact Address of the ethic committee：

61 Wanchun East Road Wenjiang District Chengdu City Sichuan Province China

伦理委员会联系人电话：

Contact phone of the ethic committee：

18980695881

伦理委员会联系人邮箱：

Contact email of the ethic committee：

316854174@qq.com

研究实施负责（组长）单位：

温江区中医医院

Primary sponsor：

Wenjiang district Hospital of traditional Chinese Medicine

研究实施负责（组长）单位地址：

四川省成都市温江区万春东路61号

Primary sponsor's address：

61 Wanchun East Road Wenjiang District Chengdu City Sichuan Province 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)：

四川省

市(区县)：

成都市

Country：

China

Province：

Sichuan Province

City：

Chengdu City

单位(医院)：

温江区中医医院

具体地址：

四川省成都市温江区万春东路61号

Institution
hospital：

Wenjiang district Hospital of traditional Chinese Medicine

Address：

61 Wanchun East Road Wenjiang District Chengdu City Sichuan Province China

经费或物资来源：

成都市医学会

Source(s) of funding：

Chengdu Medical Association

研究疾病：

假性近视

研究疾病代码：

Target disease：

False myopia

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：

其它

Others

研究目的：

观察杵针联合一指禅推法对假性近视青少年的视力及中医症状的变化，评价杵针联合一指禅推法对青少年假性近视的有效性及安全性，从而为杵针联合一指禅推法预防青少年近视提供科学依据。

Objectives of Study：

To observe the changes of visual acuity and traditional Chinese medicine (TCM) symptoms of juvenile pseudo-myopia treated with pestle needle Combined with One-Finger Pushing Manipulation and to evaluate the efficacy and safety of pestle needle Combined with One-Finger Pushing Manipulation on juvenile pseudo-myopia so as to provide scientific basis for the prevention of juvenile myopia with pestle needle Combined with One-Finger Pushing Manipulation.

药物成份或治疗方案详述：

1.1治疗组 采用杵针联合一指禅推法。 杵针治疗：①取穴：参考《杵针学》（钟枢才. 杵针学 [M]. 北京：中国中医药出版社，2006:1-2）选取百会八阵、风府八阵及大椎八阵（百会八阵 即以百会穴为中宫，百会至印堂的距离为半径画圆，将圆分为8等份，即天、地、风、云、 龙、虎、鸟、蛇，与八卦相应为乾、坤、坎、离、震、艮、兑形成8个穴位称外八阵，再将百会至外八阵的距离分为3等分，画2个圆，即为中八阵和内八阵，外、中、内八阵上的穴位即 为百会八阵穴；风府八阵以风府穴为中宫，以风府至后发际缘为半径所构成的八阵穴为风府 八阵；大椎八阵以大椎穴为中宫，以大椎到左右旁开3寸为半径所构成的八阵穴为大椎八阵。 河车路印脑段即印堂穴至脑户穴的督脉经为一线，目内眦、瞳仁、目外眦至脑户穴各一线， 左右共计六线；河车路脑椎段即脑户穴到大椎、脑户到大椎两旁与两眼内外眦、瞳仁距离相 等的左右三线）。 ②操作：常规消毒，取五星三台杵，用梅花形五脚头依次点叩百会八阵， 风府八阵，大椎八阵2 min放松局部至皮肤略微潮红，点叩频率适中如雀啄，力量在患者可 承受范围内，再取七曜混元杵，用钝爪头依次对河车路印脑段，脑椎段行分理手法，即钝爪头紧贴腧穴皮肤左右分推、上下推退5 min，分理结束再用圆弧头对百会八阵，风府八阵，大椎八阵行运转手法，即杵柄紧贴腧穴皮肤，顺时针、逆时针环形运转5 min,手法力量亦在 患者可承受范围，达到皮肤发热，最后取金刚杵，对百会八阵，风府八阵，大椎八阵、太 阳、内关行开阖手法，即杵尖垂直向下按压穴位，此为开，随后杵尖徐徐上提且不离开腧穴 皮肤，此为阖，操作5 min，力量以患者自觉酸胀耐受为度，达到气血向四周分散的目的。 隔日治疗1次，每周3次 一指禅推法：开天门、推坎宫、运太阳各1 min，拇指按揉印堂12次，一指禅峰推按晴明、鱼腰、丝竹空、阳白、承泣、四白、颧髎各6次。“8”字划圆法由睛明穴开始向上沿上眼眶向外推至下眼眶，再由下眼眶向内经目内眦推至对侧睛明穴（睛明→攒竹→鱼腰→丝竹空→瞳子髎→承泣→睛明→对侧睛明穴→……），再按推上眼眶向外、推下眼眶向内的顺序呈“∞”字形推。操作方法：用拇指桡侧偏峰着力于体表施术部位，其余四指和拇指分开并自然伸直，腕关节放松、呈微屈或自然伸直状，沉肩、垂肘，以四指和腕关节做主动摆动，带动拇指指间关节小幅度屈伸活动，频率为120～160次／分钟。隔日治疗1次，每周3次。 1.2对照组 外用消旋山莨菪碱滴眼液（南京天朗制药有限公司，国药准字H20067452，8ml：4mg）每晚睡前患眼滴1滴，滴药后压迫泪囊区5 min。 所有患儿都将接受6周的治疗，并随访12周。

