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

NCT03789526 — Not applicable, Completed, 52 participants, Al-Azhar University

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Registry	NCT03789526
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	52 (Actual)
Sponsor	Al-Azhar University (Other)
Conditions	Ultrasound Guided Injection
Interventions	ultrasound guidance (Procedure)
Dates	start 2018-12-11, primary completion 2019-01-31, completion 2019-02-01, first posted 2018-12-28, last updated 2019-06-11
Locations	1 site in Egypt

-Summary

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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Group 1	Experimental	Procedure: ultrasound guidance	* Group one: 26 patients DM patients with tenosynovitis were injected by triamcinolone under ultrasound guidance.
Group 2	No intervention		Group two: 26 patients DM patients with tenosynovitis were injected by triamcinolone under clinical guidance.

ultrasound guidance (Procedure): ultrasound guidance of tendon injection

+Outcome measures

Primary outcomes

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

Sex: All

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.

+Locations (1)

Facility	City	Country	Status
Al-Azhar university hospitals	Cairo	Egypt