Prospective Study Evaluating Cryoablation and Endoscopic Denervation of the Dorsal Sacroiliac Joint Innervation (Ramus Dorsalis L5 and S1-S3) in Patients With Sacroiliac Joint Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Pain intensity measured by Numeric Rating Scale (NRS)
研究概览
简要总结
This interventional study compares cryoablation and endoscopic denervation for the treatment of posterior sacroiliac joint pain in patients with chronic sacroiliac joint pain confirmed by a positive diagnostic block. The aim is to evaluate and compare the effectiveness of both procedures in reducing pain and improving functional status.
详细描述
Posterior sacroiliac joint pain is a common cause of chronic low back pain and may substantially impair daily functioning and quality of life. In patients with a positive diagnostic block confirming the sacroiliac joint as the source of pain, interventional procedures targeting the dorsal branches of L5 and S1-S3 may provide pain relief.
This study compares two interventional treatment methods: cryoablation and endoscopic denervation. Patients with confirmed posterior sacroiliac joint pain undergo one of these procedures after diagnostic confirmation of the pain source. Cryoablation is performed on the dorsal branches of L5 and S1-S3. Endoscopic denervation is performed on the same target nerves using an endoscopic approach.
The study evaluates the comparative effectiveness of these procedures in terms of pain reduction and functional improvement over follow-up. The findings may help clarify the role of these two techniques in the management of chronic posterior sacroiliac joint pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This was an open-label study. Neither participants nor investigators were masked to the performed intervention.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults aged 18 years or older
- •chronic sacroiliac joint pain
- •positive sacroiliac joint provocation maneuvers
- •positive diagnostic block of the dorsal branches of L5 and S1-S3 under fluoroscopic guidance
- •at least 70% pain relief after diagnostic block
- •ability to understand the study procedures and provide written informed consent
排除标准
- •radicular pain caused by lumbar disc herniation or other dominant spinal pathology
- •spinal tumor, infection, fracture, or inflammatory spinal disease
- •coagulation disorder or ongoing anticoagulant therapy contraindicating the procedure
- •pregnancy
- •severe psychiatric or medical condition preventing reliable follow-up
- •refusal to participate in the study
结局指标
主要结局
Pain intensity measured by Numeric Rating Scale (NRS)
时间窗: Baseline and 12 months follow-up
Change in pain intensity measured using an 11-point Numeric Rating Scale (0 = no pain, 10 = worst imaginable pain).
Functional disability measured by Oswestry Disability Index (ODI)
时间窗: Baseline and 12 months follow-up
Change in functional disability assessed using the Oswestry Disability Index (0-100%, higher scores indicate greater disability).
次要结局
- Change From Baseline EuroQol-5 Dimension (EQ-5D-5L) at 12 Months(Baseline and 12 months follow-up)
- Procedure-Related Complications(From procedure up to 24 months follow-up)
- Analgesic consumption measured as daily dose (mg/day)(Baseline and 12 months follow-up)