Determining the Smallest Worthwhile Effect of Rotator Cuff Repair and Supervised Exercise: A Benefit-Harm Trade-off Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 104
- 主要终点
- Smallest Worthwhile Effect in Activity Pain Measured Using the Numeric Pain Rating Scale (NPRS) of Rotator Cuff Repair Compared With Supervised Exercise
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Rotator cuff tear patients
结局指标
主要结局
Smallest Worthwhile Effect in Activity Pain Measured Using the Numeric Pain Rating Scale (NPRS) of Rotator Cuff Repair Compared With Supervised Exercise
时间窗: 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.
Smallest Worthwhile Effect in Activity Pain Measured Using the Numeric Pain Rating Scale (NPRS) of Supervised Exercise Compared With Unsupervised Exercise
时间窗: 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.
次要结局
- Activity Pain Measured Using the Numeric Pain Rating Scale (NPRS)(Baseline)
研究者
Ozan Gür, PT
Research Assistant
Kırklareli University