TendinopathyTESINaCNCT02797925
Mechanisms Behind Development of Tendinopathy
An observational study of Tendinopathy, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
There has been an increasing amount of musculoskeletal injuries the past decades and overused tendons represents a major problem both for leisure and occupational activities. A full understanding of the pathophysiology of tendinopathy is very sparse and especially the early events in tendinopathy remains unexplained. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tendinopathy
- What is being tested?
- Training
- How many people
- 400 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2016to Jun 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Physical active participants over 18 years old, both men and women. The term physical active refers to any kind of sport and not only running. Participants with pain in either Achilles or patellar tendon on one leg. Healthy participants must be symptom free and not have any diseases at all.
Who may be able to join
- Marked tendon related pain in association with exercise on one leg
- Soreness during physical examination of patella or/and Achilles tendon upon palpation
- Demonstrate an ultrasonographic (US) thickening of the tendon (2 mm larger on the affected side vs the contralateral un-symptomatic side in the anterior-posterior projection)
Who cannot join
- Surgery in Achilles and/or patella tendon
- History of Achilles and/or patella tendinopathy
- Received any form of injection in Achilles and/or patella tendon
- Lately have infection around Achilles and/or patella tendon
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Bispebjerg Hospital
Copenhagen, Kbh NV, 2400
Peter Tran, Doctor, 0045 35316086, tesinac2016@gmail.com
Nikolaj Malmgaard-Clausen, Doctor, nikolajmoelkjaer@gmail.com
About this study
Official title: Mechanisms Behind Development of Tendinopathy: Early Structural, Inflammatory, Nociceptive and Clinical Changes in Recreational Runners
There has been an increasing amount of musculoskeletal injuries the past decades and overused tendons represents a major problem both for leisure and occupational activities. A full understanding of the pathophysiology of tendinopathy is very sparse and especially the early events in tendinopathy remains unexplained. In this phd study the investigators will investigate early changes in tendon tissue overloading and development of tendinopathy. The investigators will investigate sports-active individuals with recently developed tendinopathy with regards to symptoms (pain, function), tendon morphology (ultrasonography, MRI and electron microscopy), tendon mechanical properties (ultrasonography strain), tissue molecular biology (expression and content of matrix proteins), inflammation (activity of inflammatory pathways) and vascularization (Doppler and contrast enhancement US). The investigators hypothesize a coupling between early symptoms and inflammatory activity, followed by structural changes and altered mechanical properties. The investigation will indicate what symptoms and what tendon related determined measurements are primary for disease development ("tendinopathy blue prints") and should be regarding vital in prevention of tendinopathy.
Read the detailed description
The investigators intend to study the development of tendinopathy in humans that enter a phase of relative overloading of their tendons. This will be done in a large cohort of individuals from whom the investigators have obtained basic data and tests. A percentage of these participants will develop overuse symptoms and in those the investigators will perform investigations that will identify the initial pathological changes in tendinopathy
Participants are included as soon as possible after diagnosis of either Achilles or patella 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 hyper-metabolism.
Recruiting participants will be done in collaboration with local athletic clubs in the Copenhagen area. The athletic clubs include Sparta, Københavns Idræt Forening (KIF), Frederiksberg Idræt Forening (FIF). Furthermore, the investigators will establish contact through online social media such as Facebook, Twitter and Google. In addition, Information leaflets will be handed out, and medical staff at the emergency rooms repeatedly informed about the project. Healthy participants can be directly recruited by participants already in the project, social medias and through information leaflets handed out. It is planned to inform staff at the emergency rooms at Bispebjerg Hospital, Amager Hospital, Gentofte Hospital, Herlev Hospital and Hvidovre Hospital. Patients and healthy controls can contact the primary investigator directly through email or telephone.
Recruitment to project TESINaC will focus onset of exercise pain and every participant will be evaluated by a doctor if the participant have tendinopathy or not. Once included the participant will undergo following procedures as soon as possible after diagnosis is given:
- Questionnaire regarding training history and ongoing symptoms
- Ultrasound scanning of tendons
- Ultrasound isometric
- Blood samples
- MRI of tendons on both legs MRI precedes biopsy as it can identify any diseased area within the tendon from which a biopsy can be taken. Only participants with tendinopathy will have to undergo biopsy from both patella tendons once during the project. Healthy participants will not undergo biopsy. No biopsy will be taken from the Achilles tendon as this procedure may worsen the participants symptoms.
