A Prospective Randomized 3-arm Trial Comparing Intra-articular Corticosteroid Injection vs Arthrographic Distention vs Arthrographic Distention Plus Intra-articular Corticosteroid Injection in the Treatment of Adhesive Capsulitis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Shoulder pain and disability index(SPADI)
研究概览
简要总结
Arthrographic distention of the shoulder joint is an increasingly popular treatment option in the management of patients with frozen shoulder. Most have included the intra-articular injection of a corticosteroid as part of the procedure, but it is not known if this is necessary. It is also not known whether arthrographic distention using steroid and saline is better than intra-articular steroid injection alone.
The purpose of this study is to determine whether there is an additional benefit in the combination of arthrographic distention plus intra-articular corticosteroid injection compared to arthrographic distention or intra-articular corticosteroid injection alone.
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
- •Pain and stiffness in predominantly 1 shoulder for 4 weeks or longer
- •Restriction of passive motion of greater than 30° in 2 or more planes of movement (measured to onset of pain with goniometer)
排除标准
- •Previous arthrographic distention and/or corticosteroid injection
- •Systemic inflammatory joint disease
- •Radiological evidence of osteoarthritis of the shoulder or fracture
- •Signs of a complete rotator cuff tear
- •Contraindications to arthrogram and/or distention
- •Lack of written informed consent
研究组 & 干预措施
Arthrographic distention + intra-articular corticosteroid
Arthrographic distention of the glenohumeral joint with injection of 5 ml contrast, 1 ml (40 mg) Depo Medrol(Methylprednisolone Acetate Injectable Suspension), 15 ml local anaesthetic (Prilocaine) and up to 15 ml saline.
干预措施: Arthrographic distention (Procedure)
Arthrographic distention + intra-articular corticosteroid
Arthrographic distention of the glenohumeral joint with injection of 5 ml contrast, 1 ml (40 mg) Depo Medrol(Methylprednisolone Acetate Injectable Suspension), 15 ml local anaesthetic (Prilocaine) and up to 15 ml saline.
干预措施: Intra-articular corticosteroid Depo Medrol (Drug)
Arthrographic distention
Arthrographic distention of the glenohumeral joint with injection of 5 ml contrast, 15 ml local anaesthetic (Prilocaine) and up to 15 ml saline.
干预措施: Arthrographic distention (Procedure)
Intra-articular corticosteroid
Arthrographic pseudodistention of the glenohumeral joint with injection of 5 ml contrast and 1 ml (40 mg) Depo Medrol(Methylprednisolone Acetate Injectable Suspension).
干预措施: Intra-articular corticosteroid Depo Medrol (Drug)
结局指标
主要结局
Shoulder pain and disability index(SPADI)
时间窗: 4 weeks
次要结局
- Shoulder pain and disability index (SPADI)(weekly for a period of 3 months plus at follow-up (4 months and 12 months))
- Range of motion(4 weeks, 4 months and 12 months)
- Overall pain score(weekly for a period of 3 months, plus at follow-up (4 months and 12 months))
研究者
Symons Rolf
Symons Rolf, MD
Imelda Hospital, Bonheiden