ChiCTR2500101355 版本V1.0 版本创建时间2025/04/24 08:06:42 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：

 ChiCTR2500101355 

最近更新日期：

Date of Last Refreshed on：

 2025-04-24 08:06:37 

注册时间：

Date of Registration：

 2025-04-24 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

体外冲击波联合肌贴促进大学生长跑运动员非急性期跟腱炎康复进程的随机对照研究

Public title：

A randomized controlled study on the effect of extracorporeal shock wave combined with muscle patch on the rehabilitation process of non acute heel tendinitis in college long-distance runners

注册题目简写：

English Acronym：

研究课题的正式科学名称：

体外冲击波联合肌贴促进大学生长跑运动员非急性期跟腱炎康复进程的随机对照研究

Scientific title：

A randomized controlled study on the effect of extracorporeal shock wave combined with muscle patch on the rehabilitation process of non acute heel tendinitis in college long-distance runners

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：

刘大卫 

研究负责人：

郑尉 

Applicant：

Liu Dawei 

Study leader：

Zheng Wei 

申请注册联系人电话：

Applicant telephone：

 +86 151 6885 0688

研究负责人电话：

Study leader's
telephone：

+86 151 6885 0688

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：

 SlargeV@163.com

研究负责人电子邮件：

Study leader's E-mail：

 SlargeV@163.com

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：

天津市静海区团泊新城东海道16号

研究负责人通讯地址：

天津市静海区团泊新城东海道16号

Applicant address：

No.16 Donghai Road, Tuanbo New City, Jinghai District, Tianjin

Study leader's address：

No.16 Donghai Road, Tuanbo New City, Jinghai District, Tianjin

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：

天津体育学院

Applicant's institution：

Tianjin University of Sport

研究负责人所在单位：

天津体育学院

Affiliation of the Leader：

Tianjin University of Sport

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：

 TJUS2025-052

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：

天津体育学院伦理委员会

Name of the ethic committee：

Ethics Committee of Tianjin Sport University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-04-18 00:00:00

伦理委员会联系人：

郑尉

Contact Name of the ethic committee：

Zheng Wei

伦理委员会联系地址：

天津市静海区团泊新城东海道16号天津体育学院

Contact Address of the ethic committee：

Tianjin University of Sport, No.16 Donghai Road, Tuanbo New City, Jinghai District, Tianjin

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 151 6885 0688

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：

天津体育学院

Primary sponsor：

Tianjin University of Sport

研究实施负责（组长）单位地址：

天津市静海区团泊新城东海道16号

Primary sponsor's address：

No.16 Donghai Road, Tuanbo New City, Jinghai District, Tianjin

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

天津

市(区县)：

静海

Country：

China

Province：

Tianjin

City：

Jinghai

单位(医院)：

天津体育学院

具体地址：

天津市静海区团泊新城东海道16号

Institution
hospital：

Tianjin University of Sport

Address：

No.16 Donghai Road, Tuanbo New City, Jinghai District, Tianjin

经费或物资来源：

无

Source(s) of funding：

None

研究疾病：

非急性期跟腱炎  

Target disease：

Non acute phase and tendinitis

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：

1、疗效对比：通过随机对照实验，比较体外冲击波联合肌贴（联合治疗组）、单纯体外冲击波（冲击波组）、单纯肌贴（肌贴组）在缓解跟腱疼痛、改善跟腱功能、提升足踝关节活动度及运动能力等方面的差异，明确联合治疗的协同增效作用。 2、方案优化：针对大学生运动员生长发育后期的生理特点和竞赛需求，探索安全、高效的康复方案，缩短康复周期，减少停训时间，使其尽快恢复运动水平。 3、理论贡献：丰富运动医学领域跟腱炎治疗的理论与实践，为后续研究提供参考，推动高校长跑运动的安全开展。  

Objectives of Study：

1. Comparison of therapeutic effects: Through randomized controlled trials, the differences in relieving Achilles tendon pain, improving Achilles tendon function, enhancing ankle joint mobility and exercise ability among extracorporeal shock wave combined with muscle patch (combination treatment group), extracorporeal shock wave alone (shock wave group), and muscle patch alone (muscle patch group) were compared to clarify the synergistic effect of combination therapy. 2. Optimization of the plan: Based on the physiological characteristics and competition needs of college athletes in the later stage of growth and development, explore safe and efficient rehabilitation plans, shorten the rehabilitation cycle, reduce training downtime, and enable them to recover their athletic level as soon as possible. 3. Theoretical contribution: Enriching the theory and practice of sports medicine and tendinitis treatment, providing reference for subsequent research, and promoting the safe development of long-distance running in universities.