Participants with tendinopaty will get physical reevaluated after 3, 6 and 12 months as regards to symptoms, activity of daily life, blood samples, questionnaires VISA-A/P and ultrasound measurements. Rehabilitation training of patients is expected to start as soon as possible after the biopsy have been taken.
Healthy participants will not be reevaluated nor will they undergo rehabilitation training.
It is expected that the results from this study will provide insight into the events leading up to a developing tendinopati. This study will add important information to understand the pathophysiology and provide information on timing of the phases as well. Information and results from the study will give insight into better treatment options that is more specific and earlier intervention on the individual basis. Furthermore, this study will investigate and address the question why some people develop tendinopathies and others do not when the training volume is equally raised.
- Conditions
- Tendinopathy
- Being tested
- Training
- Keywords
- Achilles tendon, Patella tendon, Inflammation, Edema, Clinical, Structural
- Medical subject headings
- Tendinopathy, Inflammation, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
Also called Long slow strength training
Long slow strength training of the tendon for 3 months to improve function
| Study group | Role | What they receive |
|---|---|---|
| Tendinopathy | Long slow strength training for 3 months that are performed at home or gym. Participants receive initial guidance to the exercises from a physiotherapist assigned to Bispebjerg H. Receives: Other: Training | |
| Healthy | No intervention. No training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate the timespan of inflammation from acute phase to resolution in tendinopathy
Markers for inflammation includes tendon thickness, vascularization, inflammatory mRNA leves, inflammatory protein signals and mechanical properties of tendon.
Measured: 3 months
Secondary outcomes (6)
Measure tendon thickness in mm (anterior-posterior) on ultrasound
Measured: 3 months
Measure TNF-alpha mRNA levels in patella biopsies as ratio to GAPDH
GAPDH is a household gene and therefore expected to have constant mRNA levels. TNF-alpha mRNA is measured relative to GAPDH.
Measured: 3 months
Measure the tendon region with maximal vascularization on ultrasound doppler signal based on visual impression from the investigators
The region with maximal vascularization is based on where the ultrasound doppler signal is most abundant, which depends on visual impression from the investigators.
Measured: 3 months
IHC stain for TNF-alpha protein signal in patella biopsies with specific antibodies
Quantification is made by visual inspection of stained tendon samples
Measured: 3 month
Measure tendon mechanical properties with ultrasound isometric
Tracking software provide details about deformation of tendon in mm, young modulus, max % strain and stiffness.
Measured: 3 months
Measure CRP levels in blood samples
Systemic inflammation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2019 (estimated)
- Study completionJun 2020 (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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Peter Hung Thanh Tran, Bispebjerg Hospital
- Investigators
- Michael Kjær, Professor, Study director, Clinical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797925
- Sponsor's protocol ID
- BBH-128
- Acronym
- TESINaC
- Status last verified
- Jan 2018
- First submitted
- 2 Jun 2016
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms Behind Development of Tendinopathy: Early Structural, Inflammatory, Nociceptive and Clinical Changes in Recreational Runners
- ClinicalTrials.gov ID
- NCT02797925
- Acronym / sponsor ID
- TESINaC / BBH-128
- Conditions
- Tendinopathy
- Keywords
- Achilles tendon, Patella tendon, Inflammation, Edema, Clinical, Structural
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Jun 2016
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 14 Jun 2016 (estimated)
- 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.
There has been an increasing amount of musculoskeletal injuries the past decades and overused tendons represents a major problem both for leisure and occupational activities. A full understanding of the pathophysiology of tendinopathy is very sparse and especially the early events in tendinopathy remains unexplained. In this phd study the investigators will investigate early changes in tendon tissue overloading and development of tendinopathy. The investigators will investigate sports-active individuals with recently developed tendinopathy with regards to symptoms (pain, function), tendon morphology (ultrasonography, MRI and electron microscopy), tendon mechanical properties (ultrasonography strain), tissue molecular biology (expression and content of matrix proteins), inflammation (activity of inflammatory pathways) and vascularization (Doppler and contrast enhancement US). The investigators hypothesize a coupling between early symptoms and inflammatory activity, followed by structural changes and altered mechanical properties. The investigation will indicate what symptoms and what tendon related determined measurements are primary for disease development ("tendinopathy blue prints") and should be regarding vital in prevention of tendinopathy.
Detailed description
The investigators intend to study the development of tendinopathy in humans that enter a phase of relative overloading of their tendons. This will be done in a large cohort of individuals from whom the investigators have obtained basic data and tests. A percentage of these participants will develop overuse symptoms and in those the investigators will perform investigations that will identify the initial pathological changes in tendinopathy
Participants are included as soon as possible after diagnosis of either Achilles or patella 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 hyper-metabolism.
