Skip to main content
OpenTrials
Completed

NCT Number: NCT03789526

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ultrasound Guided Injection Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Muscular Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Tendinopathy Tenosynovitis

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar university hospitals

Cairo, 11311, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • • 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.

Treatment and study plan

Ultrasound guidance

Procedure

ultrasound guidance of tendon injection

Primary outcomes

  1. change in Tenosynovitis pain

    Time frame: one month

    changes in VAS scale for pain,

  2. change in Tenosynovitis tenderness

    Time frame: one month

    changes in Richie index for tenderness.

  3. changes in ultrasound images of the Tenoasynovitis.

    Time frame: one month

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

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 28, 2018
Registry last updated
Jun 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.