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

Not Applicable

Completed

• Conditions: Ultrasound Guided Injection
• Interventions: Procedure: ultrasound guidance

• Registration Number: NCT03789526
• Lead Sponsor: Al-Azhar University

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.

Study Timeline

• Study Start: 2018-12-11
• Study First Submitted: 2018-12-24
• Study First Submitted QC: 2018-12-26
• Study First Posted: 2018-12-28
• Primary Completion: 2019-01-31
• Study Completion: 2019-02-01
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-10
• Last Update Posted: 2019-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• • Diabetes mellitus.

  • Disease duration 3 years or more.
  • Tenosynovitis of hand tendons with Richie tenderness grade 3.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	ultrasound guidance	* Group one: 26 patients DM patients with tenosynovitis were injected by triamcinolone under ultrasound guidance.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Al-Azhar university hospitals; 🇪🇬 Cairo, Egypt