Rheumatoid Arthritis (RA)NCT07657156
Musculoskeletal Ultrasound for Differentiating Rheumatoid and Gouty Arthritis
An observational study of Rheumatoid Arthritis (RA) and Gouty Arthritis (GA), run by Assiut University.
Trial summary
Rheumatoid arthritis (RA) and gouty arthritis (GA) are two common forms of joint inflammation that can present with very similar physical symptoms, making them difficult to tell apart early in the disease process. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA), Gouty Arthritis (GA), Gout
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Aug 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: The study population consists of adult patients, aged 18 years or older, of either sex. It includes individuals presenting with clinically suspected or confirmed rheumatoid arthritis or gouty arthritis. These participants are specifically those referred to the radiology department at Assiut University Hospitals in Assiut, Egypt, for a musculoskeletal ultrasound assessment of painful, swollen, or inflamed joints.
Who may be able to join
- Patients aged 18 years or older.
- Either sex.
- Patients with clinically suspected or confirmed rheumatoid arthritis.
- Patients with clinically suspected or confirmed gouty arthritis.
- Patients referred for musculoskeletal ultrasound assessment of painful, swollen, or inflamed joints.
- Patients able and willing to provide informed consent.
- Patients whose final diagnosis is established by clinical assessment, laboratory testing, and/or relevant imaging or synovial fluid analysis when available.
Who cannot join
- Patients younger than 18 years.
- Patients with septic arthritis or suspected joint infection.
- Patients with traumatic joint injury involving the target joint.
- Patients with other inflammatory arthropathies such as psoriatic arthritis, reactive arthritis, or systemic lupus erythematosus if they may confound imaging interpretation.
- Patients with advanced osteoarthritis in the scanned joint if it markedly limits Faculty of Medicine Institutional Review Board (IRB) Assiut Medical School Research Proposal Form 5 interpretation.
- Patients with incomplete clinical records or insufficient ultrasound windows.
- Patients who refuse consent.
- Patients whose diagnosis remains uncertain after clinical workup.
About this study
Official title: Role of Musculoskeletal Ultrasound in Differentiation of Rheumatoid Arthritis and Gouty Arthritis Using Semi-Quantitative Scoring
Rheumatoid arthritis (RA) and gouty arthritis (GA) are two common forms of joint inflammation that can present with very similar physical symptoms, making them difficult to tell apart early in the disease process. Accurate and early differentiation is crucial because the treatment strategies and long-term management for the two conditions are substantially different.
The primary purpose of this observational study is to evaluate the diagnostic performance of musculoskeletal ultrasound (MSUS) in distinguishing between RA and GA. Ultrasound is a safe, radiation-free imaging tool that can visualize joint inflammation and structural changes in real-time. This study utilizes a structured semi-quantitative scoring system (graded on a scale of 0 to 3) to systematically measure the severity of joint lining thickness (synovial hypertrophy) and active blood flow (power Doppler signal). It also checks for crystal-related deposits, such as tophi or the double contour sign, which are highly suggestive of gout.
Participants aged 18 and older with suspected or confirmed RA or GA who are referred for joint assessment at Assiut University Hospitals will undergo a standard clinical evaluation, routine laboratory testing, and an ultrasound examination of specific target joints (such as the wrists, hands, knees, and ankles). By comparing the ultrasound scores and specific structural findings between the two patient groups, the study aims to establish a reliable, standardized imaging approach to help physicians make faster, more confident diagnoses and initiate the correct disease-specific therapies sooner.
- Keywords
- Musculoskeletal Ultrasound, Semi-quantitative Scoring, Ultrasonography, Synovitis, Power Doppler, Double Contour Sign, Tophi, Diagnostic Imaging
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Gouty, Gout, Arthritis, Synovitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid Arthritis Cohort | Patients aged 18 years or older presenting with clinically suspected or confirmed rheumatoid arthritis. Participants undergo standard clinical and laboratory assessment followed by a musculoskeletal ultrasound examination of target joints (including wrists, metacarpophalangeal joints, proximal interphalangeal joints, knees, and ankles). The ultrasound evaluates the presence and severity of gray-scale synovitis, power Doppler vascularity, joint effusion, and bone erosions using a 0-3 semi-quantitative scoring system. | |
| Gouty Arthritis Cohort | Patients aged 18 years or older presenting with clinically suspected or confirmed gouty arthritis. Participants undergo standard clinical and laboratory assessment followed by a musculoskeletal ultrasound examination of target joints, particularly the first metatarsophalangeal joint and other symptomatic areas. The ultrasound applies a semi-quantitative scoring system to evaluate inflammatory changes and specifically targets crystal-related findings, including the double contour sign, tophus formation, hyperechoic aggregates, and erosions with overhanging edges. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semi-quantitative Gray-Scale Synovitis Score
Synovial hypertrophy evaluated using high-resolution musculoskeletal ultrasound, graded on a 0 to 3 scale where 0 indicates no synovial thickening, 1 indicates mild synovial hypertrophy, 2 indicates moderate synovial hypertrophy, and 3 indicates severe synovial hypertrophy.
Measured: Baseline (Single assessment at the time of the cross-sectional ultrasound examination)
Secondary outcomes (5)
Semi-quantitative Power Doppler Synovitis Score
Synovial vascularity evaluated using high-resolution musculoskeletal ultrasound, graded on a 0 to 3 scale where 0 indicates no Doppler signal, 1 indicates a mild signal, 2 indicates a moderate signal, and 3 indicates marked Doppler activity.
Measured: Baseline (Single assessment)
Presence of Double Contour Sign
The frequency of the double contour sign, representing urate crystal deposits on the articular cartilage, detected via musculoskeletal ultrasound in the target joints.
Measured: Baseline (Single assessment)
Presence of Tophi
The frequency of tophus formation, identified as hyperechoic aggregates, detected via musculoskeletal ultrasound in the target joints.
Measured: Baseline (Single assessment)
Frequency of Bone Erosions
The presence and frequency of bone erosions detected via musculoskeletal ultrasound in the target joints.
Measured: Baseline (Single assessment)
Frequency of Tenosynovitis
The presence and frequency of tenosynovitis detected via musculoskeletal ultrasound in the target joints.
Measured: Baseline (Single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kiroles Bassem Fikrey Ramzy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657156
- Sponsor's protocol ID
- US Scoring: RA vs Gout
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No