Skip to content

Identification and Treatment of Early Tendinopathy in Elite Athletes

Identification and Treatment of Early Tendinopathy in Elite Athletes

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03642392
Enrollment
70
Registered
2018-08-22
Start date
2018-08-17
Completion date
2021-08-17
Last updated
2018-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tendinopathy

Keywords

Achilles tendon, Patellar tendon, Inflammation

Brief summary

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.

Detailed description

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. Participants with tendinopathy will be physically reevaluated after 3, 6 and 12 months with regards to symptoms, the activity of daily life, blood samples, questionnaires VISA-A/P and ultrasound measurements. Furthermore, the unaffected side will also be used as a comparison. Moreover, participants will receive initial guidance about load reduction by the Chief Physician. It is expected that the results of this study will provide insight into the events leading up to a developing tendinopathy. This study will add important information to understand the pathophysiology and provide information on the timing of the phases as well. Information and results from the study will give insight into better treatment options that are more specific and earlier intervention in elite athletes. Furthermore, this study will investigate and address the question of why some elite athletes develop tendinopathies, and others do not when the training volume is equally raised.

Interventions

OTHERIdentification and treatment of early tendinopathy

Participants receive initial guidance about load reduction when tendinopathy

Sponsors

Team Denmark
CollaboratorOTHER
Bispebjerg Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* • 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

Design outcomes

Primary

MeasureTime frameDescription
Ultrasonography - Greyscale3 monthsGreyscale ultrasound for measuring tendon thickness (mm)
Ultrasonography - Power doppler3 monthsTo measure tendon vascularisation, area with power doppler signal (cm\^2)

Secondary

MeasureTime frameDescription
Tendon structural changes on MRI 3 months follow-up3 monthsMeasure tendon structural changes on MRI
Tendon structural changes on MRI 12 months follow-up12 monthsMeasure tendon structural changes on MRI
Ultrasonography - Greyscale12 monthsGreyscale ultrasound for measuring tendon thickness (mm)
Measure CRP levels in blood samples 3 months follow-up3 monthsSystemic inflammation Whole blood, serum, plasma and tissue.
Victorian Institute of Sport Assessment3 monthsStandardised score of functional capability, in patient with achilles and patellar tendinopathy. Total score will be reported; scale (0-100). 100=full functional capacity 0=poor functional capacity.
Questionnaires - Numerical Rating Scale (NRS) - Pain3 monthsQuestions on pain, both during activity and during rest. Pain during activity, (NRS); Scale (0-10) Pain after activity, (NRS); Scale (0-10) Pain at rest, (NRS); Scale (0-10) Pain I the morning, (NRS); Scale (0-10) Maximal pain during the past week, (NRS); Scale (0-10)
Ultrasonography -Power doppler12 monthTo measure tendon vascularisation, area with power doppler signal (cm\^2)
Measure CRP levels in blood samples 12 months follow-up12 monthsSystemic inflammation Whole blood, serum, plasma and tissue.

Countries

Denmark

Contacts

Primary ContactChristian Couppé, PhD
ccouppe@gmail.com+4560660825
Backup ContactChristoffer Brushøj, MD, PhD
chbr@teamdanmark.dk45 27292068

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026