Musculoskeletal Ultrasound for Differentiating Rheumatoid and Gouty Arthritis

NCT07657156 | Not Yet Recruiting

• 1 other identifier: US Scoring: RA vs Gout
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Outcome Measures

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.

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

Secondary Outcomes (5)

• Semi-quantitative Power Doppler Synovitis Score

  Baseline (Single assessment)

• Presence of Double Contour Sign

  Baseline (Single assessment)

• Presence of Tophi

  Baseline (Single assessment)

• Frequency of Bone Erosions

  Baseline (Single assessment)

• Frequency of Tenosynovitis

  Baseline (Single assessment)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Gouty; Gout; Arthritis; Synovitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Radiology Department, Assiut University

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: June 18, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 18, 2026

Record last verified: 2026-06