NCT03613610Unknown不适用
Three Needles Approach... A New Technique of Genicular Nerve Radio-frequency Ablation for Pain Relief in Advanced Knee Osteoarthritis
Alaa Fouli Gaber Ebrahim1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年2月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Visual analogue score
研究概览
简要总结
The study is designed to evaluate and compare the efficacy of three needles approach as a new technique in radiofrequency neurotomy of genicular nerve versus the traditional single needle approach as a treatment of advanced knee osteoarthritic pain. Primary outcome:
- Pain intensity via the visual analogue score (VAS).
- Function and pain via the Oxford Knee Score. Evaluated after 6 months of the procedure
Secondary outcome:
- Failure rate.
- Incidence of any complication.
- Total analgesic requirement during the period of follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1- Age 35-85 years old 2- Patients with stage 3 or higher OA-related radiological changes based on Kellgren-Lawrence (K/L) rating scale 3- Knee pain for at least 3 months 4-Patients are clinically unresponsive to conservative treatment modalities (physical therapy and rehabilitation practices, orally administered analgesics and anti-inflammatory drugs).
排除标准
- •1- Patients with other causes of pain as radiculopathy, neurological disorders or intermittent claudication. 2- Previous knee trauma. 3- Previous knee surgery. 4- Patients received intra-articular injection during the previous three months.
- •5- Acute knee pain. 6- Crystal arthropathy. 7- Joint effusion. 8- Serious neurological or psychiatric disorders. 9- On anticoagulant medication. 10- Any other connective tissue disorder that affects the knee joint. 11- skin infection at the site of injection. 12-patient refusal.
研究组 & 干预措施
Single needle group
Active Comparator
干预措施: Radio-frequency ablation of genicular nerves (Radiation)
Three needles group
Active Comparator
干预措施: Radio-frequency ablation of genicular nerves (Radiation)
结局指标
主要结局
Visual analogue score
时间窗: 6 months after the procedure
Pain intensity via the visual analogue score (VAS).
Oxford knee score
时间窗: 6 months after the procedure
Follow up of pain and function via the Oxford knee score
次要结局
- Incidence of complication(6 months after the procedure)
- Failure rate(6 months after the procedure)
研究者
Alaa Fouli Gaber Ebrahim
Resident of anesthesia and intensive care
Minia University
研究点 (1)
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