ChiCTR2500099750 版本V1.0 版本创建时间2025/03/27 18:05:12 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：

 ChiCTR2500099750 

最近更新日期：

Date of Last Refreshed on：

 2025-03-27 18:05:02 

注册时间：

Date of Registration：

 2025-03-27 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

水针联合针刀治疗颈脊髓损伤后肩痛伴上肢水肿的疗效分析

Public title：

The Efficacy Analysis of Hydroacupuncture Combined with Acupotomy in Treating Shoulder Pain with Upper Limb Edema after Cervical Spinal Cord Injury

注册题目简写：

English Acronym：

研究课题的正式科学名称：

水针联合针刀治疗颈脊髓损伤后肩痛伴上肢水肿的疗效分析

Scientific title：

The Efficacy Analysis of Hydroacupuncture Combined with Acupotomy in Treating Shoulder Pain with Upper Limb Edema after Cervical Spinal Cord Injury

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：

朱春明 

研究负责人：

朱春明 

Applicant：

Zhu Chunming 

Study leader：

Zhu Chunming 

申请注册联系人电话：

Applicant telephone：

 +86 135 6793 8126

研究负责人电话：

Study leader's
telephone：

+86 135 6793 8126

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：

 79667489@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 79667489@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：

浙江省宁波市鄞州区桑田路502号

研究负责人通讯地址：

浙江省宁波市鄞州区桑田路502号

Applicant address：

502 Sangtian Road, Yinzhou District, Ningbo City, Zhejiang Province

Study leader's address：

502 Sangtian Road, Yinzhou District, Ningbo City, Zhejiang 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：

宁波市康复医院

Applicant's institution：

Ningbo Rehabilitation Hospital

研究负责人所在单位：

宁波市康复医院

Affiliation of the Leader：

Ningbo Rehabilitation 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：

 (2005)年伦理审查(科研第006)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：

宁波市康复医院伦理审查委员会

Name of the ethic committee：

Ningbo Rehabilitation Hospital Ethics Review Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-03-17 00:00:00

伦理委员会联系人：

刘晓广

Contact Name of the ethic committee：

Liu Xiaoguang

伦理委员会联系地址：

浙江省宁波市鄞州区桑田路502号

Contact Address of the ethic committee：

502 Sangtian Road, Yinzhou District, Ningbo City, Zhejiang Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 134 2936 5136

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：

宁波市康复医院

Primary sponsor：

Ningbo Rehabilitation Hospital

研究实施负责（组长）单位地址：

浙江省宁波市鄞州区桑田路502号

Primary sponsor's address：

502 Sangtian Road, Yinzhou District, Ningbo City, Zhejiang 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)：

浙江省

市(区县)：

Country：

China

Province：

Zhejiang Province

City：

单位(医院)：

宁波市康复医院

具体地址：

宁波市鄞州区桑田路502号

Institution
hospital：

Ningbo Rehabilitation Hospital

Address：

502 Sangtian Road, Yinzhou District, Ningbo City

经费或物资来源：

浙江省基层卫生软科学研究

Source(s) of funding：

Research on Soft Science in Basic Health Care in Zhejiang Province

研究疾病：

颈部脊髓损伤  

Target disease：

Cervical spinal cord injury

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：

目的探讨水针联合针刀、单纯康复训练治疗颈脊髓损伤后肩痛伴上肢水肿的效果是否要优于单纯康复训练治疗的效果。研究探讨的联合治疗对改善肩痛及水肿具有促进作用，可以提高治疗疗效，则值得在临床工作中推广。  

Objectives of Study：

ObjectiveTo investigate whether the effect of water injection combined with acupuncture and rehabilitation training alone in the treatment of shoulder pain with upper limb edema after cervical spinal cord injury was better than that of rehabilitation training alone. The combined therapy discussed in this study has a promoting effect on improving shoulder pain and edema, and can improve the therapeutic efficacy, which is worthy of promotion in clinical work.

