- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01677416
Joint Ultrasound Evaluation of Asymptomatic Rheumatic Feet
Joint Ultrasound Evaluation of Asymptomatic Feet in Patients With Rheumatoid Arthritis: A Controlled Study
Objectives: The aims of the present study were to compare ultrasound on asymptomatic feet of patients with rheumatoid arthritis (RA) and normal controls, determine the association between ultrasound and global disease activity, function and goniometric measures in patients with RA and determine the correlation between ultrasound and radiography in the detection of bone erosion.
Methods: The foot joints (talocrural, talocalcaneal, talonavicular, naviculocuneiform, calcaneocuboid, 5th tarsometatarsal and 1st to 5th metatarsophalangeal [MTP] joints) of 50 healthy subjects and 50 patients with RA (all with asymptomatic feet) were evaluated bilaterally regarding quantitative/semi-quantitative synovitis, semi-quantitative Power Doppler (PD) signals and erosion using ultrasound. Statistical significance was set to 5%.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
SP - Sao Paulo
-
Sao Paulo, SP - Sao Paulo, Brasil, 04023-062
- Universidade Federal de São Paulo
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
Rheumatoid Arthritis Group:
- RA with at least one year since diagnosis
- Asymptomatic feet
- Age between 18 and 65 years Control group
- absence of known osteoarticular disease
Exclusion Criteria for both groups:
- Peripheral venous insufficiency with retrograde venous flow and/or ochre dermatitis
- Previous surgical intervention and/or fracture in feet/ankles
- Intra-articular corticosteroid injection in previous three months in any of the joints evaluated
- Foot neuropathy
- Pain and swelling in feet or ankles
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
---|
Rheumatoid Arthritis Group
RA with at least one year since diagnosis, asymptomatic feet, and age between 18 and 65 years
|
Control group
Absence of known osteoarticular disease
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Presence of synovial effusion and/or synovial hypertrophy
Periodo de tiempo: Baseline
|
Ultrasound evaluation - quantitative measurement considered the distance between the joint capsule and subchondral bone of the joints studied (talocrural, talocalcaneal (medial, lateral and posterior windows); dorsal face of calcaneocuboid, talonavicular, medial naviculocuneiform, 5th tarsometatarsal and metatarsophalangeal (MTP) (dorsal and volar faces of 1st to 5th MTP joints and lateral face of 1st and 5th MTP joints).
A modified score was used for the semi-quantitative measurement, ranging from 0 to 3: 0-no synovial thickening; 1-minimal synovial thickening in joint recess; 2-synovial thickening in entire joint recess causing bulging of joint capsule; and 3-synovial thickening in joint recess with bulging of joint capsule and extending to at least one bone diaphysis.
"Presence of synovitis" was defined as synovial hypertrophy of at least Grade 1 in the semi-quantitative analysis (gray scale - ultrasound)
|
Baseline
|
Presence of bone erosion
Periodo de tiempo: Baseline
|
defined based on the preliminary OMERACT criteria: intra-articular discontinuity of the bone surface observed on two perpendicular planes.
A previously established semi-quantitative score (0-3) was employed: 0-uniform bone surface; 1-irregular bone surface; 2-bone surface defect on two planes; 3-bone defect causing extensive bone destruction.
The "presence of erosion" was defined as the presence of at least Grade 2 erosion.
|
Baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Radiographic evaluation
Periodo de tiempo: Baseline
|
A blinded radiologist analysed the presence of erosion in each joint studied.
For such, ankle (AP and profile) and foot (AP and profile with load) radiographs were taken.
|
Baseline
|
Intraobserver and interobserver agreement
Periodo de tiempo: Baseline
|
The patients with RA were submitted to clinical and ultrasound evaluations of the feet and ankles on the same day.
The ultrasound measurements intraobserver/interobserver agreement was performed on the talocrural, talonavicular and 5th MTP joints, using 20% of the sample.
For this, the ultrasound exams were performed by another rheumatologist.
|
Baseline
|
Presence of synovial blood flow
Periodo de tiempo: Baseline
|
The presence of Power Doppler (PD) signals was evaluated in the bone margins, joint spaces, and peri-articular tissues (frequency of 8 MHz and pulse repetition rate of 750 MHz).
A semi-quantitative score (0-3) was employed[14]: 0-no signal; 1-minimal signal, presence of simple vessels; 2-moderate signal, presence of confluent vessels with signal in less than 50% of the area evaluated; 3-intense signal (more than 50% of area evaluated).
"Active synovitis" or "presence of PD signal" was defined as the presence of intra-articular synovitis with a positive PD signal (at least Grade 1).
|
Baseline
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Rita Furtado, MD, Federal University of São Paulo
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
Otros números de identificación del estudio
- UNIFESP/2011
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. .