- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07657156
Musculoskeletal Ultrasound for Differentiating Rheumatoid and Gouty Arthritis
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
Estado
Tipo de estudio
Inscripción (Estimado)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
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
¿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
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Artropatías por cristales
- Enfermedades musculoesqueléticas
- Enfermedades Articulares
- Enfermedades reumáticas
- Metabolismo de purina-pirimidina, errores congénitos
- Metabolismo, errores congénitos
- Enfermedades Genéticas Congénitas
- Enfermedades metabólicas
- Enfermedades del tejido conectivo
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Enfermedades Nutricionales y Metabólicas
- Enfermedades de la piel y del tejido conectivo
- Gota
- Artritis
- Artritis Reumatoide
- Sinovitis
- Artritis Gotosa
Otros números de identificación del estudio
- US Scoring: RA vs Gout
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. .