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针刺治疗股四头肌劳损的随机对照临床研究

注册号：

Registration number：

ITMCTR2025001138

最近更新日期：

Date of Last Refreshed on：

2025-06-08

注册时间：

Date of Registration：

2025-06-08

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

针刺治疗股四头肌劳损的随机对照临床研究

Public title：

A randomized controlled clinical study on acupuncture treatment of quadriceps femoris strain

注册题目简写：

English Acronym：

研究课题的正式科学名称：

针刺治疗股四头肌劳损的随机对照临床研究

Scientific title：

A randomized controlled clinical study on acupuncture treatment of quadriceps femoris strain

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：

张玉

研究负责人：

关玲

Applicant：

Yu Zhang

Study leader：

Ling Guan

申请注册联系人电话：

Applicant telephone：

17736910174

研究负责人电话：

Study leader's telephone：

13520575830

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：

1053635825@qq.com

研究负责人电子邮件：

Study leader's E-mail：

guanling30@sina.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：

北京市海淀区阜成路6号

研究负责人通讯地址：

北京市海淀区阜成路6号

Applicant address：

No. 6 Fucheng Road Haidian District Beijing

Study leader's address：

No. 6 Fucheng Road Haidian District Beijing

申请注册联系人邮政编码：

Applicant postcode：

100048

研究负责人邮政编码：

Study leader's postcode：

100048

申请人所在单位：

解放军总医院第六医学中心中医医学部针灸科

Applicant's institution：

Acupuncture Department Department of Traditional Chinese Medicine the Sixth Medical Center of the PLA General 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：

HZKY-PJ-2025-18

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：

中国人民解放军总医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the General Hospital of the People's Liberation Army of China

伦理委员会批准日期：

Date of approved by ethic committee：

2025/4/16 0:00:00

伦理委员会联系人：

郑驰

Contact Name of the ethic committee：

Chi Zheng

伦理委员会联系地址：

中国人民解放军总医院第六医学中心（原海军总医院）

Contact Address of the ethic committee：

No. 6 Fucheng Road Haidian District Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

010-66957410

伦理委员会联系人邮箱：

Contact email of the ethic committee：

17736910174@163.com

研究实施负责（组长）单位：

解放军总医院第六医学中心中医医学部针灸科

Primary sponsor：

No. 6 Fucheng Road Haidian District Beijing

研究实施负责（组长）单位地址：

北京市海淀区阜成路6号

Primary sponsor's address：

No. 6 Fucheng Road Haidian 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(区县)：

海淀区

Country：

CHINA

Province：

BeiJing

City：

HaiDIAN

单位(医院)：

解放军总医院第六医学中心中医医学部针灸科

具体地址：

北京市海淀区阜成路6号

Institution
hospital：

Acupuncture Department Department of Traditional Chinese Medicine the Sixth Medical Center of the PLA General Hospital

Address：

No. 6 Fucheng Road Haidian District Beijing

经费或物资来源：

自筹

Source(s) of funding：

self-raised

研究疾病：

股四头肌劳损

研究疾病代码：

Target disease：

quadriceps femoris strain

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：

本研究旨在评估针刺治疗股四头肌劳损的有效性和安全性

Objectives of Study：

This study aims to evaluate the efficacy and safety of acupuncture in the treatment of quadriceps femoris strain

药物成份或治疗方案详述：

试验组：仰卧位，膝下可垫一软枕，完全暴露所查得的筋结点。超声选择肌骨模式，打开中位线，令筋结点点体表定位点位于中位线上，观察超声声像，经筋病灶点在超声下常有肌束膜回声增强、肌束膜增厚、滑膜增厚、滑囊积液、韧带和肌腱回声信号改变等异常。针刺点选择触诊硬结、条索处并结合超声下异常声像信号改变的位置来确定，超声动态观察下设计针刺路径并确定皮肤进针点，确定的进针点既要避免穿刺针在穿刺路径上损伤重要的血管和神经，又要便于超声引导操作。采用直径0.40mm✖75mm的针灸针。先用左手卡住病变的肌肉条索，右手持针在距离目标肌肉2cm处垂直入针，进针后调整针的方向，使针斜向穿过病变肌束；刺中后，将针退至皮下，微调针刺方向再次穿透病变肌束，重复2~3个方向后出针，以针刺后肌束变柔软效应指征，不留针。针刺后再次触诊查体，如果肌束变柔软则止，不柔软则再刺。针灸反应：针刺过程中，患者可能会感到明显的酸麻胀痛，局部肌肉可能还会出现抽搐反应，并记录肌肉跳动次数。嘱患者治疗部位8h内禁止污染，避免感染，依据需治疗的筋结点总数，每次治疗4-8个点(可找到8个及以上治疗点，治疗即可)，2次/周，每次约持续20分钟，连续2周，均由同一组治疗医师完成。 对照组：研究期间不接受针刺治疗，研究结束后予以相同的针刺治疗。

