Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07657156

Musculoskeletal Ultrasound for Differentiating Rheumatoid and Gouty Arthritis

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Semi-quantitative Gray-Scale Synovitis Score

    Time frame: Baseline (Single assessment at the time of the cross-sectional ultrasound examination)

    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.

Secondary outcomes

  1. Semi-quantitative Power Doppler Synovitis Score

    Time frame: Baseline (Single assessment)

    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.

  2. Presence of Double Contour Sign

    Time frame: Baseline (Single assessment)

    The frequency of the double contour sign, representing urate crystal deposits on the articular cartilage, detected via musculoskeletal ultrasound in the target joints.

  3. Presence of Tophi

    Time frame: Baseline (Single assessment)

    The frequency of tophus formation, identified as hyperechoic aggregates, detected via musculoskeletal ultrasound in the target joints.

  4. Frequency of Bone Erosions

    Time frame: Baseline (Single assessment)

    The presence and frequency of bone erosions detected via musculoskeletal ultrasound in the target joints.

  5. Frequency of Tenosynovitis

    Time frame: Baseline (Single assessment)

    The presence and frequency of tenosynovitis detected via musculoskeletal ultrasound in the target joints.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Role of Musculoskeletal Ultrasound in Differentiation of Rheumatoid Arthritis and Gouty Arthritis Using Semi-Quantitative Scoring

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.