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临床试验/NCT04314609
NCT04314609已完成不适用

The Success Rate of Ultrasound Guided Sacroiliac Joint Steroid Injections in Sacroiliitis: Are we Getting Better

Karim Alaaeldin Tawfik2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2019年10月1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
34
试验地点
2
主要终点
success rate of ultrasound sacroiliac joint injection

研究概览

简要总结

To re-investigate the success rate of Ultrasound guided sacroiliac joint steroid injection in depositing the drug inside the joint capsule (confirmed by contrast spread in fluoroscopy) and if there is a difference in clinical outcome between injections done strictly inside the joint and injections done periarticular.

详细描述

An IV cannula will be inserted, and basic ASA monitors applied, then the patients will be positioned in prone position. After disinfection of the skin, Ultra sonography will be used to Guide Needle Placement in SIJ (the hypoechoic cleft between the surface of the sacrum and the ilium) under complete a sepsis as the technique previously described in the literature.

A low frequency (2-5 Hz) curvilinear transducer will be used in a sterile cover, the posterior superior iliac spine, lateral borderof sacrum, and ilium will be identified in transverse orientation. Subsequently, the probe will be moved caudally until the superior part of the posterior SIJ is identified. The SIJ will be traced caudally until the distal third of the SIJ is visualized as evident by the flat contour of the iliac crest and the presence of the second sacral foramen on the medial aspect of the sacrum.

After local anesthetic infiltration of skin and subcutaneous tissues using Lidocaine 1%, a 21-gauge spinal needle will be advanced from a medial to lateral direction using an in-plane technique. After reaching the joint, a total volume of 4 ml of injectate will be injected which consists of: 1 ml 40 mg of methylprednisoloneacetate (Depo-Medrol®, Pfizer), 2 ml Lidocaine 2%, 1 ml Iohexol (Omnipaque 300®, GE Healthcare).

Control fluoroscopy

After injection of the drug and withdrawal of the needle, a antero-posterior fluoroscopy image will be obtained and recorded for the injected joint to detect the spread pattern of the contrast and whether its pre-dominantly intra or periarticular. (N.B: Periarticular injection is any injection done near the joint as evidenced by US but on fluoroscopy no contrast is detected inside the joint). Then a sterile patch will be applied to the puncture site and patient discharged to the recovery room for follow-up for 30 minutes before discharge to home.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject has sacroiliitis (acute or chronic) by history.
  • Failed conservative therapy eg. bed rest, anti-inflammatory medications and physical therapy for at least 6 weeks.

排除标准

  • Subject has BMI above 35 kg/m2
  • Coagulopathy.
  • Renal or Hepatic Failure.
  • Current Pregnancy or actively pursuing pregnancy.
  • Known allergy to local anesthetic or steroids.
  • Infection at site of needle placement or SIJ infection.
  • Prior surgical procedures involving the SIJ.
  • Previous surgical Fixation involving the lumbar spine.

结局指标

主要结局

success rate of ultrasound sacroiliac joint injection

时间窗: Immediately after injection

Percent of successful intraarticular drug injections during USG SIJ steroid injection (as confirmed by contrast spread in fluoroscopy)

次要结局

  • Difference in clinical outcome between intraarticular and periarticular injections.(After 10 minutes, 1 week and 1 month)
  • Clinical improvement(After 10 minutes, 1 week ,1 month)

研究者

发起方
Karim Alaaeldin Tawfik
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Karim Alaaeldin Tawfik

Doctor

Cairo University

研究点 (2)

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