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Ultrasound Probe Pressure on the Intratendon Doppler Signal in Patellar Tendinopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04682496
Recruitment Status : Recruiting
First Posted : December 23, 2020
Last Update Posted : January 26, 2021
Information provided by (Responsible Party):
SERGIO MONTERO NAVARRO, Cardenal Herrera University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Patellar Tendinitis Procedure: Intratendon vascularization Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of the Influence of Ultrasound Probe Pressure on the Intratendon Doppler Signal in Patellar Tendinopathy
Actual Study Start Date : December 18, 2020
Actual Primary Completion Date : January 25, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tendinitis

Arm Intervention/treatment
Experimental: intratendon vascularization
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.

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04682496

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Contact: SERGIO MONTERO-NAVARRO, PhD 965426486 ext 67704

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Ceu Cardenal Herrera University Recruiting
Elche, Alicante, Spain, 03204
Contact: SERGIO MONTERO NAVARRO, PhD    +34651472265   
Contact: SERGIO MONTERO NAVARRO, PhD    651472265   
Sponsors and Collaborators
Cardenal Herrera University
  Study Documents (Full-Text)

Documents provided by SERGIO MONTERO NAVARRO, Cardenal Herrera University:
Additional Information:
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Responsible Party: SERGIO MONTERO NAVARRO, Principal Investigator, Cardenal Herrera University Identifier: NCT04682496    
Other Study ID Numbers: CEI20/073
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries