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CompletedNCT03789526Updated Jun 11, 2019

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

An interventional study of ultrasound guidance in Ultrasound Guided Injection, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2019-06-11.

Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Ultrasound Guided Injection

Keywords

  • Tenosynovitis
  • ultrasound
  • diabetes mellitus
03

In context

Tenosynovitis

17 studies on the registry are indexed under Tenosynovitis; 4 are open to participants now.

This study's enrollment of 52 is close to the median of 52 across 13 interventional studies indexed under Tenosynovitis.

Browse Tenosynovitis studies →

Lead sponsor

Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    • Diabetes mellitus.

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

Exclusion criteria

Exclusion Criteria:

    • Patients with recent hand trauma.

      • Patients with inflammatory hand arthritis.
      • Previous tendon surgery.
      • Previous tendon injection.
      • Patients with for injection as related infection, uncontrolled DM or bleeding tendency.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    Group 1

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

    Procedure: ultrasound guidance

  • No intervention
    Group 2

    Group two: 26 patients DM patients with tenosynovitis were injected by triamcinolone under clinical guidance.

Interventions

  • Procedureultrasound guidance

    ultrasound guidance of tendon injection

06

What researchers measure

Primary outcomes

  1. change in Tenosynovitis pain

    changes in VAS scale for pain,

    Time frame: one month

  2. change in Tenosynovitis tenderness

    changes in Richie index for tenderness.

    Time frame: one month

  3. changes in ultrasound images of the Tenoasynovitis.

    changes in Gery scale images, and power Doppler images of the tendons

    Time frame: one month

07

Study locations

1 site
  • Al-Azhar university hospitals
    Cairo, 11311, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2018 to primary completion in Jan 2019, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 24, 2018
First posted
Dec 28, 2018
StartActual
Dec 11, 2018
Primary completionActual
Jan 31, 2019
CompletionActual
Feb 1, 2019
Last update
Jun 11, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03789526
Responsible party
Ahmed Abogamal (clinical professor of Rheumatology, Al-Azhar University) — Principal investigator
First posted
Dec 28, 2018
Start date
Dec 11, 2018
Primary completion
Jan 31, 2019
Completion
Feb 1, 2019
Last update
Jun 11, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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