Back to resultsDiagnostic Value of Hand Ultrasound in Assessment of Rheumatoid Arthritis
Primary Purpose
Patient's With Rheumatoid Arthritis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Patient's With Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Adult-onset disease.
- Patients who fulfill the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis.
Exclusion Criteria:
- Any patient with any collagen disease rather than Rheumatoid arthritis.
- Patients with joints deformities.
Sites / Locations
- Sohag University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cases
Arm Description
Outcomes
Primary Outcome Measures
Diagnostic performance of Ultrasound in Rheumatoid Arthritis of the hand
detecting hand ultrasound findings in 30 patients with clinical manifestations suggesting Rheumatoid Arthritis (including synovial thickening, joint effusion, tenosynovitis, bone erosions) particularly in early disease activity, reporting the collected data to assess aspects of strength and weakness of ultrasound use in those patients
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05158400
Brief Title
Diagnostic Value of Hand Ultrasound in Assessment of Rheumatoid Arthritis
Official Title
Diagnostic Value of Hand Ultrasound in Assessment of Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 15, 2021 (Anticipated)
Primary Completion Date
March 15, 2022 (Anticipated)
Study Completion Date
March 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Rheumatoid arthritis (RA) is one of the most common autoimmune rheumatic diseases, affecting one in 100 individuals worldwide. It is considered a complex systemic multifactorial inflammatory process in which the immune system targets synovial joints and causes mild to severe joint destruction with extra-articular manifestations.
If left untreated, RA leads to deformity, considerable disability, and major comorbid conditions, including cardiovascular disease and increased mortality.
Early treatment with targeted therapies can alter long-term outcomes by minimizing disease activity, preventing joint damage and disability, and improving patients' quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient's With Rheumatoid Arthritis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cases
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Ultrasound
Intervention Description
Ultrasound examination on the hand
Primary Outcome Measure Information:
Title
Diagnostic performance of Ultrasound in Rheumatoid Arthritis of the hand
Description
detecting hand ultrasound findings in 30 patients with clinical manifestations suggesting Rheumatoid Arthritis (including synovial thickening, joint effusion, tenosynovitis, bone erosions) particularly in early disease activity, reporting the collected data to assess aspects of strength and weakness of ultrasound use in those patients
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult-onset disease.
Patients who fulfill the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis.
Exclusion Criteria:
Any patient with any collagen disease rather than Rheumatoid arthritis.
Patients with joints deformities.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fady B A, resident
Phone
01091799614
Email
fady011123@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Nahla M A, assistant professor
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama R ElSherif, dean of the faculty
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31898524
Citation
Kaeley GS, Bakewell C, Deodhar A. The importance of ultrasound in identifying and differentiating patients with early inflammatory arthritis: a narrative review. Arthritis Res Ther. 2020 Jan 2;22(1):1. doi: 10.1186/s13075-019-2050-4.
Results Reference
background
PubMed Identifier
23230093
Citation
Tan YK, Ostergaard M, Conaghan PG. Imaging tools in rheumatoid arthritis: ultrasound vs magnetic resonance imaging. Rheumatology (Oxford). 2012 Dec;51 Suppl 7:vii36-42. doi: 10.1093/rheumatology/kes329.
Results Reference
background
PubMed Identifier
21862794
Citation
Rowbotham EL, Grainger AJ. Rheumatoid arthritis: ultrasound versus MRI. AJR Am J Roentgenol. 2011 Sep;197(3):541-6. doi: 10.2214/ajr.11.6798.
Results Reference
background
Learn more about this trial
Diagnostic Value of Hand Ultrasound in Assessment of Rheumatoid Arthritis
We'll reach out to this number within 24 hrs