NCT03789526

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 11, 2018

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 24, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 28, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

June 11, 2019

Status Verified

June 1, 2019

Enrollment Period

2 months

First QC Date

December 24, 2018

Last Update Submit

June 10, 2019

Conditions

Ultrasound Guided Injection

Keywords

Tenosynovitisultrasounddiabetes mellitus

Outcome Measures

Primary Outcomes (3)

  • change in Tenosynovitis pain

    changes in VAS scale for pain,

    one month

  • change in Tenosynovitis tenderness

    changes in Richie index for tenderness.

    one month

  • changes in ultrasound images of the Tenoasynovitis.

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

    one month

Study Arms (2)

Group 1

EXPERIMENTAL

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

Procedure: ultrasound guidance

Group 2

NO INTERVENTION

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

Interventions

ultrasound guidancePROCEDURE

ultrasound guidance of tendon injection

Group 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar university hospitals

Cairo, 11311, Egypt

Location

MeSH Terms

Conditions

TenosynovitisDiabetes Mellitus

Condition Hierarchy (Ancestors)

TendinopathyMuscular DiseasesMusculoskeletal DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: * 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor of Rheumatology

Study Record Dates

First Submitted

December 24, 2018

First Posted

December 28, 2018

Study Start

December 11, 2018

Primary Completion

January 31, 2019

Study Completion

February 1, 2019

Last Updated

June 11, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)