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Not yet recruitingNCT07657156Updated Jun 18, 2026

Musculoskeletal Ultrasound for Differentiating Rheumatoid and Gouty Arthritis

An observational study in Rheumatoid Arthritis (RA), Gouty Arthritis (GA) and Gout, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Rheumatoid Arthritis (RA)
  • Gouty Arthritis (GA)
  • Gout
  • Inflammatory Arthritis

Keywords

  • Musculoskeletal Ultrasound
  • Semi-quantitative Scoring
  • Ultrasonography
  • Synovitis
  • Power Doppler
  • Double Contour Sign
  • Tophi
  • Diagnostic Imaging
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In context

Arthritis, Rheumatoid

3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.

This study's planned enrollment of 100 is below the median of 176 across 1,016 observational studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  • Patients whose final diagnosis is established by clinical assessment, laboratory testing, and/or relevant imaging or synovial fluid analysis when available.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. 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.

    Time frame: Baseline (Single assessment)

  2. 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.

    Time frame: Baseline (Single assessment)

  3. Presence of Tophi

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

    Time frame: Baseline (Single assessment)

  4. Frequency of Bone Erosions

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

    Time frame: Baseline (Single assessment)

  5. Frequency of Tenosynovitis

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

    Time frame: Baseline (Single assessment)

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07657156
Lead sponsor
Assiut University
Responsible party
Kiroles Bassem Fikrey Ramzy (Resident at Radiology Department, Assiut University, Assiut University) — Principal investigator
First posted
Jun 18, 2026
Start date
Jul 2026 (estimated)
Primary completion
Jul 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Jun 18, 2026
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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