- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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".
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, Belgio, 3000
- University Hospitals
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Local tendon tissue displacement in three layers of the tendon (deep, middle and superficial layer); as measured by ultrasound-based speckle tracking
Lasso di tempo: Immediately during isometric exercise
|
Millimeter
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Immediately during isometric exercise
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Non-uniform displacement; as measured by ultrasound-based speckle tracking
Lasso di tempo: 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)
|
Immediately during isometric exercise
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Anticipato)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
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
Altri numeri di identificazione dello studio
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