Back to resultsDiagnostic Value of Hand Ultrasound Versus MRI in Rheumatoid Arthritis
Primary Purpose
Patient's With Rheumatoid Arthritis
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasound and MRI
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.
- Patient's with implanted metal clips or wires or artificial pacemaker.
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 and MRI in Rheumatoid Arthritis of the hand
determine the diagnostic value and associated weakness and strength aspects of hand ultrasound versus MRI in patients with rheumatoid arthritis, particularly in early disease.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04961853
Brief Title
Diagnostic Value of Hand Ultrasound Versus MRI in Rheumatoid Arthritis
Official Title
Diagnostic Value of Hand Ultrasound Versus MRI in Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2021 (Anticipated)
Primary Completion Date
November 1, 2021 (Anticipated)
Study Completion Date
November 1, 2021 (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 and MRI
Intervention Description
Ultrasound examination and magnetic resonance imaging on the hand
Primary Outcome Measure Information:
Title
Diagnostic performance of Ultrasound and MRI in Rheumatoid Arthritis of the hand
Description
determine the diagnostic value and associated weakness and strength aspects of hand ultrasound versus MRI in patients with rheumatoid arthritis, particularly in early disease.
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.
Patient's with implanted metal clips or wires or artificial pacemaker.
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
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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
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PubMed Identifier
18045811
Citation
Hodgson RJ, O'Connor P, Moots R. MRI of rheumatoid arthritis image quantitation for the assessment of disease activity, progression and response to therapy. Rheumatology (Oxford). 2008 Jan;47(1):13-21. doi: 10.1093/rheumatology/kem250. Epub 2007 Nov 28.
Results Reference
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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
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Learn more about this trial
Diagnostic Value of Hand Ultrasound Versus MRI in Rheumatoid Arthritis
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