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.根据《脊柱脊髓损伤康复治疗专家共识（2020版）》[5]及《过伸性颈脊髓损伤诊疗临床循证指南》[6]中的诊断标准确诊为颈部脊髓损伤，病程在1-3个月；2.上肢出现功能障碍的同时伴有肩区疼痛症状，并且肩关节在进行前屈、外展或者外旋动作时，相应肌群的肌张力按照改良Ashworth分级标准评定，结果达到＞＝1 +级；3.患者的生命体征平稳，意识清晰，简易精神状态检查量表评分≥20分，能够积极配合后续的诊断与治疗工作。

Inclusion criteria

1.According to the diagnostic criteria in the Expert Consensus on Rehabilitation Treatment of Spinal Cord Injury (2020 Edition) [5] and the Clinical Evidence-based Guidelines for the Diagnosis and Treatment of Hyperextensor Cervical Spinal Cord Injury [6], the diagnosis of cervical spinal cord injury was confirmed, and the course of the disease was 1-3 months; 2. Upper limb dysfunction accompanied by pain in the shoulder area, and when the shoulder joint is bent forward, abducted or externally rotated, the muscle tone of the corresponding muscle groups is evaluated according to the modified Ashworth grading criteria, and the result reaches >=1; 3. The patient's vital signs are stable, the consciousness is clear, the score of the Mini-Mental State Examination Scale is ≥ 20 points, and the patient can actively cooperate with the follow-up diagnosis and treatment. According to the diagnostic criteria in the "Expert Consensus on Rehabilitation Treatment of Spinal Cord Injury (2020 Edition)" [5] and the "Evidence based Clinical Guidelines for the Diagnosis and Treatment of Stretching Cervical Spinal Cord Injury" [6], it is diagnosed as cervical spinal cord injury with a course of 1-3 months; 2. When there is functional impairment in the upper limbs accompanied by shoulder pain symptoms, and when the shoulder joint performs forward flexion, abduction, or external rotation movements, the muscle tension of the corresponding muscle group is evaluated according to the modified Ashworth grading standard, and the result is ≥ 1+level; 3. The patient's vital signs are stable, consciousness is clear, and the score on the simple mental state examination scale is ≥ 20 points. They are able to actively cooperate with subsequent diagnosis and treatment work.

排除标准：

1.既往有肩关节疾患或肩关节手术史；2.患病以来经其他方法治疗过后；3.患者存在意识障碍或严重精神疾病、恶性肿瘤病史。

Exclusion criteria：

1. Previous history of shoulder joint diseases or shoulder joint surgeries; 2. After being treated with other methods since the onset of the illness; 3. The patient has a history of consciousness disorders, severe mental illness, or malignant tumors.

研究实施时间：

Study execute time：

从 From 2023-05-01 00:00:00至 To 2025-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-05-01 00:00:00 至 To 2023-08-01 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 31

Group：

Control group

Sample size：

干预措施：

对照组给予常规康复训练、超声波治疗和冲击波治疗，所有患者均依照颈脊髓损伤的康复治疗方案开展常规康复训练，涵盖肢体关节活动训练、肢体功能训练以及日常生活能力训练等方面。训练时间安排为20min/次，2次/天，5天/周，整个康复训练周期持续4周。超声波治疗选用SONOPULS190超声波治疗仪，频率100MHz，0.50W/ cm2。10min/次，1次/天，5天/周。体外冲击波治疗选用SWissDolorClast，治疗频率设定为0-5Hz，冲击头：15mm，每次持续2000次，能量设置在2-4bar/power范围内。选择5个肩部触发点（斜方肌、肩胛提肌、冈上肌、冈下肌及小圆肌）进行冲击治疗，3-5天治疗1次，持续治疗6次。

