A Single Blinded Randomized Controlled Clinical Trial Comparing Outcome Measures of Pulsed Radiofrequency of the Genicular Nerves When Performed With and Without Concomitant Local Corticosteroid Administration
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Improvement in chronic knee pain
研究概览
简要总结
A single blinded randomized controlled trial to compare outcomes of patients with chronic knee pain receiving radiofrequency with or without corticosteroids.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women with pain secondary to osteoarthritis of the knee
- •Age of 18 years and up
- •Fits criteria for procedure of genicular nerve block and pulsed radiofrequency neuromodulation
排除标准
- •Patients who are incapable of judgment and/or to give informed consent
- •Patients who are pregnant
- •Patients who are under 18 years old
- •Patients who have allergies to local anesthetic
- •Patients with platelet dysfunction or bleeding disorders
- •Patients who are currently mentally unstable
- •Patients who have a diagnosis of fibromyalgia
研究组 & 干预措施
radiofrequency with corticosteroids
corticosteroids- 80mg depo-medrol Pulsed radiofrequency to 42 derees celsius for 6 minutes
干预措施: pulsed radiofrequency modulation (Device)
radiofrequency without corticosteroids
Pulsed radiofrequency to 42 derees celsius for 6 minutes
干预措施: pulsed radiofrequency modulation (Device)
结局指标
主要结局
Improvement in chronic knee pain
时间窗: 2nd and 6th week
Measured by the Knee injury and Osteoarthritis Outcome Score; higher scores indicating that the patients experiences more impairment (All items are scored 0-4; for each subscale the scores are transformed to a 0-100 scale; 0 representing extreme knee problems and 100 representing no knee problems).
次要结局
未报告次要终点
研究者
Dr. Itay GoorAryeh
Doctor Head of Pain Clinics, Sheba Medical Center
Sheba Medical Center