Comparison of the Treatment Outcomes of the Facet Intra-articular Pulsed Radiofrequency and Median Branch Pulsed Radiofrequency Interventions in Lumbar Facet-related Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Change of the pain severity score
研究概览
简要总结
Facet joint-related pain is one of the leading causes of low back pain. Facet joint-related disorders can have a negative impact on quality of life and daily living activities, in addition to the pain.Conservative treatment methods such as analgesic medications, physical therapy, and manual therapy are used for facet joint-related low back pain, and interventional pain management practices are used in patients who do not respond adequately to these treatments.
Pulse radiofrequency application, which is a recent popular treatment in interventional pain management, is also frequently applied in the treatment of facet-joint related pain. Pulsed radiofrequency intervention can be applied directly intra-articularly or can be applied to the median branch, which is important structure in pain transmission. Although both methods are frequently used in pain management, there is a lack of information in the literature about which is more effective. This study aimed to compare the treatment results of intraarticular pulse radiofrequency application and median branch pulse radiofrequency application in facet joint-related 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
- Double (Participant, Outcomes Assessor)
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
- 否
入选标准
- •Having facet joint-related low back pain at least 3 months
- •No response to other conservative treatments (analgesic medications, physical therapy, manuel therapy etc.)
- •Patients with a pain severity score of at least 6 according to NRS
排除标准
- •History of lumbar region surgery
- •Patients with bleeding disorders
- •Presence of pregnancy and breastfeeding status
- •Presence of the infection related findings and any other systemic disorder
- •History of allergic reaction to contrast agent
- •Patients who do not have sufficient mental function to fill out the scales during the follow-up periods
结局指标
主要结局
Change of the pain severity score
时间窗: Pre-intervention, post-intervention 1th month and post-intervention 6th month
Pain severity is assessed by using "Numeric Rating Scale" (NRS). Patients give score of their pain between 0 (no pain) and 10 (worst possible pain). The change in NRS scores between the two groups will be compared.
次要结局
- Change of the disability score(Pre-intervention, post-intervention 1th month and post-intervention 6th month)