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）18-25岁，在校大学生长跑运动员； （2）病程超过2周； （3）经临床检查（如体格检查、超声检查等）确诊为非急性期跟腱炎； （4）跟腱处有隐痛、僵硬感，活动后疼痛加重，休息后缓解，采用视觉模拟评分法（VAS）评估疼痛程度，VAS 评分在3 - 7分之间； （5）沟通能力正常，能配合冲击波、肌内效贴治疗； （6）可100％提供此项研究涉及相关数据与资料； （7）自愿参与本研究，并签署知情同意书。

Inclusion criteria

(1) 18-25 years old, college long-distance runner; (2) The course of illness exceeds 2 weeks; (3) Diagnosed with non acute phase tendinitis through clinical examination (such as physical examination, ultrasound examination, etc.); (4) There is dull pain and stiffness in the Achilles tendon, which worsens after activity and improves after rest. The degree of pain is evaluated using the Visual Analog Scale (VAS), with a VAS score between 3-7 points; (5) Normal communication skills, able to cooperate with shock wave and intramuscular plaster therapy; (6) We can provide 100% of the relevant data and information related to this research; (7) Voluntarily participate in this study and sign an informed consent form.

排除标准：

（1）急性损伤：近期（2周内）有跟腱急性损伤或加重； （2）合并其他足部或踝关节疾病：排除患有足部骨折（包括陈旧性骨折）、踝关节脱位、踝关节不稳、痛风性关节炎、类风湿关节炎等可能影响足部和踝关节功能的疾病； （3）近期相关治疗史：过去3个月内接受过跟腱部位手术治疗、局部注射皮质类固醇、富血小板血浆（PRP）治疗；过去1个月内接受过体外冲击波治疗、肌贴治疗或其他针对跟腱炎的物理治疗（如超声波、红外线治疗等）； （4）全身性疾病或特殊生理状态：患有严重心血管疾病（如冠心病、心力衰竭）、未控制的糖尿病、血液系统疾病（如白血病、血小板减少性紫癜）、自身免疫性疾病（如系统性红斑狼疮、强直性脊柱炎）等全身性疾病，以及处于怀孕或哺乳期的女性； （5）存在严重精神疾病（如精神分裂症、重度抑郁症）或认知障碍，无法理解研究内容、配合完成治疗和评估的受试者 ； （6）过敏史：对体外冲击波或肌贴材料过敏； （7）心理因素：存在心理障碍或依从性差。

Exclusion criteria：

(1) Acute injury: Recent (within 2 weeks) acute injury or exacerbation of Achilles tendon; (2) Merge other foot or ankle joint diseases: exclude diseases that may affect foot and ankle joint function, such as foot fractures (including old fractures), ankle dislocation, ankle instability, gouty arthritis, rheumatoid arthritis, etc; (3) Recent treatment history: Received surgical treatment at the Achilles tendon site, local injection of corticosteroids, and treatment with platelet rich plasma (PRP) within the past 3 months; Received extracorporeal shock wave therapy, muscle patch therapy, or other physical treatments (such as ultrasound, infrared therapy, etc.) for Achilles tendinitis within the past month; (4) Systemic diseases or special physiological conditions: women with serious cardiovascular diseases (such as coronary heart disease, heart failure), uncontrolled diabetes, blood system diseases (such as leukemia, thrombocytopenic purpura), autoimmune diseases (such as systemic lupus erythematosus, ankylosing spondylitis) and other systemic diseases, as well as women in pregnancy or lactation; (5) Subjects with severe mental illness (such as schizophrenia, major depression) or cognitive impairment who are unable to understand the research content, cooperate in completing treatment and evaluation; (6) Allergy history: Allergic to extracorporeal shock waves or muscle patch materials; (7) Psychological factors: the presence of psychological disorders or poor compliance.

