Metabolic Syndrome and Persistent Shoulder Pain 1 Year After Primary Diagnosis: The Prospective Vejle Hospital Shoulder Cohort (VHS Cohort) With Focus on Prognostic Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,100
- 试验地点
- 1
- 主要终点
- Number of patients with more than 41% improvement in disability 12 months after diagnosis as measured by Quick-DASH.
研究概览
简要总结
In a longitudinal cohort project, the objective is to evaluate general prognostic and individual risk factors for long lasting shoulder pain, with a specific focus on evaluation of the association between metabolic syndrome and tendinopathy, while simultaneous adjusting for other potential prognostic candidate variables (PROGRESS Theme I-II).
详细描述
The VHS Cohort is a prospective cohort trial evaluating a wide range of patient reported and clinical prognostic factors, attained prior to initiation of treatment, among shoulder patients referred for diagnostic evaluation at the specialized shoulder unit at Vejle Hospital, Denmark. The department receives approximately 2000 new patients each year.
Prior to medical examination, patients will be asked to fill in a baseline questionnaire, and from the electronic patient record, a range of different clinical factors will be obtained.
Subsequently, patients will be asked to answer questionnaires on patient reported outcomes after 1, 3, 6, and 12 months. Five years after inclusion into the trial, work affiliation will be retrieved from registries in order to evaluate association between shoulder disorders and work affiliation.
The objective of the VHS Cohort Project is to evaluate general prognostic and individual risk factors for long lasting shoulder pain. A specific focus is evaluation of the association between metabolic syndrome and rotator cuff tendinopathy while simultaneously adjusting for other potential prognostic candidate variables (PROGRESS Theme I-II). In a subsequent cohort (VHS Cohort Project II), the objective will be to develop a prognostic model for the treatment effect of Rotator Cuff Related Shoulder Pain (RCRSP) (PROGRESS Theme III).
VHS Cohort Project I:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referred for medical examination to the shoulder sector, orthopedic Department, Vejle Hospital - Hospital Lillebaelt
- •Older than 18 years
- •Diagnosed with shoulder disorder at medical examination.
排除标准
- •Significant cognitive impairment or language issues
- •Symptomatic cervical spine pathology
- •Older than 75 years.
结局指标
主要结局
Number of patients with more than 41% improvement in disability 12 months after diagnosis as measured by Quick-DASH.
时间窗: 12 months
Quick-DASH (Disabilities of the Arm, Shoulder and Hand) is a patient reported questionnaire measuring upper extremity function and pain.
次要结局
- Number of patients in the normal able-bodied population changing from "Being associated with the labour market" to "Not being associated with the labour market" in work participation classification.(5 years)