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

Primary Purpose

Ultrasound Guided Injection

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound guidance
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ultrasound Guided Injection focused on measuring Tenosynovitis, ultrasound, diabetes mellitus

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Al-Azhar university hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group 1

Group 2

Arm Description

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.

Outcomes

Primary Outcome Measures

change in Tenosynovitis pain
changes in VAS scale for pain,
change in Tenosynovitis tenderness
changes in Richie index for tenderness.
changes in ultrasound images of the Tenoasynovitis.
changes in Gery scale images, and power Doppler images of the tendons

Secondary Outcome Measures

Full Information

First Posted
December 24, 2018
Last Updated
June 10, 2019
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT03789526
Brief Title
Ultrasound-guided Intervention and Hand Tenosynovitis in Patients With Diabetes Mellitus
Official Title
Ultrasound-guided Intervention and Hand Tenosynovitis in Patients With Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
December 11, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
February 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ultrasound Guided Injection
Keywords
Tenosynovitis, ultrasound, diabetes mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Group one: 26 patients DM patients with tenosynovitis were injected by triamcinolone under ultrasound guidance.
Arm Title
Group 2
Arm Type
No Intervention
Arm Description
Group two: 26 patients DM patients with tenosynovitis were injected by triamcinolone under clinical guidance.
Intervention Type
Procedure
Intervention Name(s)
ultrasound guidance
Intervention Description
ultrasound guidance of tendon injection
Primary Outcome Measure Information:
Title
change in Tenosynovitis pain
Description
changes in VAS scale for pain,
Time Frame
one month
Title
change in Tenosynovitis tenderness
Description
changes in Richie index for tenderness.
Time Frame
one month
Title
changes in ultrasound images of the Tenoasynovitis.
Description
changes in Gery scale images, and power Doppler images of the tendons
Time Frame
one month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Al-Azhar university hospitals
City
Cairo
ZIP/Postal Code
11311
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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