Supervised Exercises Compared With Radial Extracorporal Shock Wave Therapy (rESWT) in Patients With Subacromial Impingement Syndrome: A Single Blind Clinical Randomized Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Shoulder Pain and Disability Index (SPADI)
研究概览
简要总结
The purpose of this study is to compare Supervised Exercises with another non-operative frequently used treatment, Radial Extracorporeal Shockwave Therapy (rESWT), for patients with subacromial impingement syndrome.
详细描述
Shoulder pain is, in succession to back, neck, and knee, the fourth most frequently localized musculoskeletal pain reported by patients to general practitioners and physical therapists. A majority of shoulder complaints lasts for more than three months and become chronic. Few of the different interventions for rehabilitation of chronic shoulder pain, have documented effect. Patients with shoulder pain are associated with significant disability and loss of quality of life which interfere with activities related to daily living.
Supervised exercises, a treatment method which has been compared to surgery and placebo laser, is one that has documented effect for both short (6 months) and long time (2½ years). The purpose of this study was to compare Supervised Exercises with another non-operative common used treatment method for these patients, radial Extracorporeal Shockwave Therapy (rESWT).
The study is designed as a randomised, single blind clinical controlled study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subacromial shoulder pain lasting for at least three months and age between 18 and 70 years.
- •Dysfunction or pain on abduction
- •Had a normal passive glenohumeral range of movement
- •Pain during two of three isometric tests (abduction, external- or internal rotation at 0º or 30º)
- •Positive Hawkins-Kennedys test.
排除标准
- •Shoulder pain bilateral (both shoulders required treatment)
- •Earlier operated in affected shoulder
- •Had multidirectional instability
- •Had the cervical syndrome
- •Rheumatoid arthritis
- •Clinical and radiological findings indicating glenohumeral - or acromioclavicular joint pathology
- •Not able to understand spoken or written Norwegian
- •Considerable emotional distress
- •Needed anticoagulant medicine
- •Being pregnant
- •Had had Shock Wave Therapy or Supervised Exercises before.
结局指标
主要结局
Shoulder Pain and Disability Index (SPADI)
时间窗: Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months
次要结局
- Pain intensity labelled "no pain" and "severe pain" at its extremes, are measured on nine point scales for activity and rest during last week.(Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months)