Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
400 participants
OBSERVATIONAL
2016-06-30
2020-06-30
Brief Summary
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Detailed Description
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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.
Participants with tendinopaty will get physical reevaluated after 3, 6 and 12 months as regards to symptoms, activity of daily life, blood samples, questionnaires VISA-A/P and ultrasound measurements. Rehabilitation training of patients is expected to start as soon as possible after the biopsy have been taken.
Healthy participants will not be reevaluated nor will they undergo rehabilitation training.
It is expected that the results from this study will provide insight into the events leading up to a developing tendinopati. This study will add important information to understand the pathophysiology and provide information on timing of the phases as well. Information and results from the study will give insight into better treatment options that is more specific and earlier intervention on the individual basis. Furthermore, this study will investigate and address the question why some people develop tendinopathies and others do not when the training volume is equally raised.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Tendinopathy
Long slow strength training for 3 months that are performed at home or gym. Participants receive initial guidance to the exercises from a physiotherapist assigned to Bispebjerg H.
Training
Long slow strength training of the tendon for 3 months to improve function
Healthy
No intervention. No training
No interventions assigned to this group
Interventions
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Training
Long slow strength training of the tendon for 3 months to improve function
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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University of Copenhagen
OTHER
Bispebjerg Hospital
OTHER
Responsible Party
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Peter Hung Thanh Tran
Doctor, phd student
Principal Investigators
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Michael Kjær, Professor
Role: STUDY_DIRECTOR
Clinical Medicine
Locations
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Bispebjerg Hospital
Copenhagen, Kbh NV, Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BBH-128
Identifier Type: -
Identifier Source: org_study_id
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