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A clinical study protocol for Qihuang needle therapy for mid-term rehabilitation after shoulder sleeve repair surgery under arthroscopic surgery

注册号：

Registration number：

ITMCTR2025000062

最近更新日期：

Date of Last Refreshed on：

2025-01-10

注册时间：

Date of Registration：

2025-01-10

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

岐黄针疗法对关节镜下肩袖修补术后中期康复的临床研究方案

Public title：

A clinical study protocol for Qihuang needle therapy for mid-term rehabilitation after shoulder sleeve repair surgery under arthroscopic surgery

注册题目简写：

English Acronym：

研究课题的正式科学名称：

岐黄针疗法对关节镜下肩袖修补术后中期康复的临床研究方案

Scientific title：

A clinical study protocol for Qihuang needle therapy for mid-term rehabilitation after shoulder sleeve repair surgery under arthroscopic surgery

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：

余金艳

研究负责人：

陈振虎

Applicant：

Jinyan Yu

Study leader：

Zhenhu Chen

申请注册联系人电话：

Applicant telephone：

15761422356

研究负责人电话：

Study leader's telephone：

13728063180

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：

3306667853@qq.com

研究负责人电子邮件：

Study leader's E-mail：

chen@gzucm.edu.cn

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：

中国广东省广州市机场路16号

研究负责人通讯地址：

中国广东省广州市机场路16号

Applicant address：

No.16 Airport Road Guangzhou Guangdong China

Study leader's address：

No.16 Airport Road Guangzhou Guangdong 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：

广州中医药大学第一附属医院

Applicant's institution：

The First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou China.

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：

NO. JY2024-106

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

广州中医药大学第一附属医院伦理委员会教研分会

Name of the ethic committee：

Ethics Committee Teaching and Research Branch of the First Affiliated Hospital of Guangzhou University of Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2024/8/30 0:00:00

伦理委员会联系人：

黄纯美

Contact Name of the ethic committee：

Huang Chunmei

伦理委员会联系地址：

广州中医药大学第一附属医院

Contact Address of the ethic committee：

The First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou China.

伦理委员会联系人电话：

Contact phone of the ethic committee：

020-36585411

伦理委员会联系人邮箱：

Contact email of the ethic committee：

530000739@qq.com

研究实施负责（组长）单位：

广州中医药大学第一附属医院

Primary sponsor：

The First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou China.

研究实施负责（组长）单位地址：

中国广东省广州市机场路16号

Primary sponsor's address：

No.16 Airport Road Guangzhou Guangdong China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

Guangdong Province

市(区县)：

Guangzhou

Country：

China

Province：

Guangdong Province

City：

Guangzhou

单位(医院)：

广州中医药大学第一附属医院

具体地址：

中国广东省广州市机场路16号

Institution
hospital：

The First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou China.

Address：

No.16 Airport Road Guangzhou Guangdong China

经费或物资来源：

中医药古籍文献和特色技术传承专项、广州地区中西医协同临床重大创新技术建设项目

Source(s) of funding：

State Administration of Traditional Chinese Medicine of the People's Republic of China(GZY-KJS-2022-026) Major Innovation Technology Construction Project of Synergistic Chinese Medicine and Western Medicine of Guangzhou (No.2023-2318)

研究疾病：

肩袖损伤修补术后的康复

研究疾病代码：

Target disease：

Rehabilitation after rotator cuff injury repair

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：

其它

Others

研究目的：

针对在肩袖修补术后中期康复患者，探究岐黄针治疗的临床疗效

Objectives of Study：

Exploring the clinical efficacy of qihuang needle therapy in patients undergoing mid-term rehabilitation after rotator cuff repair surgery

药物成份或治疗方案详述：

参与研究的患者继续维持入组前用药方案。岐黄针组：在基础治疗之上予岐黄针疗法治疗。对照组：给予基础治疗（塞来昔布胶囊、超声波理疗、关节松动术、康复训练）。

Description for medicine or protocol of treatment in detail：

Patients participating in the study continued to maintain their pre-enrollment medication regimen. Qihuang Acupuncture Group: Qihuang Acupuncture Therapy was given on top of the basic treatment. Control group: basic treatment (celecoxib capsules ultrasound physiotherapy joint release rehabilitation).

