Ultrasound Probe Pressure on the Intratendon Doppler Signal in Patellar Tendinopathy
Primary Purpose
Patellar Tendinitis
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Intratendon vascularization
Sponsored by
About this trial
This is an interventional other trial for Patellar Tendinitis
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.
Sites / Locations
- Ceu Cardenal Herrera University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intratendon vascularization
Arm Description
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.
Outcomes
Primary Outcome Measures
number of signals (n)
number of intratendon doppler signals (unit)
Average pixel intensity (0-255 Units on a scale)
average pixel color intensity (0-255 Units on a scale)
Area (mm^2)
intratendon Doppler signal area (mm^2)
Perimeter (mm)
perimeter of the intratendon Doopler signal (mm)
major diameter (mm)
major diameter of the intratendon Doppler signal (mm)
minor diameter (mm)
minor diameter of the intratendon Doppler signal (mm)
Circularity
measure of roundness or circularity, area-to perimeter ratio. (0-1 Units on a scale)
Solidity
measures the density of an object (0-1 Units on a scale)
Resistance index
resistance index of intratendon Doppler signals (0-1 Units on a scale)
Force
force applied by the probe on the knee during the scan (N)
Secondary Outcome Measures
Age (years)
subject's age (years)
Sex (female or male)
subject's sex (female or male)
Time of evolution (months)
time since the patient had the first symptoms (months)
Dominance
Dominant leg (right-left)
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)
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.
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
Time without training (months)
time without training (months). This question is asked just before the intervention.
Full Information
NCT ID
NCT04682496
First Posted
December 9, 2020
Last Updated
February 7, 2023
Sponsor
Cardenal Herrera University
1. Study Identification
Unique Protocol Identification Number
NCT04682496
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 18, 2020 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
February 7, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardenal Herrera University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellar Tendinitis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intratendon vascularization
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intratendon vascularization
Intervention Description
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 Measure Information:
Title
number of signals (n)
Description
number of intratendon doppler signals (unit)
Time Frame
during intervention
Title
Average pixel intensity (0-255 Units on a scale)
Description
average pixel color intensity (0-255 Units on a scale)
Time Frame
during intervention
Title
Area (mm^2)
Description
intratendon Doppler signal area (mm^2)
Time Frame
during intervention
Title
Perimeter (mm)
Description
perimeter of the intratendon Doopler signal (mm)
Time Frame
during intervention
Title
major diameter (mm)
Description
major diameter of the intratendon Doppler signal (mm)
Time Frame
during intervention
Title
minor diameter (mm)
Description
minor diameter of the intratendon Doppler signal (mm)
Time Frame
during intervention
Title
Circularity
Description
measure of roundness or circularity, area-to perimeter ratio. (0-1 Units on a scale)
Time Frame
during intervention
Title
Solidity
Description
measures the density of an object (0-1 Units on a scale)
Time Frame
during intervention
Title
Resistance index
Description
resistance index of intratendon Doppler signals (0-1 Units on a scale)
Time Frame
during intervention
Title
Force
Description
force applied by the probe on the knee during the scan (N)
Time Frame
during intervention
Secondary Outcome Measure Information:
Title
Age (years)
Description
subject's age (years)
Time Frame
Post-intervention
Title
Sex (female or male)
Description
subject's sex (female or male)
Time Frame
post-intervention
Title
Time of evolution (months)
Description
time since the patient had the first symptoms (months)
Time Frame
months
Title
Dominance
Description
Dominant leg (right-left)
Time Frame
post-intervention
Title
Pain location
Description
Location of pain in the patellar tendon (lower pole of the patella-body of the tendon-insertion in the anterior tuberosity of the tibia)
Time Frame
Immediately pre-intervention
Title
Victorian Institute of Sport Assessment-Patella (VISA-P)
Description
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.
Time Frame
Immediately pre-intervention
Title
hours of training (hours)
Description
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
Time Frame
Immediately pre-intervention
Title
Time without training (months)
Description
time without training (months). This question is asked just before the intervention.
Time Frame
Immediately pre-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Ceu Cardenal Herrera University
City
Elche
State/Province
Alicante
ZIP/Postal Code
03204
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
21765223
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.
Results Reference
background
PubMed Identifier
28922185
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.
Results Reference
background
PubMed Identifier
22499574
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.
Results Reference
background
PubMed Identifier
22328709
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.
Results Reference
background
Links:
URL
http://www.uchceu.es
Description
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
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Ultrasound Probe Pressure on the Intratendon Doppler Signal in Patellar Tendinopathy
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