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临床试验/NCT03013205
NCT03013205Unknown不适用

Efficacy of Corticosteroid Injection Into Coracohumeral Ligament in Patients With Adhesive Capsulitis of the Shoulder

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Shoulder function (The Disabilities of the Arm, Shoulder and Hand Score, QuickDash) improvement

研究概览

简要总结

Steroid injections are widely utilized to reduce inflammation and fibrosis in patients with the frozen shoulder. In this study, investigators will compare intra-articular steroid injections with direct coracohumeral ligament steroid injection to conventional intra-articular steroid injection. Investigators will measure the primary outcome as shoulder function improvement and secondary outcomes as ROM, pain scale and stiffness of coracohumeral ligament under elastogram.

详细描述

Adhesive capsulitis of the shoulder, also known as the frozen shoulder, often leads to severe pain and shoulder range of motion limitation. Steroid injections are widely utilized to reduce inflammation and fibrosis. The thickening of the coracohumeral ligament was thought to play an important role in the pathogenesis of frozen shoulder, resulting in limited external rotation of the shoulder. While the elastogram of coracohumeral ligament will significantly increase stiffness under the shear-wave ultrasound (shear-wave elastography).

Therefore, in this study, investigators will compare intra-articular steroid injections with direct coracohumeral ligament steroid injection to conventional intra-articular steroid injection. Investigators will measure the primary outcome as shoulder function improvement and secondary outcomes as ROM, pain scale and stiffness of coracohumeral ligament under elastogram.

(the patient will not have additional risk of injection under ultrasound guidance)

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 (Participant)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Shoulder function (The Disabilities of the Arm, Shoulder and Hand Score, QuickDash) improvement

时间窗: 2 years

shoulder function improvement (The Disabilities of the Arm, Shoulder and Hand Score, QuickDash), score 0-100

次要结局

  • Change of Visual analogue scale(2 years)
  • Stiffness of coracohumeral ligament under elastogram (KPa)(2 years)
  • Shoulder range of motion improvement(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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