- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Tipo di studio
Iscrizione (Stimato)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Semi-quantitative Gray-Scale Synovitis Score
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Semi-quantitative Power Doppler Synovitis Score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Artropatie cristalline
- Malattie muscoloscheletriche
- Malattie articolari
- Malattie reumatiche
- Metabolismo delle purine-pirimidine, errori congeniti
- Metabolismo, errori congeniti
- Malattie genetiche, congenite
- Malattie metaboliche
- Malattie del tessuto connettivo
- Malattie autoimmuni
- Malattie del sistema immunitario
- Malattie e anomalie congenite, ereditarie e neonatali
- Malattie nutrizionali e metaboliche
- Malattie della pelle e del tessuto connettivo
- Gotta
- Artrite
- Artrite, reumatoide
- Sinovite
- Artrite, gotta
Altri numeri di identificazione dello studio
- US Scoring: RA vs Gout
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .