ChiCTR2500113726 版本V1.0 版本创建时间2025/12/02 14:45:22 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：

 ChiCTR2500113726 

最近更新日期：

Date of Last Refreshed on：

 2025-12-02 14:45:17 

注册时间：

Date of Registration：

 2025-12-02 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

体外冲击波联合综合护理治疗新兵胫骨应力性骨折的疗效

Public title：

Study on the therapeutic effect of extracorporeal shock wave combined with comprehensive nursing guidance on tibial stress fractures in new recruits

注册题目简写：

English Acronym：

研究课题的正式科学名称：

体外冲击波联合综合护理治疗新兵胫骨应力性骨折的疗效

Scientific title：

Study on the therapeutic effect of extracorporeal shock wave combined with comprehensive nursing guidance on tibial stress fractures in new recruits

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：

苏文杰 

研究负责人：

温慧敏 

Applicant：

Wenjie Su 

Study leader：

Huimin Wen 

申请注册联系人电话：

Applicant telephone：

 +86 180 6048 2495

研究负责人电话：

Study leader's
telephone：

+86 186 5950 5855

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：

 ptsuwenjie@163.com

研究负责人电子邮件：

Study leader's E-mail：

 796206499@qq.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：

福建省泉州市丰泽区花园路180号

研究负责人通讯地址：

福建省泉州市丰泽区花园路180号

Applicant address：

No. 180, Huayuan Road, Fengze District, Quanzhou City, Fujian Province

Study leader's address：

No. 180, Huayuan Road, Fengze District, Quanzhou City, Fujian Province

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：

中国人民解放军联勤保障部队第九一〇医院

Applicant's institution：

The 910th Hospital of the Joint Logistic Support Force of the People's Liberation Army of China

研究负责人所在单位：

中国人民解放军联勤保障部队第九一〇医院

Affiliation of the Leader：

The 910th Hospital of the Joint Logistic Support Force of the People's Liberation Army of China

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：

 院医伦[2022]60号

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：

中国人民解放军联勤保障部队第九一〇医院

Name of the ethic committee：

The 910th Hospital of the Joint Logistic Support Force of the People's Liberation Army of China

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-09-20 00:00:00

伦理委员会联系人：

苏辉强

Contact Name of the ethic committee：

Huiqiang Su

伦理委员会联系地址：

福建省泉州市丰泽区花园路180号

Contact Address of the ethic committee：

No. 180, Huayuan Road, Fengze District, Quanzhou City, Fujian Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 595 2891 9038

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：

中国人民解放军联勤保障部队第九一〇医院

Primary sponsor：

The 910th Hospital of the Joint Logistic Support Force of the People's Liberation Army of China

研究实施负责（组长）单位地址：

福建省泉州市丰泽区花园路180号

Primary sponsor's address：

No. 180, Huayuan Road, Fengze District, Quanzhou City, Fujian Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

福建省

市(区县)：

泉州市

Country：

China

Province：

Fujian

City：

Quanzhou

单位(医院)：

中国人民解放军联勤保障部队第九一〇医院

具体地址：

福建省泉州市丰泽区花园路180号

Institution
hospital：

The 910th Hospital of the Joint Logistic Support Force of the People's Liberation Army of China

Address：

No. 180, Huayuan Road, Fengze District, Quanzhou City, Fujian Province

经费或物资来源：

研究所在单位配套

Source(s) of funding：

The research institute is equipped within the unit

研究疾病：

胫骨应力性骨折  

Target disease：

Tibial stress fracture

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：

寻找促进胫骨应力性骨折愈合的方法并在此基础上维持肌肉功能，调整心态。在冲击波治疗的基础上，增加疼痛、营养、心理、康复等综合护理干预，观察二者联合应用治疗新兵胫骨应力性骨折的疗效，以期为新兵胫骨应力性骨折的治疗提供新的思路和方案。  

Objectives of Study：

Seek methods to promote the healing of tibial stress fractures and, on this basis, maintain muscle function and adjust one's mindset. Based on shock wave therapy, comprehensive nursing interventions such as pain, nutrition, psychology and rehabilitation were added to observe the therapeutic effect of the combined application of the two in the treatment of tibial stress fractures in recruits, in order to provide new ideas and plans for the treatment of tibial stress fractures in recruits.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

诊断标准：符合《军事训练伤诊断与防治原则专家共识（2022版）》中应力性骨折的诊断要点：1.小腿存在无明显原因的疼痛且部位较为固定；2.疼痛出现前几周内有强度较大的训练；3.休息时疼痛减轻，运动时疼痛加重；4.沿胫骨长轴有局部固定的压痛点，伴或不伴软组织肿胀；5.X线检查可发现骨折征象。 纳入标准：1.年龄＞＝18岁；2.入伍时间为1年内；3.近3个月内参与＞＝2次/周的高强度军事训练；4.自愿签署知情同意书且配合治疗者。

