Clinical trial NCT04682496: Ultrasound Probe Pressure on the Intratendon Doppler Signal in Patellar Tendinopathy
Official title: Evaluation of the Influence of Ultrasound Probe Pressure on the Intratendon Doppler Signal in Patellar Tendinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellar Tendinitis
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: number of signals (n)
timeFrame: during intervention
measure: Average pixel intensity (0-255 Units on a scale)
timeFrame: during intervention
measure: Area (mm^2)
timeFrame: during intervention
measure: Perimeter (mm)
timeFrame: during intervention
measure: major diameter (mm)
timeFrame: during intervention
measure: minor diameter (mm)
timeFrame: during intervention
measure: Circularity
timeFrame: during intervention
measure: Solidity
timeFrame: during intervention
measure: Resistance index
timeFrame: during intervention
measure: Force
timeFrame: during intervention
Secondary outcomes:
measure: Age (years)
timeFrame: Post-intervention
measure: Sex (female or male)
timeFrame: post-intervention
measure: Time of evolution (months)
timeFrame: months
measure: Dominance
timeFrame: post-intervention
measure: Pain location
timeFrame: Immediately pre-intervention
measure: Victorian Institute of Sport Assessment-Patella (VISA-P)
timeFrame: Immediately pre-intervention
measure: hours of training (hours)
timeFrame: Immediately pre-intervention
measure: Time without training (months)
timeFrame: Immediately pre-intervention
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Ceu Cardenal Herrera University
state: Alicante
Study officials:
References:
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.
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.
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.
citation: 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.