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临床试验/NCT03642392
NCT03642392Unknown不适用

Identification and Treatment of Early Tendinopathy in Elite Athletes

Bispebjerg Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年8月17日最近更新:
适应症

试验速览

阶段
不适用
入组人数
70
试验地点
1
主要终点
Ultrasonography - Power doppler

研究概览

简要总结

Tendon injuries represent a significant problem in elite athletes. The understanding of the pathophysiology of tendinopathy is very sparse, and especially the early events in tendinopathy are unknown. In this study, the investigators will investigate early changes in tendon tissue overloading and development of tendinopathy. The investigators will examine elite athletes with recently developed tendinopathy with regards to symptoms (pain, function), tendon morphology (ultrasonography, MRI), inflammation (the activity of inflammatory pathways) and vascularization (Doppler US). The investigators hypothesize a coupling between early symptoms and inflammatory activity, followed by structural changes. The investigation will indicate what symptoms and what tendon related measurements are primary for disease development ("tendinopathy blueprints") and should be regarding vital in the prevention of tendinopathy.

详细描述

The investigators intend to study the development of tendinopathy in elite athletes (badminton and handball players) that enter a phase of relative overloading of their tendons. This will be done in a large cohort of elite athletes from whom the investigators have obtained essential data and tests. A percentage of these elite athletes will develop overuse symptoms, and in those, the investigators will perform investigations that will try to identify the initial pathological changes in tendinopathy.

Participants are included as soon as possible after diagnosis of either Achilles or patellar tendinopathy because the investigators wish to investigate the early changes in tendinopathy. The hypothesis is, that at the early development of tendinopathy there will be a mismatch between matrix protein anabolic and catabolic pathways, and will be associated with a secondary upregulation of inflammatory and apoptotic markers in the tendon and result in hypervascularization and hypermetabolism.

Recruiting participants will be done in collaboration with TEAM DANMARK (the Danish sport elite sports organization) together with The Danish Badminton, Handball and Volleyball Associations). Furthermore, the investigators will establish contact with all relevant coaches and medical teams of these associations mentioned above. Information leaflets will repeatedly be sent about the project. Elite athletes can contact the chief physician of TEAM DANMARK directly through email or telephone. In comparison, a control group of healthy athletes is already recruited in the former project of recreational athletes.

Recruitment to the project will focus onset of exercise pain, and every participant will be examined by the chief physician of TEAM DANMARK if the participant has tendinopathy or not. Once included the participant will undergo following procedures as soon as possible after diagnosis is given:

  • A questionnaire regarding training history and ongoing symptoms
  • Ultrasound scanning of patellar or Achilles tendons (bilateral)
  • Blood samples
  • MRI of the tendon that can identify any diseased area.

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 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Marked tendon related pain in association with exercise on one leg
  • Soreness during physical examination of patellar or/and Achilles tendon upon palpation
  • Demonstrate an ultrasonographic (US) thickening of the tendon on the affected side vs the contralateral un-symptomatic side in the anterior-posterior projection

排除标准

  • • Surgery in Achilles and/or patellar tendon
  • History of Achilles and/or patellar tendinopathy
  • Received any form of an injection in Achilles and/or patella tendon
  • Lately, have an infection around Achilles and/or patella tendon

结局指标

主要结局

Ultrasonography - Power doppler

时间窗: 3 months

To measure tendon vascularisation, area with power doppler signal (cm\^2)

Ultrasonography - Greyscale

时间窗: 3 months

Greyscale ultrasound for measuring tendon thickness (mm)

次要结局

  • Measure CRP levels in blood samples 12 months follow-up(12 months)
  • Tendon structural changes on MRI 3 months follow-up(3 months)
  • Ultrasonography -Power doppler(12 month)
  • Measure CRP levels in blood samples 3 months follow-up(3 months)
  • Victorian Institute of Sport Assessment(12 months)
  • Ultrasonography - Greyscale(12 months)
  • Questionnaires - Numerical Rating Scale (NRS) - Pain(12 months)
  • Tendon structural changes on MRI 12 months follow-up(12 months)

研究者

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

Christian Couppé

Senior researcher, MSc.PT, PhD.

Bispebjerg Hospital

研究点 (1)

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