Description for medicine or protocol of treatment in detail：

Test group: Lie on your back, with a soft pillow placed under your knees to fully expose the identified tendon nodes. The musculoskeletal mode was selected by ultrasound. The median line was opened, and the body surface positioning points of the fascia nodes were placed on the median line. The ultrasound image was observed. Under ultrasound, the lesion points through the fascia often had abnormalities such as enhanced echo of the perimytoma, thickened perimytoma, thickened synovium, bursae effusion, and changes in the echo signals of ligaments and tendons. The acupuncture points were selected at the palpated hard lumps and cords, combined with the positions of abnormal acoustic image signal changes under ultrasound. The acupuncture path was designed under dynamic ultrasound observation and the skin needle entry points were determined. The determined needle entry points should not only avoid damaging important blood vessels and nerves along the puncture path with the puncture needle, but also facilitate ultrasound-guided operations. Acupuncture needles with a diameter of 0.40mm x 75mm are used. First, hold the diseased muscle cord with the left hand, and insert the needle vertically at a distance of 2cm from the target muscle with the right hand. After inserting the needle, adjust the direction of the needle to make it pass diagonally through the diseased muscle bundle. After the needle is punctured, the needle is retracted under the skin, and the direction of the needle is slightly adjusted to penetrate the diseased muscle bundle again. Repeat this process 2 to 3 times before removing the needle. The indication of the softening effect of the muscle bundle after the needle is observed, and no needle is retained. After needling, perform a physical examination by palpation again. If the muscle bundles become soft, stop the needling; if not, proceed with another needling. Acupuncture reaction: During the acupuncture process, the patient may experience obvious soreness, numbness, distension and pain. Local muscles may also have twitching reactions, and the number of muscle beats should be recorded. Instruct the patient to avoid contamination of the treatment area within 8 hours to prevent infection. Depending on the total number of tendon nodes to be treated, 4 to 8 points should be treated each time (if 8 or more treatment points can be found, treatment is sufficient), twice a week, each time lasting about 20 minutes, for two consecutive weeks, all completed by the same group of treating physicians. Control group: No acupuncture treatment was received during the study period, and the same acupuncture treatment was given after the study ended.

纳入标准：

①符合股四头肌劳损中西医诊断标准，西医诊断标准 参照2020年人民卫生出版社的卢鼎厚《人体骨骼肌劳损阿是穴治疗与预防》并结合临床，拟定股四头肌劳损诊断标准：①由于运动导致股四头肌损伤者，即刻产生疼痛；②伴局部肌肉压痛或痛性条索；③功能障碍：股四头肌伸膝或屈膝抗阻试验阳性。中医诊断标准 参照中华人民共和国中医药行业标准《中医病证诊断疗效标准》（ZY/T001.1-94）肌痹诊断，①有反复劳损或伤后日久而发，肌肉酸痛，肌肉不仁；②局部触及硬块；③肌萎筋缓，活动受限。舌淡暗，苔白，脉弦细。； ②年龄18-50周岁，不限性别； ③在视觉疼痛评分(NRS)上的疼痛程度≥4分以上； ④治疗期间不可使用抗炎止痛类药物； ⑤签署知情同意书。

