Evaluating the Efficacy of Ultrasonography Guided Subacromial Sodium Hyaluronate Injection in the Treatment of Rotator Cuff Disease
试验速览
- 阶段
- 2 期
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change from baseline in pain severity after 3 weeks.
研究概览
简要总结
This study will be performed to examine the effect of ultrasound-guided subacromial sodium hyaluronate injection in patients with impingement syndrome without rotator cuff complete tear.
详细描述
Rotator cuff disease in particular is a common cause of shoulder pain and weakness and comprises a significant proportion of the musculoskeletal complaints presenting to primary care doctors. Ultrasound is a readily available and cheap modality for looking more specifically at the rotator cuff and surrounding structures. More recently, ultrasound guidance has become a commonly employed method to perform diagnostic or therapeutic interventions. Despite the long history and the fact that this is a common diagnosis made in clinical practice, the exact cause and best treatment for this condition still are being explored. Although there are a few high-quality studies demonstrating the efficacy of sodium hyaluronate injection for rotator cuff disease, this study will be performed to examine the effect of ultrasound-guided subacromial sodium hyaluronate injection in patients with impingement syndrome without rotator cuff complete tear.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •age >= 18 years
- •subacromial impingement syndrome
- •without a complete tear of rotator cuff
- •willingness to participate
排除标准
- •had any rheumatic disease, glenohumeral osteoarthritis, full-thickness rotator cuff tears, fractures, diabetes mellitus, infections, or tumors.
- •had hypersensitivity to hyaluronate
- •had participated in any other study within 6 months
- •had received a subacromial injection within 8 weeks
- •were pregnant or planned to become pregnant
- •were at risk of complications of intra-articular injections such as patients who received anti-coagulant drugs.
研究组 & 干预措施
Sodium hyaluronate
Ultrasound guided injection of sodium hyaluronate
干预措施: Sodium Hyaluronate (Drug)
Normal saline
Ultrasound guided injection of normal saline
干预措施: Normal saline (Drug)
结局指标
主要结局
Change from baseline in pain severity after 3 weeks.
时间窗: Up to 3 weeks
The pain score (100 mm Visual Analogue Score ) is evaluated before the first injection and one week after each injection up to 3rd week.
次要结局
未报告次要终点
研究者
Farnaz Dehgan Hosseinabadi
Principal Investigator
Isfahan University of Medical Sciences
