Effect of Monopolar Radiofrequency Ablation for Genicular Nerves Compared to Bipolar Radiofrequency Ablation Using Ultrasound in Treating Chronic Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Osteoarthritis pain
研究概览
简要总结
Radiofrequency ablation of the genicular nerves using ultrasound is safe and effective for treating intractable knee osteoarthritis pain by using either monopolar or bipolar radiofrequency ablation.
This technique is based on anatomical studies demonstrating that genicular nerves are accompanied by genicular arteries. Ultrasound-guided RF genicular ablation yielded both significant reductions in knee pain and improvements in functional capacity.
详细描述
The aim of this study is to compare between ultrasound guided monopolar and bipolar radiofrequency ablation in chronic knee osteoarthritis.
Osteoarthritis of knee joint is one of the most common disease conditions with advanced age and leads to considerable morbidity in terms of pain, stiffness, limitation in functions, disturbance in sleep and psychological disturbance
A diagnostic genicular nerve block (GNB) with local anesthetic is performed before RF genicular ablation, and a successful response to GNB is considered to indicate the need for RF genicular ablation
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)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiologic tibiofemoral Osteoarthritis (Kellgren-Lawrence grade 2-4).
- •Patients not responding to other treatments as physiotherapy, oral analgesics, and intraarticular injection with hyaluronic acids or steroids.
- •Patients refused surgery.
排除标准
- •Patient refusal.
- •Prior knee surgery.
- •Acute knee pain.
- •Intra-articular knee corticosteroid or hyaluronic acid injection in the past 3 months.
- •Connective tissue diseases that affected the knee.
- •Anticoagulant medication use.
- •Local skin infection and sepsis at the site of intervention
结局指标
主要结局
Osteoarthritis pain
时间窗: basal value, at 1, 4, 12, 24 weeks post procedure
The mean changes from baseline levels of osteoarthritis pain using visual analogue scale used to measure pain intensity. It is 10 cm scale where 0 cm represent no pain and 10 cm represent the worst pain ever
次要结局
- Oxford Knee Score(basal value, at 1, 4, 12, 24 weeks post procedure)
- The procedure time(from the start of advancement of the cannula to end of procedure.)
- Patient satisfaction score(up to 24 weeks post procedure)
- Changes in doses of rescue analgesics(up to 24 weeks post procedure)
- The incidence of numbness(up to 24 weeks post procedure)
- The incidence of paresthesia(up to 24 weeks post procedure)
- The incidence of motor weakness(up to 24 weeks post procedure)
- the proportion of successful responders(up to 24 weeks post procedure)