Comparative Study Between Intra Articular Injection of Hyaluronic Acid (HA) With Platelet Rich Plasma (PRP) Versus Genicular Nerve Thermal Radiation in Management of Pain in Knee Osteoarthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain Measurment via Visual analogue score
研究概览
简要总结
Intraarticular injection (IAI) of Platelet rich plasma (PRP) with Hyaluronic acid (HA) Versus Radiofrequency (RF) of genicular nerve for pain reduction of of knee osteoarthritis , Improving daily activity and reduction analgesia requirements
详细描述
In this study the investigators to comparing between the effect of Intra articular injection of hyaluronic acid (HA) with platelet rich plasma (PRP) versus genicular nerve thermal radiation in management of pain in knee osteoarthritis.
Knee assessment and pain score recorded according to Visual Analogue Scale (VAS) after one week, one month, three months, six months following intraarticular injection and radiation.
All analgesics stopped and only (Arcoxia "etoricoxib" 60 mg, 90 mg) was taken after the procedure, total day dose and frequency will be reported, other analgesics taken by the patient is reported also.
Improvement of daily activities and clinical examination for the studied knees is observed.
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
- Double (Participant, Care Provider)
盲法说明
Closed Opauqe Envelopes
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mild to moderate Knee osteoarthritis.
- •Body mass index: 24 - 42 kg/m2
排除标准
- •Coagulopathy.
- •Acute local or systemic infections with knee effusion Previous knee surgery (relative Contraindication).
研究组 & 干预措施
Intraarticular injection Group
Patients included in the study had been received 2 ml hyaluronic acid with concentration of 22mg/ml . Platelet rich plasma is arranged by withdrawing 10 ml of patient's personal venous blood, anticoagulant is added, and centrifuged by duo-spin method, at the rate of 3500 rpm for five minutes then injected twice with 2 weeks interval
干预措施: Intra articular injection Group (Drug)
Radiofrequency Group
Radiofrequency Generator is a four electrode pain management for interventional pain management procedures. Patients had been placed in the supine position and their knee will be supported by a small pillow placed beneath the popliteal fossa. Fluoroscopic images of knee joint had been obtained. Possible locations of genicular nerves had been determined on the lateral, medial aspects of the lower end of the femoral bone and on the medial aspect of the tibia, under fluoroscopic guidance.
干预措施: Radiofrequency Group (Device)
结局指标
主要结局
Pain Measurment via Visual analogue score
时间窗: Measured throuout 6 months follow up session
Visual analogue score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-10. A higher score indicates greater pain intensity was measured throuout 6 months follow up session
次要结局
- Improvement of daily activities between 2 groups(Throuout 6 months follow up session)
- Analgesic requirements Comparison(Throuout 6 months follow up session)
研究者
Ahmed Abdalla
Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University
Cairo University