Genicular Nerve Phenol Neurolysis Versus Radiofrequency Ablation for Pain Relief in Grade 4 Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 114
- 主要终点
- Numeric rating scale
研究概览
简要总结
The goal of this clinical trial is to compare the efficiency and efficacy of genicular nerves blockade by chemical phenol neurolysis versus radiofrequency ablation in managing pain in patients suffering from grade IV KOA in term of NRS pain score.
The participants will be evaluated by numeric rating scale and oxford knee score for assessment of pain relief up to 16 weeks.
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
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Grade 4 knee osteoarthritis according to Kellgren-Lawrence radiological classification.
- •Failure to manage pain with conservative methods.
排除标准
- •Prior knee replacement
- •Patients with cardiac pacemakers or implantable cardiac defibrillators.
- •Septic knee or systemic sepsis.
- •Allergy to any of the drugs used in the study.
- •Coagulopathy or patients on anticoagulants.
- •Patients with psychiatric illness.
研究组 & 干预措施
genicular nerve phenol neurolysis
chemical neurolysis using 2 mL of 9% phenol solution prepared from crystallized phenol will be applied to each genicular nerve.
干预措施: genicular nerve neurolysis (Procedure)
genicular nerve radiofrequency ablation
Radiofrequency thermocoagulation will be applied to each nerve at 80 degrees for 90 seconds.
干预措施: genicular nerve neurolysis (Procedure)
结局指标
主要结局
Numeric rating scale
时间窗: baseline, 2, 4, 8,12 and 16 weeks after the procedure
By an independent physician pain will be recorded using numeric rating scale which is a screening tool used to assess pain severity using a 0 - 10 scale with zero meaning no pain and 10 meaning the worst pain ever.
次要结局
- oxford knee score(baseline, 4, 8, 12, 16 weeks after the procedure)