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

June 10, 2019 updated by: Ahmed Abogamal, Al-Azhar University
Evaluates the efficacy of ultrasound guided versus clinically guided steroid injection in the management of tenosynovitis in DM patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11311
        • Al-Azhar University hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
  • Group one: 26 patients DM patients with tenosynovitis were injected by triamcinolone under ultrasound guidance.
Procedure: ultrasound guidance
ultrasound guidance of tendon injection
No Intervention: Group 2
Group two: 26 patients DM patients with tenosynovitis were injected by triamcinolone under clinical guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in Tenosynovitis pain
Time Frame: one month
changes in VAS scale for pain,
one month
change in Tenosynovitis tenderness
Time Frame: one month
changes in Richie index for tenderness.
one month
changes in ultrasound images of the Tenoasynovitis.
Time Frame: one month
changes in Gery scale images, and power Doppler images of the tendons
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2018

Primary Completion (Actual)

January 31, 2019

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

December 24, 2018

First Submitted That Met QC Criteria

December 26, 2018

First Posted (Actual)

December 28, 2018

Study Record Updates

Last Update Posted (Actual)

June 11, 2019

Last Update Submitted That Met QC Criteria

June 10, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC-AFMG 2018/6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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