About this trial
The goal of this observational study is to test whether a new ultrasound method, called SUper Resolution ultrasound imaging of Erythrocytes (SURE), can image the small blood vessels found in tendons of persons with a tendon overuse injury (tendinopathy). The main questions it aims to answer are:
* Is the method sensitive enough to detect the smallest blood vessels * What information about the blood flow can be obtained (flow velocity, pressure, shape of the vessels) * Can the flow in an injured tendon be distinguished from that of a healthy one
Participants will receive a non-invasive ultrasound examination of their Achilles (heel) or patellar (knee) tendon, using an advanced high frequency research ultrasound system.
Researchers will compare participants with either an Achilles or patellar tendon overuse injury to participants with healthy tendons, to see if there are distinct differences in the blood vessels that could help diagnose and treat the injuries.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18 to 70 years of age.
BMI below 30.
Able to lie still for 1 minute.
Capable of providing signed informed consent.
Disqualifiers
Pregnancy.
Dementia.
Smoking.
Diabetes.
Trial population
Healthy participants: Persons who have no self-reported current or historical injuries to the tendon and surrounding tissue, and display no symptoms of tendinopathy upon examination. Participants with tendinopathy: Persons who have no self-reported current or historical injuries to the tendon and surrounding tissue, aside from a uni- or bi-lateral tendinopathy of the patellar or Achilles tendon based on two clinical criteria: Tendon pain during physical activity and Tendon pain on local palpation.
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Super-Resolution Ultrasound Imaging of Erythrocytes (SURE)
Diagnostic testResearch ultrasound sequence for tracking erythrocytes and thereby generating a super-resolution image of the vasculature.
Treatment groups
Trial outcomes
Primary outcomes
Vessel density (all)
Mean difference in blood vessel density detected by SURE imaging, between the healthy and tendinopathic group (across both patellar and Achilles).
Secondary outcomes
Repeatability (vessel density)
Intraclass correlation of blood vessel density detected by SURE imaging in repeated ultrasound scans of the same tendon across all participants.
Other outcomes
Vessel density (PT/AT)
Mean difference in blood vessel density detected by SURE imaging, between the healthy and tendinopathic group (within the patellar or Achilles individually).
Other quantifiable measures of microvasculature
To-be-defined quantitative image analysis outcome of the microvasculature (due to the novelty of the method, the exact image analysis pipeline is not yet defined)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Bispebjerg and Frederiksberg
Lead sponsor
Technical University of Denmark
Collaborator