- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03642392
Identification and Treatment of Early Tendinopathy in Elite Athletes
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Christian Couppé, PhD
- Phone Number: +4560660825
- Email: ccouppe@gmail.com
Study Contact Backup
- Name: Christoffer Brushøj, MD, PhD
- Phone Number: 45 27292068
- Email: chbr@teamdanmark.dk
Study Locations
-
-
Bispebjerg Hospital , København NV
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Copenhagen NV, Bispebjerg Hospital , København NV, Denmark, 2400
- Recruiting
- Institute of Sports Medicine
-
Contact:
- Christian Couppé, PT, PhD
- Phone Number: 60660825
- Email: christian.couppe@regionh.dk
-
Contact:
- Christoffer Brushøj, MD
- Phone Number: 27 29 20 68
- Email: mailto:chbr@teamdanmark.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Tendinopathy
Athletes with unilateral tendinopathy
|
Participants receive initial guidance about load reduction when tendinopathy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ultrasonography - Greyscale
Time Frame: 3 months
|
Greyscale ultrasound for measuring tendon thickness (mm)
|
3 months
|
Ultrasonography - Power doppler
Time Frame: 3 months
|
To measure tendon vascularisation, area with power doppler signal (cm^2)
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure CRP levels in blood samples 3 months follow-up
Time Frame: 3 months
|
Systemic inflammation Whole blood, serum, plasma and tissue.
|
3 months
|
Measure CRP levels in blood samples 12 months follow-up
Time Frame: 12 months
|
Systemic inflammation Whole blood, serum, plasma and tissue.
|
12 months
|
Tendon structural changes on MRI 3 months follow-up
Time Frame: 3 months
|
Measure tendon structural changes on MRI
|
3 months
|
Tendon structural changes on MRI 12 months follow-up
Time Frame: 12 months
|
Measure tendon structural changes on MRI
|
12 months
|
Ultrasonography - Greyscale
Time Frame: 12 months
|
Greyscale ultrasound for measuring tendon thickness (mm)
|
12 months
|
Ultrasonography -Power doppler
Time Frame: 12 month
|
To measure tendon vascularisation, area with power doppler signal (cm^2)
|
12 month
|
Victorian Institute of Sport Assessment
Time Frame: 3 months
|
Standardised 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.
|
3 months
|
Victorian Institute of Sport Assessment
Time Frame: 12 months
|
Standardised 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.
|
12 months
|
Questionnaires - Numerical Rating Scale (NRS) - Pain
Time Frame: 3 months
|
Questions 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) |
3 months
|
Questionnaires - Numerical Rating Scale (NRS) - Pain
Time Frame: 12 months
|
Questions 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) |
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Christian Couppé, PhD, Unversity of Copenhagen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CC_1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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