Predicting ROtator Cuff Tears Outcomes After Physical Therapy Treatment (the PROTO Study): a Multivariable Prediction Model Development Study
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 386
- 试验地点
- 1
- 主要终点
- Shoulder disability
研究概览
简要总结
The aim of this multicenter non-controlled study is to develop a multivariable prediction model of pain/disability improvements in patients with full-thickness rotator cuff tears, after a physical therapy treatment based on therapeutic exercise and education.
详细描述
A multivariable prediction model for the improvement in shoulder pain and disability will be developed based on the following predictors:
- Body mass index [kg/m2, Fractional polynomials FP2].
- Smoking [Years, linear relationship].
- Employment status [3 categories].
- Maximum education degree [4 categories].
- Previous performance of physical exercise [2 categories].
- Baseline disability (measured with the Shoulder Pain and Disability Index) [Fractional polynomials FP2].
- Baseline pain intensity (measured with a numeric pain rating scale) [Fractional polynomials FP2].
- Pain duration [Weeks, linear relationship]
- Pain catastrophizing (measured with the Pain Catastrophizing Scale) [Linear relationship].
- Patient's expectations (measured with the Musculoskeletal Outcomes Data Evaluation and Management System) [Linear relationship].
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Full-thickness supraspinatus rotator cuff tear diagnosed by ultrasound imaging or magnetic resonance imaging.
- •Pain during resisted abduction and/or external rotation.
- •Pain intensity equal or greater to 3 points on a numeric pain rating scale, or a degree of disability equal or greater to 15% on the Shoulder Pain and Disability Index.
- •Pain lasting for at least 3 months.
- •Adequate comprehension of written and spoken Spanish
排除标准
- •Loss of passive external rotation at 0º of shoulder abduction equal or greater to 50% compared to contralateral side.
- •Suspected neck-related shoulder pain.
- •Suspected visceral-related shoulder pain.
- •Sings or symptoms of shoulder instability, including dislocations and/or subluxation within the last year.
- •Humerus and/or scapular fractures within the last year.
- •Previous rotator cuff repair surgery within the last year.
- •Presence of cancer, fibromyalgia, neurological and/or other systemic diseases.
- •Cognitive impairment that makes it impossible to perform therapeutic exercise.
研究组 & 干预措施
Therapeutic exercise plus education
The treatment will consist of a progressive resistance exercise program along with education.
干预措施: Therapeutic resistance exercise (Other)
Therapeutic exercise plus education
The treatment will consist of a progressive resistance exercise program along with education.
干预措施: Education (Other)
结局指标
主要结局
Shoulder disability
时间窗: Change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.
Shoulder disability measured with the Shoulder Pain and Disability Index, which ranges from 0 (no disability) to 100 (maximum degree of disability).
次要结局
- Shoulder pain intensity(Change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.)
- Need for surgery(3-month, 6-month, and 1-year.)
研究者
Rubén Fernández Matías
Principal Investigator
Hospital Universitario Fundación Alcorcón