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

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ClinicalTrials.gov Identifier: NCT03789526
Recruitment Status : Completed
First Posted : December 28, 2018
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Abogamal, Al-Azhar University

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

Condition or disease Intervention/treatment Phase
Ultrasound Guided Injection Procedure: ultrasound guidance Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Ultrasound-guided Intervention and Hand Tenosynovitis in Patients With Diabetes Mellitus
Actual Study Start Date : December 11, 2018
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Group 1
  • Group one: 26 patients DM patients with tenosynovitis were injected by triamcinolone under ultrasound guidance.
Procedure: ultrasound guidance
ultrasound guidance of tendon injection

No Intervention: Group 2
Group two: 26 patients DM patients with tenosynovitis were injected by triamcinolone under clinical guidance.



Primary Outcome Measures :
  1. change in Tenosynovitis pain [ Time Frame: one month ]
    changes in VAS scale for pain,

  2. change in Tenosynovitis tenderness [ Time Frame: one month ]
    changes in Richie index for tenderness.

  3. changes in ultrasound images of the Tenoasynovitis. [ Time Frame: one month ]
    changes in Gery scale images, and power Doppler images of the tendons



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789526


Locations
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Egypt
Al-Azhar university hospitals
Cairo, Egypt, 11311
Sponsors and Collaborators
Al-Azhar University

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Responsible Party: Ahmed Abogamal, clinical professor of Rheumatology, Al-Azhar University
ClinicalTrials.gov Identifier: NCT03789526     History of Changes
Other Study ID Numbers: REC-AFMG 2018/6
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed Abogamal, Al-Azhar University:
Tenosynovitis
ultrasound
diabetes mellitus
Additional relevant MeSH terms:
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Tenosynovitis
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases