Evaluation of the Effect of Biofiller PRP Application on Range of Motion, Pain, Quality of Life and Femoral Cartilage Thickness in Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) Change from baseline in pain on the VAS at month 3
研究概览
简要总结
The aim of this study is to evaluate the effects of biofiller PRP, on pain, range of motion, quality of life, and femoral cartilage thickness in patients with knee osteoarthritis.
详细描述
Patients who are admitted and diagnosed with knee osteoarthritis based on anamnesis, physical examination and imaging methods are included in the study
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
- 45 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1-45-65 years old 2-Diagnosis of knee OA according to ACR clinical and radiological diagnostic criteria 3-Kellgren Lawrence stage II or III 4-Knee pain for at least 6 months 5-Visual analog scale (VAS) score of at least 3 or more
排除标准
- •1 - History of surgery or traumatic injury 2-Inflammatory arthritis 3-History of cancer, bleeding diathesis and psychiatric disease 4-Those who have a disease that limits their participation in exercises (severe chronic obstructive lung disease, severe heart failure, history of cerebrovascular events) 5-Hip and ankle problems 6-Participating in another physical therapy program in the last 3 months 7-History of intra-articular injections in the last 6 months
研究组 & 干预措施
Platelet rich plasma
Ten ml of the patient's blood wasdrawn in a syringe . It wascentrifuged firstat 4000 rotations per minute (RPM)for 10 min . The upper part,i.e.,platelet-poor plasma (PPP) was withdrawn in a 5 mL syringe
干预措施: biofiller prp (Other)
Biofiller platelet rich plasma
Ten ml of the patient's blood wasdrawn in a syringe . It wascentrifuged firstat 4000 rotations per minute (RPM)for 10 min . The upper part,i.e.,platelet-poor plasma (PPP) was withdrawn in a 5 mL syringe. PRP was incubated in hot incubator at 75 °C for 10 min and then cooled in a refrigerator for 5 min.
干预措施: biofiller prp (Other)
结局指标
主要结局
Visual Analog Scale (VAS) Change from baseline in pain on the VAS at month 3
时间窗: Baseline and month 3
Visual Analog Scale (VAS) is used to measure and monitor the intensity of pain. This is a 10 cm ruler that describes painlessness at one end and the most severe pain at the other. A patient scores his/her pain from 0 to 10.
次要结局
- Western OntarioMacMaster (WOMAC) Change from baseline in pain and physical functions on Western OntarioMacMaster scale at month(Baseline and month 3)
- Femoral cartilage thickness Change from baseline in knee joint on the measuring the femoral cartilage thickness at month 3(Baseline and month 3)
研究者
Banu Ordahan
professor
Necmettin Erbakan University
