The Effectiveness of Intra-articular Pulsed Radiofrequency in Patients With Painful Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Numeric Rating Scale
研究概览
简要总结
The aim of this study is to investigate the additional effect of Intra-articular Pulsed Radiofrequency (IAPRF) on pain and functional activities in addition to intra-articular steroids in patients with grade II and III knee osteoarthritis.
详细描述
This randomized controlled trial included patients over 18 years of age with knee pain persisting for more than 3 months and stage II-III knee OA according to the Kellgren-Lawrence scale. The participants were randomized into two groups: the IAPRF + steroid injection (Group 1) and only steroid injection (Group 2) groups. The injections were administered under fluoroscopic guidance in both groups, and the needle was advanced to the midline of the tibiofemoral joint in the anteroposterior and lateral views. Group 1 received 8 mg of intra-articular dexamethasone after IAPRF application for 360 s at 45 V voltage, with the temperature not exceeding 42°C. Group 2 received 8 mg of intra-articular dexamethasone only. Pain intensity and participation in daily activities were evaluated using the numerical rating scale (NRS) and Western Ontario and McMaster Universities arthritis index (WOMAC), respectively, before the procedure and 1, 4, and 12 weeks after the procedure.
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 (Investigator)
盲法说明
Procedures and evaluations were performed by different practitioners
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years,
- •Having knee pain persisting for more than 3 months due to knee osteoarthritis (OA),
- •Kellgren-Lawrence Classification grades II and III OA,
- •Giving written and verbal informed consents.
排除标准
- •Patients with a history of undergoing knee surgery and/or receiving any intra-articular knee injection within the previous 6 months,
- •Having a local or systemic infection or a coagulation disorder,
- •Patients who refused to participate in the study.
研究组 & 干预措施
Group 1
Intra-articular Pulsed Radiofrequency and Steroid Injection
干预措施: Intra-articular Pulsed Radiofrequency (Procedure)
Group 1
Intra-articular Pulsed Radiofrequency and Steroid Injection
干预措施: Steroid Injection (Drug)
Group 2
Only Intra-articular Steroid Injection
干预措施: Steroid Injection (Drug)
结局指标
主要结局
Numeric Rating Scale
时间窗: 0, 1, 4 and 12 weeks
Pain levels before and 1, 4, 12 weeks after the procedure were evaluated with Numeric Rating Scale (NRS). The patients were instructed to score their pain intensity on a scale of 0 to 10, where "0" represents "no pain at all" and "10" represents "worst pain ever possible."
次要结局
- Western Ontario and McMaster Universities Arthritis Index(0, 1, 4 and 12 weeks)
研究者
Burak Erken
Medical Doctor
Başakşehir Çam & Sakura City Hospital