Inclusion criteria

① It meets the diagnostic criteria for quadriceps femoris strain in both traditional Chinese medicine and Western medicine Referring to Lu Dinghou's "Treatment and Prevention of Human Skeletal Muscle Strain at Ashi Point" published by People's Medical Publishing House in 2020 and combining with clinical practice the diagnostic criteria for quadriceps femoris strain are formulated as follows: ① For those with quadriceps femoris injury caused by exercise immediate pain occurs; ② Accompanied by local muscle tenderness or painful cords; ③ Functional impairment: Positive resistance test for knee extension or flexion of the quadriceps. Diagnostic criteria of Traditional Chinese Medicine According to the "Diagnostic and Therapeutic Standards for Diseases and Syndroms of Traditional Chinese Medicine" (ZY/T001.1-94) the diagnosis of muscle arthralgia should be made in accordance with the industry standard of traditional Chinese Medicine of the People's Republic of China "Diagnostic and Therapeutic Standards for Diseases and Syndroms of Traditional Chinese Medicine". ① There is repeated strain or long-term onset after injury with muscle soreness and muscle stiffness; ② Local palpation of hard lumps; ③ Muscle atrophy and weakness with restricted movement. The tongue is pale and dark the coating is white and the pulse is taut and fine. ; ② Age: 18 to 50 years old gender not limited; ③ The degree of pain on the Visual Pain Scale (NRS) is ≥4 points or above; Anti-inflammatory and analgesic drugs should not be used during the treatment period. ⑤ Sign the informed consent form.

排除标准：

①已有膝关节置换手术史或正等待换膝手术的患者； ②其他疾病如风湿性关节或痛风引起的膝关节疼痛； ③由于外伤或骨折导致的肌肉疼痛； ④近1年关节内窥镜检查或近6个月接收过膝关节腔注射治疗； ⑤严重的急性或慢性器质性疾病或精神疾病严重，凝血功能障碍，金属过敏或畏针，妊娠妇女或哺乳妇女。

Exclusion criteria：

Patients who have a history of knee replacement surgery or are waiting for knee replacement surgery; ② Knee pain caused by other diseases such as rheumatic joints or gout; ③ Muscle pain caused by trauma or fractures; ④ Have undergone joint endoscopy within the past year or received knee cavity injection treatment within the past six months; ⑤ Severe acute or chronic organic diseases or mental disorders, coagulation dysfunction, metal allergy or fear of needles, pregnant or lactating women.

研究实施时间：

Study execute time：

从From 2025-04-16

至To      2025-06-30

征募观察对象时间：

Recruiting time：

从From 2025-04-16

至To      2025-06-30

干预措施：

Interventions：

组别：

对照组

样本量：

30

Group：

control group

Sample size：

干预措施：

等待治疗，仅必要时外用或口服止疼药。试验结束后予观察组相同的治疗方案。

干预措施代码：

2

Intervention：

35/5000 Wait for treatment and apply topical or oral painkillers only if necessary. After the trial the same treatment plan was given to the observation group.

Intervention code：

组别：

观察组

样本量：

30

Group：

observation group

Sample size：

干预措施：

针刺

干预措施代码：

1

Intervention：

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)：

海淀

Country：

CHINA

Province：

BeiJing

City：

HaiDian

单位(医院)：

解放军总医院第六医学中心中医医学部针灸科

单位级别：

三甲医院

Institution/hospital：

Acupuncture Department Department of Traditional Chinese Medicine the Sixth Medical Center of the PLA General Hospital

Level of the institution：

Tertiary hospital

测量指标：

Outcomes：

指标中文名：

5次单腿坐立实验

指标类型：

次要指标

Outcome：

Five one-legged sitting experiments

Type：

Secondary indicator

测量时间点：

治疗前，治疗2周，随访2周

测量方法：

选取相同外形高度为45 cm的无扶手椅子，受试者双手交叉抱于胸前，从最初端坐位开始，以最快的速度连续完成5次端坐位到直立位的动作，用秒表记录全过程所需时间。时间单位为“s”

Measure time point of outcome：

Before treatment, the treatment lasted for 2 weeks and followed up for 2 weeks

Measure method：

Select armless chairs of the same shape and height of 45 cm. The subjects cross their hands over their chests. Starting from the initial upright position, they complete five consecutive movements from the upright position to the upright position at the fastest speed. The time required for the entire process is recorded with a stopwatch. The time unit is "s".

