Subacromial Ultrasound-guided or Systemic Steroid Injection for Rotator Cuff Disease, a Randomized Double Blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 主要终点
- Shoulder Pain and Disability Index (SPADI)
研究概览
简要总结
Corticosteroid injections is a popular treatment option in shoulder disease. The evidence of effectiveness of corticosteroid injections is however contradicting. The importance of the accuracy of the steroid placement have been discussed and recently there are a few studies indicating better treatment effect if the injections are guided towards specific anatomical structures by real time ultrasound imaging. None of these studies have been double blinded. The aim of this study is to investigate the importance of placement of steroid injection in patients with rotator cuff disease by comparing systemic and ultrasound-guided injection in the subacromial bursa using a double blinded design.
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
- •above 18 years
- •shoulder pain for more than 3 months
- •pain at abduction of the affected shoulder
- •less than 50 % reduced passive glenohumeral range of motion in no more than one direction of either abduction, external or internal rotation
- •2 of 3 positive isometric test of external rotation, internal rotation and abduction
- •positive Hawkins-Kennedy impingement test
排除标准
- •SPADI score below 30 points
- •symptomatic acromioclavicular arthritis
- •clinical and radiological findings indicating glenohumeral joint pathology
- •referred pain from neck or internal organs
- •clinical signs of a cervical syndrome
- •generalized muscular pain syndrome with bilateral muscular pain in the neck and shoulders
- •history of inflammatory arthritis
- •diabetes mellitus type 1
- •contraindications to local steroid or lidocaine hydrochloride injections
- •corticosteroid injections last month before inclusion
- •unable to respond to questionnaires
研究组 & 干预措施
A
Local
干预措施: triamcinolone and lidocaine hydrochloride (Drug)
B
Systemic
干预措施: triamcinolone and lidocaine hydrochloride (Drug)
结局指标
主要结局
Shoulder Pain and Disability Index (SPADI)
时间窗: 2 and 6 weeks
次要结局
- Western Ontario Rotator Cuff Index (WORC)(2 and 6 weeks)
- Pain in activity (7 point ordinal scale)(2 and 6 weeks)
- Pain at rest (7 point ordinal scale)(2 and 6 weeks)
- Change in main complaint (18 point ordinal scale)(2 and 6 weeks)
- Active range of motion(2 and 6 weeks)