An interventional study of Intratendon vascularization in Patellar Tendinitis, sponsored by Cardenal Herrera University. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Cardenal Herrera University · Not applicable, Interventional, and Other
In the sports field, patellar tendinopathy is, as a pathology, one of the main concerns for athletes, both because of its incidence and because of the difficulty involved in their recovery. At the ultrasound level, tendinopathies can be divided, depending on the presence or absence of an intratendon Doppler signal, into hypervascular or hypovascular tendinopathy. Its classification is, today and clinically speaking, merely qualitative through the observation of the explorer. The ultrasound evaluation is carried out through a probe that is placed on the patient's skin, the procedure to be followed to obtain a vascular image is merely operator-dependent, that is, the position of the probe, the pressure exerted on the skin or even ultrasound optimization parameters can drastically modify the results.
Due to high pressure on the probe, the intratendon Doppler signal may be diminished in the quantitative variables of area, number of signals, pixel intensity, perimeter, solidity, perfusion index, circularity, major and minor diameter.
From a certain pressure on the probe, the intratendon Doppler signal can be drastically altered.
This study will try to evaluate the influence of the pressure exerted by the examiner with the probe on the quantitative variables of the intratendon Doppler signal in patellar tendinopathy.
To carry out the study, a single group with patellar tendinopathy will be established. Ultrasound evaluations with Doppler mode will be performed on the tendon using different probe pressures, monitoring the applied force and recording the images obtained for later analysis.
413 studies on the registry are indexed under Tendinopathy; 64 are open to participants now.
This study's enrollment of 30 is below the median of 50 across 339 interventional studies indexed under Tendinopathy.
Browse Tendinopathy studies →Cardenal Herrera University is the lead sponsor of 104 studies on the registry; 23 are open to participants now.
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Intratendon vascularization will be quantified using a proprietary methodology using ImageJ 1.47v image analysis software, determining the different variables related to the Doppler signal within an intratendon region of interest.
Procedure: Intratendon vascularization
Ultrasonic exploration by power-Doppler of the intratratendon vascularization, making longitudinal cuts of the patellar tendon and with previously pre-established Doppler optimization parameters for all patients. The optimization parameters of the power-Doppler signal will be set at a Doppler frequency of 6.7 MHz, pulse repetition frequency (PRF) of 0.7 kHz. The lowest wall filter and a standardized gain just below the level that produces random noise will be applied. This examination will be repeated several times with different probe pressures, which will be quantitatively adjusted through the force sensor and maintained with the articulated arm. A 4-second static video will be recorded of the longitudinal section that presents a higher Doppler signal in each of the scans at different probe pressures.
number of signals (n)
number of intratendon doppler signals (unit)
Time frame: during intervention
Average pixel intensity (0-255 Units on a scale)
average pixel color intensity (0-255 Units on a scale)
Time frame: during intervention
Area (mm^2)
intratendon Doppler signal area (mm\^2)
Time frame: during intervention
Perimeter (mm)
perimeter of the intratendon Doopler signal (mm)
Time frame: during intervention
major diameter (mm)
major diameter of the intratendon Doppler signal (mm)
Time frame: during intervention
minor diameter (mm)
minor diameter of the intratendon Doppler signal (mm)
Time frame: during intervention
Circularity
measure of roundness or circularity, area-to perimeter ratio. (0-1 Units on a scale)
Time frame: during intervention
Solidity
measures the density of an object (0-1 Units on a scale)
Time frame: during intervention
Resistance index
resistance index of intratendon Doppler signals (0-1 Units on a scale)
Time frame: during intervention
Force
force applied by the probe on the knee during the scan (N)
Time frame: during intervention
Age (years)
subject's age (years)
Time frame: Post-intervention
Sex (female or male)
subject's sex (female or male)
Time frame: post-intervention
Time of evolution (months)
time since the patient had the first symptoms (months)
Time frame: months
Dominance
Dominant leg (right-left)
Time frame: post-intervention
Pain location
Location of pain in the patellar tendon (lower pole of the patella-body of the tendon-insertion in the anterior tuberosity of the tibia)
Time frame: Immediately pre-intervention
Victorian Institute of Sport Assessment-Patella (VISA-P)
Knee pain and function rating scale (0-100 Units on a scale). The maximum score possible is 100 points and represents an asymptomatic athlete who can fully engage in sports. The theoretical minimum is 0 point. The test is carried out just before the intervention to relate the results of the Doppler quantification with the severity of the pain.
Time frame: Immediately pre-intervention
hours of training (hours)
Current training hours per week (hours). This question is asked just before the intervention in order to relate the results of the Doppler quantification with the hours of training performed
Time frame: Immediately pre-intervention
Time without training (months)
time without training (months). This question is asked just before the intervention.
Time frame: Immediately pre-intervention
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Cardenal Herrera University