研究实施时间：

Study execute time：

从 From 2025-04-14 00:00:00至 To 2025-06-10 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-04-25 00:00:00 至 To 2025-06-06 00:00:00

干预措施：

Interventions：

组别：

体外冲击波组

样本量：

 15

Group：

Extracorporeal shock wave group

Sample size：

干预措施：

在常规康复治疗基础上，采用[瑞士SWISS Dolor Clast]体外冲击波治疗仪。治疗前，通过触诊和超声检查确定跟腱疼痛及病变部位，做好标记。治疗期间，患者取俯卧位，使跟腱保持拉伸状态。完成体位及仪器相关准备工作后调节仪器，设置治疗参数：频率7Hz，治疗压力2.0-3.0 bar，冲击波次数2000次，先用间歇波试治疗几次，由患者感觉冲击波定位是否与实际痛点吻合，调整治疗头位置直到冲击部位与痛点吻合后开始连续波治疗。每次治疗时间5分钟，每周治疗2次，共治疗6周。

干预措施代码：

Intervention：

On the basis of conventional rehabilitation treatment, the Swiss SWISS Dolor Clast extracorporeal shock wave therapy device was used. Before treatment, determine the location of Achilles tendon pain and lesions through palpation and ultrasound examination, and mark them properly. During treatment, the patient is placed in a prone position to maintain a stretched state of the Achilles tendon. After completing the preparation of body position and instrument, adjust the instrument, set the treatment parameters: frequency 7Hz, treatment pressure 2.0-3.0 bar, number of shock waves 2000 times. First, treat with intermittent wave test for several times, and the patient will feel whether the shock wave positioning is consistent with the actual pain point. Adjust the position of the treatment head until the impact site is consistent with the pain point, and then start continuous wave treatment. Each treatment lasts for 5 minutes, with 2 treatments per week for a total of 6 weeks.

Intervention code：

组别：

肌贴组

样本量：

 15

Group：

Muscle patch group

Sample size：

干预措施：

常规康复治疗基础上，根据运动员跟腱的形态和疼痛区域，选用[NITREAT日东医疗用贴布(北康，中国福州)]进行贴扎。贴扎方法共选用3条贴布： （1）小腿三头肌促进贴布：取1条I形贴布，从足底中后1/3的位置开始，沿着小腿后侧，一直贴至小腿中段1/2处。该贴布主要用于促进小腿三头肌的功能，帮助缓解跟腱炎带来的相关症状。 （2）筋膜引导贴布：选用1条Y形贴布，将其锚（即贴扎起端，长度占Y形贴布的 1/3 ）贴扎在足底中后1/3处，尾端（贴扎末端，长度占 Y 形贴布的 2/3 ）均分为 2 条，呈双手交叉状重叠贴于小腿后侧中上 1/3 处。这样的贴扎方式能够引导筋膜，辅助跟腱恢复。 （3）跟腱支持贴布：针对跟腱疼痛明显的部位，采用肌内效布I形或X形进行痛点贴扎。 在贴扎过程中需注意，贴布上不施加任何拉力或仅施加10%以下的拉力。贴扎频率为 1 次 / 3天，每次贴扎后维持48h左右，两次贴扎之间需休息1天。治疗方案为1次冲击波治疗后，紧接着进行2次肌内效贴贴扎，持续使用6周。患者需在1天内同时接受冲击波和贴扎治疗，且先完成冲击波治疗，再进行贴扎操作，这是为了避免贴扎干扰冲击波治疗时对痛点的识别。

