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Study on Optimization of Clinical Program for Painless Treatment of Shoulder Tendinitis with Ding's Massage Therapy

注册号：

Registration number：

ITMCTR2025001484

最近更新日期：

Date of Last Refreshed on：

2025-07-26

注册时间：

Date of Registration：

2025-07-26

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

丁氏推拿无痛化治疗肩周炎临床方案的优化研究

Public title：

Study on Optimization of Clinical Program for Painless Treatment of Shoulder Tendinitis with Ding's Massage Therapy

注册题目简写：

English Acronym：

研究课题的正式科学名称：

丁氏推拿无痛化治疗肩周炎临床方案的优化研究

Scientific title：

Study on Optimization of Clinical Program for Painless Treatment of Shoulder Tendinitis with Ding's Massage Therapy

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：

SHDC22024241

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：

严振

研究负责人：

严振

Applicant：

Yan zhen

Study leader：

Yan zhen

申请注册联系人电话：

Applicant telephone：

+86 139 1727 2504

研究负责人电话：

Study leader's telephone：

+86 139 1727 2504

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：

yantan1102@126.com

研究负责人电子邮件：

Study leader's E-mail：

yantan1102@126.com

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：

上海市虹口区甘河路 110 号

研究负责人通讯地址：

上海市虹口区甘河路 110 号

Applicant address：

No. 110 Ganhe Road Hongkou District Shanghai

Study leader's address：

No. 110 Ganhe Road Hongkou District Shanghai

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：

上海中医药大学附属岳阳中西医结合医院

Applicant's institution：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine

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：

2024-185

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：

上海中医药大学附属岳阳中西医结合医院伦理委员会

Name of the ethic committee：

Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2024/7/24 0:00:00

伦理委员会联系人：

郑莉

Contact Name of the ethic committee：

Zheng Li

伦理委员会联系地址：

上海市虹口区甘河路 110 号

Contact Address of the ethic committee：

No. 110 Ganhe Road Hongkou District Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 21 6516 1782

伦理委员会联系人邮箱：

Contact email of the ethic committee：

yantan1102@126.com

研究实施负责（组长）单位：

上海中医药大学附属岳阳中西医结合医院

Primary sponsor：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

上海市虹口区甘河路110号

Primary sponsor's address：

No. 110 Ganhe Road Hongkou District Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海市

市(区县)：

上海市

Country：

China

Province：

Shanghai

City：

Shanghai

单位(医院)：

上海中医药大学附属岳阳中西医结合医院

具体地址：

上海市虹口区甘河路110号

Institution
hospital：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine

Address：

No. 110 Ganhe Road Hongkou District Shanghai

经费或物资来源：

上海申康医院发展中心

Source(s) of funding：

Shanghai Hospital Development Center

研究疾病：

肩周炎

研究疾病代码：

FB53.0

Target disease：

frozen shoulder

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：

1. 本次研究采用丁氏推拿优化方案无痛化治疗不同分期肩周炎患者，通过临床疗效观察，以期形成规范化管理方案。 2. 初步探索不同分期肩周炎患者肩周软组织纤维化的MRI表现。

Objectives of Study：

1. This study uses Ding's massage optimization plan to treat patients with different stages of shoulder arthritis painlessly and through clinical efficacy observation in order to form a standardized management plan. 2. Preliminary exploration of MRI manifestations of shoulder soft tissue fibrosis in patients with different stages of rotator cuff tendinitis.

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: 符合肩周炎中西医诊断标准 2: 年龄在40-80岁之间者 3: 无肩部撞伤、摔伤、拉伤等外伤史者 4: 未合并推拿禁忌症患者 5: 治疗前2周内停用一切药物治疗及其他治疗者 6: 自愿参与本项研究，并签署知情同意书者

Inclusion criteria

1: Meets the criteria for diagnosis of shoulder arthritis by both traditional Chinese medicine and Western medicine. 2: People aged between 40 and 80 3: No history of shoulder injuries falls pulls or other external injuries 4: Patients with contraindications to massage who have not been combined 5: All medications and other treatments should be stopped for 2 weeks before treatment. 6: Those who voluntarily participate in this study and sign the informed consent form

排除标准：

1: 肩关节脱位、骨折、结核、肿瘤等导致的肩关节疼痛 2: 有消化系统、心脑血管疾病及精神类疾病 3: 肝肾功能异常、存在MRI检查禁忌症者 4: 对治疗所用药物过敏者 5: 患肩局部皮肤破损或存在皮肤系统疾病 6: 妊娠期及哺乳期妇女 7: 患者正在参加或结束临床试验不超过1月

