Comparison Between Platelet Rich Plasma and Corticosteroids for the Treatment of Rotator Cuff Tendinopathy Randomized Controlled Double Blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
The goal of this clinical trial is to test if Plateth-rich plasma would provide improved pain relief and function in patients with rotator cuff tendinopathy compared to standard treatment of corticosterone injections.
Researchers will compare a control group of patients treated with a corticosterone injection with a case group of patients treated with Plateth-rich plasma injection.
The purpose of this study is to perform a double-blind randomized controlled trial, comparing PRP with corticosteroids to provide pain relief and improve function in patients with rotator cuff tendinopathy. The hypothesis of this study is that PRP would provide improved pain relief and function in patients with rotator cuff tendinopathy compared to standard treatment of CS injections.
详细描述
Rotator cuff tendinopathy represents the most common pathology of the shoulder and is the main reason for outpatient consultation for pathologies related to the shoulder girdle. First-line treatment for rotator cuff tendinopathy usually consists of activity modification, stretching and strengthening exercises, oral anti-inflammatory medications. When these initial measures are not effective, a second line of treatment consists of local infiltrations with corticosteroids. However, most of the studies evaluating the effectiveness of corticosteroids in patients with rotator cuff tendinopathy show that the clinical results are usually short-lived.
In this sense, platelet-rich plasma (PRP) emerges as a promising alternative due to its ability to release pro-regenerative growth factors (FsC) and cytokines at the lesion site. Platelet Rich Plasma is considered a minimal handling product. Specifically, at the Hospital Italiano de Buenos Aires (HIBA), platelet-rich plasma has been used for more than 10 years for different musculoskeletal conditions, both on an outpatient basis or as an adjuvant to different surgical procedures.
Several small cohort studies and randomized controlled trials have examined the clinical benefit of PRP for treating patients with rotator cuff tendinopathy, however their results have been confounded by small patient samples, lack of a control group, variable or insufficient data from the PRP preparations and short-term follow-up.
The purpose of this study is to perform a double-blind randomized controlled trial, comparing PRP with corticosteroids to provide pain relief and improve function in patients with rotator cuff tendinopathy. The hypothesis of this study is that PRP would provide improved pain relief and function in patients with rotator cuff tendinopathy compared to standard treatment of CS injections.
Hypothesis
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
At the time of blood collection, patients will be placed in a hemotherapy extraction chair with a screen that will prevent the patient from seeing their arm at the time of blood collection.
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptomatic rotator cuff tendinopathy (confirmed by ultrasound).
- •At least 3 months of failed conservative treatment (decreased activity, anti-inflammatories, kinesiology for at least 3 months before diagnosis).
排除标准
- •Refusal to participate or informed consent
- •Previous shoulder surgery,
- •Partial or total tears of the rotator cuff,
- •Patients with shoulder osteoarthritis
- •Advanced fatty infiltration of the rotator cuff muscles
- •Systemic or rheumatoid arthritis,
- •Uncontrolled diabetes,
- •Acute or chronic infections of the shoulder to be operated on
- •Ongoing cancer chemotherapy therapies
- •Sepsis, septic arthritis, osteomyelitis or other ongoing infectious processes;
- •Patients with autoimmune diseases;
- •Pregnants
研究组 & 干预措施
Corticoid
Patients that recieve corticosterone injection instead of plathet rich plasma.
干预措施: Corticosteroid (Drug)
Plathet rich plasma
Patients that recieve plathet rich plasma instead of corticoesterone
干预措施: Plathet rich plasma (Biological)
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: 1 year
From 1 (no pain at all) to 10 (worst pain in patient's life)
次要结局
- ASES (American Shoulder and Elbow Surgeons)(1 year)
- Pittsburgh Score(1 year)
- Constant's score(1 year)
研究者
LUCIANO ANDRES ROSSI
Shoulder surgeon attending, Clinical professor, Principal investigator
Hospital Italiano de Buenos Aires
