ChiCTR2500108020 版本V1.0 版本创建时间2025/08/22 10:50:09 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2500108020 

最近更新日期：

Date of Last Refreshed on：

 2025-08-22 10:49:48 

注册时间：

Date of Registration：

 2025-08-22 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

针刺髋膝肌筋膜触发点对举重运动员膝前痛的疗效研究

Public title：

Effect of Dry Needling of Hip and Knee Myofascial Trigger Points on Anterior Knee Pain in Weightlifters

注册题目简写：

English Acronym：

研究课题的正式科学名称：

针刺髋膝肌筋膜触发点对举重运动员膝前痛的疗效研究

Scientific title：

Effect of Dry Needling of Hip and Knee Myofascial Trigger Points on Anterior Knee Pain in Weightlifters

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：

吴宗辉 

研究负责人：

吴宗辉 

Applicant：

Zonghui Wu 

Study leader：

Zonghui Wu 

申请注册联系人电话：

Applicant telephone：

 +86 133 7070 7766

研究负责人电话：

Study leader's
telephone：

+86 133 7070 7766

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：

 wuzh@swu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 wuzh@swu.edu.cn

申请单位网址(自愿提供)：

Applicant 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：

重庆市北碚区天生街道天生路2号西南大学医院

研究负责人通讯地址：

重庆市北碚区天生街道天生路2号西南大学医院

Applicant address：

Southwest University Hospital, No. 2 Tiansheng Road, Tiansheng Subdistrict, Beibei District, Chongqing, China

Study leader's address：

Southwest University Hospital, No. 2 Tiansheng Road, Tiansheng Subdistrict, Beibei District, Chongqing, 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：

西南大学医院

Applicant's institution：

Southwest University Hospital

研究负责人所在单位：

西南大学医院

Affiliation of the Leader：

Southwest University Hospital

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 SWU-ETH-2025-05-12-02

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

西南大学医院伦理委员会

Name of the ethic committee：

Ethics Committee of Southwest University Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-05-20 00:00:00

伦理委员会联系人：

胡晓琳

Contact Name of the ethic committee：

Xiaolin Hu

伦理委员会联系地址：

重庆市北碚区天生街道天生路2号西南大学医院

Contact Address of the ethic committee：

Southwest University Hospital, No. 2 Tiansheng Road, Tiansheng Subdistrict, Beibei District, Chongqing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 138 8364 2020

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：

西南大学医院

Primary sponsor：

Southwest University Hospital;Institute of Sports Rehabilitation, Southwest University

研究实施负责（组长）单位地址：

重庆市北碚区天生街道天生路2号西南大学医院

Primary sponsor's address：

Southwest University Hospital, No. 2 Tiansheng Road, Tiansheng Subdistrict, Beibei District, Chongqing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

重庆市

市(区县)：

北碚区

Country：

China

Province：

Chongqing

City：

Beibei District

单位(医院)：

西南大学医院

具体地址：

重庆市北碚区天生街道天生路2号西南大学医院

Institution
hospital：

Southwest University Hospital

Address：

Southwest University Hospital, No. 2 Tiansheng Road, Tiansheng Subdistrict, Beibei District, Chongqing

经费或物资来源：

重庆市体育局重点科研项目（B202414）

Source(s) of funding：

Key Scientific Research Project of Chongqing Municipal Sports Bureau (B202414)

研究疾病：

膝前痛  

Target disease：

Anterior Knee Pain

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究将肌筋膜触发点理论应用于膝前痛运动员的临床治疗中，探讨灭活臀肌MTrPs治疗是否优于单一针刺大腿前后侧肌群MTrPs治疗，并讨论是否能通过加入灭活臀肌MTrPs改善下肢的整体稳定性。  

Objectives of Study：

This study applies the myofascial trigger point (MTrP) theory to the clinical treatment of athletes with anterior knee pain, aiming to investigate whether inactivation of gluteal MTrPs is superior to dry needling of MTrPs in the anterior and posterior thigh muscles alone. Furthermore, the study explores whether adding gluteal MTrP inactivation can improve overall lower limb stability.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

（1）年龄18~30岁, 持有国家二级及以上等级证书的举重运动员，且每周至少参加五次有组织的训练或比赛； （2）膝关节部疼痛对日常训练或比赛表现产生影响，疼痛时间超过一年； （3）入组前1周内未接受其他相关治疗； （4）Lysholm评分≤65分； （5）签署知情同意书，承诺配合完成所有研究流程。

Inclusion criteria

1. Aged between 18 and 30 years, certified weightlifters holding a national level-2 or higher qualification, who participate in at least five organized training sessions or competitions per week; 2. Experiencing knee pain that affects daily training or competitive performance, with a duration of more than one year; 3. No relevant treatment received within one week prior to enrollment; 4. Lysholm score <= 65 points; 5. Signed informed consent and agreed to complete all study procedures as required.

