NCT04446988已完成不适用
Ultrasound Versus Fluoroscopic Guided Sacroiliac Joint Injection In Patients With Chronic Sacroiliac Joint Pain
Minia University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年10月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Numeric Rating Scale (NRS) pain scores
研究概览
简要总结
Sacroiliac joint injection in sacroiliitis
详细描述
Comparison of ultrasound guided and fluoroscopic guided sacroiliac joint injection
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of sacroiliitis.
- •At least 3 positive physical examination maneuvers [FABER (flexion, abduction, and external rotation), POSH (posterior shear), REAB (resisted abduction), Fortin's finger test],
- •Moderate to severe pain (NRS pain score ≥ 3/10) refractory to oral anti-inflammatory.
- •Age from 18ys to 60ys.
排除标准
- •Ages less than 18 or more than 85 years.
- •Body Mass Index (BMI) above 35 kg/m
- •A diagnosis of severe anxiety or depression and other psychological disorders.
- •Allergy to local anesthetics or steroids and pregnancy.
- •Multiple comorbidities (renal , hepatic, cardiac).
- •Coagulation disorder as bleeding tendency and platelet dysfunction.
- •Contraindication for prone position or radiological exposure.
- •Patient refuse .
- •Pain suggestive of bilateral sacroiliac joint involvement (it would have been difficult to assess pain and disability secondary to each SIJ).
结局指标
主要结局
Numeric Rating Scale (NRS) pain scores
时间窗: 3 months
It measures pain intensity (0 no pain - 10 worst pain imaginable)
Oswestry disability index score
时间窗: 1 month
It evaluates the physical function (0% minimal disability - 100% bed - bound patient)
次要结局
- Procedure time(Procedure)
- Analgesic requirement(1 month)
- Patient satisfaction ( global perceived effect on a 7-point scale (GPE) )(3 months)
研究者
DR. Abd El-Raheem Mahmoud
Clinical Professor
Minia University
研究点 (2)
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