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临床试验/NCT01735058
NCT01735058Unknown2 期

Evaluating the Efficacy of Ultrasonography Guided Subacromial Sodium Hyaluronate Injection in the Treatment of Rotator Cuff Disease

Isfahan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2012年2月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Ultrasound guided injection of sodium hyaluronate

干预措施: Sodium Hyaluronate (Drug)

Normal saline

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Farnaz Dehgan Hosseinabadi

Principal Investigator

Isfahan University of Medical Sciences

研究点 (1)

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