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临床试验/NCT03789526
NCT03789526已完成不适用

Ultrasound-guided Intervention and Hand Tenosynovitis in Patients With Diabetes Mellitus

Al-Azhar University2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2018年12月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
2
主要终点
change in Tenosynovitis pain

研究概览

简要总结

Evaluates the efficacy of ultrasound guided versus clinically guided steroid injection in the management of tenosynovitis in DM patients.

详细描述

The current study will based on follow up study, conducted among patients presenting at outpatient rheumatology clinics of Al-Azhar University Hospitals, Egypt. with Diabetes mellitus duration at least 3 years and tenosynovitis of hand tendons with Richie tenderness grade 3.

All patients will randomized in two groups: Group one: 26 patients DM patients with tenosynovitis were injected by triamcinolone under ultrasound guidance. Group two: 26 patients DM patients with tenosynovitis were injected by triamcinolone under clinical guidance.

The affected tendons will scanned and scored for inflammation using ultrasound in all patients before the triamcinolone injection and then to be reassessed one month after the injection to determine the change in the tendons in both groups.

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

性别
All
接受健康志愿者

入选标准

  • • Diabetes mellitus.
  • Disease duration 3 years or more.
  • Tenosynovitis of hand tendons with Richie tenderness grade 3.

排除标准

  • • Patients with recent hand trauma.
  • Patients with inflammatory hand arthritis.
  • Previous tendon surgery.
  • Previous tendon injection.
  • Patients with contraindication for injection as related infection, uncontrolled DM or bleeding tendency.

研究组 & 干预措施

Group 1

Experimental
  • Group one: 26 patients DM patients with tenosynovitis were injected by triamcinolone under ultrasound guidance.

干预措施: ultrasound guidance (Procedure)

Group 2

No Intervention

Group two: 26 patients DM patients with tenosynovitis were injected by triamcinolone under clinical guidance.

结局指标

主要结局

change in Tenosynovitis pain

时间窗: one month

changes in VAS scale for pain,

changes in ultrasound images of the Tenoasynovitis.

时间窗: one month

changes in Gery scale images, and power Doppler images of the tendons

change in Tenosynovitis tenderness

时间窗: one month

changes in Richie index for tenderness.

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 Abogamal

clinical professor of Rheumatology

Al-Azhar University

研究点 (2)

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