Pilot Study of Ultrasound in Rheumatoid Arthritis
A Pilot Study of Musculoskeletal Ultrasound Assessment in Patients With Rheumatoid Arthritis
Little is currently known as to the predictive value of ultrasound in guiding the decision to taper drug treatment in patients with stable rheumatoid arthritis, nor the influence that patients' views and opinions regarding their medications may have upon this. In this study, patients with stable rheumatoid arthritis will undergo a simple examination of their joints to look for any swelling or tenderness followed by an ultrasound scan to look for joint inflammation. Half of the patients will also complete an interview to assess their views and opinions of arthritis drug treatment. The study will be completed in a single patient visit - no invasive tests will be performed, and no changes to treatment will be made.
This study is being conducted as part of a Masters degree from Newcastle University. The results of this study will be used to inform the feasibility of inclusion of ultrasound assessment within the design of a future PhD study to investigate potential markers of remission in patients with rheumatoid arthritis.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Newcastle upon Tyne, Royaume-Uni, NE7 7DN
- Musculoskeletal Outpatient Department, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Diagnosis of rheumatoid arthritis with symptom onset at least 12 months previously
- Current disease-modifying anti-rheumatic drug (DMARD) therapy or biologic therapy
- Currently stable arthritis defined as no change in DMARD treatment over previous 6 months, and no use of steroids (enteral, parenteral or intra-articular) over previous 6 months
Exclusion Criteria:
- Inability to provide informed consent
- Current or recent (within 4 months) participation within another clinical trial
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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Observational study group
Musculoskeletal ultrasound (all patients) and semi-structured patient interview (anticipated maximum 15 patients)
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7-joint musculoskeletal ultrasound scan
Semi-structured patient interview
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Evidence of reliability of intra- and inter-rater ultrasound agreement for power Doppler synovitis score
Délai: At recruitment
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Defined as Kappa statistic of at least 0.4.
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At recruitment
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Qualitative data relating to patients' views and opinions of their arthritis medication
Délai: At recruitment
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Based upon data collected by a semi-structured interview approach and analysed using standard qualitative techniques.
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At recruitment
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Simplified Disease Activity Index (SDAI)
Délai: At recruitment
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At recruitment
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Disease Activity Score in 28 joints (DAS-28)
Délai: At recruitment
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At recruitment
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Disease Activity Score (DAS)
Délai: At recruitment
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At recruitment
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: John D Isaacs, PhD, MB BS, Newcastle University
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NUTH6919
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