排除标准：

（1）进行过膝关节手术、植入全膝假体时间未满一年者； （2）已被诊断为纤维肌瘤、血管疾病或者神经疾病且病情得到有效控制者； （3）患有严重系统性疾病（如结核病或者心血管疾病）者； （4）实验过程中因训练而导致再次意外受伤，膝部病变或病痛加重者； （5）无法接受实验方案或无法配合的治疗者。

Exclusion criteria：

1. Individuals who have undergone knee surgery or total knee arthroplasty within the past year; 2. Individuals diagnosed with fibromatosis, vascular diseases, or neurological disorders, even if the condition is under effective control; 3. Individuals with severe systemic diseases (e.g., tuberculosis or cardiovascular diseases); 4. Individuals who sustain new injuries, knee lesions, or aggravated knee conditions due to training during the study period; 5. Individuals unable to comply with the study protocol or cooperate with the treatment.

研究实施时间：

Study execute time：

从 From 2025-07-31 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-08-10 00:00:00 至 To 2025-08-30 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 20

Group：

Control group

Sample size：

干预措施：

采用针刺大腿前后侧肌群（主要为腘绳肌和股四头肌）MTrPs的方式进行治疗及对相应肌肉进行拉伸训练，

干预措施代码：

Intervention：

Dry needling of the myofascial trigger points (MTrPs) in the anterior and posterior thigh muscles combined with stretching exercises for the corresponding muscles.

Intervention code：

组别：

试验组

样本量：

 20

Group：

Experimental group

Sample size：

干预措施：

采用针刺髋部肌肉（主要为臀中肌、臀大肌、臀小肌）MTrPs联合针刺大腿前后肌群MTrPs的治疗方式。在针刺后，对相应肌肉进行拉伸训练。

干预措施代码：

Intervention：

Dry needling of the gluteal myofascial trigger points (MTrPs) combined with dry needling of the anterior and posterior thigh muscle MTrPs, followed by stretching exercises for the corresponding muscles.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 重庆市 

市(区县)：

 北碚区 

Country：

China

Province：

Chongqing

City：

Beibei District

单位(医院)：

 西南大学医院 

单位级别：

 二级 

Institution
hospital：

Southwest University Hospital

Level of the institution：

Secondary

测量指标：

Outcomes：

指标中文名：

压力疼痛阈值

指标类型：

主要指标

Outcome：

Pressure Pain Threshold

Type：

Primary indicator

测量时间点：

干预结束后一周内

测量方法：

PPT是一种通过施加渐增压力，评估患者对疼痛刺激感知的最低压力水平的客观方法，其原理是根据压力刺激的强度或持续时间，观察患者开始感知疼痛的最小压力值。本研究选择患者自觉压痛最为明显的肌筋膜触发点处进行PPT测量，以1kg/s的速度逐渐给予压力，当受试者反映有痛感时，测试者立即停止按压并读取压力计上的压力值。在排除首次测量误差后，进行多次重复测量，每次间隔1分钟，取3次测量的平均值以减少误差，确保数据的稳定性及治疗前后测量点的一致性。

Measure time point of outcome：

Within one week after the end of the intervention

Measure method：

PPT is an objective method used to assess the minimum pressure level at which a patient perceives a painful stimulus by applying gradually increasing pressure. The principle is to determine the lowest pressure value at which the patient begins to perceive pain, based on the intensity or duration of the pressure stimulus. In this study, PPT measurements were performed at the myofascial trigger point where the patient reported the most pronounced tenderness. Pressure was applied progressively at a

指标中文名：

双脚下蹲起立LSF

指标类型：

主要指标

Outcome：

Length-Scale Factor Index of Plantar Pressure during Double-Leg Squat

Type：

Primary indicator

测量时间点：

干预结束后一周内

测量方法：

本研究以完整的“双足下蹲、短暂停留、起立”周期作为分析窗口，操作流程为受试者赤足立于足底压力测试仪Motux Studio (ver1.9.7)内，双足比肩稍宽、足尖平行，目视同高前方视标，双臂交叉置于胸前限制上肢代偿；在评估者统一口令与节奏提示下，以约3–4 s匀速下蹲到底，静止1 s后再以3-4 s匀速起立回到起始位，休息约10s后进行下一次测试，共测3次，取最终平均值。全程两足不得离板或移动，脚跟与脚尖保持接触，躯干尽量维持中立。正式采集前完成一次示教与一次熟悉化尝试以统一节奏与幅度；若出现足底离板、步幅调整、视线明显偏离或显著代偿，判定该次无效并于1 min内重测一次；力平台以固定采样50Hz频率连续记录从口令开始至回到静止的COP轨迹；软件据此计算轨迹总长度（mm）与95% 置信椭圆面积（mm2），并输出 LSF＝长度/面积。

