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注册号: Registration number: |
ChiCTR2500112816 |
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最近更新日期: Date of Last Refreshed on: |
2025-11-19 17:52:49 |
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注册时间: Date of Registration: |
2025-11-19 00:00:00 |
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注册号状态: |
预注册 |
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Registration Status: |
Prospective registration |
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注册题目: |
肩胛-胸椎整合训练对慢性肩痛患者肩部功能及运动学的影响 |
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Public title: |
The Effect of Combined Scapular Stability and Thoracic Mobility Training on Shoulder Function and Kinematics in Chronic Shoulder Pain Patients |
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注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
肩胛-胸椎整合训练对慢性肩痛患者肩部功能及运动学的影响 |
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Scientific title: |
The Effect of Combined Scapular Stability and Thoracic Mobility Training on Shoulder Function and Kinematics in Chronic Shoulder Pain Patients |
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研究课题代号(代码): Study subject ID: |
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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: |
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申请注册联系人: |
张飞跃 |
研究负责人: |
张飞跃 |
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Applicant: |
Feiyue Zhang |
Study leader: |
Feiyue Zhang |
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申请注册联系人电话: Applicant telephone: |
+86 157 6036 1778 |
研究负责人电话:
Study leader's |
+86 157 6036 1778 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
xyzrefly@163.com |
研究负责人电子邮件: Study leader's E-mail: |
xyzrefly@163.com |
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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): |
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申请注册联系人通讯地址: |
四川省成都市东部新区环湖北路1942号 |
研究负责人通讯地址: |
四川省成都市东部新区环湖北路1942号 |
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Applicant address: |
Chengdu Sport University, 1942 Huanhu Road, East New District, Jianyang City, Chengdu, |
Study leader's address: |
Chengdu Sport University, 1942 Huanhu Road, East New District, Jianyang City, Chengdu, |
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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: |
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申请人所在单位: |
成都体育学院 |
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Applicant's institution: |
Chengdu Sport University |
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研究负责人所在单位: |
成都体育学院 |
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Affiliation of the Leader: |
Chengdu Sport University |
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是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
成体伦理(2025)154号 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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批准本研究的伦理委员会名称: |
成都体育学院伦理委员会 |
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Name of the ethic committee: |
Ethics Committee of Chengdu Sport University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2025-09-26 00:00:00 | ||
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伦理委员会联系人: |
杜传佳 |
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Contact Name of the ethic committee: |
Chuanjia Du |
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伦理委员会联系地址: |
四川省成都市简阳市东部新区环湖北路1942号成都体育学院 |
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Contact Address of the ethic committee: |
Chengdu Sport University, 1942 Huanhu Road, East New District, Jianyang City, Chengdu, Sichuan Province, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 28 8509 4700 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
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研究实施负责(组长)单位: |
成都体育学院 |
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Primary sponsor: |
Chengdu Sport University |
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研究实施负责(组长)单位地址: |
四川省成都市东部新区环湖北路1942号 |
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Primary sponsor's address: |
Chengdu Sport University, 1942 Huanhu Road, East New District, Jianyang City, Chengdu, Sichuan Province, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
成都体育学院 |
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Source(s) of funding: |
Chengdu Sport University |
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研究疾病: |
慢性肩痛 |
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Target disease: |
Chronic shoulder pain |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
