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临床试验/NCT03848598
NCT03848598Unknown不适用

Is There a Mechanistic Reason for the Response or Non-response to Isometric Exercise in Tendinopathy?

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Local tendon tissue displacement in three layers of the tendon (deep, middle and superficial layer); as measured by ultrasound-based speckle tracking

研究概览

简要总结

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".

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • previous treatment for patellar tendinopathy
  • rupture of patellar tendon on ultrasound
  • unclear differential diagnosis with patellofemoral pain
  • concomitant neuromuscular disorders

结局指标

主要结局

Local tendon tissue displacement in three layers of the tendon (deep, middle and superficial layer); as measured by ultrasound-based speckle tracking

时间窗: Immediately during isometric exercise

Millimeter

次要结局

  • Non-uniform displacement; as measured by ultrasound-based speckle tracking(Immediately during isometric exercise)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stijn Bogaerts

Resident staff member Physical & Rehabilitation Medicine

Universitaire Ziekenhuizen KU Leuven

研究点 (1)

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