TendinopathyNCT03642392
Identification and Treatment of Early Tendinopathy in Elite Athletes
An observational study of Tendinopathy, run by Bispebjerg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Tendinopathy
- What is being tested?
- Identification and treatment of early tendinopathy
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Aug 2018to 17 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Elite athletes 18 years and older
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Institute of Sports Medicine
Copenhagen NV, Bispebjerg Hospital , København NV, 2400
Christian Couppé, PT, PhD, 60660825, christian.couppe@regionh.dk
Christoffer Brushøj, MD, 27 29 20 68, mailto:chbr@teamdanmark.dk
About this study
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.
Read the 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.
- Conditions
- Tendinopathy
- Being tested
- Identification and treatment of early tendinopathy
- Keywords
- Achilles tendon, Patellar tendon, Inflammation
- Medical subject headings
- Tendinopathy, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identification and treatment of early tendinopathyOther
Participants receive initial guidance about load reduction when tendinopathy
| Study group | Role | What they receive |
|---|---|---|
| Tendinopathy | Athletes with unilateral tendinopathy Receives: Other: Identification and treatment of early tendinopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonography - Greyscale
Greyscale ultrasound for measuring tendon thickness (mm)
Measured: 3 months
Ultrasonography - Power doppler
To measure tendon vascularisation, area with power doppler signal (cm^2)
Measured: 3 months
Secondary outcomes (10)
Measure CRP levels in blood samples 3 months follow-up
Systemic inflammation Whole blood, serum, plasma and tissue.
Measured: 3 months
Measure CRP levels in blood samples 12 months follow-up
Systemic inflammation Whole blood, serum, plasma and tissue.
Measured: 12 months
Tendon structural changes on MRI 3 months follow-up
Measure tendon structural changes on MRI
Measured: 3 months
Tendon structural changes on MRI 12 months follow-up
Measure tendon structural changes on MRI
Measured: 12 months
Ultrasonography - Greyscale
Greyscale ultrasound for measuring tendon thickness (mm)
Measured: 12 months
Ultrasonography -Power doppler
To measure tendon vascularisation, area with power doppler signal (cm^2)
Measured: 12 month
Victorian Institute of Sport Assessment
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.
Measured: 3 months
Victorian Institute of Sport Assessment
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.
Measured: 12 months
Questionnaires - Numerical Rating Scale (NRS) - Pain
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)
Measured: 3 months
Questionnaires - Numerical Rating Scale (NRS) - Pain
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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start17 Aug 2018
- Primary completion17 Aug 2020 (estimated)
- Study completion17 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Team Denmark
- Responsible party
- Principal investigator, Christian Couppé, Bispebjerg Hospital
- Investigators
- Christian Couppé, PhD, Study director, Unversity of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642392
- Sponsor's protocol ID
- CC_1
- Status last verified
- Aug 2018
- First submitted
- 16 Aug 2018
- Last updated
- 4 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Treatment of Early Tendinopathy in Elite Athletes
- ClinicalTrials.gov ID
- NCT03642392
- Acronym / sponsor ID
- CC_1
- Conditions
- Tendinopathy
- Keywords
- Achilles tendon, Patellar tendon, Inflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Team Denmark
- Study start
- 17 Aug 2018 (actual)
- Primary completion
- 17 Aug 2020 (estimated)
- Study completion
- 17 Aug 2021 (estimated)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tendinopathy | – | Other: Identification and treatment of early tendinopathyAthletes with unilateral tendinopathy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Elite athletes 18 years and older
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- • Surgery in Achilles and/or patellar tendon
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Identification and treatment of early tendinopathyParticipants receive initial guidance about load reduction when tendinopathy | Other | Tendinopathy |
Primary outcome
Ultrasonography - Greyscale
Time frame: 3 months
Greyscale ultrasound for measuring tendon thickness (mm)
Ultrasonography - Power doppler
Time frame: 3 months
To measure tendon vascularisation, area with power doppler signal (cm^2)
10 secondary outcomes
Measure CRP levels in blood samples 3 months follow-up
Time frame: 3 months
Measure CRP levels in blood samples 12 months follow-up
Time frame: 12 months
Tendon structural changes on MRI 3 months follow-up
Time frame: 3 months
Tendon structural changes on MRI 12 months follow-up
Time frame: 12 months
Ultrasonography - Greyscale
Time frame: 12 months
Ultrasonography -Power doppler
Time frame: 12 month
Victorian Institute of Sport Assessment
Time frame: 3 months
Victorian Institute of Sport Assessment
Time frame: 12 months
Questionnaires - Numerical Rating Scale (NRS) - Pain
Time frame: 3 months
Questionnaires - Numerical Rating Scale (NRS) - Pain
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
- Individual participant dataSharing planned: No
Related trials for Tendinopathy
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Synovial Tissue as a Biomarker in the Management of Pigmented Villonodular Synovitis
Synovitis Villonodular
Enrolling by invitation
High and Low Level Laser Therapy in De Quervain's Tenosynovitis
DeQuervain Tendinopathy
Recruiting
High-intensity Laser Therapy Versus Extracorporeal Shock Wave on Tendon Thickness and Occupation Ratio In Patients With Chronic Supraspinatus Tendinopathy
Supraspinatus Tendinopathy
Recruiting
Vibratory Anesthesia on Pain Following Corticosteroid Injections
Bilateral Arthritis of Wrist, Tendinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Couppé, PhD study director
Unversity of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tendinopathy, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Couppé, PhD (+4560660825, ccouppe@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasonography - Greyscale (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2018.