NCT01144533已完成不适用
Comparative Analysis of Intra-articular Injection of Steroid and/or Sodium Hyaluronate in Adhesive Capsulitis: A Randomized, Double-blind, Placebo-controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- SPADI Score (Shoulder Pain and Disability Index)
研究概览
简要总结
The purpose of this study is to compare the efficacy of intra-articular steroid injection, sodium hyaluronate injection, a combination of the two, and placebo in the treatment of adhesive capsulitis of the shoulder.
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
- Triple (Participant, 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
- •clinical diagnosis : Adhesive Capsulitis of the Shoulder
- •defining of adhesive capsulitis
- •the presence of shoulder pain
- •limitation of both active and passive movements of the glenohumeral joint of ≥25% in at list 2 directions(abduction,flexion,external rotation,internal rotation), as compared with the contralateral shoulder
- •duration : symptomatic for < 1 year
排除标准
- •bilateral symptoms
- •uncontrolled diabetes mellitus
- •overt hypothyroidism or hyperthyroidism
- •previous shoulder surgery
- •previous glenohumeral joint injection within recent 6months
- •trauma to the shoulder the last six months that required hospital care
- •neurological symptoms
- •allergy to injection material
- •secondary adhesive capsulitis
- •systemic inflammatory ds including rheumatoid arthritis
- •degenerative arthritis of shoulder joint
- •infectious arthritis of shoulder joint
- •dislocation of shoulder joint
- •blood coagulation disease
- •rotator cuff tear
- •serious mental illness
- •pregnancy
- •fracture in shoulder lesion
研究组 & 干预措施
Steroid + Hyaluronate
Experimental
干预措施: steroid and hyaluronate injection into the glenohumeral joint (Procedure)
Steroid
Experimental
干预措施: steroid injection into the glenohumeral joint (Procedure)
Hyaluronate
Experimental
干预措施: sodium hyaluronate injection into the glenohumeral joint (Procedure)
Isotonic saline
Placebo Comparator
干预措施: isotonic saline injection into the glenohumeral joint (Procedure)
结局指标
主要结局
SPADI Score (Shoulder Pain and Disability Index)
时间窗: Postinjection 1month
次要结局
未报告次要终点
研究者
Hyunchul Jo
Assistant Professor, SMG-SNU Boramae Medical Center.
Seoul National University Hospital
研究点 (1)
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