Role of Alpha Lipoic Acid Combined With Pulsed Radiofrequency in Treatment of Chronic Lumbosacral Radicular Pain: Prospective, Randomized Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Numerical Pain Rating Scale (NRS)
研究概览
简要总结
In this study, we try to evaluate the effect of using ALA as an adjuvant treatment in patients scheduled for pulsed radiofrequency treatment (PRFT) of the affected dorsal root ganglion (DRG) for treatment of Lumbo-Sacral radicular pain.
详细描述
Study design: The study is prospective, randomized, and open label started in August 2013 and was completed in March 2017 at Assiut University Hospital, Pain Unit after local ethical committee approval. All patients were informed verbally and in writing about the study, and they signed a detailed written informed consent about the procedure and the nature of the study.
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
- Single (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
- •Patients over 18 years with severe chronic lumbo-sacral radicular pain of more than 6 months duration, not responding to medical treatment, and their Pain scores were > 7 were included in the study.
排除标准
- •coagulopathy, surgical interference, advanced malignancy, known concurrent neurological or neurodegenerative disease, including those with impaired neurotransmission e.g. myasthenia gravis, multiple sclerosis, spinal cord injury, breastfeeding or pregnancy, allergy/sensitivity to lidocaine anesthetic or/ and non-ionic contrast media or/and steroid therapy, active psychiatric or mental conditions and uncontrolled medical condition.
研究组 & 干预措施
Group I
Each patient in this group was treated with pulsed radiofrequency on the affected dorsal root ganglion at 42°C for 120 seconds
干预措施: pulsed radiofrequency (Procedure)
Group II
Each patient in this group was treated with pulsed radiofrequency as in group I plus oral alpha lipoic acid (ALA) 600 mg.
干预措施: pulsed radiofrequency plus alpha lipoic acid (Drug)
结局指标
主要结局
Numerical Pain Rating Scale (NRS)
时间窗: 6 months after treatment
The pain was evaluated using standard 10-point Numerical Pain Rating Scale (NRS) with 0 being no pain, and 10 representing the worst pain imaginable.
次要结局
未报告次要终点
研究者
Abdelrady S Ibrahim, MD
Assistant professor
Assiut University