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Study phase: |
N/A |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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研究目的: |
1. 探究胸椎灵活性联合肩胛稳定性训练对慢性肩痛人群肩部运动学的影响; 2. 评估联合训练对肩部功能表现的改善效果; 3. 基于结果提出针对性康复建议,优化慢性肩痛管理策略。 |
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Objectives of Study: |
1. Investigate the effect of combined thoracic and scapular stability training on shoulder kinematics in individuals with chronic shoulder pain; 2. Evaluate the improvement of shoulder functional performance through the combined training; 3. Propose targeted rehabilitation recommendations based on the results to optimize chronic shoulder pain management strategies. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
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Inclusion criteria |
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排除标准: |
1.特定肩部病变与病史:诊断为粘连性肩关节囊炎(“冻结肩”),表现为主动与被动活动度均严重受限;有肩关节脱位史、肩关节不稳、或盂肱关节骨关节炎;有肩部或颈部手术史、骨折史;肩袖全层撕裂或肱二头肌长头腱完全断裂(经超声或MRI证实)。 2.其他疼痛来源: 疼痛主要源于颈椎,表现为颈部运动可诱发肩部症状或存在神经根性体征(如放射性疼痛、麻木、无力);存在胸廓出口综合征、纤维肌痛或全身性炎症性疾病(如类风湿性关节炎)。 3.全身性及严重疾病: 患有未控制的心血管/呼吸系统疾病、感染、癌症;患有严重神经系统疾病(如脑卒中、帕金森病、多发性硬化)影响上肢功能;重度抑郁症或其他严重精神疾病未控制。 4.近期治疗干扰: 近3个月内接受过针对肩部的系统性物理治疗、手法治疗或注射治疗;于肩部区域注射过皮质类固醇。 5.其他因素: 妊娠期或哺乳期女性;存在视觉、听觉或认知障碍,无法理解和配合研究流程。 |
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Exclusion criteria: |
1. Specific shoulder pathologies and medical history: Diagnosis of adhesive capsulitis ("frozen shoulder") characterized by severe limitations in both active and passive range of motion; history of shoulder dislocation, shoulder instability, or glenohumeral osteoarthritis; history of shoulder/neck surgery or fracture; full-thickness rotator cuff tear or complete rupture of the long head of the biceps tendon (confirmed by ultrasound or MRI). 2. Other sources of pain: Pain primarily originating from the cervical spine, manifested as neck movement-induced shoulder symptoms or presence of radicular signs (e.g., radiating pain, numbness, weakness); presence of thoracic outlet syndrome, fibromyalgia, or systemic inflammatory diseases (e.g., rheumatoid arthritis). 3. Systemic and severe diseases: Uncontrolled cardiovascular/respiratory diseases, infections, or cancer; severe neurological diseases (e.g., stroke, Parkinson's disease, multiple sclerosis) affecting upper limb function; uncontrolled major depression or other severe mental illnesses. 4. Recent therapeutic interference: Receipt of systematic physical therapy, manual therapy, or injection therapy for the shoulder within the past 3 months; corticosteroid injections in the shoulder region. 5. Other factors: Pregnant or lactating women; visual, auditory, or cognitive impairments preventing understanding and cooperation with the study protocol. |
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研究实施时间: Study execute time: |
从 From 2025-11-20 00:00:00至 To 2026-02-28 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2025-11-20 00:00:00 至 To 2025-12-01 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
使用 SPSS 26.0 软件随机生成 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
Randomly generated using SPSS 26.0 software |
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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 |
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盲法: |
本研究对测试评估者设置了盲法。测试评估者只负责数据的收集与分析,不参与本研究的其他环节。所有的测试评估者对受试者的病情、分组以及个人信息都是不知晓的,只对其提供试验受试者的编号、身高、体重以及病程等必要信息。为了更好降低测试评估者在测试过程中可能带来的主观偏倚,测试时由受试者在规定时间段内自主选择合适的时间进行测试,增加了两组受试者参与测试评估的随机性。 |
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Blinding: |
This study was blinded to the test assessor. The test assessors were only responsible for data collection and analysis and were not involved in any other part of this study. All test evaluators were unaware of the condition, grouping, and personal information of the subjects, and were only provided with the necessary information such as the number, height, weight, and disease duration of the test subjects. In order to minimize the subjective bias of the test evaluators during the test, the test was conducted at a time chosen by the subjects within a specified period of time, which increased the randomness of the participation of subjects in two groups in the test evaluation. |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
否No |
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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): |
无 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
none |
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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: |
无 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
none |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |