跳至主要内容
临床试验/NCT02797925
NCT02797925Unknown不适用

Mechanisms Behind Development of Tendinopathy: Early Structural, Inflammatory, Nociceptive and Clinical Changes in Recreational Runners

Bispebjerg Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
1
主要终点
Investigate the timespan of inflammation from acute phase to resolution in tendinopathy

研究概览

简要总结

There has been an increasing amount of musculoskeletal injuries the past decades and overused tendons represents a major problem both for leisure and occupational activities. A full understanding of the pathophysiology of tendinopathy is very sparse and especially the early events in tendinopathy remains unexplained. In this phd study the investigators will investigate early changes in tendon tissue overloading and development of tendinopathy. The investigators will investigate sports-active individuals with recently developed tendinopathy with regards to symptoms (pain, function), tendon morphology (ultrasonography, MRI and electron microscopy), tendon mechanical properties (ultrasonography strain), tissue molecular biology (expression and content of matrix proteins), inflammation (activity of inflammatory pathways) and vascularization (Doppler and contrast enhancement US). The investigators hypothesize a coupling between early symptoms and inflammatory activity, followed by structural changes and altered mechanical properties. The investigation will indicate what symptoms and what tendon related determined measurements are primary for disease development ("tendinopathy blue prints") and should be regarding vital in prevention of tendinopathy.

详细描述

The investigators intend to study the development of tendinopathy in humans that enter a phase of relative overloading of their tendons. This will be done in a large cohort of individuals from whom the investigators have obtained basic data and tests. A percentage of these participants will develop overuse symptoms and in those the investigators will perform investigations that will identify the initial pathological changes in tendinopathy

Participants are included as soon as possible after diagnosis of either Achilles or patella 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 hyper-metabolism.

Recruiting participants will be done in collaboration with local athletic clubs in the Copenhagen area. The athletic clubs include Sparta, Københavns Idræt Forening (KIF), Frederiksberg Idræt Forening (FIF). Furthermore, the investigators will establish contact through online social media such as Facebook, Twitter and Google. In addition, Information leaflets will be handed out, and medical staff at the emergency rooms repeatedly informed about the project. Healthy participants can be directly recruited by participants already in the project, social medias and through information leaflets handed out. It is planned to inform staff at the emergency rooms at Bispebjerg Hospital, Amager Hospital, Gentofte Hospital, Herlev Hospital and Hvidovre Hospital. Patients and healthy controls can contact the primary investigator directly through email or telephone.

Recruitment to project TESINaC will focus onset of exercise pain and every participant will be evaluated by a doctor if the participant have tendinopathy or not. Once included the participant will undergo following procedures as soon as possible after diagnosis is given:

  • Questionnaire regarding training history and ongoing symptoms
  • Ultrasound scanning of tendons
  • Ultrasound isometric
  • Blood samples
  • MRI of tendons on both legs MRI precedes biopsy as it can identify any diseased area within the tendon from which a biopsy can be taken. Only participants with tendinopathy will have to undergo biopsy from both patella tendons once during the project. Healthy participants will not undergo biopsy. No biopsy will be taken from the Achilles tendon as this procedure may worsen the participants symptoms.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older 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 patella or/and Achilles tendon upon palpation
  • Demonstrate an ultrasonographic (US) thickening of the tendon (2 mm larger on the affected side vs the contralateral un-symptomatic side in the anterior-posterior projection)

排除标准

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

结局指标

主要结局

Investigate the timespan of inflammation from acute phase to resolution in tendinopathy

时间窗: 3 months

Markers for inflammation includes tendon thickness, vascularization, inflammatory mRNA leves, inflammatory protein signals and mechanical properties of tendon.

次要结局

  • Measure TNF-alpha mRNA levels in patella biopsies as ratio to GAPDH(3 months)
  • Measure tendon thickness in mm (anterior-posterior) on ultrasound(3 months)
  • Measure tendon mechanical properties with ultrasound isometric(3 months)
  • Measure CRP levels in blood samples(3 months)
  • IHC stain for TNF-alpha protein signal in patella biopsies with specific antibodies(3 month)
  • Measure the tendon region with maximal vascularization on ultrasound doppler signal based on visual impression from the investigators(3 months)

研究者

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

Peter Hung Thanh Tran

Doctor, phd student

Bispebjerg Hospital

研究点 (1)

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