Intra-articular Injection of Allogeneic PRP for Adhesive Capsulitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- SPADI(Shoulder Pain and Disability Index)Score
研究概览
简要总结
The purpose of this study is to compare the efficacy of intra-articular allogenic Platelet Rich Plasma injection and steroid injection 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
- 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
- •Male or female 18 years of age and older
- •Patients who have had pain at least for 12 months
- •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 in the scapular plane and in progressive degree of horizontal adduction
排除标准
- •Patients with concurrent bilateral shoulder pain
- •Patients with Diabetes mellitus
- •Patient with overt hypothyroidism or hyperthyroidism
- •Patients who received any drug by intra-articular injection for treatment within 6 months prior to this enrollment.
- •Patients who have a history of shoulder trauma including dislocation- subluxation- and fracture- breast cancer- or surgery around shoulder- neck and upper back
- •Patients with neurological deficit
- •Patients who have a History of allergic adverse reactions to corticosteroid
- •Patients with secondary adhesive capsulitis
- •Patients with systemic inflammatory disease including rheumatoid arthritis
- •Patients with degenerative arthritis, infectious arthritis of shoulder joint
- •Patients who have a history of shoulder trauma including dislocation, fracture
- •Patients taking anticoagulants
- •Patients who have a full-thickness rotator cuff tear
- •Patients who are difficulty participating in data collection due to communication problem and serious mental illness
- •Pregnant women or lactating mothers
- •Patients with cerebrovascular accident
- •Patients with symptomatic cervical spine disorders
- •Patients with serious condition which can affect this study such as severe cardiovascular diseases- renal diseases- liver diseases- endocrine diseases- and cancers
结局指标
主要结局
SPADI(Shoulder Pain and Disability Index)Score
时间窗: Postinjection 1month
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use.
Safety determined with symptoms & signs of infection and immune response and adverse events evaluated with NCI-CTCAE v3.0
时间窗: Postinjection 1month
Presence of general symptoms or signs associated with infection and immune response, such as rash, pruritus, fever, chills, urticaria, or dyspnea. Injection sites were examined to identify erythema, swelling, or abnormal discharge. Adverse events were categorised with use of the National Cancer Institute Common Terminology Criteria for Adverse Events scale, version 3.0.
次要结局
未报告次要终点
研究者
Hyunchul Jo
Associate Professor, SMG-SNU Boramae Medical Center
Seoul National University Hospital