Treatment of Rotator Cuff Syndrome With Injection of Autologous Platelet Rich Plasma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pain and Disability of the Shoulder Through Validated Questionnaires
研究概览
简要总结
The purpose of this investigator initiated study is to clinically evaluate the efficacy of a new treatment for subacromial impingement syndrome and partial thickness rotator cuff tears. This treatment consists of a platelet rich plasma injection into and around the rotator cuff. It is thought that this treatment will dramatically improve outcomes for patients suffering from these two conditions.
Subjects will be randomized by choosing a slip of paper from an envelope. This process will randomize 25 patients to the experimental group, and 25 patients to the control. The experimental group will undergo a blood draw, allowing for an injection of platelet rich plasma around the rotator cuff. The control group will undergo a corticosteroid injection into the subacromial space surrounding the rotator cuff as sole treatment. Patients will be followed for three months for pain, and will fill out questionnaires at six weeks and three months post injection, which will give insight into functionality and pain changes that the rotator cuff is experiencing due to treatment.
Subjects will be outpatients. Subjects may include employees, students, minorities, and elderly, although no subsets of these will be formed.
Subjects will be between 18 and 89 years of age.
In total, subject participation will last approximately 3 months.
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
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with rotator cuff symptoms for at least 4 weeks
- •Examination reveals diffuse pain with provocative maneuvers
- •Impingement symptoms with or without a partial thickness tear (if available MRI study must be less than 50% tear)
- •Willingness to participate in an investigational technique
- •Willingness to forgo any other concomitant conservative treatment modality including NSAID (must be stopped for at least one week)
排除标准
- •Previous rotator cuff repair
- •Complete rotator cuff tear or two tendon tears
- •Pt w/ complex regional pain syndrome
- •Cervical neuropathy or other nerve pathology
- •RA, local or systemic infection, PVD, metabolic disease such as gout, clotting disorder, anticoagulation therapy
- •Evidence of intraarticular arthritis
- •Work related or compensable injury
- •Previous treatment: corticosteroid injection in the last 6 months
- •Patients who are currently pregnant
研究组 & 干预措施
control
corticosteroid injection into subacromial space
干预措施: corticosteroid injection (Drug)
experimental
patients will receive an injection of platelet rich plasma into the subacromial space
干预措施: platelet rich plasma injection (Biological)
结局指标
主要结局
Pain and Disability of the Shoulder Through Validated Questionnaires
时间窗: 15 minutes prior to initial injection of corticosteroid versus platelet rich plasma
Patients will be asked to fill out questionnaires to provide insight into how their condition is progressing, consisting of components of the American Shoulder and Elbow Surgeons (ASES) total score. The maximum score is 100, made up by pain and function components' sums. Only the total score is recorded, 100 being full normal function without pain, 0 being severe pain and no function.
次要结局
未报告次要终点
研究者
Montri D. Wongworawat
Professor
Loma Linda University