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临床试验/NCT04326699
NCT04326699已完成不适用

Therapeutic Potentials of Bilateral Sacroiliac Joint Injection in Lumbar Disc Prolapse: a Prospective Study

Sohag University2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2020年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
2
主要终点
Pain assessment by visual analogue scale.

研究概览

简要总结

Bilateral sacroiliac joint injection in symptomatic lumbar disc prolapse under ultrasound guidance and studying the effect of this technique on pain, spine mobility and activity of daily living.

详细描述

86 Patients with lumbar disc prolapse diagnosed by either MRI or CT will be included. All of them aged > 18 years with no special condition for the duration of disc prolapse. All of them had clinical manifestations in the form of mechanical low back pain or sciatica or limited spine mobility. All participants had no or poor response to conservative treatment. Previous surgery, severe facet arthropathy, ankylosing spondylitis, sensory or motor deficit and wedge fracture were considered as exclusion criteria. Distraction, compression, thigh thrust, and sacral thrust were used to assess SIJ dysfunction only at baseline before injection. Fingertip to floor and Oswestry disability index (ODI) were used to assess mobility and function of the spine at baseline (before and after injection) and after 2 and 16 weeks. Visual Analogue Scale (VAS) was used for pain appraisal at the same intervals. Participants will be randomly assigned into active and control group using 1:1 allocation. In the active group bilateral SIJ injection will be performed under ultrasound US guidance. Under US guidance a 22G spinal needle, where 1 mL 2 % lidocaine hydrochloride (xylocaine, AstraZeneca) mixed with triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) will be injected in each SIJ.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

入选标准

  • Lumbar disc prolapse diagnosed by either MRI or CT were included.
  • All of them aged > 18 years
  • No special condition for the duration of disc prolapse.
  • All of them had clinical manifestations in the form of mechanical low back pain or sciatica or limited spine mobility.
  • All participants had no or poor response to conservative treatment

排除标准

  • Previous surgery
  • Severe facet arthropathy
  • Ankylosing spondylitis
  • Sensory or motor deficit
  • Wedge fracture

结局指标

主要结局

Pain assessment by visual analogue scale.

时间窗: at baseline 0 time, after 2 weeks and after 16 weeks

Visual analogue scale, 0 means no pain and 10 means the maximum possible pain.

Spine mobility, finger tip to floor test

时间窗: Baseline 0 time, after 2 weeks and after 16 weeks

comparison to the intial values with each visit to detect changes with no definite references.

Oswestry disability index

时间窗: Baseline 0 time, after 2 weeks and after 16 weeks

0 value means no disability and 100 means complete disability

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mahrous

Associate professor

Sohag University

研究点 (2)

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