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Completed

NCT Number: NCT04682496

Ultrasound Probe Pressure on the Intratendon Doppler Signal in Patellar Tendinopathy

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ceu Cardenal Herrera University

Elche, Alicante, 03204, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acceptance of participation in the study.
  • Diagnosis of patellar tendinopathy with the presence of an intratendon Doppler signal.
  • Subjects between the ages of 18 and 65.

Exclusion criteria

  • Present some type of surgical intervention in the region to be explored that could alter in some way the ultrasound evaluation.
  • Refer vascular pathology or the intake of medication that may alter blood flow or density.
  • Having been treated with sclerosing techniques that can alter the perfusion or vascular resistance of the tendon tissue.

Treatment and study plan

Intratendon vascularization

Procedure

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.

Primary outcomes

  1. number of signals (n)

    Time frame: during intervention

    number of intratendon doppler signals (unit)

  2. Average pixel intensity (0-255 Units on a scale)

    Time frame: during intervention

    average pixel color intensity (0-255 Units on a scale)

  3. Area (mm^2)

    Time frame: during intervention

    intratendon Doppler signal area (mm^2)

  4. Perimeter (mm)

    Time frame: during intervention

    perimeter of the intratendon Doopler signal (mm)

  5. major diameter (mm)

    Time frame: during intervention

    major diameter of the intratendon Doppler signal (mm)

  6. minor diameter (mm)

    Time frame: during intervention

    minor diameter of the intratendon Doppler signal (mm)

  7. Circularity

    Time frame: during intervention

    measure of roundness or circularity, area-to perimeter ratio. (0-1 Units on a scale)

  8. Solidity

    Time frame: during intervention

    measures the density of an object (0-1 Units on a scale)

  9. Resistance index

    Time frame: during intervention

    resistance index of intratendon Doppler signals (0-1 Units on a scale)

  10. Force

    Time frame: during intervention

    force applied by the probe on the knee during the scan (N)

Secondary outcomes

  1. Age (years)

    Time frame: Post-intervention

    subject's age (years)

  2. Sex (female or male)

    Time frame: post-intervention

    subject's sex (female or male)

  3. Time of evolution (months)

    Time frame: months

    time since the patient had the first symptoms (months)

  4. Dominance

    Time frame: post-intervention

    Dominant leg (right-left)

  5. Pain location

    Time frame: Immediately pre-intervention

    Location of pain in the patellar tendon (lower pole of the patella-body of the tendon-insertion in the anterior tuberosity of the tibia)

  6. Victorian Institute of Sport Assessment-Patella (VISA-P)

    Time frame: Immediately pre-intervention

    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.

  7. hours of training (hours)

    Time frame: Immediately pre-intervention

    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

  8. Time without training (months)

    Time frame: Immediately pre-intervention

    time without training (months). This question is asked just before the intervention.

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Registry information

Official study title

Evaluation of the Influence of Ultrasound Probe Pressure on the Intratendon Doppler Signal in Patellar Tendinopathy

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Dec 23, 2020
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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