Recruiting participants will be done in collaboration with local athletic clubs in the Copenhagen area. The athletic clubs include Sparta, Københavns Idræt Forening (KIF), Frederiksberg Idræt Forening (FIF). Furthermore, the investigators will establish contact through online social media such as Facebook, Twitter and Google. In addition, Information leaflets will be handed out, and medical staff at the emergency rooms repeatedly informed about the project. Healthy participants can be directly recruited by participants already in the project, social medias and through information leaflets handed out. It is planned to inform staff at the emergency rooms at Bispebjerg Hospital, Amager Hospital, Gentofte Hospital, Herlev Hospital and Hvidovre Hospital. Patients and healthy controls can contact the primary investigator directly through email or telephone.
Recruitment to project TESINaC will focus onset of exercise pain and every participant will be evaluated by a doctor if the participant have tendinopathy or not. Once included the participant will undergo following procedures as soon as possible after diagnosis is given:
- Questionnaire regarding training history and ongoing symptoms
- Ultrasound scanning of tendons
- Ultrasound isometric
- Blood samples
- MRI of tendons on both legs MRI precedes biopsy as it can identify any diseased area within the tendon from which a biopsy can be taken. Only participants with tendinopathy will have to undergo biopsy from both patella tendons once during the project. Healthy participants will not undergo biopsy. No biopsy will be taken from the Achilles tendon as this procedure may worsen the participants symptoms.
Participants with tendinopaty will get physical reevaluated after 3, 6 and 12 months as regards to symptoms, activity of daily life, blood samples, questionnaires VISA-A/P and ultrasound measurements. Rehabilitation training of patients is expected to start as soon as possible after the biopsy have been taken.
Healthy participants will not be reevaluated nor will they undergo rehabilitation training.
It is expected that the results from this study will provide insight into the events leading up to a developing tendinopati. This study will add important information to understand the pathophysiology and provide information on timing of the phases as well. Information and results from the study will give insight into better treatment options that is more specific and earlier intervention on the individual basis. Furthermore, this study will investigate and address the question why some people develop tendinopathies and others do not when the training volume is equally raised.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tendinopathy | – | Other: TrainingLong slow strength training for 3 months that are performed at home or gym. Participants receive initial guidance to the exercises from a physiotherapist assigned to Bispebjerg H. |
| Healthy | – | –No intervention. No training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Physical active participants over 18 years old, both men and women. The term physical active refers to any kind of sport and not only running. Participants with pain in either Achilles or patellar tendon on one leg. Healthy participants must be symptom free and not have any diseases at all.
Key inclusion criteria (3 listed)
- Marked tendon related pain in association with exercise on one leg
- Soreness during physical examination of patella or/and Achilles tendon upon palpation
- Demonstrate an ultrasonographic (US) thickening of the tendon (2 mm larger 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 patella tendon
- History of Achilles and/or patella tendinopathy
- Received any form of injection in Achilles and/or patella tendon
- Lately have infection around Achilles and/or patella 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 |
|---|---|---|
| TrainingAlso: Long slow strength trainingLong slow strength training of the tendon for 3 months to improve function | Other | Tendinopathy |
Primary outcome
Investigate the timespan of inflammation from acute phase to resolution in tendinopathy
Time frame: 3 months
Markers for inflammation includes tendon thickness, vascularization, inflammatory mRNA leves, inflammatory protein signals and mechanical properties of tendon.
6 secondary outcomes
Measure tendon thickness in mm (anterior-posterior) on ultrasound
Time frame: 3 months
Measure TNF-alpha mRNA levels in patella biopsies as ratio to GAPDH
Time frame: 3 months
Measure the tendon region with maximal vascularization on ultrasound doppler signal based on visual impression from the investigators
Time frame: 3 months
IHC stain for TNF-alpha protein signal in patella biopsies with specific antibodies
Time frame: 3 month
Measure tendon mechanical properties with ultrasound isometric
Time frame: 3 months
Measure CRP levels in blood samples
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Tendinopathy
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
RecruitingObservational study
Effectiveness and Safety of OSTENIL® TENDON in the Treatment of Pain and Restricted Mobility in Tendon Disorders
Tendinopathy
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
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.
Michael Kjær, Professor study director
Clinical Medicine
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 19 Jan 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 Peter Tran, Doctor (+45 27428164, Tesinac2016@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigate the timespan of inflammation from acute phase to resolution in tendinopathy (time frame: 3 months). 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 19 Jan 2018.