Exclusion criteria：

1: Shoulder joint pain caused by dislocation fracture tuberculosis tumor etc. 2: There are digestive system cardiovascular and cerebrovascular diseases and mental diseases. 3: Patients with abnormal liver and kidney function or MRI contraindications 4: People who are allergic to the drugs used in treatment 5: Local skin damage or skin disease in the shoulder 6: Pregnant and lactating women 7: Patients are participating in or finishing clinical trials within 1 month

研究实施时间：

Study execute time：

从From 2024-06-01

至To      2026-06-01

征募观察对象时间：

Recruiting time：

从From 2024-07-24

至To      2026-06-01

干预措施：

Interventions：

组别：

对照组

样本量：

76

Group：

Control group

Sample size：

干预措施：

对照组采取传统丁氏推拿治疗方案。

干预措施代码：

Intervention：

The control group adopts the traditional Ding's massage treatment protocol.

Intervention code：

组别：

试验组

样本量：

76

Group：

Experimental group

Sample size：

干预措施：

（1）疼痛期 联合现代肌骨超声可视化治疗技术，后续治疗采取传统丁氏推拿治疗方案。 2）冻结期 在静脉麻醉联合臂丛神经阻滞技术下行丁氏推拿肩关节松解术。后续治疗采取传统丁氏推拿治疗方案。 （3）缓解期 以丁氏推拿传统手法治疗联合功能训练为主。

干预措施代码：

Intervention：

(1) Painful Stage Combine modern musculoskeletal ultrasound-guided therapy; follow with traditional Ding's Tuina treatment. (2) Freezing Stage Perform Ding's Tuina shoulder release under intravenous anesthesia and brachial plexus block; follow with traditional Ding's Tuina treatment. (3) Thawing Stage Focus on traditional Ding's Tuina treatment combined with functional training.

Intervention code：

样本总量 Total sample size ： 152

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

上海市

市(区县)：

上海市

Country：

China

Province：

Shanghai

City：

Shanghai

单位(医院)：

上海中医药大学附属岳阳中西医结合医院

单位级别：

三甲

Institution/hospital：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

视觉模拟量表

指标类型：

主要指标

Outcome：

visual analogue scale

Type：

Primary indicator

测量时间点：

治疗前，治疗6周后，3个月随访，6个月随访

测量方法：

此法利用标尺，根据患者主观判断，测量患者肩关节疼痛度，VAS评分（0-10）越高，疼痛越严重。无任何疼痛感觉，计0分；轻度疼痛，不影响工作、生活，计1～3分；中度疼痛，影响工作，不影响生活，计4～6分；重度疼痛，影响工作及生活，计7～10分。

Measure time point of outcome：

Before treatment at 6 weeks post-treatment at 3-month follow-up and at 6-month follow-up

Measure method：

This method uses a scale to measure the patient's shoulder joint pain degree based on the patient's subjective judgment. The higher the VAS score (0-10) the more severe the pain. No pain 0 points; mild pain that does not affect work or life 1-3 points; moderate pain that affects work but does not affect life 4-6 points; severe pain that affects work and life 7-10 points.

指标中文名：

肩关节评分量表

指标类型：

次要指标

Outcome：

Constant-Murley Score

Type：

Secondary indicator

测量时间点：

治疗前，治疗6周后，3个月随访，6个月随访

测量方法：

本评分量表包含四个方面，总分100分。其中，疼痛程度（15分）、日常生活（20分）、肩关节活动度（40分）以及肌力（25分）。四部分总分为100分，≥90分为优，81～89分为良，60～80分为尚可，＜60分为差。分数越高，代表肩关节功能状态越好。

Measure time point of outcome：

Before treatment at 6 weeks post-treatment at 3-month follow-up and at 6-month follow-up

Measure method：

This scoring scale includes four aspects with a total score of 100 points. Among them pain degree (15 points) daily life (20 points) shoulder joint range of motion (40 points) and muscle strength (25 points). The total score of the four aspects is 100 points ≥90 points is excellent 81~89 points is good 60~80 points is acceptable <60 points is poor. The higher the score the better the shoulder joint function status.

