Comparative Study Between Knee Genicular Nerve Ablation by Thermal Radiofrequency vs Thermal Radiofrequency Plus Alcohol Neurolysis for Treatment of Symptomatic Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- pain relief after 1 month
研究概览
简要总结
the aim of our study is to compare effectiveness (satisfaction) and duration of pain relief between patients receiving the conventional thermal radiofrequency on the genicular nerves alone vs patients who will receive the conventional method plus alcohol neurolysis of the targeted nerves.
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
- None
入排标准
- 年龄范围
- 60 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders.
- •Age between 60-70 years.
- •ASA 1,2 & 3 physical status.
- •x ray imaging confirming the osteoarthritis and unwell or not candidate for knee replacement surgery
排除标准
- •Neurological disorders.(previous cerebrovascular stroke , neuropathy , or weakness )
- •coagulopathy ( plt < 50000, INR > 1.7 )
- •Infection at or near the injection site.
- •presence of pacemaker or defibrillator 5 - Acute knee injury.
- •6- age < 60 or >70 years
研究组 & 干预措施
control group
The patients are placed in supine position with knee preparation using an iodine-based product and drape in a sterile manner Then the ground pad of the radio frequency machine will be placed in the other leg (we used the Neurotherm NT1100 re generator) All the patients will be monitored by ECG, noninvasive blood pressure and pulse oximetry The 3 entry sites will be detected under fluoroscopy then local anesthesia will be performed using lidocaine 2% followed by the insertion of the 3 radiofrequency cannulas (STRYKER 20 G, 9 cm with 1 cm active tip) targeting the 3 main nerves ( superior medial genicular, superior lateral genicular and the inferior medial genicular nerves ). this group will receive radio frequency alone .
干预措施: genicular nerve ablation by thermal radiofrequency (Procedure)
study group
this group will pass through the all steps but after the radiofrequency is done at each level a 1 ml of 70% alcohol will be injected making a total of 3 ml injection to each nerve.
干预措施: genicular nerve ablation by thermal radiofrequency plus alcohol neurolysis (Procedure)
study group
this group will pass through the all steps but after the radiofrequency is done at each level a 1 ml of 70% alcohol will be injected making a total of 3 ml injection to each nerve.
干预措施: genicular nerve ablation by thermal radiofrequency (Procedure)
结局指标
主要结局
pain relief after 1 month
时间窗: 1 month
evaluating degree of pain relief after knee genicular nerve ablation by thermal radiofrequency plus alcohol neurolysis using numeric pain rating scale ( 11 number score scale where 0 indicates no pain and 10 indicates worst pain imaginable )after 1 month.
次要结局
未报告次要终点
研究者
Lydia edward aziz zakhary
Principal Investigator
Ain Shams University