Description for medicine or protocol of treatment in detail：

1.1 Treatment groups pestle needle Combined with One-Finger Pushing Manipulation was used. Treatment with Pestle Needle: ① Acupoint selection: refer to Pestle Needle (Zhong shucai. Pestle Needle [M]. Beijing: China Traditional Chinese Medicine Press, 2006:1-2) selected Baihui "bazhen", Fengfu "bazhen" and Dazhui "bazhen" (Baihui "bazhen" refers to drawing a circle with Baihui acupoint as the middle palace and the distance from Baihui to Yintang as the radius. The circle is divided into 8 equal parts, namely heaven, earth, wind, cloud, dragon, tiger, bird and snake. The corresponding eight hexagon points are Gan, Kun, kan, Li, zhen, gen and dui, which are called "outer bazhen". The distance between Baihui (GV 20) and outer "bazhen" is divided into three equal parts, and two circles are drawn, which are the middle "bazhen" and the inner "bazhen". In the Fengfu "bazhen", the Fengfu point is the middle palace, and the "bazhen" point formed by the Fengfu point to the posterior hairline is the radius of the "bazhen". In "bazhen" (Dazhui), the Dazhui (Dazhui) is taken as the middle palace, and the "bazhen" (Dazhui) constituted by the radius of 3 cun from Dazhui to the left and right side is called Dazhui (Dazhui). The Yinnao segment of Heche Road, namely the governor vessel meridian from Yintang (GV 29) to Naohu (GV 29), is the first line, with the first line from the inner canthus, the pupils' kernel, the outer canthus to Naohu (GV 29), and the left and right lines are six in total. The Naozhui segment of Heche Road refers to the left and right three lines from Naohu point to Dazhui (GV 14), and from both sides of Naohu point to Dazhui (GV 14) with the same distance from the inner and outer canthus and the pupils of both eyes). ② Operation: For routine disinfection, take five star three peaches, tap Baihui "bazhen", Fengfu "bazhen" and Dazhui "bazhen" in turn with five feet in the shape of plum flower for 2 minutes to loosen the local area until the skin is slightly flushed. The tapping frequency is moderate as sparrow pecking, and the strength is within the patient's bearable range, and then take "qiyaohunyuanchu". The brain segment and the brain vertebral segment of Heche Lu were divided by the blunt claw head in turn, that is, the blunt claw head was pressed against the skin of the acupoints left and right, and pushed back up and down for 5 minutes. After the division, the circular arc-head was used to run the Baihui "bazhen", Fengfu "bazhen" and Dazhui "bazhen", that is, the pesthandle was pressed against the skin of the acupoints. Finally, take "jingangchu", "Baihui" "bazhen", "Fengfu" "bazhen", "Dazhui" "bazhen", "Taiyang" and "Neiguan" to open and close the acupuncture points, that is, press the pesttip vertically down, this is "Kai". Then the peststick tip was lifted up slowly without leaving the skin of the acupoint, which was called Fushu. The operation was performed for 5 minutes, and the force was based on the patient's self-conscious tolerance to acid and distension, so as to achieve the purpose of dispersive qi and blood to the surrounding areas. The treatment was given once every other day, 3 times a week One-Finger Pushing Manipulation: Open Tianmen, push Kangong and Yuntaiyang for 1 min each, press and knead Yintang 12 times with the thumb, and push and knead Qingming, Yuyao, Sizhukong, Yangbai, Chengqi, Sibai and Zygoliao 6 times each with the Zen peak. The "8" circle method starts from Jingming point upward along the upper orbit and outward to the lower orbit, and then from the lower orbit inward through the inner canthus of the eye to the opposite Jingming point (Jingming → Cuanzhu → Yuyao → Sizhuong → Tongziliao → Chengqi → Jingming → contralateral Jingming →......). And then push the upper orbit outward, push the lower orbit inward in the order of "∞" shape push. The wrist joint was relaxed, slightly fleyed or naturally extended, and the shoulder and elbow were dropped. The four fingers and wrist joints were actively swung to drive the thumb interphalangeal joint flexion and extension in a small range, with a frequency of 120-160 times/min. The treatment was given once every other day, 3 times a week. 1.2 Control group Topical racemanisodamine eye drops (Nanjing Tianlong Pharmaceutical Co., LTD., Chinese Medicine approved number H20067452, 8ml: 4mg) should be given 1 drop to the affected eye before going to bed every night, and the lacrimal sac area was pressed for 5 minutes after the drops. All children will be treated for 6 weeks and followed up for 12 weeks.