干预措施代码：

Intervention：

On the basis of routine rehabilitation treatment, according to the shape and pain area of the athlete's Achilles tendon, NITREAT Nitto Medical Patch (Beikang, Fuzhou, China) was selected for ligation. Three adhesive tapes were selected for the binding method: (1) Triceps promotion patch for calves: Take one I-shaped patch and start from the back one-third of the foot, along the back of the calf, and continue until the middle half of the calf. This patch is mainly used to promote the function of the calf triceps and help alleviate symptoms related to tendinitis. (2) Fascia guided adhesive patch: Select one Y-shaped adhesive patch and anchor it (i.e. the starting end of the patch, with a length accounting for 1/3 of the Y-shaped adhesive patch) at the back 1/3 of the foot. Divide the tail end (the end of the patch, with a length accounting for 2/3 of the Y-shaped adhesive patch) into two equal strips and overlap them in a crossed pattern on the upper 1/3 of the back of the calf. This binding method can guide the fascia and assist in the recovery of the Achilles tendon. (3) Achilles tendon support patch: For areas with obvious Achilles tendon pain, an intramuscular effect patch in the shape of I or X is used for pain point attachment. During the pasting process, it is important to note that no tension is applied to the sticker or only 10% or less tension is applied. The frequency of pasting is once every three days, and it should be maintained for about 48 hours after each pasting. A day of rest is required between two pasting. The treatment plan is to perform one shock wave therapy followed by two intramuscular efficacy patches, which will be used continuously for 6 weeks. Patients need to receive both shock wave and patch therapy within one day, and complete the shock wave therapy before performing the patch operation to avoid interference with the identification of pain points during shock wave therapy.

Intervention code：

组别：

联合治疗组

样本量：

 15

Group：

Combination therapy group

Sample size：

干预措施：

在常规康复治疗基础上，同时进行上述体外冲击波和肌贴治疗，治疗参数及贴扎方法、更换频率与体外冲击波组、肌贴组一致，治疗周期为6周。

干预措施代码：

Intervention：

On the basis of conventional rehabilitation treatment, the above-mentioned extracorporeal shock wave and muscle patch treatment were performed simultaneously. The treatment parameters, patch methods, and replacement frequency were the same as those of the extracorporeal shock wave group and muscle patch group, and the treatment period was 6 weeks.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 天津 

市(区县)：

 静海 

Country：

China

Province：

Tianjin

City：

Jinghai

单位(医院)：

 天津体育学院 

单位级别：

 大学 

Institution
hospital：

Tianjin University of Sport

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

跟腱疼痛评分

指标类型：

主要指标

Outcome：

Achilles tendon pain score

Type：

Primary indicator

测量时间点：

测量方法：

视觉模拟评分VAS

Measure time point of outcome：

Measure method：

Visual Analogue Scale (VAS)

指标中文名：

跟腱功能评分

指标类型：

主要指标

Outcome：

Achilles tendon function score

Type：

Primary indicator

测量时间点：

测量方法：

维多利亚体育研究所跟腱问卷（VISA - A）

Measure time point of outcome：

Measure method：

Victoria Sports Institute Achilles Tendon Questionnaire (VISA-A)

指标中文名：

足踝关节功能评分

指标类型：

主要指标

Outcome：

Ankle joint function score

Type：

Primary indicator

测量时间点：

测量方法：

足踝关节功能评分量表（AOFAS）

Measure time point of outcome：

Measure method：

Foot and Ankle Joint Function Scale (AOFAS)

指标中文名：

最长跑步时间

指标类型：

主要指标

Outcome：

Maximum running time

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

跟腱结构变化

指标类型：

主要指标

Outcome：

Structural changes of Achilles tendon

Type：

Primary indicator

测量时间点：

测量方法：

超声

Measure time point of outcome：

Measure method：

Ultrasound

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 25 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）：

随机数字表法

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

Random number table method

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：

无

Blinding：

None

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）：

2025年4月14日，腾讯微云，https://www.weiyun.com/

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

April 14, 2025, Tencent Weiyun, https://www.weiyun.com/

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：

病例记录表由统一治疗师对患者进行记录，过程对患者的隐私进行严格保密，仅收集与实验相关的数据。采集和管理由境内数据服务器进行存储，对分析用数据去标识化（如用 User123 替代真实姓名），确保无法关联到个人。

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

The case record form is recorded by a unified therapist for patients, with strict confidentiality of their privacy during the process, and only data related to the experiment is collected. The collection and management are stored by domestic data servers, and the data used for analysis is de identified (such as using User123 instead of real names) to ensure that it cannot be associated with individuals.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-04-24 08:06:37