干预措施代码：

Intervention：

313/1000 313/1000.,.20,2,5,4.SONOPULS190,100MHz,0.50W/cm2.10,,5.SWissDolorCast,0-5Hz,15mm,2000.2-4/.5(),3-5, The control group received routine rehabilitation training, ultrasound therapy, and shock wave therapy. All patients underwent routine rehabilitation training according to the rehabilitation treatment plan for cervical spinal cord injury, including limb joint activity training, limb function training, and daily living ability training. The training schedule is 20 minutes per session, 2 sessions per day, 5 days per week, and the entire rehabilitation training cycle lasts for 4 weeks. SONOPULS190 ultrasonic therapy device is selected for ultrasonic therapy, with a frequency of 100MHz and 0.50W/cm2. 10 minutes per session, once per day, 5 days per week. SWissDolorClast is selected for extracorporeal shock wave therapy, with a treatment frequency set at 0-5Hz, a shock head of 15mm, and a duration of 2000 times each time. The energy is set within the range of 2-4 bar/power. Select 5 shoulder trigger points (trapezius muscle, levator scapula muscle, supraspinatus muscle, infraspinatus muscle, and teres minor muscle) for impact therapy, treatment once every 3-5 days, continuous treatment

Intervention code：

组别：

观察组

样本量：

 31

Group：

Observation group

Sample size：

干预措施：

观察组在对照组的基础上给予超声引导下水针+针刀治疗。水针治疗：超声引导下患侧肩关节腔内曲安奈德注射液+盐酸利多卡因注射液注射治疗，超声仪器采用东芝aplio50型超声仪（日本东芝医疗系统株式会社），PLT-1204BT高频线阵探头(7-18MHz)。

干预措施代码：

Intervention：

The observation group received ultrasound-guided water needle and needle knife treatment on the basis of the control group. Water needle therapy: Under ultrasound guidance, the affected shoulder joint cavity is treated with injection of triamcinolone acetonide injection and lidocaine hydrochloride injection. The ultrasound instrument used is Toshiba APLIO50 ultrasonic instrument (Toshiba Medical Systems Co., Ltd., Japan) and PLT-1204BT high-frequency linear array probe (7-18MHz).

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江省 

市(区县)：

  

Country：

China

Province：

Zhejiang Province

City：

单位(医院)：

 宁波市康复医院 

单位级别：

 三级 

Institution
hospital：

Ningbo Rehabilitation Hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

ConstantMurley肩关节评分

指标类型：

主要指标

Outcome：

ConstantMurley Shoulder Score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

上肢肿胀积分

指标类型：

主要指标

Outcome：

Upper limb swelling score

Type：

Primary 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：

N/A

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 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）：

简单随机

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

Simple and random 126/1000.,,,.,.,. Patients with cervical spinal cord injury and shoulder pain accompanied by upper limb edema who meet the diagnostic criteria and have recovered at Ningbo Rehabilitation Hospital will be included. The patients will be enrolled in a single blind study, and the person in charge will number and group them, and put them in sealed envelopes to shuffle the order. After opening the envelopes one by one according to the numbering order, the surgeon applied the corresponding protocol. The recorder and analyst were unaware of the patient grouping, and the entire study was unblinded after completion.

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：

研究分析人员不知道分组。

Blinding：

The study analyst was not aware of the grouping.

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）：

http://www.medresman.org.cn/pub/cn/proj/search.aspx

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

http://www.medresman.org.cn/pub/cn/proj/search.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：

我们将采用病例记录表（Case Record Form, CRF）和电子数据采集和管理系统（Electronic Data Capture, EDC，如ResMan）来进行数据采集和管理。CRF由研究团队指定人员填写，包含患者基本信息、临床信息。数据随后录入EDC系统，确保其准确性和安全性。EDC系统通过云服务器存储数据，具备高水平的安全防护措施，并通过分级管理确保访问权限。数据定期审核，遵循法规和指南，保护患者隐私。研究团队将使用统计软件进行数据分析，确保数据质量和可靠性。

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

We will adopt standardized data collection and management systems, including Case Record Forms (CRF) and Electronic Data Collection Systems (EDCs, such as ResMan). The research team will use CRF to collect basic patient information and clinical data, and input the data into the EDC system. The system provides real-time data input, data validation, secure storage, and hierarchical access permissions to ensure the accuracy and security of data. The data will be regularly reviewed and cleaned up, and finally exported for statistical analysis to ensure the scientific and reliable nature of the research data.

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：

  2025-03-27 18:05:02