Measure time point of outcome：

Within one week after the end of the intervention

Measure method：

In this study, a complete ‘double-leg squat, brief hold, and stand-up’ cycle was used as the analysis window. The procedure was as follows: participants stood barefoot on the plantar pressure testing system (Motux Studio, ver. 1.9.7) with feet slightly wider than shoulder width and toes parallel, gazing at a target at eye level, and crossing their arms in front of the chest to restrict upper limb compensation. Under standardized verbal instructions and rhythmic cues from the assessor, subjects s

指标中文名：

膝关节功能量表

指标类型：

次要指标

Outcome：

Lysholm Knee Function Score

Type：

Secondary indicator

测量时间点：

干预结束后一周内

测量方法：

在不干扰患者的状态下让其根据真实感受客观填写。评估包含8个项目管理，各个服务项目的等级和得分不尽相同，依次是跛行、支撑、绞锁、不稳、水肿、上楼、下蹲、疼痛，总分为100分。低于65分表示不及格，65~83分表示及格，84~94分表示正常，95~100分表示优良，得分越高，表明膝盖机能越好

Measure time point of outcome：

Within one week after the end of the intervention

Measure method：

Without interfering with the patient’s condition, they were instructed to complete the assessment objectively based on their actual experience. The evaluation consists of eight items, each with different rating criteria and scores, namely: limping, support, locking, instability, swelling, stair climbing, squatting, and pain, with a total possible score of 100 points. A score below 65 indicates failure, 65–83 indicates pass, 84–94 indicates normal, and 95–100 indicates excellent.

指标中文名：

单腿支撑足底压力平均速度

指标类型：

次要指标

Outcome：

Mean Velocity of Plantar Pressure during Single-Leg Stance

Type：

Secondary indicator

测量时间点：

干预结束后一周内

测量方法：

本研究采用“患侧单腿站立”任务评估静态平衡。操作流程为受试者赤足直立于平台中央，双臂交叉置于胸前限制上肢代偿，目视同高前方视标；抬起非患侧下肢使其悬空且不接触支撑腿，骨盆尽量保持水平、躯干中立，在评估者开始指令后保持单腿站立10s，期间支撑足不得移动或抓地。计时前由评估者核对站位与视标并示范一次，以稳定呼吸与凝视；休息约10s后进行下一次测试，共测三次，取最终平均值。正式测试中若出现触地、支撑足位移、上肢明显摆动或其他显著代偿，立即终止并于 1 min内按相同步骤重测一次，直至获得完整有效试次。力平台以固定采样50Hz频率记录全段 COP 轨迹并计算轨迹总长度与持续时间，由此得到平均速度。

Measure time point of outcome：

Within one week after the end of the intervention

Measure method：

This study assessed static balance using a ‘single-leg stance on the affected side’ task. The procedure was as follows: participants stood barefoot at the center of the platform with arms crossed in front of the chest to limit upper limb compensation, gazing at a target at eye level. The non-affected lower limb was lifted off the ground without touching the supporting leg, with the pelvis maintained as level as possible and the trunk in a neutral position. Upon the assessor’s start command, part

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 30 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

本实验为双盲、随机对照试验，用电脑产生1~40共40个随机数字将研究对象分为2组，患者知情同意后由第三方拆封后按照分配方案实施治疗。（1）盲受试者。入组受试者不清楚自己的分组情况。此外，每组受试者采用单间治疗室隔开，避免彼此间的交流；（2）盲评价者。评价者由非本次研究人员参与，其本身不清楚分组情况及其意义，并减少与受试者进行不必要的交流。

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

This study is a double-blind, randomized controlled trial. Forty participants were randomly assigned into two groups using computer-generated random numbers (1–40). After obtaining informed consent, a third party opened the allocation and administered the treatment according to the assigned groups. (1) Blinding of participants: The enrolled participants were unaware of their group assignments. In addition, participants from different groups were treated in separate single rooms to prevent communication between them. (2) Blinding of assessors: Outcome assessors were individuals not involved in this study, who were unaware of the group assignments and their significance. Unnecessary communication between assessors and participants was minimized.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

