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

Sponsor

Al-Azhar University (Other)

Overall Status

Completed

CT.gov ID

NCT03789526

Collaborator

(none)

Enrollment

Location

Arms

1.7

Actual Duration (Months)

30.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ultrasound Guided Injection	Procedure: ultrasound guidance	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 11, 2018

Actual Primary Completion Date :

Jan 31, 2019

Actual Study Completion Date :

Feb 1, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Al-Azhar university hospitals	Cairo		Egypt	11311

Sponsors and Collaborators

Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Abogamal, clinical professor of Rheumatology, Al-Azhar University

ClinicalTrials.gov Identifier:

NCT03789526

Other Study ID Numbers:

REC-AFMG 2018/6

First Posted:

Dec 28, 2018

Last Update Posted:

Jun 11, 2019

Last Verified:

Jun 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ahmed Abogamal, clinical professor of Rheumatology, Al-Azhar University

Tenosynovitis

ultrasound

diabetes mellitus

Additional relevant MeSH terms:

Tenosynovitis

Diabetes Mellitus

Study Results

No Results Posted as of Jun 11, 2019