Observational Study to Investigate Proportion of Patients With Hemiplegic Shoulder Pain Within 72 Hours Post-stroke and at Follow-up 8-10 Weeks Later.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- Change from baseline NIH Stroke Score Upper limb (Motor Arm) at 8-10 weeks
研究概览
简要总结
This is an observational study to address the following questions.
- How many people develop stroke-shoulder pain within 3 days of stroke?
- How many people have stroke shoulder pain at 8-10 weeks after stroke?
- Does having stroke-shoulder pain within 3 days of stroke predict the likelihood of having stroke-shoulder pain at 8-10 weeks?
- What are the best bedside examination tests to identify stroke-shoulder pain?
详细描述
Patients will be assessed very early after stroke (within 72 hours) and followed up 8-10 weeks later. Findings will enable planning of fully-powered randomised controlled trials of both, pain-prevention strategies and treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of haemorrhagic or ischaemic stroke
排除标准
- •Transient Ischaemic attack,
- •Neurological symptoms due to causes other than acute stroke,
- •Unconscious,
- •Severe behavioural disturbance,
- •Severe agitation,
- •Severe dementia,
- •For palliation,
- •Totally unable to communicate using any method - written, verbal, pictures, gesture
结局指标
主要结局
Change from baseline NIH Stroke Score Upper limb (Motor Arm) at 8-10 weeks
时间窗: within 72 hours and 8-10 weeks
Muscle Strength
Change from baseline Shoulder-Hand-Score at 8-10 weeks
时间窗: within 72 hours and 8-10 weeks
Measurement of pain, oedema, passive range of shoulder abduction and passive range of shoulder external rotation
Change from baseline presence/absence of pain on palpation at 8-10 weeks
时间窗: within 72 hours and 8-10 weeks
Palpation of shoulder joint line and surrounding soft tissues
Change from baseline presence/absence of inferior glenohumeral subluxation at 8-10 weeks
时间窗: within 72 hours and 8-10 weeks
Palpable gap in sub-acromial region with arm dependent
Change from baseline severity of hemiplegic shoulder pain at 8-10 weeks
时间窗: within 72 hours and 8-10 weeks
Questionnaire including visual analogue scales
次要结局
未报告次要终点