Ultrasound Probe Pressure on the Intratendon Doppler Signal in Patellar Tendinopathy

NCT04682496 | Completed

• 1 other identifier: CEI20/073
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Patellar Tendinitis

Outcome Measures

Primary Outcomes (10)

• number of signals (n)

  number of intratendon doppler signals (unit)

  during intervention

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

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

  during intervention

• Area (mm^2)

  intratendon Doppler signal area (mm\^2)

  during intervention

• Perimeter (mm)

  perimeter of the intratendon Doopler signal (mm)

  during intervention

• major diameter (mm)

  major diameter of the intratendon Doppler signal (mm)

  during intervention

• minor diameter (mm)

  minor diameter of the intratendon Doppler signal (mm)

  during intervention

• Circularity

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

  during intervention

• Solidity

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

  during intervention

• Resistance index

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

  during intervention

• Force

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

  during intervention

Secondary Outcomes (8)

• Age (years)

  Post-intervention

• Sex (female or male)

  post-intervention

• Time of evolution (months)

  months

• Dominance

  post-intervention

• Pain location

  Immediately pre-intervention

Study Arms (1)

intratendon vascularization

EXPERIMENTAL

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

Interventions

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.

intratendon vascularization

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardenal Herrera University: lead

Study Sites (1)

Ceu Cardenal Herrera University

Elche, Alicante, 03204, Spain

Location

Related Publications (4)

• Hernandez-Sanchez S, Hidalgo MD, Gomez A. Cross-cultural adaptation of VISA-P score for patellar tendinopathy in Spanish population. J Orthop Sports Phys Ther. 2011 Aug;41(8):581-91. doi: 10.2519/jospt.2011.3613. Epub 2011 Jul 12.

  PMID: 21765223 BACKGROUND

• Dhyani M, Roll SC, Gilbertson MW, Orlowski M, Anvari A, Li Q, Anthony B, Samir AE. A pilot study to precisely quantify forces applied by sonographers while scanning: A step toward reducing ergonomic injury. Work. 2017;58(2):241-247. doi: 10.3233/WOR-172611.

  PMID: 28922185 BACKGROUND

• Malliaras P, Chan O, Simran G, Martinez de Albornoz P, Morrissey D, Maffulli N. Doppler ultrasound signal in Achilles tendinopathy reduces immediately after activity. Int J Sports Med. 2012 Jun;33(6):480-4. doi: 10.1055/s-0032-1304636. Epub 2012 Apr 12.

  PMID: 22499574 BACKGROUND

• Boesen AP, Boesen MI, Torp-Pedersen S, Christensen R, Boesen L, Holmich P, Nielsen MB, Koenig MJ, Hartkopp A, Ellegaard K, Bliddal H, Langberg H. Associations between abnormal ultrasound color Doppler measures and tendon pain symptoms in badminton players during a season: a prospective cohort study. Am J Sports Med. 2012 Mar;40(3):548-55. doi: 10.1177/0363546511435478. Epub 2012 Feb 9.

  PMID: 22328709 BACKGROUND

Related Links

• The University CEU-Cardenal Herrera is th first private university in the Valencian Community. It belongs to the Foundation San Pablo - CEU and is the leading educational organization in Spain with three Universities all over Spain

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 23, 2020
• Study Start: December 18, 2020
• Primary Completion: August 30, 2022
• Study Completion: February 7, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

ES (1)