Evaluation of the Effect of Epidural Pulsed Radiofrequency Treatment on Pain in Patients Diagnosed With Failed Back Surgery Syndrome (Persistant Spinal Pain Syndrome)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 主要终点
- Change in pain severity score
研究概览
简要总结
Low back pain can persist in some patients with history of back surgery. In some cases, an increase in pain may even occur, and chronic pain may make treatment more difficult. A component of chronic pain is neuropathic pain, and its specific evaluation and treatment is important. Low back pain and radicular pain in the lower extremities are the main symptoms of failed back surgery syndrome (also called persistent spinal pain syndrome in new terminology).
There are many methods for treatment of failed back surgery syndrome, such as analgesic medications, physical therapy, interventional pain treatment applications, and re-surgery options. Epidural pulsed radiofrequency therapy has recently become popular among interventional pain management procedures, and studies on its effectiveness are increasing. However, studies with a multifaceted approach that also evaluate neuropathic pain are lacking in the literature. In this study, it was planned to investigate the effect of epidural pulsed radiofrequency therapy on pain palliation, including neuropathic pain, in patients diagnosed with failed back surgery syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being between the ages of 18-80
- •History of at least one operation due to lumbar disc herniation
- •Having radicular pain radiating to the lower extremities
排除标准
- •Having undergone surgery for an etiology other than lumbar disc herniation
- •Accompanying spinal stenosis and spondylolisthesis
- •Presence of fracture, infection, coagulopathy and pregnancy
- •Mental disorders that may negatively affect cooperation during assessments.
结局指标
主要结局
Change in pain severity score
时间窗: A single point in time (post-procedural 12.month)
Pain severity is evaluated by using Numerical Rating Scale (NRS). In evaluation, the patient scores the pain intensity between 0 (no pain) and 10 (worst pain). It is easy to apply and takes a short time.
Change in the number of patients with neuropathic pain
时间窗: A single point in time (post-procedural 12.month)
The presence of neuropathic pain is assessed by Doleur Neuropathique-4 (DN-4) Questionnaire. It consists of two parts, including a physician examination part and a neuropathic pain related findings part in which the patients are questioned. A score above 4 indicates the presence of neuropathic pain.
次要结局
未报告次要终点
研究者
Burak Erken
Dr.
Başakşehir Çam & Sakura City Hospital