Intradiscal Combination of Gelified Ethanol and Pulsed Radiofrequency Versus Gelified Ethanol Injection for the Treatment of Chronic Discogenic Low Back Pain. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Numeric Rating Scale (NRS)
研究概览
简要总结
Many different minimally invasive techniques have been used for the treatment of chronic discogenic low back pain refractory to conservative treatments, with various results. The aim of this study is to assess the efficacy of the combination of intradiscal pulsed radiofrequency and gelified ethanol versus gelified ethanol alone, on pain and quality of life of patients sufferring from chronic discogenic low back pain.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Discogenic low back pain > 6 months,
- •pain refractory to conservative treatment,
- •no other aetiology for pain,
- •pain reported during provocative discography according to standard criteria,
- •MRI imaging indicating disk degenarative disease
排除标准
- •Red flags for low back pain,
- •lumbosacral radiculopathy,
- •extruded or sequestered lumbar disc,
- •severe spinal stenosis,
- •facet joint syndrome,
- •sacroiliac joint pain,
- •neurological disorders,
- •psychiatric disorders,
- •rheumatoid arhtritis, ancylosing spondylitis, other autoimmune arthritis,
- •coagulation disorders,
- •pregnancy
研究组 & 干预措施
Gelified ethanol
Gelified ethanol (Discogel) is a sterile, implantable medical solution containing ethyl alcohol, cellulose derivative product and an opaque agent (tungsten). The implant is administered within the affected intervertebral disc nucleus pulposus, via a fine needle which is guided into the center of the disc, transdermally. The implant causes migration of fluid (by hydrophilic and osmotic phenomena) from the periphery towards the center, causing disk reinforcement. Filling of the annulus fibrosus tears interrupts the outflow of inflammatory factors towards dorsal root ganglions, dura and posterior longitudinal ligament.
干预措施: Gelified ethanol (Drug)
Gelified ethanol combined to pulsed radiofrequency
Pulsed radiofrequency treatment is performed intradiscally for the management of chronic discogenic low back pain.Intradiscal pulsed radiofrequency is first applied and then combined to gelified ethanol injection via the same radiofrequency needle.
干预措施: Gelified ethanol combined to pulsed radiofrequency (Drug)
结局指标
主要结局
Change in Numeric Rating Scale (NRS)
时间窗: One, three, six and twelve months after the procedure.
Mean pain intensity assessed by VAS 1, 3, 6 and 12 months after the procedure.
Change in Rolland Morris questionnaire
时间窗: One, three, six and twelve months after the procedure.
Functional status of patient assessed by Rolland Morris questionnaire 1, 3, 6 and 12 months after the procedure.
次要结局
- Change in Satisfaction from therapy ( assessed via NRS 0-10)(One, three, six and twelve months after the procedure.)
- Change in Quality of life (EQ 5D)(One, three, six and twelve months after the procedure.)
研究者
Chrysanthi Batistaki
Assistant Professor of Anesthesiology, 2nd Department of Anesthesiology, School of Medicine, University of Athens, Greece
Attikon Hospital