NCT03642392

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

August 17, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2021

Completed
Last Updated

September 4, 2018

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

August 16, 2018

Last Update Submit

August 30, 2018

Conditions

Tendinopathy

Keywords

Achilles tendonPatellar tendonInflammation

Outcome Measures

Primary Outcomes (2)

  • Ultrasonography - Greyscale

    Greyscale ultrasound for measuring tendon thickness (mm)

    3 months

  • Ultrasonography - Power doppler

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

    3 months

Secondary Outcomes (10)

  • Measure CRP levels in blood samples 3 months follow-up

    3 months

  • Measure CRP levels in blood samples 12 months follow-up

    12 months

  • Tendon structural changes on MRI 3 months follow-up

    3 months

  • Tendon structural changes on MRI 12 months follow-up

    12 months

  • Ultrasonography - Greyscale

    12 months

  • +5 more secondary outcomes

Study Arms (1)

Tendinopathy

Athletes with unilateral tendinopathy

Other: Identification and treatment of early tendinopathy

Interventions

Identification and treatment of early tendinopathyOTHER

Participants receive initial guidance about load reduction when tendinopathy

Tendinopathy

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Elite athletes 18 years and older

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sports Medicine

Copenhagen NV, Bispebjerg Hospital , København NV, 2400, Denmark

RECRUITING

MeSH Terms

Conditions

TendinopathyInflammation

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christian Couppé, PhD

    Unversity of Copenhagen

    STUDY DIRECTOR

Central Study Contacts

Christian Couppé, PhD

CONTACT

+4560660825ccouppe@gmail.com

Christoffer Brushøj, MD, PhD

CONTACT

45 27292068chbr@teamdanmark.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior researcher, MSc.PT, PhD.

Study Record Dates

First Submitted

August 16, 2018

First Posted

August 22, 2018

Study Start

August 17, 2018

Primary Completion

August 17, 2020

Study Completion

August 17, 2021

Last Updated

September 4, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)