A Prospective Randomized Comparison of Fluoroscopy and Ultrasound Guidance for Sacral Lateral Branch Radiofrequency Ablation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in pain numerical rating score from baseline
研究概览
简要总结
Sacroiliac joint is a diarthroidal and synovial joint that receives sensory innervatin by the sacral lateral branches ( commonly S1-3, with variable contributions from L5 dorsal ramus and S4 lateral branch). Sacral lateral branch radiofrequency ablation and block techniques are widely used for the management of sacroiliac joint pain. With the increasing use of ultrasound technology in pain medicine, the ultrasound guided approaches gained popularity. To our knowledge, there are no randomized controlled trials comparing the ultrasound and fluoroscopy approaches for sacral lateral branch radiofrequency ablation. This study aims to compare the ultrasound and fluoroscopy guidance techniques for sacral lateral branch radiofrequency ablation.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low back pain due to sacroiliac joint dysfunction >6 months with a score ≥ 4 on a numeric rating scale.
- •50% pain relief after prognostic sacral lateral branch block
- •At least 3 positive physical examination maneuvers [ Faber ( flexioni abduction and external rotation), POSH (posteripr shear), REAB ( resisted abduction), Gaenslen's test, Distraction test]
- •Refractory to conservative therapy
排除标准
- •The exclusion criteria were;
- •Uncontrolled psychiatric or neurological illness
- •Sacroiliac joint pain due to other disorders,
- •Lumbar radiculopathy
- •Rheumatological diseases
- •Systemic active infections
- •Malignancies, previous surgery on the affected sacroiliac joint,
- •History of traumatic hip injury,
- •History of bleeding disorders,
- •Platelet values < 150.000 / µl,
- •Sacroiliac joint injection within the preceding 3 months,
- •Allergy to local anesthetics and steroids,
- •Pregnancy, inability to concent, Implanted pacemaker or defibrilator.
结局指标
主要结局
Change in pain numerical rating score from baseline
时间窗: 3 months
The numerical rating score (NRS) will be used to assess the severity of pain felt by a patient. . The patient rates pain on a scale of 0 to 10; 0 represents 'no pain' and 10 ,represents 'worst pain imaginable'
次要结局
- Performance time(During the procedure)
- Patient satisfaction(At 3 months)
- Pain medication use(At 3 months)
- Success rate(At 3 months)
- Functional disability(At 1 and 3 months)
- Quality of life ( SF-36)(At 1 and 3 months)
- The number of needle passess(During the procedure)
研究者
Halil Cihan Kose
Principle Investigator
Diskapi Teaching and Research Hospital