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Musculoskeletal Ultrasound for Differentiating Rheumatoid and Gouty Arthritis

14 de junio de 2026 actualizado por: Kiroles Bassem Fikrey Ramzy, Assiut University

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.

Descripción general del estudio

Tipo de estudio

De observación

Inscripción (Estimado)

100

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

N/A

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Semi-quantitative Gray-Scale Synovitis Score
Periodo de tiempo: 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.
Baseline (Single assessment at the time of the cross-sectional ultrasound examination)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Semi-quantitative Power Doppler Synovitis Score
Periodo de tiempo: 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.
Baseline (Single assessment)
Presence of Double Contour Sign
Periodo de tiempo: 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.
Baseline (Single assessment)
Presence of Tophi
Periodo de tiempo: Baseline (Single assessment)
The frequency of tophus formation, identified as hyperechoic aggregates, detected via musculoskeletal ultrasound in the target joints.
Baseline (Single assessment)
Frequency of Bone Erosions
Periodo de tiempo: Baseline (Single assessment)
The presence and frequency of bone erosions detected via musculoskeletal ultrasound in the target joints.
Baseline (Single assessment)
Frequency of Tenosynovitis
Periodo de tiempo: Baseline (Single assessment)
The presence and frequency of tenosynovitis detected via musculoskeletal ultrasound in the target joints.
Baseline (Single assessment)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

1 de julio de 2027

Finalización del estudio (Estimado)

1 de agosto de 2027

Fechas de registro del estudio

Enviado por primera vez

14 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

14 de junio de 2026

Publicado por primera vez (Actual)

18 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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