Patellar TendinitisNCT04682496
Ultrasound Probe Pressure on the Intratendon Doppler Signal in Patellar Tendinopathy
A study testing Intratendon vascularization in people with Patellar Tendinitis, run by Cardenal Herrera University at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Patellar Tendinitis
- What is being tested?
- Intratendon vascularization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 18 Dec 2020to 7 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Influence of Ultrasound Probe Pressure on the Intratendon Doppler Signal in Patellar Tendinopathy
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.
Read more
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
- Being tested
- Intratendon vascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intratendon vascularizationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Intratendon vascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of signals (n)
number of intratendon doppler signals (unit)
Measured: during intervention
Average pixel intensity (0-255 Units on a scale)
average pixel color intensity (0-255 Units on a scale)
Measured: during intervention
Area (mm^2)
intratendon Doppler signal area (mm^2)
Measured: during intervention
Perimeter (mm)
perimeter of the intratendon Doopler signal (mm)
Measured: during intervention
major diameter (mm)
major diameter of the intratendon Doppler signal (mm)
Measured: during intervention
minor diameter (mm)
minor diameter of the intratendon Doppler signal (mm)
Measured: during intervention
Circularity
measure of roundness or circularity, area-to perimeter ratio. (0-1 Units on a scale)
Measured: during intervention
Solidity
measures the density of an object (0-1 Units on a scale)
Measured: during intervention
Resistance index
resistance index of intratendon Doppler signals (0-1 Units on a scale)
Measured: during intervention
Force
force applied by the probe on the knee during the scan (N)
Measured: during intervention
Secondary outcomes (8)
Age (years)
subject's age (years)
Measured: Post-intervention
Sex (female or male)
subject's sex (female or male)
Measured: post-intervention
Time of evolution (months)
time since the patient had the first symptoms (months)
Measured: months
Dominance
Dominant leg (right-left)
Measured: post-intervention
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)
Measured: Immediately pre-intervention
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.
Measured: Immediately pre-intervention
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
Measured: Immediately pre-intervention
Time without training (months)
time without training (months). This question is asked just before the intervention.
Measured: Immediately pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start18 Dec 2020
- Primary completion30 Aug 2022
- Study completion7 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Patellar TendinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SERGIO MONTERO NAVARRO, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682496
- Sponsor's protocol ID
- CEI20/073
- Status last verified
- Feb 2023
- First submitted
- 9 Dec 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21765223Dhyani 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.
PubMed 28922185Malliaras 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.
PubMed 22499574Boesen 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.
PubMed 22328709
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Influence of Ultrasound Probe Pressure on the Intratendon Doppler Signal in Patellar Tendinopathy
- ClinicalTrials.gov ID
- NCT04682496
- Acronym / sponsor ID
- CEI20/073
- Conditions
- Patellar Tendinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 7 Feb 2023 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intratendon vascularization | Experimental | Procedure: Intratendon vascularizationIntratendon 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intratendon vascularizationUltrasonic 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. | Procedure or surgery | intratendon vascularization |
Primary outcome
number of signals (n)
Time frame: during intervention
number of intratendon doppler signals (unit)
Average pixel intensity (0-255 Units on a scale)
Time frame: during intervention
average pixel color intensity (0-255 Units on a scale)
Area (mm^2)
Time frame: during intervention
intratendon Doppler signal area (mm^2)
Perimeter (mm)
Time frame: during intervention
perimeter of the intratendon Doopler signal (mm)
major diameter (mm)
Time frame: during intervention
major diameter of the intratendon Doppler signal (mm)
minor diameter (mm)
Time frame: during intervention
minor diameter of the intratendon Doppler signal (mm)
Circularity
Time frame: during intervention
measure of roundness or circularity, area-to perimeter ratio. (0-1 Units on a scale)
Solidity
Time frame: during intervention
measures the density of an object (0-1 Units on a scale)
Resistance index
Time frame: during intervention
resistance index of intratendon Doppler signals (0-1 Units on a scale)
Force
Time frame: during intervention
force applied by the probe on the knee during the scan (N)
8 secondary outcomes
Age (years)
Time frame: Post-intervention
Sex (female or male)
Time frame: post-intervention
Time of evolution (months)
Time frame: months
Dominance
Time frame: post-intervention
Pain location
Time frame: Immediately pre-intervention
Victorian Institute of Sport Assessment-Patella (VISA-P)
Time frame: Immediately pre-intervention
hours of training (hours)
Time frame: Immediately pre-intervention
Time without training (months)
Time frame: Immediately pre-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Background: PubMed 21765223Hernandez-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.
- Background: PubMed 28922185Dhyani 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.
- Background: PubMed 22499574Malliaras 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.
- Background: PubMed 22328709Boesen 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.
- 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 SpainLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intratendon vascularization in people with Patellar Tendinitis, run by Cardenal Herrera University at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of signals (n) (time frame: during intervention). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04682496, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.