Identification and Treatment of Early Tendinopathy in Elite Athletes

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.

Study Overview

• Status: Unknown
• Conditions: Tendinopathy
• Intervention / Treatment: Other: Identification and treatment of early 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 Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

Study Locations

• Denmark
  • Bispebjerg Hospital , København NV
    • 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: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Elite athletes 18 years and older

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?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tendinopathy; Athletes with unilateral tendinopathy	Other: Identification and treatment of early 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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure CRP levels in blood samples 3 months follow-up	Systemic inflammation Whole blood, serum, plasma and tissue.	3 months
Measure CRP levels in blood samples 12 months follow-up	Systemic inflammation Whole blood, serum, plasma and tissue.	12 months
Tendon structural changes on MRI 3 months follow-up	Measure tendon structural changes on MRI	3 months
Tendon structural changes on MRI 12 months follow-up	Measure tendon structural changes on MRI	12 months
Ultrasonography - Greyscale	Greyscale ultrasound for measuring tendon thickness (mm)	12 months
Ultrasonography -Power doppler	To measure tendon vascularisation, area with power doppler signal (cm^2)	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.	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.	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)	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)	12 months

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Collaborators: Team Denmark
• Investigators: Study Director: Christian Couppé, PhD, Unversity of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2018
• Primary Completion (Anticipated): August 17, 2020
• Study Completion (Anticipated): August 17, 2021

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: August 19, 2018
• First Posted (Actual): August 22, 2018

Study Record Updates

• Last Update Posted (Actual): September 4, 2018
• Last Update Submitted That Met QC Criteria: August 30, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Inflammation; Achilles tendon; Patellar tendon
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy
• Other Study ID Numbers: CC_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No