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临床试验/NCT02688543
NCT02688543已完成不适用

Analgesic Effect and Functional Improvement Caused by Radiofrequency Ablation of Genicular Nerves in Patients With Advanced Osteoarthrosis of the Knee Joint Until 1 Year Following Treatment

Hospital General de Jerez de la Frontera2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2013年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
2
主要终点
Pain reduction

研究概览

简要总结

Pharmacological treatment of pain due to osteoarthritis of the knee often proves to be inadequate and/or cause intolerable side effects. Arthroplasty of the knee may offer a solution, but waiting lists may be long or certain patients may not be apt for a surgical intervention. Therefore an alternative pain treatment that is effective and has little side effects allowing to offer pain relief to those difficult to manage patients would be an added value in the therapeutic options.

We studies the short and long-term effects of radio frequency treatment of the genicular nerves in patients with severe pain due to osteoarthritis of the knee.

详细描述

Radio frequency treatment (RF) of the genicular nerves was found to be effective in a randomized controlled trial. Because of the blinding patients were allowed to continue pre-intervention pharmacological treatment, which may have interfered with the outcome. The short follow-up (12 weeks) does not allow drawing conclusion on the duration of the effect.

We aimed at assessing the pain reducing effect of RF of the genicular nerves and the duration of the effect.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

接受健康志愿者

入选标准

  • patients suffering from pain caused by osteoarthrosis of the knee joint
  • osteoarthrosis of the knee joint (grade 3-4 according to the Kellgren Lawrence classification)
  • pain of moderate to severe intensity (VAS≥5, on a 10-point scale) during >3 months
  • pain resistant to conservative treatments

排除标准

  • acute knee pain associated with radicular neuropathy or intermittent claudication, connective tissue diseases affecting the knee, serious neurologic or psychiatric disorders, mental deterioration impeding adequate communication or collaboration, injection with steroids or hyaluronic acids during the previous 3 months, anticoagulant medications, pacemakers, and prior electro-acupuncture treatment

结局指标

主要结局

Pain reduction

时间窗: 1, 6 and 12 months

Pain intensity is measured using a 10-point VAS score

次要结局

  • Global patient satisfaction(1,6 and 12 months)
  • Improvement of quality of life(1,6 and 12 months)

研究者

发起方
Hospital General de Jerez de la Frontera
申办方类型
Other
责任方
Sponsor

研究点 (2)

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