Inclusion criteria

Diagnostic criteria: In line with the key points for diagnosing stress fractures as stipulated in the "Expert Consensus on Principles of Diagnosis and Prevention of Military Training Injuries (2022 Edition)" : 1.There is unexplained pain in the lower leg and the location is relatively fixed; 2.There was intense training within a few weeks before the pain occurred; 3.The pain lessens at rest but intensifies during exercise.4.There are locally fixed tender points along the long axis of the tibia, with or without soft tissue swelling; 5.X-ray examination can detect signs of fractures. Inclusion criteria: 1. Age >=18 years old; 2.The enlistment time is within one year. 3. Have participated in high-intensity military training at least twice a week within the past three months; 4.Those who voluntarily sign the informed consent form and cooperate with the treatment.

排除标准：

1.有下肢外伤史者；2.存在因肿瘤等病理因素导致的胫骨骨折者；3.骨折严重，对功能影响较大，或持久不愈合等有手术指征需要手术者；4.伴有其他系统疾病或心理疾病者；5.存在其它疾病需要药物等其它治疗，影响疗效评估者。

Exclusion criteria：

1.Those with a history of lower limb trauma; 2.Those with tibial fractures caused by pathological factors such as tumors; 3.Those with severe fractures that have a significant impact on function, or those with persistent non-union and other surgical indications requiring surgery; 4.Those accompanied by other systemic diseases or mental disorders; 5.Those who have other diseases that require medication or other treatments and affect the evaluation of therapeutic effects.

研究实施时间：

Study execute time：

从 From 2022-07-01 00:00:00至 To 2026-03-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-10-12 00:00:00 至 To 2025-03-12 00:00:00

干预措施：

Interventions：

组别：

常规治疗组

样本量：

 30

Group：

Conventional treatment group

Sample size：

干预措施：

采用传统常规治疗：在休息的基础上给予止痛药物及促进骨折愈合药物治疗。

干预措施代码：

Intervention：

Conventional treatment is adopted: painkillers and drugs promoting fracture healing are administered on the basis of rest.

Intervention code：

组别：

ESWT组

样本量：

 30

Group：

ESWT group

Sample size：

干预措施：

在常规治疗的基础上增加ESWT治疗：首先由经验丰富的医生应用肌骨超声（深圳迈瑞生物医疗电子股份有限公司，型号：M55）对骨折处进行精确定位并标记，接着沿胫骨长轴及周围进行触诊，寻找压痛明显的位置，并做好标记。应用瑞士STORZ MP100型放射式体外冲击波治疗仪，对标记部位进行治疗，治疗频率为10 Hz，压强为1.0-2.0 Bar（根据耐受程度进行调整），骨折部位冲击2000次，其余部位2000次，总共冲击4000次。冲击波治疗由一名经过培训、经验丰富的主管治疗师实施，每周1次，治疗于每周的同一天进行，共治疗8周。

干预措施代码：

Intervention：

On the basis of conventional treatment, ESWT treatment is added: First, an experienced doctor uses musculoskeletal ultrasound (Shenzhen Mindray Bio-Medical Electronics Co., LTD., model: M55) to precisely locate and mark the fracture site. Then, palpation is performed along the long axis of the tibia and its surrounding area to find the location with obvious tenderness and make a mark. The Swiss STORZ MP100 radiative extracorporeal shock wave therapy device was applied to treat the marked areas. The treatment frequency was 10 Hz, and the pressure was 1.0-2.0 Bar (adjusted according to the tolerance level). The fracture area was impacted 2000 times, and the other areas were impacted 2000 times, totaling 4000 times. Shock wave therapy is performed by a trained and experienced chief therapist once a week, on the same day of each week, for a total of 8 weeks.

Intervention code：

组别：

联合组

样本量：

 30

Group：

Joint Group

Sample size：

干预措施：

在ESWT组的基础上增加CN干预。CN干预：1.疼痛护理：包括疼痛相关知识的宣教、止痛药物规范化使用指导、日常生活舒适体位与减痛技巧、注意力分散技巧与心理调适等四个方面内容；2.营养护理：告知新兵均衡饮食及每日各种营养物质的摄入比例，每日膳食须做到“三低三高”—低油、低盐、低糖，高蛋白、高钙、高维生素；每日蛋白质约1.2–1.5 g/kg体重供给，钙元素不少于1000 mg，并搭配维生素D 800 IU促进吸收，三大营养素供能比例控制为碳水55%、蛋白25%、脂肪20%。同时禁油炸、肥肉、奶油蛋糕等高脂食物，烹调以蒸、煮、焯、炖为主，帮助骨痂形成并减少脂肪摄入，并推荐常见的高蛋白、高钙食物供新兵参考。3.心理护理：先用通俗语言向新兵逐条解释TSF的成，并用骨骼模型演示“裂缝—修复—重塑”的完整愈合过程，说6-8周保护性训练后90%以上可恢复原有运动水平；随后引导其说出对疼痛、训练落后及未来考核的担忧，即时进行情绪标注与共情回应。同时，分享以往治愈病例，增强信心。4.康复护理：指导新兵进行四肢尤其是受伤肢体的功能锻炼，先从仰卧位踝泵、被动屈伸膝、踝各10次热身，再过渡到坐位弹力带踝背屈、跖屈、伸膝、屈膝等主动-抗阻结合动作，重点针对股四头肌、腘绳肌、腓肠肌、胫前肌等做中等负荷力量训练，训练后冰敷10分钟防止微肿，根据自身感觉确保强度控制在“微酸不痛”区间，逐步恢复受伤肢体的力量与灵活性。 CN治疗由一名进过培训且经验丰富的主管护师进行，每周指导一次，于ESWT治疗后进行，每次持续时间约45分钟，持续8周，具体内容可根据具体情况进行适当调整。

