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

Study Overview
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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.

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

Conditions
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Ultrasound Guided Injection

Intervention / Treatment
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* Procedure: ultrasound guidance


Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tenosynovitis, ultrasound, diabetes mellitus