Effect of Platelet Rich Plasma Therapy for Shoulder Osteoarthritis :Double Blinded Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Change in patient's pain score
研究概览
简要总结
Patients with shoulder osteoarthritis are suffering from pain and disabilities which lead to difficulties in life. The presence of platelet-rich plasma as regenerative therapy which helps in healing of damaged tissues like ligaments and joint might be of great benefit in managing such conditions.
详细描述
Primary and secondary osteoarthritis of the shoulder occurs due to destruction of the articular surface of the humeral head and glenoid , Patient mainly presented with pain and decreases in the range of motion .
Treatment of shoulder osteoarthritis is often controversial and is typically based on the patient's age, the severity of symptoms, and level of activity, radiographic findings, and medical comorbidities.
The new era of management include regenerative therapy ,Platelet-rich plasma (PRP) is one of the regenerative therapy that prove its effect as injections of a concentration of a patient's own platelets to accelerate the healing of injured tendons, ligaments, muscles and joints.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient's age: From 21 years.
- •Acute symptoms on a background of at least a 3-month history of chronic pain or swelling of the shoulder joint with radiological confirmed (X-ray or MRI)
- •Mild or moderate osteoarthritis of the shoulder joint according to The Samilson-Prieto classification.
- •Numerical Rating Scale for pain scores greater than five on a 10 scale
排除标准
- •Under 21 years of age
- •Severe osteoarthritis according to The Samilson-Prieto classification. (Figure 1)
- •Neuropsychiatric disorders.
- •Immunocompromised patients.
- •Active infection or malignancy at the joint.
- •Pregnancy and breastfeeding.
- •Patients may have thrombocytopenia, bleeding disorders, or on anticoagulant therapy.
- •Shoulder surgery within 3 months or inflammatory arthritis; previous infection of the shoulder joint.
结局指标
主要结局
Change in patient's pain score
时间窗: 2 weeks after each injection
By using NUMERICAL PAIN SCALE patient will mention them pain score on scale from 1 to 10, where the pain score to be included in the study is 5 and more , we will measure pain score for each patient after 2 weeks from injection ,where decrease of the number from the initial recorded number before injection means improvement.
次要结局
- change in the range of motion(2 weeks after each injection)