Allogeneic Platelet-Rich Plasma Versus Corticosteroid Injection for the Treatment of Rotator Cuff Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Constant-Murley score
研究概览
简要总结
The purpose of this study is to investigate the efficacy of allogeneic PRP in patients with subacromial impingement disease
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 unilateral shoulder pain.
- •Patients who have had pain at least for 3 months
- •To be included in the study- participants are required to have a & b.(mentioned below)
- •Pain with one of the two tests
- •Neer's sign: passive overpressure at full shoulder flexion with the scapula fixed
- •Hawkins test: passive internal rotation at 90 degree of shoulder flexion in the scapular plane and in progressive degree of horizontal adduction
- •Pain with one of the two tests
- •Painful arc: active shoulder abduction
- •Jobe's test: The examiner passively elevates the patient's shoulder to 90 degrees of abduction with internal rotation. The examiner then applies a downward pressure against the arm
排除标准
- •Patients who received any drug by subacromial injection for treatment within 3 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 who have a isolated acromioclavicular joint pathology
- •Patients who have a full-thickness rotator cuff tear (evidenced by MR or ultrasonography)
- •Patients with symptomatic cervical spine disorders
- •Patients who have a History of allergic adverse reactions to corticosteroid
- •Patients are unable to give informed consent to participate in the study
- •Patients are unable to come into the clinic for regular follow-up
- •Patients with adhesive capsulitis- acromioclavicular arthropathy- polyarthritis- infectious arthritis- rheumatoid arthritis or diagnosed fibromyalgia
- •Patients with concurrent bilateral shoulder pain
- •Patients with neurological deficit
- •Patients who have severely abnormal radiological findings including malignancy, severe osteoarthritis of the glenohumeral joint, severe skeletal abnormalities decreasing the subacromial space and etc.
- •Presence of shoulder pain with limitation of both active and passive movements of the glenohumeral joint of 25% in at least 2 directions (abduction, flexion, external rotation, internal rotation), as compared with the contralateral shoulder or with normal values
- •Patients with Diabetes mellitus
- •Patients taking anticoagulants
- •Pregnant women or lactating mothers
- •Patients who are difficulty participating in data collection due to communication problem and serious mental illness
- •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
Constant-Murley score
时间窗: Postinjection 1month
The Constant-Murley score (CMS) is a 100-points scale composed of parameters defining the level of pain and the ability of performing daily activities.
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