Comparison Between Traditional Bipolar Radiofrequency and Cooled Radiofrequency in Sacroiliac Joint Pain Patients Prospective Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- • Pain intensity measured by Visual Analog Scale (VAS) .
研究概览
简要总结
Sacroiliac joint pain is contributor to chronic low back pain, accounting for 15-30% of cases. It is a synovial and syndesmotic articulation plays a role in load transfer between spine and lower extremities. Its limited mobility, strong ligaments makes it susceptible to pain generation in cases of inflammation and degeneration.
The innervation of the SIJ is derived from the dorsal sacral rami (S1-S3), with contributions from L4-L5 dorsal rami. This explains the variability in pain distribution. Patients present with low back pain that may radiate to buttock, groin, or posterior thigh.
The diagnosis of SIJ pain relies on diagnostic blocks. At least 70-75% pain relief following intra-articular injection . However, diagnostic blocks have limitations, including false-positive rates and variability in technique .
Management for SIJ pain include conservative, interventional, and surgical approaches. Conservative treatment consists of physical therapy, NSAIDs, and activity modification.While a significant proportion progress to interventional therapies due to persistent pain .
RFA is as an effective minimally invasive treatment. Monopolar RFA was initially used; however, its efficacy was limited by small lesion size and anatomical variability .
Bipolar radiofrequency were developed, allowing the creation of larger and continuous lesions. This has been associated with improved outcomes .
Cooled radiofrequency represents an advancement in RFA . By internally cooling the electrode, CRF prevents tissue charring allowing for greater energy delivery, resulting larger lesions.
Randomized controlled trials demonstrated that CRF provides significant pain relief at 6 and 12 months .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-70 years
- •Chronic sacroiliac joint pain for ≥ 3 months
- •Pain intensity ≥ 5 on the Visual Analog Scale (VAS)
- •Positive SI joint provocative tests (at least 3 out of 5)
- •≥ 50% pain relief following diagnostic SI joint block
- •Failure of conservative treatment for at least 6 weeks
排除标准
- •Coagulopathy or anticoagulant therapy not appropriately managed
- •Local or systemic infection
- •Pregnancy
- •Severe psychiatric illness
- •Previous radiofrequency ablation of the SI joint
- •Spinal pathology explaining pain other than SI joint dysfunction
研究组 & 干预措施
Traditional bipolar radiofrequency group
干预措施: Traditional bipolar radiofrequency (Device)
Cooled radiofrequency group
干预措施: Cooled radiofrequency (Device)
结局指标
主要结局
• Pain intensity measured by Visual Analog Scale (VAS) .
时间窗: 6 months
A Visual Analog Scale (VAS) is a psychometric instrument used to measure subjective experiences that cannot be directly quantified (like pain severity, fatigue, or mood). It typically features a 10cm or 100mm horizontal or vertical line with descriptive anchors at each extreme, and respondents indicate their level of feeling by making a mark on the line. Score Interpretation (e.g., for Pain): 0 to 4 mm: No pain 5 to 44 mm: Mild pain 45 to 74 mm: Moderate pain 75 to 100 mm: Severe pain
次要结局
- •Functional disability using Oswestry Disability Index (ODI)(6 months)
- • Quality of life using 36 item short form health survey (SF-36) questionnaire(6 months)
研究者
Osama Khaled Ahmed Abodeef
Dr Osama Khaled Ahmed Abodeef
Assiut University