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

NCT ID: NCT03789526

Last Updated: 2019-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-11

Study Completion Date

2019-02-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Ultrasound Guided Injection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

* 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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

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

Group Type EXPERIMENTAL

ultrasound guidance

Intervention Type PROCEDURE

ultrasound guidance of tendon injection

Group 2

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ultrasound guidance

ultrasound guidance of tendon injection

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Abogamal

clinical professor of Rheumatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al-Azhar university hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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REC-AFMG 2018/6

Identifier Type: -

Identifier Source: org_study_id

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