纳入标准：

（1）同时符合肩袖修补术后中期康复的中西医诊断标准； （2）年龄 18 岁-70 岁； （3）由本团队同一高级别医生进行的关节镜下肩袖修复术，术中测量肩袖撕裂前后宽度为中小型肩袖撕裂（撕裂大小 10-30 mm）； 术后肩关节外展支具常规固定 4-6 周后，复查患肩磁共振（MRI）检查提示肩袖修复术后肌腱连续性良好，但患者主诉仍有术侧肩部疼痛及活动受限，且活动痛或夜间痛 VAS 评分≥ 30 mm，并以肩关节外展、前屈上举、外旋、后伸内旋主动活动受限为主，伴 或不伴有被动活动受限。 （4）自愿且能够配合完成治疗并收集临床数据资料； （5）签署知情同意书、接受定期随访。

Inclusion criteria

(1) Meets the diagnostic criteria of Chinese and Western medicine for mid-term rehabilitation after rotator cuff repair; (2) Aged 18-70 years; (3) Arthroscopic rotator cuff repair performed by the same high-level surgeon of the team and the width of the rotator cuff before and after the rotator cuff tear was measured as a small to medium-sized rotator cuff tear (the size of the tear was 10-30 mm) during the operation; after the postoperative shoulder abduction brace was fixed routinely for 4 to 6 weeks the Magnetic Resonance Imaging (MRI) examination of the affected shoulder showed that the continuity of the tendon after rotator cuff repair was good. After 4-6 weeks of postoperative immobilization in a shoulder abduction brace magnetic resonance imaging (MRI) examination of the affected shoulder showed that the continuity of the tendon was good after rotator cuff repair but the patient still complained of pain and limitation of movement on the operated side of the shoulder and the VAS score of the pain in movement or pain at night was ≥30 mm with the limitation of the shoulder joint's active movement in abduction forward flexion and supination external rotation and posterior extension and internal rotation and with or without limitation of passive movement. (4) Voluntarily and cooperatively complete the treatment and collect clinical data; (5) Sign the informed consent form and accept regular follow-up.

排除标准：

（1）术前诊断合并钙化性肌腱炎； （2）既往患侧肩部多次手术史； （3）术后出现术侧肩关节皮肤溃烂、感染、外伤、骨折、脱位。 （4）有精神、心脑血管疾病、恶性肿瘤、血液病等重大基础疾病。 （5）有塞来昔布相关禁忌症，如胃肠道溃疡、出血或穿孔等。 （6）术后曾接受过针刺治疗。 （7）同时参与其他临床试验者； （8）有针刺禁忌症、晕针或无法配合针灸治疗。 （9）处于妊娠期或哺乳期或正准备妊娠的妇女。

Exclusion criteria：

(1) Preoperative diagnosis of combined calcific tendonitis; (2) Previous history of multiple surgeries on the affected shoulder; (3) Postoperative ulceration of the skin of the shoulder joint on the operated side infection trauma fracture dislocation. (4) Major underlying diseases such as mental cardiovascular and cerebrovascular diseases malignant tumors and blood diseases. (5) Have contraindications related to celecoxib such as gastrointestinal ulcers bleeding or perforation. (6) Have received postoperative acupuncture treatment. (7) Those who are also participating in other clinical trials; (8) Those who have contraindications to acupuncture are dizzy with needles or are unable to cooperate with acupuncture treatment. (9) Women who are pregnant or breastfeeding or are preparing for pregnancy.

研究实施时间：

Study execute time：

从From 2023-11-30

至To      2025-06-30

征募观察对象时间：

Recruiting time：

从From 2024-08-30

至To      2025-06-30

干预措施：

Interventions：

组别：

对照组

样本量：

44

Group：

control subjects

Sample size：

干预措施：

基础治疗（塞来昔布胶囊、超声波理疗、关节松动术、康复训练）

干预措施代码：

Intervention：

basic treatment (celecoxib capsules ultrasonic physiotherapy joint mobilization and rehabilitation training).

