Reducing Shoulder Complaints in Employees With High Occupational Shoulder Exposures: a Cluster-randomised Controlled Study (The Shoulder-Café Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Shoulder complaints
研究概览
简要总结
Aim: To evaluate the effectiveness of Shoulder-Café (intervention) compared to Shoulder-Guidance (control intervention) with respect to shoulder exposures and shoulder complaints.
Hypothesis: The Shoulder-Café, which unifies education, diagnostic clarification, supervised and home-based shoulder exercises, and advice from a health and safety consultant on workplace interventions, will reduce shoulder exposures and shoulder complaints more effectively than an individual-oriented control intervention with home-based shoulder exercises and written general advice on workplace interventions.
详细描述
Introduction:
Shoulder complaints prevail in the working age population and constitute a common cause of contacts with general practitioners. In occupations with high mechanical shoulder exposures, these complaints are especially frequent. Persons with high occupational mechanical shoulder exposures and shoulder complaints seem an obvious target group for secondary prevention efforts, and more research on interventions targeting shoulder complaints in occupations with high shoulder exposures is needed.
The aim is to develop and evaluate a Shoulder-Café intervention to reduce high occupational mechanical shoulder exposures and prolonged shoulder complaints.
The specific objectives are:
I. To evaluate the effectiveness of the Shoulder-Café as compared to the control-intervention, the Shoulder-Guidance, measured on reductions in shoulder complaints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessor will be masked with respect to mechanical shoulder exposures. Statistical analyses will be performed blinded to intervention arm.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Employed in occupations with expected high mechanical shoulder exposures (industry, construction and service)
- •Shoulder complaints
- •Able to read and understand Danish
排除标准
- •Previous shoulder surgery
- •Breast cancer operation
- •Pregnancy
- •Sickness absence expected to continue into the intervention period
结局指标
主要结局
Shoulder complaints
时间窗: Follow-up 3 months after end of intervention.
Monitored with the Danish version of the Oxford Shoulder Score (questionnaire).
Mechanical shoulder exposures
时间窗: Follow-up at end of intervention, an average of 2-3 months
Measured during 1-5 working days in terms of % time with the arm elevated at different angles and shoulder angular velocity (°/s) using an Axivity accelerometer. Degree of exertion for the arms monitored with Borg CR10 (questionnaire). Participants will fill out questions in Borg CR 10 when they are using the Axivity accelerometer.
次要结局
- Patients' Global Impression of Change(Follow-up 3 months after end of intervention.)
- Fear Avoidance Beliefs (FABQ) about physical activity (PA)(Follow-up 3 and 9 months after end of intervention.)
- Shoulder complaints(Follow-up 9 months after end of intervention)