指标中文名：

年龄

指标类型：

次要指标

Outcome：

Age

Type：

Secondary indicator

测量时间点：

治疗前

测量方法：

询问患者

Measure time point of outcome：

Before treatment

Measure method：

ask patient

指标中文名：

膝关节最大主动关节活动度

指标类型：

次要指标

Outcome：

The maximum active range of motion of the knee joint

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肌力

指标类型：

次要指标

Outcome：

Muscle Strength

Type：

Secondary indicator

测量时间点：

治疗前，治疗2周，随访2周

测量方法：

使用便携式肌力评估仪（MicroFET3，北京言鼎商贸有限公司）检测单侧股四头肌肌力：患者坐位，被测试的腿屈膝约伸直位，微微外展髋关节，患者双手双脚无支撑，医生一手固定患者踝关节，另一手将触垫放在患者胫骨前侧靠近踝关节的位置，使患者抵抗触垫伸膝。

Measure time point of outcome：

Before treatment, the treatment lasted for 2 weeks and followed up for 2 weeks

Measure method：

The unilateral quadriceps muscle strength was detected using the portable muscle strength assessment instrument (MicroFET3, Beijing Yandin Trading Co., LTD.) : The patient is in a sitting position, with the tested leg bent approximately straight and the hip joint slightly abducted. The patient has no support in both hands and feet. The doctor holds the patient's ankle joint with one hand and places a touch pad on the front side of the tibia near

指标中文名：

性别

指标类型：

次要指标

Outcome：

Gender

Type：

Secondary indicator

测量时间点：

治疗前

测量方法：

询问患者

Measure time point of outcome：

Before treatment

Measure method：

ask patient

指标中文名：

肌肉压痛阈值

指标类型：

次要指标

Outcome：

Muscle tenderness threshold

Type：

Secondary indicator

测量时间点：

治疗前，治疗2周，随访2周

测量方法：

采用测力计计算压痛阈值

Measure time point of outcome：

Before treatment, the treatment lasted for 2 weeks and followed up for 2 weeks

Measure method：

The tenderness threshold was calculated using a dynamometer

指标中文名：

体重指数

指标类型：

次要指标

Outcome：

BMI

Type：

Secondary indicator

测量时间点：

治疗前

测量方法：

询问患者

Measure time point of outcome：

Before treatment

Measure method：

ask patient

指标中文名：

肌张力

指标类型：

次要指标

Outcome：

Muscle tone

Type：

Secondary indicator

测量时间点：

治疗前，治疗2周，随访2周

测量方法：

使用MyotonPRO数字化软组织触诊仪(爱沙尼亚 MyotonPro AS)对患侧股四头肌进行检测，在肌肉高点处标记测量点，在肌肉放松状态下测量相关参数。振荡频率:简称F值, F值越大,表示肌肉的张力越大。动态硬度:简称S值,S值越大,表示肌肉抵抗收缩或抵抗外部压力使之形变的能力越强(肌肉的硬度越大)。机械压力释放时间:简称R值, R值越大,表示肌肉的缓冲能力越好。

Measure time point of outcome：

Before treatment, the treatment lasted for 2 weeks and followed up for 2 weeks

Measure method：

The tenderness threshold was calculated using a dynamometer The quadriceps femoris on the affected side was examined using the MyotonPRO digital soft tissue palpation instrument (Estonia MyotonPro AS). Measurement points were marked at the high points of the muscle, and relevant parameters were measured while the muscle was relaxed. Oscillation frequency: Abbreviated as F value. The larger the F value, the greater the muscle tension. Dynamic har

指标中文名：

病程

指标类型：

次要指标

Outcome：

disease duration

Type：

Secondary indicator

测量时间点：

治疗前

测量方法：

询问患者

Measure time point of outcome：

427/5000 Before treatment

Measure method：

ask patient

指标中文名：

数字评价量表

指标类型：

主要指标

Outcome：

numerical rating scale

Type：

Primary indicator

测量时间点：

治疗前、治疗后、随访2周

测量方法：

评估肌肉疼痛程度，分数范围从0到10分

Measure time point of outcome：

Before treatment, the treatment lasted for 2 weeks and followed up for 2 weeks

Measure method：

Score on the numerical rating scale (NRS) and make comparisons. The NRS score ranges from 0 to 10 points. The higher the score, the more severe the pain. NRS Pain Score: It assesses the degree of muscle pain, with a score range from 0 to 10.

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 50 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）：

采用SPSS29.0软件将60个随机数字按1︰1比例分组

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

The 60 random numbers were grouped in a 1:1 ratio using SPSS29.0 software

盲法：

Blinding：

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）：

2027年ResMan临床试验公共管理平台“http://www.medresman.org.cn/uc/index.aspx”。

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

2027 ResMan clinical trials of public management platform "http://www.medresman.org.cn/uc/index.aspx".

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：

Collection of case record forms

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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