Efficacy and Cost-effectiveness of Physiotherapy for Chronic Rotator Cuff Pathology
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Shoulder Pain and Disability Index
研究概览
简要总结
The purpose of this study is to investigate whether a physiotherapy program reduces pain and improves disability and quality-of-life in people with chronic shoulder pain.
The main study hypotheses are that (i) A 10-week physiotherapy treatment will result in significantly greater reductions in pain and disability than placebo treatment in individuals with chronic shoulder pain (ii) Improvements in pain and disability following a 10-week physiotherapy treatment will be maintained at a 3-month follow-up.
详细描述
Chronic rotator cuff pathology (CRCP) is a common cause of musculoskeletal morbidity in the community. Physiotherapy is often the first line of management for this condition. However, the effectiveness of physiotherapy for CRCP has not been well studied. Thus this project primarily aims to investigate the effect of a multimodality physiotherapy program to treat CRCP where effect is measured in terms of pain, disability and health-related quality of life. The secondary aim is to evaluate the cost-effectiveness of physiotherapy as a treatment for CRCP.
Comparison: physiotherapy program comprising stretches, exercises, manual techniques versus placebo physiotherapy
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
- Double (Participant, Outcomes Assessor)
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
- •diagnosis of CRCP as evident by symptoms and signs including pain on active abduction or external rotation and positive impingement test;
- •symptoms of pain in shoulder for > 3 months;
- •average movement pain > 3 on a 10 cm visual analogue scale;
- •aged ≥ 18 years;
- •able to understand written and spoken English.
排除标准
- •severe pain at rest, defined as > 7 on a visual analogue scale;
- •global restriction of shoulder movements;
- •systemic inflammatory joint disease;
- •x-ray evidence of shoulder osteoarthritis or fracture;
- •calcification about the shoulder joint;
- •reason to suspect a complete rotator cuff rupture (eg. weakness of arm elevation, a positive "drop arm sign", a high riding humerus visible on x-ray or a complete tear on ultrasound);
- •previous shoulder surgery on affected arm;
- •physiotherapy, corticosteroid injection or hydrodilatation for shoulder in past 3 months;
- •commenced non-steroidal antiinflammatory medication (NSAIDs) or conservative intervention in past 2 weeks.
研究组 & 干预措施
Active physiotherapy
Manual therapy and home exercise program
干预措施: Physiotherapy program (Procedure)
Placebo physiotherapy
Manual therapy and home exercise program
干预措施: Placebo physiotherapy treatment (Procedure)
结局指标
主要结局
Shoulder Pain and Disability Index
时间窗: Baseline and 11 weeks
Participant perceived global rating of change post treatment
时间窗: 11 weeks
次要结局
- Shoulder Pain and Disability Index at followup(22 weeks)
- Participant perceived global rating of change at followup(22 weeks)
- Australian Quality of Life Index at followup(Baseline, 11 weeks and 22 weeks)
- Isometric Shoulder strength using manual muscle tester post treatment and followup(Baseline, 11 weeks and 22 weeks)
- Participant assessment of average pain and restriction of activity post treatment and followup(Baseline, 11 weeks and 22 weeks)
- Cost effectiveness analysis(Baseline, 11 weeks and 22 weeks)
研究者
Kim Bennell
Professor
University of Melbourne