Mechanisms Behind Development of Tendinopathy (TESINaC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02797925|
Recruitment Status : Recruiting
First Posted : June 14, 2016
Last Update Posted : January 19, 2018
|Condition or disease||Intervention/treatment|
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.
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.
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Mechanisms Behind Development of Tendinopathy: Early Structural, Inflammatory, Nociceptive and Clinical Changes in Recreational Runners|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2020|
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.
Long slow strength training of the tendon for 3 months to improve function
Other Name: Long slow strength training
No intervention. No training
- Investigate the timespan of inflammation from acute phase to resolution in tendinopathy [ Time Frame: 3 months ]Markers for inflammation includes tendon thickness, vascularization, inflammatory mRNA leves, inflammatory protein signals and mechanical properties of tendon.
- Measure tendon thickness in mm (anterior-posterior) on ultrasound [ Time Frame: 3 months ]
- Measure TNF-alpha mRNA levels in patella biopsies as ratio to GAPDH [ Time Frame: 3 months ]GAPDH is a household gene and therefore expected to have constant mRNA levels. TNF-alpha mRNA is measured relative to GAPDH.
- Measure the tendon region with maximal vascularization on ultrasound doppler signal based on visual impression from the investigators [ Time Frame: 3 months ]The region with maximal vascularization is based on where the ultrasound doppler signal is most abundant, which depends on visual impression from the investigators.
- IHC stain for TNF-alpha protein signal in patella biopsies with specific antibodies [ Time Frame: 3 month ]Quantification is made by visual inspection of stained tendon samples
- Measure tendon mechanical properties with ultrasound isometric [ Time Frame: 3 months ]Tracking software provide details about deformation of tendon in mm, young modulus, max % strain and stiffness.
- Measure CRP levels in blood samples [ Time Frame: 3 months ]Systemic inflammation
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797925
|Contact: Peter Tran, Doctor||+45 27428164||Tesinac2016@gmail.com|
|Copenhagen, Kbh NV, Denmark, 2400|
|Contact: Peter Tran, Doctor 0045 35316086 email@example.com|
|Contact: Nikolaj Malmgaard-Clausen, Doctor firstname.lastname@example.org|
|Study Director:||Michael Kjær, Professor||Clinical Medicine|