Analgesic Efficacy of Epidural Neuroplasty Using Racz Catheter During Lumbar Fixation in Situ for Lumbosacral Spondylolisthesis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Degree of Disability
研究概览
简要总结
This study aims to evaluate the analgesic efficacy of epidural neuroplasty using a Racz catheter during lumber fixation in situ for lumbosacral spondylolisthesis.
详细描述
Lumbosacral spondylolisthesis, a common neurosurgical disorder, involves the anterior displacement of a vertebra in relation to the one below it. It often leads to back pain and neurologic symptoms.
Epidural lysis of adhesions is a procedure which treat chronic LBP in patients which didn't respond to medical treatments.The technique of Radiofrequency ablation (RFA) uses high-frequency current to produce tissue coagulation and heat. It involves the use of radio waves, applied through a percutaneous probe to generate heat and create a lesion in a spinal sensory nerve
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 65 years.
- •Both sexes.
- •Patients suffering from spondylolisthesis grade 0, 1, 2 complaining of low back pain and/or sciatica.
排除标准
- •Uncooperative patients.
- •Patients in need of discectomy for lumber disc prolapse.
- •Patients with severe canal stenosis and in need of spinal laminectomy.
- •Contraindications to perform the proper technique e.g., coagulopathy and skin infection.
- •Body mass index (BMI) ≥35 kg/m
- •History of allergy to contrast medium.
- •Previously operated traditional spine surgeries.
研究组 & 干预措施
Racz catheter group
Patients will undergo epidural neuroplasty using Racz catheter during lumber fixation.
干预措施: Racz catheter (Procedure)
Control group
Patients will undergo classic lumber fixation.
干预措施: Classic lumber fixation (Procedure)
结局指标
主要结局
Degree of Disability
时间窗: 6 month post-procedure
Degree of Disability will be assessed using Oswestry Low Back Disability Questionnaire: This questionnaire has been designed to give us information as to how back pain has affected a patient's ability to manage everyday life. It consists of 10 questions for each question, there is a possible 5 points (0 for the first answer, 1 for the second answer, etc). Add up the total for the 10 questions and rate them on the scale (0-4 no disability, 5-14 mild disability, 15-24 moderate disability, 25-34 severe disability, 35-50 complete disability). It will be assisted pre-procedure as a baseline, after 1, 2, 4, 6 month post-procedure
次要结局
- Degree of pain(6 month post-procedure)
- Degree of patient satisfaction(6 month post-procedure)
- Incidence of complications(6 month post-procedure)
研究者
Mohammed Said ElSharkawy
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University