Injection With Amniotic Fluid Versus Corticosteroid in Patients With Stenosing Tenosynovitis: a Randomized, Blinded Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Patient reported pain level
研究概览
简要总结
The proposed study aims to investigate whether amniotic fluid injections are a better alternative to corticosteroid injections as a conservative treatment for stenosing tenosynovitis. Based on results from our most recent pilot study exploring patient outcomes after receiving an amnion injection, we were able to observe symptom resolution in more than half of the study population. Adverse events were extremely rare and not related to study participation. Given the numerous occurrences of successful symptom resolution, the next step is to compare patient outcomes to those of patients who receive the standard steroid injection. This study will compare outcome measurements of patients who receive amnion injections to those who receive steroid injections.
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 (Participant)
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
- •Patient is at least 18 years of age
- •Patient is diagnosed with stenosing tenosynovitis
排除标准
- •Patient is less than 18 years of age
- •Pregnancy
- •Enrolling clinician does not believe that the patient is mentally capable of understanding the research nature of the procedure due to mental handicap/disability or illiteracy.
结局指标
主要结局
Patient reported pain level
时间窗: 12 months
Analog pain scale (0-10)
次要结局
- Disabilities of the Arm Shoulder and Hand score(12 months)
- Trigger frequency(12 months)