Radiofrequency Ablation for the Treatment of Chronic Sacroiliac Joint Arthropathy; Comparing the Use of Bipolar RF at Six Points Versus Monopolar RF at Six Points and Three Points
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- patient satisfaction
研究概览
简要总结
Expecting using bipolar RF at six points, in spite of potentially consuming more intraoperative time, to be more effective and long lasting in the management of pain resultant from chronic sacroiliac joint arthropathy than the other 2 techniques using the monopolar RF even if using six points.
详细描述
A Prospective, single center, double blind, controlled randomized trial.
Sample Size:
Total of 60 patients divided into three groups:
Group 1: 20 patients will be receiving bipolar RF at six points. Group 2: 20 patients will be receiving monopolar RF at six points. Group 3: 20 patients will be receiving monopolar RF at three points.
Sampling technique:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Moderate to severe low back pain for more than six months with positive Patrick's and Yeoman's tests with tenderness over the SI joint.
- •Pain is not responding to the usual medical treatment.
- •More than 50 % pain relief after diagnostic injection with local anesthetic.
排除标准
- •• Patient refusal to do the procedure or to share in the study
- •Focal Neurologic Signs.
- •significant anticoagulation e.g. clopedogril (low dose aspirin will be excluded)
- •Pregnancy, breast feeding or planning on becoming pregnant during the trial.
- •Infection at the intended injection site.
结局指标
主要结局
patient satisfaction
时间窗: 6-12 months
Patients suffering chronic low back pain due to sacroiliac joint arthropathy will receive a potentially more effective method of radiofrequency ablation with an overall better patient satisfaction.
次要结局
未报告次要终点