- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03848598
Is There a Mechanistic Reason for the Response or Non-response to Isometric Exercise in Tendinopathy?
In early phase tendinopathy, isometric exercises are seen as ideal to provide pain relief to patients. This approach is mainly based on a paper by Rio et al (2016), where they found that isometric exercises of a certain load magnitude and time (5 repetitions of 45 second hold at 70% of maximum) gave 100% pain relief for 45 minutes in patients with patellar tendinopathy. This then helps patients to perform their more heavy load exercises during rehabilitation, which would otherwise be too painful.
Unfortunately, the study of Rio et al only consisted of 6 participants, and recent papers have contradicted the findings. In Achilles tendinopathy, plantar fasciopathy and lateral elbow tendinopathy, the pain relief was not consistently present, with "responders" and "non-responders" being found in these studies. Also, a study yet to be published (poster at conference), replicating Rio et al, also found a heterogeneous response, debunking the "one size fits all" approach that seemed to work.
However, in our understanding, isometric exercises do have a crucial role in early tendinopathy management, but the way the exercise is performed, in which position, what magnitude of load, time under tension, … has an important influence. The same protocol (5 repetitions of 45 second hold at 70% of maximum) might lead to big inter-individual differences. Therefore, there might be a mechanistic reason why some patients respond, and others do not.
Fortunately, the P.I. of this current trial application has recently optimized an ultrasound-based method to quantify local tendon deformation during exercises. The main purpose of this trial is therefore to evaluate the local tendon deformation pattern of patients with tendinopathy during isometric exercises and evaluate whether there is an interindividual difference in pattern between "responders" and "non-responders".
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, Bélgica, 3000
- University Hospitals
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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:
- Clinical diagnosis of patellar tendinopathy, consisting of
- pain located at the proximal part of the patellar tendon
- painful at palpation the proximal part of the patellar tendon
- Numeric Rating Scale > 1/10 with squat on decline (20°) board
Exclusion Criteria:
- previous treatment for patellar tendinopathy
- rupture of patellar tendon on ultrasound
- unclear differential diagnosis with patellofemoral pain
- concomitant neuromuscular disorders
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Responders
Patients suffering from patellar tendinopathy who have complete pain resolution after performing isometric exercises.
|
Ultrasound-based speckle tracking to evaluate the local tendon tissue displacement during isometric exercise.
|
|
Non-responders
Patients suffering from patellar tendinopathy who do not have complete pain resolution after performing isometric exercises.
|
Ultrasound-based speckle tracking to evaluate the local tendon tissue displacement during isometric exercise.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Local tendon tissue displacement in three layers of the tendon (deep, middle and superficial layer); as measured by ultrasound-based speckle tracking
Periodo de tiempo: Immediately during isometric exercise
|
Millimeter
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Immediately during isometric exercise
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Non-uniform displacement; as measured by ultrasound-based speckle tracking
Periodo de tiempo: Immediately during isometric exercise
|
% (measure for relative displacement of the superficial layer of the tendon versus the deep layer, and then divided by the mean total displacement of the three layers combined)
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Immediately during isometric exercise
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Otros números de identificación del estudio
- SBogaerts
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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