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- Ensaio 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.
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Estimado)
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Semi-quantitative Gray-Scale Synovitis Score
Prazo: Baseline (Single assessment at the time of the cross-sectional ultrasound examination)
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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.
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Baseline (Single assessment at the time of the cross-sectional ultrasound examination)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Semi-quantitative Power Doppler Synovitis Score
Prazo: Baseline (Single assessment)
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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.
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Baseline (Single assessment)
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Presence of Double Contour Sign
Prazo: Baseline (Single assessment)
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The frequency of the double contour sign, representing urate crystal deposits on the articular cartilage, detected via musculoskeletal ultrasound in the target joints.
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Baseline (Single assessment)
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Presence of Tophi
Prazo: Baseline (Single assessment)
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The frequency of tophus formation, identified as hyperechoic aggregates, detected via musculoskeletal ultrasound in the target joints.
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Baseline (Single assessment)
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Frequency of Bone Erosions
Prazo: Baseline (Single assessment)
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The presence and frequency of bone erosions detected via musculoskeletal ultrasound in the target joints.
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Baseline (Single assessment)
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Frequency of Tenosynovitis
Prazo: Baseline (Single assessment)
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The presence and frequency of tenosynovitis detected via musculoskeletal ultrasound in the target joints.
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Baseline (Single assessment)
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Artropatias Cristais
- Doenças musculoesqueléticas
- Doenças articulares
- Doenças Reumáticas
- Metabolismo de Purina-Pirimidina, Erros Inatos
- Metabolismo, Erros Inatos
- Doenças Genéticas, Congênitas
- Doenças Metabólicas
- Doenças do Tecido Conjuntivo
- Doenças autoimunes
- Doenças do sistema imunológico
- Doenças e Anormalidades Congênitas, Hereditárias e Neonatais
- Doenças Nutricionais e Metabólicas
- Doenças da Pele e do Tecido Conjuntivo
- Gota
- Artrite
- Artrite, Reumatóide
- Sinovite
- Artrite, Gota
Outros números de identificação do estudo
- US Scoring: RA vs Gout
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