Efficacy of Corticosteroid Injection Into Coracohumeral Ligament in Patients With Adhesive Capsulitis of the Shoulder
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 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
- 否
入选标准
- •A.Inclusion criteria：
- •Age 20-80 years old
- •Unilateral shoulder pain more than 3 months
- •At least one shoulder ROM limitation in three dimensions which decreased over 50% (Abduction, Flexion, External rotation)
- •Visual analog scale more than 30 (total 100)
- •No fracture or subluxation or arthritis in shoulder Xray.
排除标准
- •History of shoulder or chest surgery
- •History of shoulder trauma in 2 recent years
- •Ever receiving shoulder joint injection in recent 3 months
- •With cervical radiculopathy or any central CNS disorders
- •With osteoarthritis or rheumatic arthritis of shoulder
- •Diagnosed as rotator cuff tear, tendon calcification or bursitis
- •Systemic diseases including diabetes or thyroid disorder
- •Allergy history of steroid
研究组 & 干预措施
PT+IA
- Intraarticular triamcinolone injection
- Intraarticular Xylocaine injection
- Physiotherapy
干预措施: Physiotherapy (Procedure)
PT+IA+CHL
- Intraarticular triamcinolone injection
- Intraarticular Xylocaine injection
- Coracohumeral ligament triamcinolone injection
- Physiotherapy
干预措施: Intraarticular triamcinolone injection (Procedure)
PT+IA+CHL
- Intraarticular triamcinolone injection
- Intraarticular Xylocaine injection
- Coracohumeral ligament triamcinolone injection
- Physiotherapy
干预措施: Intraarticular Xylocaine injection (Procedure)
PT+IA+CHL
- Intraarticular triamcinolone injection
- Intraarticular Xylocaine injection
- Coracohumeral ligament triamcinolone injection
- Physiotherapy
干预措施: Coracohumeral ligament triamcinolone injection (Procedure)
PT+IA+CHL
- Intraarticular triamcinolone injection
- Intraarticular Xylocaine injection
- Coracohumeral ligament triamcinolone injection
- Physiotherapy
干预措施: Physiotherapy (Procedure)
PT+IA
- Intraarticular triamcinolone injection
- Intraarticular Xylocaine injection
- Physiotherapy
干预措施: Intraarticular triamcinolone injection (Procedure)
PT+IA
- Intraarticular triamcinolone injection
- Intraarticular Xylocaine injection
- Physiotherapy
干预措施: Intraarticular Xylocaine injection (Procedure)
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)