Comparing Subacromial Injection of Platelet-rich Plasma Versus Methylprednisolone in the Treatment of Shoulder Subacromial Impingement Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Constant-Murley Total Score
研究概览
简要总结
The purpose of this study is to determine whether injection of platelet-rich plasma derived from patient's blood is effective in treatment of shoulder subacromial impingement syndrome as compared to the current protocol of methylprednisolone injection.
详细描述
Patients presenting with shoulder pain to the study location will be screened by the principal investigator. Once diagnosed clinically with shoulder subacromial impingement syndrome, they will be invited to join the study. They will be invited to separate academic office to be explained about the study, its voluntary and confidential basis as per our Institutional Review Board (IRB) approved protocols.
After signing informed consent form and recruitment, they will be assigned randomly to one of the study arms through software-generated sequential allocation packaged in an opaque envelope. All involved except the principal investigator and patient are blinded.
There are two groups/arms in the study. The experimental arm will include subacromial injection of study subjects with autologous platelet-rich plasma; wheres subjects in the other study arm will be injected with methylprednisolone.
The outcome will be assessed through three scores. The study subjects will be asked to complete Oxford Shoulder Score questionnaire and health-related quality of life SF-36 questionnaire and Constant-Murley score will be measured through physician-based assessment done by the residents involved in the study. This will be done during the baseline visit before injection and repeated at 2, 6, 12 weeks and 6 months follow-up visits.
Also any adverse effects of both treatment arms will be monitored and reported as appropriate.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any adult male or female between 18 and 65 years of age, inclusive, with clinical diagnosis of shoulder subacromial impingement
排除标准
- •Age below 18 or above 65 years
- •History of prior shoulder injections or surgery
- •History of fracture of the acromion, clavicle, scapula, or proximal humerus
- •Known allergy to corticosteroids
- •Known allergy to lidocaine
研究组 & 干预措施
platelet-rich plasma group
Autologous platelet-rich plasma subacromial injection
干预措施: platelet-rich plasma group (Drug)
Methylprednisolone group
Methylprednisolone subacromial injection
干预措施: Methylprednisolone group (Drug)
结局指标
主要结局
Constant-Murley Total Score
时间窗: 6 months post-injection
The sum of scores from different domains of Constant-Murley Questionnaire
次要结局
- Constant-Murley Pain Score(6 months post-injection)
- Constant-Murley Function score(6 months post-injection)
- Constant-Murley ROM score(6 months post-injection)
研究者
Muhyeddine Al-Taki
Assistant Professor of Clinical Surgery
American University of Beirut Medical Center