NCT06087601已完成4 期
The Impact of Genicular Nerves Chemical Neurolysis on the Quality of Life of Patients with Advanced Knee Osteoarthritis. a Randomized, Double-blinded, Clinical Trial
Poznan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年10月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- NRS
研究概览
简要总结
Genicular nerves chemical neurolysis in advanced osteoarthritis of the knee joint.
详细描述
The study aims to assess the safety and effectiveness of regional pain treatment methods and their impact on the quality of life of patients with advanced osteoarthritis of the knee joint.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of the Pain Treatment Clinic of the Transfiguration of Jesus Clinical Hospital of the Medical University of Poznań will be qualified for the study
- •patients with gonarthrosis who failed to achieve satisfactory pain control (NRS>3) despite the use of NSAIDs, Paracetamol, and co-analgesics
- •Age of patients: from 18 to 110 years of age.
- •Caucasian patients can give informed, complete, written consent.
排除标准
- •suspected or diagnosed opioid dependence syndrome
- •active cancer
研究组 & 干预措施
Sham blocks
Active Comparator
US-guided Bilateral genicular nerve block with 0,9% NaCl
干预措施: 0.9% Sodium chloride (Drug)
Genicular nerve neurolysis
Active Comparator
US-guided Bilateral genicular nerve neurolysis with 0,5ml 95% ethanol
干预措施: 95% ethanol (Drug)
结局指标
主要结局
NRS
时间窗: 6 months after procedure
The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
次要结局
- Health Questionnaire (EQ-5D-5L)(6 months after surgery)
- neurological deficits(6 months after procedures)
- total opioid consumption(6 months after procedure)
研究者
研究点 (1)
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