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Smallest Worthwhile Effect of Rotator Cuff Repair and Supervised Exercise

2026年8月18日更新者：Ozan Gür, PT、Kırklareli University

Determining the Smallest Worthwhile Effect of Rotator Cuff Repair and Supervised Exercise: A Benefit-Harm Trade-off Study

The goals of this observational study are (1) to determine the smallest worthwhile effect of rotator cuff repair surgery compared to exercise therapy in rotator cuff patients; (2) to determine the smallest worthwhile effect of supervised exercise therapy compared to unsupervised exercise therapy in rotator cuff patients. Another objective of the study is to identify the demographic and clinical factors affecting the smallest worthwhile effect.

The main questions it aims to answer are:

What is the smallest worthwhile effect of rotator cuff repair surgery compared to exercise therapy?
What is the smallest worthwhile effect of supervised exercise therapy compared to unsupervised exercise therapy?
Do demographic and clinical factors influence the smallest worthwhile effect? Participants will be asked to provide demographic and clinical data and to answer questions on a survey.

研究概览

地位

尚未招聘

条件

肩袖撕裂 (RCT)

详细说明

Baseline demographic and clinical characteristics, including age, sex, education level, employment status, annual income, activity pain, symptom duration, and previous treatment for rotator cuff tears, will be assessed. These variables will be evaluated as potential factors associated with the smallest worthwhile effect using regression analyses.

研究类型

观察性的

注册 (估计的)

104

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Patients who applied to the hospital's physical therapy unit and were referred for treatment in the physical therapy unit

描述

Inclusion Criteria:

Over 18 years of age
Diagnosed with rotator cuff tear by a specialist doctor
Having pain and functional limitation for at least 4 weeks
Having a pain level of 3 or higher on the Numeric Pain Scale (NPS)

Exclusion Criteria:

Presence of another pathology in the affected shoulder region
Presence of radiculopathy originating from the cervical region or internal organs
Presence of neurological, rheumatological, or oncological disease
Insufficient cooperation of the patient with the procedures to be performed within the scope of the study

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
Rotator cuff tear patients

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Smallest Worthwhile Effect in Activity Pain Measured Using the Numeric Pain Rating Scale (NPRS) of Rotator Cuff Repair Compared With Supervised Exercise 大体时间：Baseline	Participants will be provided with standardized descriptions of the characteristics, benefits, limitations, and potential drawbacks of the treatment options. They will then be asked, hypothetically, how much greater reduction in activity pain they would require from rotator cuff repair compared with supervised exercise in order to prefer rotator cuff repair. Activity pain will be assessed using the Numeric Pain Rating Scale (NPRS). The SWE will be reported as the minimum additional percentage reduction in activity pain required for participants to prefer rotator cuff repair over supervised exercise.	Baseline
Smallest Worthwhile Effect in Activity Pain Measured Using the Numeric Pain Rating Scale (NPRS) of Supervised Exercise Compared With Unsupervised Exercise 大体时间：Baseline	Participants will be provided with standardized descriptions of the characteristics, benefits, limitations, and potential drawbacks of the treatment options. They will then be asked, hypothetically, how much greater reduction in activity pain they would require from supervised exercise compared with unsupervised exercise in order to prefer supervised exercise. Activity pain will be assessed using the Numeric Pain Rating Scale (NPRS). The SWE will be reported as the minimum additional percentage reduction in activity pain required for participants to prefer supervised exercise over unsupervised exercise.	Baseline

次要结果测量

结果测量	措施说明	大体时间
Activity Pain Measured Using the Numeric Pain Rating Scale (NPRS) 大体时间：Baseline	Participants will rate their current shoulder pain during activity using the Numeric Pain Rating Scale (NPRS), ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater activity pain.	Baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Kırklareli University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年8月12日

首先提交符合 QC 标准的

2026年8月18日

首次发布 (实际的)

2026年8月21日

研究记录更新

最后更新发布 (实际的)