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

Ultrasound Guided Injection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03789526
• Other study ID #: REC-AFMG 2018/6
• Status: Completed
• Phase: N/A
• Start date: December 11, 2018
• Est. completion date: February 1, 2019

Study information

• Verified date: June 2019
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 1, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Tenosynovitis
• Ultrasound Guided Injection

Intervention

Procedure:
• ultrasound guidance
ultrasound guidance of tendon injection

Locations

Country	Name	City	State
Egypt	Al-Azhar university hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Tenosynovitis pain	changes in VAS scale for pain,	one month
Primary	change in Tenosynovitis tenderness	changes in Richie index for tenderness.	one month
Primary	changes in ultrasound images of the Tenoasynovitis.	changes in Gery scale images, and power Doppler images of the tendons	one month