Intervention code：

组别：

岐黄针组

样本量：

44

Group：

Qihuang needle group

Sample size：

干预措施：

基础治疗（塞来昔布胶囊、超声波理疗、关节松动术、康复训练）和岐黄针疗法治疗

干预措施代码：

Intervention：

basic treatment (celecoxib capsules ultrasonic physiotherapy joint mobilization and rehabilitation training) and Qihuang needle therapy treatment

Intervention code：

样本总量 Total sample size ： 88

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

广东省

市(区县)：

广州市

Country：

China

Province：

Guangdong Province

City：

Guangzhou

单位(医院)：

广州中医药大学第一附属医院

单位级别：

三级甲等公立医院

Institution/hospital：

The First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou China.

Level of the institution：

Public hospital Grade A Level 3

测量指标：

Outcomes：

指标中文名：

视觉疼痛模拟评分

指标类型：

主要指标

Outcome：

Visual pain simulation score

Type：

Primary indicator

测量时间点：

治疗前，治疗后7天，随访4周时

测量方法：

询问患者主观感受

Measure time point of outcome：

Before treatment 7 days after treatment followed up for 4 weeks

Measure method：

Ask patients about their subjective feelings

指标中文名：

美国 UCLA肩关节评分系统

指标类型：

次要指标

Outcome：

UCLA Shoulder Scoring System

Type：

Secondary indicator

测量时间点：

治疗前，治疗后7天，随访4周时

测量方法：

由研究者测量和询问患者主观感受

Measure time point of outcome：

Before treatment 7 days after treatment followed up for 4 weeks Measure

Measure method：

Measured by the researcher and asked about the patient's subjective feelings

指标中文名：

改良Barthel指数评分量表（MBI）

指标类型：

次要指标

Outcome：

Modified Barthel Index Rating Scale (MBI)

Type：

Secondary indicator

测量时间点：

治疗前，治疗后7天，随访4周时

测量方法：

询问患者主观感受

Measure time point of outcome：

Before treatment 7 days after treatment followed up for 4 weeks

Measure method：

Ask patients about their subjective feelings

指标中文名：

英国Constant-Murley肩关节评分系统

指标类型：

次要指标

Outcome：

Constant-Murley Shoulder Scoring System UK

Type：

Secondary indicator

测量时间点：

治疗前，治疗后7天，随访4周时

测量方法：

由研究者测量和询问患者主观感受

Measure time point of outcome：

Before treatment 7 days after treatment followed up for 4 weeks

Measure method：

Measured by the researcher and asked about the patient's subjective feelings

指标中文名：

肩关节活动度评分

指标类型：

主要指标

Outcome：

Shoulder mobility score

Type：

Primary indicator

测量时间点：

治疗前，治疗后7天，随访4周时

测量方法：

由研究者测量

Measure time point of outcome：

Before treatment 7 days after treatment followed up for 4 weeks

Measure method：

Measured by the researcher

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

blood

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

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 70 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）：

专人负责使用 SPPS25.0 软件生成随机数字，将数字按 1:1 随机分为岐黄针组和对照组，将随机分配结果通过网络中央随机化分配系统发布。

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

A dedicated person is responsible for generating random numbers using SPPS 25.0 software dividing the numbers randomly by 1: 1 into the Qi Huang needle group and the control group and publishing the random distribution results through the network central randomization distribution system.

盲法：

由于针刺操作的特殊性，无法对受试者和操作者设盲；实施第三方设盲， 即负责数据收集、结果评估、数据分析的人员，不会知晓患者的分组情况。所有操作过程按照既定标准操作规程（Standard Operation Procedure，SOP）完成。

Blinding：

Due to the specific nature of the needling operation it is not possible to blind subjects and operators; third-party blinding is implemented i.e. those responsible for data collection evaluation of results and data analysis will not be aware of the grouping of patients. All procedures were performed according to established Standard Operation Procedure (SOP).

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）：

广州中医药大学第一附属医院(http://www.gztcm.com.cn)

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

The First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou China.(http://www.gztcm.com.cn)

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：

本研究中病例记录表可以详见已上传的临床研究方案PDF中，数据管理内容可以详见广州中医药大学第一附属医院网站，待试验完成后所有数据均会上传可查询。

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

The case record table for this study can be detailed in the uploaded clinical research protocol PDF and the data management content can be viewed in detail on the website of the First Hospital of Guangzhou University of Chinese Medicine. All data will be uploaded and searchable when the trial is completed.

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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