对研究参与者、评估者设盲

Blinding：

Blinding of study participants and evaluators

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

文章发表后，经研究者同意后可邮箱获取

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

After the article is published, it can be obtained by email with the consent of the researcher

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.受试者信息保密方法：所有涉及受试者个人信息（如姓名、联系方式、病历记录等）的纸质和电子数据将严格分开存储。纸质数据将保存在专门的档案柜中，并由专人负责管理，确保只有授权人员能够访问。电子数据将存储在密码保护的服务器中，并且定期进行备份和安全检查，防止数据丢失或泄露。 2.纸质数据处理与存储：所有纸质数据将被保存在封闭式、上锁的档案柜中，且仅限于经过授权的研究人员处理。纸质数据存储期间，所有档案柜的钥匙由指定的研究人员保管，确保数据不被未经授权的人员访问。实验结束后，所有纸质资料将在规定时间内保留，期满后将按照相关法规进行销毁。 3.电子数据保护与访问控制：电子数据将存储在符合国家信息安全标准的加密服务器中，所有的访问行为都将进行严格的权限管理和日志记录。研究人员仅能在研究需要的情况下访问数据，并根据职责分配相应权限。任何未经授权的访问行为都会被立即报告并进行处理。 4.防止信息泄露措施：所有研究人员和辅助人员在接触受试者的个人信息时，均需签署保密协议。所有相关数据的传输、共享和使用，均通过加密方式进行。无论是纸质还是电子形式的资料，均不得在公开场合展示，确保受试者信息的隐私不被外泄。 5.数据保密与销毁：所有数据处理期间，无论是纸质还是电子数据，研究团队都将采取必要的措施确保其完整性与安全性。项目完成后，所有涉及受试者信息的纸质数据将在保密销毁后处理，电子数据则将在确保其不再需要的情况下进行安全删除，防止被恢复或滥用。 6.知识产权与研究成果保密：研究过程中产生的所有数据、分析结果及相关文献，知识产权归属于西南大学体育学院及运动康复研究所。在研究成果公开前，所有涉及受试者信息的部分将进行匿名化处理，确保受试者隐私得到最大保护。学术成果发布时，将严格遵守隐私保护法规，确保无任何个人信息泄露。 7.研究总结与出版交流：研究成果将在学术期刊或会议上进行公开交流时，确保所有数据去标识化，且不会泄露任何受试者的个人信息。所有参与者的身份信息将被隐藏，确保研究内容的透明性与受试者的隐私安全。

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

1. Confidentiality of Participant Information: All paper-based and electronic data involving participants’ personal information (such as names, contact information, and medical records) will be strictly stored separately. Paper records will be kept in dedicated, locked filing cabinets under the supervision of designated personnel, ensuring access is limited to authorized individuals. Electronic data will be stored on password-protected servers with regular backups and security checks to prevent data loss or leakage. 2. Handling and Storage of Paper-Based Data: All paper-based data will be stored in locked, secured filing cabinets and handled exclusively by authorized research personnel. During storage, keys to the filing cabinets will be held by designated researchers to prevent unauthorized access. After study completion, paper records will be retained for a specified period and then destroyed in accordance with relevant regulations. 3. Protection of Electronic Data and Access Control: Electronic data will be stored on encrypted servers compliant with national information security standards. All access will be strictly permission-controlled with detailed access logs. Researchers may access the data only when required for the study and within the scope of their assigned responsibilities. Any unauthorized access will be promptly reported and addressed. 4. Measures to Prevent Information Leakage: All research and support staff with access to participants’ personal information are required to sign confidentiality agreements. Data transmission, sharing, and usage will be carried out exclusively through encrypted channels. Neither paper-based nor electronic data may be disclosed in public settings, ensuring the privacy of participant information is fully protected. 5. Data Confidentiality and Disposal: Throughout the study, necessary measures will be taken to ensure the integrity and security of both paper-based and electronic data. Upon project completion, all paper-based records involving participant information will be confidentially destroyed, while electronic data will be securely deleted once no longer needed, preventing recovery or misuse. 6. Intellectual Property and Research Data Confidentiality: All data, analysis results, and related documents generated during the study shall be the intellectual property of the School of Physical Education and the Institute of Sports Rehabilitation, Southwest University. Before research findings are made public, any participant-related information will be anonymized to maximize privacy protection. Academic publications will strictly comply with privacy regulations, ensuring no personal information is disclosed. 7. Research Reporting and Academic Dissemination: When research results are shared through academic journals or conferences, all data will be de-identified to prevent disclosure of participants’ personal information. Participant identities will remain confidential, ensuring transparency of research content while safeguarding privacy.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-08-22 10:49:48