指标中文名：

静止性肌张力测试

指标类型：

次要指标

Outcome：

Static muscle tone test

Type：

Secondary indicator

测量时间点：

治疗前、治疗6周后

测量方法：

采用组织硬度仪-压痛仪（品牌型号：伊藤OE-220；产地：日本）测定。测试点为：①前三角肌：肩峰前角下方3.5cm；②中三角肌：前、后三角肌中点连线与肩峰、三角肌结节中点连线的交点；③后三角肌：肩峰后角下方2 cm。

Measure time point of outcome：

Before treatment and 6 weeks after treatment

Measure method：

The measurement was conducted with a tissue hardness and algometer (Ito OE-220 Japan). Test points included: ① Anterior deltoid 3.5 cm below the acromions anterior angle; ② Middle deltoid at the intersection extended from midlines of anterior-posterior deltoids and acromion-deltoid tuberosity; ③ Posterior deltoid 2 cm below the acromions posterior angle.

指标中文名：

MRI检查

指标类型：

次要指标

Outcome：

MRI examination

Type：

Secondary indicator

测量时间点：

治疗前、治疗6周后

测量方法：

给予患者患肩关节MRI常规检查及T1 mapping成像。观察指标包括：①FS特征性表现：有无盂肱下韧带水肿、腋囊外周水肿、喙突下脂肪三角消失情况、关节周围积液等；②测量肩周软组织（三角肌、喙肱韧带）增强前后的T1值，计算出ECV值。

Measure time point of outcome：

Before treatment and 6 weeks after treatment

Measure method：

Patients underwent routine MRI of the shoulder joint and T1 mapping imaging. Observation indicators included: ①FS characteristic manifestations: whether there was subacromial bursitis subacromial bursitis edema absence of subacromial fat triangle synovial effusion around the joint etc. ② Measurement of T1 value of shoulder soft tissue (pectoralis major muscle coracohumeral ligament) before and after enhancement calculate ECV value.

指标中文名：

匹兹堡睡眠质量指数评定

指标类型：

次要指标

Outcome：

Pittsburgh Sleep Quality Index rating

Type：

Secondary indicator

测量时间点：

治疗前，治疗6周后，3个月随访，6个月随访

测量方法：

采用匹兹堡睡眠质量指数问卷评定患者睡眠治疗，问卷由19个自评和５个他评项目组成，并构成７项成分：①睡眠质量；②入睡时间；③睡眠时间；④睡眠效率；⑤睡眠障碍；⑥催眠药物；⑦日间功能。

Measure time point of outcome：

Before treatment at 6 weeks post-treatment at 3-month follow-up and at 6-month follow-up

Measure method：

The Pittsburgh Sleep Quality Index questionnaire was used to evaluate the sleep treatment of patients. The questionnaire consisted of 19 self-rated and 5 rated items and formed 7 components: ① sleep quality; ② time to fall asleep; ③ sleep time; ④ sleep efficiency; ⑤ sleep disorders; ⑥ hypnotic drugs; ⑦ daytime function.

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 30 岁
Min age years
最大 80 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）：

本试验采用分层随机方法，首先按照FS临床分期进行分层，随后在各分层中按照简单随机法进行分组。采用SPSS 26.0软件产生随机数字列表，并按照1:1的比例随机分为2组，严格按照诊断标准、纳入标准及排除标准对病例进行精确筛选，确定入组后按照所得到的随机号码分配到本试验研究不同分层下的对应组别，按照流程严格完成总观察病例数后结束试验。

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

This study used a stratified random method. First it was stratified according to the clinical stage of FS and then it was divided into groups according to simple random method in each stratum. A random number list was generated using SPSS 26.0 software and the cases were randomly divided into two groups in a 1:1 ratio. The cases were accurately screened according to the diagnostic criteria inclusion criteria and exclusion criteria and the random numbers obtained were assigned to the corresponding groups in different strata of the study. The study was terminated after strictly completing the total number of observed cases according to the process.

盲法：

第一、盲评价者。评价者由参与了统一培训的非研究人员承担，评价者本身并不知道患者的分组情况，也不参与临床治疗过程，只参与本次评价过程，整个过程中尽量减少与患者进行不必要的交流。 第二、盲统计者。本次研究得到的所有数据均有第三方统计人员进行管理及统计分析，由我校公卫学院的老师担任，该老师不清楚分组情况和意义。

Blinding：

First the blinded evaluator. The evaluator is undertaken by non-research personnel who have participated in unified training. The evaluator is unaware of the patient's group allocation and does not participate in the clinical treatment process but only in the evaluation process. Throughout the process unnecessary communication with patients is minimized as much as possible.Second the blinded statistician. All data obtained in this study are managed and statistically analyzed by a third-party statistician who is a faculty member from the School of Public Health of our university. This individual is unaware of the group allocation and its significance.

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/uc/index.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/uc/index.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：

通过病例记录表数据采集和管理

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

Data collection and management through case report forms (CRFs)

数据管理委员会：

Data Managemen Committee：

暂未确定

Not yet

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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