Efficacy of Platelet-Rich Plasma Versus Home-Based Exercise in Patients With Partial-Thickness Supraspinatus Tears: A Prospective Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Shoulder Pain (VAS)
研究概览
简要总结
This study evaluates the clinical effectiveness of platelet-rich plasma (PRP) injections compared with a home-based exercise program in patients with partial-thickness tears of the supraspinatus tendon. Partial supraspinatus tears are a common cause of chronic shoulder pain and functional limitation. PRP has been proposed as a biological treatment that may promote tissue healing, while therapeutic exercise remains a standard conservative intervention.
This prospective, controlled study includes two parallel groups. The PRP group receives three monthly ultrasound-guided intratendinous PRP injections, preceded by local anesthesia. The control group follows a structured home-based exercise program for the same overall treatment period. All participants are assessed at baseline and again two months after completing their assigned intervention.
The primary outcome is shoulder pain measured with a Visual Analog Scale (VAS). Secondary outcomes include shoulder range of motion (flexion, extension, abduction, adduction, internal and external rotation) and functional disability measured with the Constant-Murley Score. The study also analyzes whether patient characteristics such as age or sex are associated with clinical improvement.
The aim of this research is to compare two commonly used conservative treatment strategies and provide evidence to guide clinical decision-making for patients with partial-thickness supraspinatus tears.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 70 years.
- •Shoulder pain for more than 6 months with a Visual Analog Scale (VAS) score >
- •Partial-thickness tear of the supraspinatus tendon confirmed by ultrasound.
- •No improvement in VAS after conservative treatment with NSAIDs and/or physical therapy during the previous 6 months.
- •Willingness to undergo blood extraction and PRP infiltrations as required by the protocol.
排除标准
- •Age < 20 or > 70 years.
- •Full-thickness tear of the supraspinatus tendon.
- •Active infection (osteomyelitis, septic arthritis).
- •Current treatment with NSAIDs, antiplatelet agents, or systemic immunosuppressants.
- •Severe thrombocytopenia.
- •Positive serology (syphilis, HIV, HBV, HCV).
研究组 & 干预措施
PRP Injection
Participants receive three monthly ultrasound-guided intratendinous injections of platelet-rich plasma (PRP) in the affected supraspinatus tendon, preceded by local anesthetic infiltration in the subacromial bursa.
干预措施: Platelet-Rich Plasma (PRP) (Biological)
Home-Based Exercise Program
Active Comparator
干预措施: Home Exercise Program (Other)
结局指标
主要结局
Shoulder Pain (VAS)
时间窗: Baseline and 2 months after completing the intervention.
Pain intensity measured using a 0-10 Visual Analog Scale (VAS). Higher scores indicate greater pain.
次要结局
- Shoulder Range of Motion (Flexion, Extension, Abduction, Adduction, Internal and External Rotation)(Baseline and 2 months after completing the intervention.)
- Constant-Murley Score(Baseline and 2 months post-intervention.)
- Roles and Maudsley Score(Baseline and 2 months post-intervention.)
- QuickDASH Score(Baseline and 2 months post-intervention.)
研究者
Carlos Fernández-Morales
Clinical Professor
Universidad de Extremadura