纳入标准：

①年龄≥6岁，且≤14岁，性别不限； ②符合上述中西医诊断标准； ③双眼患病； ④患儿自愿参与本研究； ⑤患儿家属或监护人同意并签署知情同意书。 满足以上5项的患者方可纳入。

Inclusion criteria

① Age ≥6 years old, and ≤14 years old, regardless of gender; ② meet the above diagnostic criteria of traditional Chinese and western medicine; ③ binocular disease; ④ Children voluntarily participated in this study; ⑤ The family members or guardians of the children agreed and signed the informed consent. Patients were eligible if they met all five of these criteria.

排除标准：

①父母一方或双方存在高度近视； ②施术部位存在破损或其它原因影响操作； ③伴随斜视或者弱视； ④存在其它眼部疾病； ⑤正在或准备接受其它眼部治疗。 满足以上1项或多项要求者即予排除。

Exclusion criteria：

①High myopia in one or both parents; ② The operation site is damaged or other reasons affect the operation; (3) concomitant strabismus or amblyopia; (4) the presence of other eye diseases; (5) undergoing or preparing for other eye treatments; Those fulfilling one or more of the above criteria were excluded.

研究实施时间：

Study execute time：

从From 2023-05-15

至To      2026-12-31

征募观察对象时间：

Recruiting time：

从From 2025-05-31

至To      2026-05-31

干预措施：

Interventions：

组别：

对照组

样本量：

55

Group：

Control group

Sample size：

干预措施：

消旋山莨菪碱滴眼液

干预措施代码：

Intervention：

Racemic anisodamine eye drops

Intervention code：

组别：

治疗组

样本量：

55

Group：

Treatment group

Sample size：

干预措施：

杵针联合一指禅推法

干预措施代码：

Intervention：

pestle needle Combined with One-Finger Pushing Manipulation

Intervention code：

样本总量 Total sample size ： 110

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

四川省

市(区县)：

成都市

Country：

China

Province：

Sichuan Province

City：

Chengdu City

单位(医院)：

温江区中医医院

单位级别：

四川省成都市温江区万春东路61号

Institution/hospital：

Wenjiang district Hospital of traditional Chinese Medicine

Level of the institution：

61 Wanchun East Road Wenjiang District Chengdu City Sichuan Province China

测量指标：

Outcomes：

指标中文名：

有效率

指标类型：

次要指标

Outcome：

Effective rate

Type：

Secondary indicator

测量时间点：

治疗6周后

测量方法：

Measure time point of outcome：

After 6 weeks of treatment

Measure method：

指标中文名：

等效球镜

指标类型：

主要指标

Outcome：

Spherical equivalent

Type：

Primary indicator

测量时间点：

治疗前、治疗6周、第一次随访（第12周）和第二次随访（第18周）

测量方法：

Measure time point of outcome：

Before treatment, at 6 weeks of treatment, at first visit (week 12), and at second visit (week 18)

Measure method：

指标中文名：

眼轴

指标类型：

次要指标

Outcome：

axial length

Type：

Secondary indicator

测量时间点：

治疗前、治疗6周和第二次随访（第18周）

测量方法：

Measure time point of outcome：

Before treatment, at 6 weeks of treatment, and at the second visit (week 18)

Measure method：

指标中文名：

裸眼视力水平

指标类型：

次要指标

Outcome：

Uncorrected visual acuity level

Type：

Secondary indicator

测量时间点：

治疗前、治疗6周和第二次随访（第18周）

测量方法：

Measure time point of outcome：

Before treatment, at 6 weeks of treatment, and at the second visit (week 18)

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 6 岁
Min age years
最大 14 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）：

随机号码由未参加该项目的统计人员使用R软件生成。

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

Random numbers were generated using R software by statisticians not involved in the project.

盲法：

Blinding：

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）：

不公开

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

None

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：

由项目数据管理中心与本课题组共同负责本项目的数据管理。项目组提出数据管理和统计要求，数据管理中心按照课题提出的要求制定相关计划。

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

The project data management center and our research group are responsible for the data management of this project. The project team put forward the data management and statistical requirements, and the data management center made relevant plans according to the requirements of the project.

数据管理委员会：

Data Managemen Committee：

有

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):

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