干预措施代码：

Intervention：

Add CN intervention on the basis of the ESWT group. CN intervention: (1) Pain care: It includes four aspects: education on pain-related knowledge, guidance on the standardized use of painkillers, comfortable positions in daily life and pain reduction techniques, attention distraction techniques and psychological adjustment; (2) Nutritional care: Inform new recruits of a balanced diet and the proportion of daily intake of various nutrients. Daily meals must follow the "three lows and three highs" - low oil, low salt, and low sugar, high protein, high calcium, and high vitamins. Daily protein intake should be approximately 1.2 to 1.5 grams per kilogram of body weight, calcium intake should be no less than 1000 mg, and 800 IU of vitamin D should be combined to promote absorption. The energy supply ratio of the three major nutrients should be controlled as 55% carbohydrates, 25% protein, and 20% fat. At the same time, high-fat foods such as fried foods, fatty meats, and cream cakes should be avoided. Cooking methods should mainly include steaming, boiling, blanching, and stewing to help form callus and reduce fat intake. Common high-protein and high-calcium foods are recommended for new recruits to refer to. (3) Psychological care: First, explain the formation of TSF to the new recruits item by item in plain language, and demonstrate the complete healing process of "crack - repair - remodeling" with a bone model. Say that over 90% of them can restore their original exercise level after 6-8 weeks of protective training. Then guide them to express their concerns about pain, training lag and future performance evaluations, and immediately provide emotional labeling and empathetic responses. At the same time, share previous cured cases to boost confidence. (4) Rehabilitation Nursing Guide the new recruits to perform functional exercises for their limbs, especially the injured ones. Start with 10 warm-up exercises each in the supine position with ankle pump, passive knee flexion and extension, and ankle. Then transition to sitting position with resistance band ankle dorsiflexion, plantar flexion, knee extension, and knee flexion, which combine active and resistance movements. Focus on moderation-load strength training for the quadriceps, hamstrings, gastrocnemius, and tibialis anterior muscles. After the training, apply ice packs for 10 minutes to prevent slight swelling. Make sure the intensity is controlled within the "slightly sore but not painful" range based on your own feelings, and gradually restore the strength and flexibility of the injured limb. CN treatment is carried out by a trained and experienced head nurse, who provides guidance once a week after ESWT treatment. Each session lasts approximately 45 minutes and lasts for 8 weeks. The specific content can be appropriately adjusted according to the specific situation.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 福建省 

市(区县)：

  

Country：

China

Province：

Fujian Province

City：

单位(医院)：

 中国人民解放军联勤保障部队第九一〇医院 

单位级别：

 三甲 

Institution
hospital：

The 910th Hospital of the Joint Logistic Support Force of the People's Liberation Army of China

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

胫骨骨折愈合的影像学评分

指标类型：

主要指标

Outcome：

Radiographic Union Score for Tibia,RUST

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肌肉力量

指标类型：

主要指标

Outcome：

Muscle strength

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

延迟性肌肉酸痛症疲劳程度评分

指标类型：

次要指标

Outcome：

delayed onset muscle soreness,DOMS

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

坦帕运动恐惧症量表

指标类型：

次要指标

Outcome：

TAMPA Kinesiophobia Scale,TKS

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

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：

结束

/Completed

年龄范围：

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

由温慧敏运用随机数字表法进行随机分组

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

Random grouping was conducted by Wen Huimin using the PLAN process based on the SAS software

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：

单盲：疗效评估、基本资料等数据收集及处理的人员不清楚患者的分组情况

Blinding：

Single-blind: The personnel responsible for data collection and processing such as efficacy evaluation and basic information are not clear about the grouping of patients

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）：

预计2030年9月于国家生物信息中心(https://ngdc.cncb.ac.cn/gsub/)共享原始数据

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

Is expected in September 2030 the national biological information center (https://ngdc.cncb.ac.cn/gsub/) to share the raw data

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：

通过CRF和EDC进行数据采集与管理

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

Data collection and management through CRF and EDC.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-12-02 14:45:17