Ultrasound Probe Pressure on the Intratendon Doppler Signal in Patellar Tendinopathy

Patellar Tendinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04682496
• Other study ID #: CEI20/073
• Status: Completed
• Phase: N/A
• Start date: December 18, 2020
• Est. completion date: February 7, 2023

Study information

• Verified date: February 2023
• Source: Cardenal Herrera University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 7, 2023
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Patellar Tendinitis
• Tendinopathy

Intervention

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.

Locations

Country	Name	City	State
Spain	Ceu Cardenal Herrera University	Elche	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Cardenal Herrera University

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of signals (n)	number of intratendon doppler signals (unit)	during intervention
Primary	Average pixel intensity (0-255 Units on a scale)	average pixel color intensity (0-255 Units on a scale)	during intervention
Primary	Area (mm^2)	intratendon Doppler signal area (mm^2)	during intervention
Primary	Perimeter (mm)	perimeter of the intratendon Doopler signal (mm)	during intervention
Primary	major diameter (mm)	major diameter of the intratendon Doppler signal (mm)	during intervention
Primary	minor diameter (mm)	minor diameter of the intratendon Doppler signal (mm)	during intervention
Primary	Circularity	measure of roundness or circularity, area-to perimeter ratio. (0-1 Units on a scale)	during intervention
Primary	Solidity	measures the density of an object (0-1 Units on a scale)	during intervention
Primary	Resistance index	resistance index of intratendon Doppler signals (0-1 Units on a scale)	during intervention
Primary	Force	force applied by the probe on the knee during the scan (N)	during intervention
Secondary	Age (years)	subject's age (years)	Post-intervention
Secondary	Sex (female or male)	subject's sex (female or male)	post-intervention
Secondary	Time of evolution (months)	time since the patient had the first symptoms (months)	months
Secondary	Dominance	Dominant leg (right-left)	post-intervention
Secondary	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)	Immediately pre-intervention
Secondary	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.	Immediately pre-intervention
Secondary	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	Immediately pre-intervention
Secondary	Time without training (months)	time without training (months). This question is asked just before the intervention.	Immediately pre-intervention

External 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