Patellar TendinopathyNCT07095738
Textural Analysis and Effect of ROI Size on Infrared Thermography in Athletes With Patellar Tendinopathy
An observational study of Patellar Tendinopathy and Diagnostic Accuracy, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
Patellar tendinopathy (PT) is a common knee disorder, particularly among elite athletes, with a reported prevalence of approximately 14.2%. Athletes affected by PT may experience persistent pain, functional impairment, reduced quality of life, decreased physical performance, and even premature career termination. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Patellar Tendinopathy, Diagnostic Accuracy, Infrared Thermography
- What is being tested?
- thermal images (IT)
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2025to 19 Sep 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All participants will be instructed not to engage in physical exercise; not to drink alcohol, coffee, or energy drinks 12 hours prior to measurements; not to smoke in the 6 hours prior to measurements; not to apply creams or lotions to their legs to avoid altering skin emissivity; to report any medication or treatments they were taking; and to try to avoid altering their rest and meal habits. These requirements minimise the influence of individual extrinsic factors on the IT results.
Who may be able to join
- Specific functional tests.
- Ultrasound evaluation.
- Symptom evolution time of more than 3 months.
- A VISA-P score of less than 80.
- The performance of a differential diagnosis to rule out other potential causes of anterior knee pain.
Who cannot join
- Lower limb pathology.
- Nerve or vascular disorder, or skin lesion in the knee area that could alter thermal information in the patellar tendon region.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Textural Analysis and Effect of ROI Size on Infrared Thermography in Athletes With Patellar Tendinopathy. A Cross-sectional Study
Patellar tendinopathy (PT) is a common knee disorder, particularly among elite athletes, with a reported prevalence of approximately 14.2%. Athletes affected by PT may experience persistent pain, functional impairment, reduced quality of life, decreased physical performance, and even premature career termination. Diagnosing PT remains challenging due to the absence of a gold standard diagnostic method. Although imaging techniques such as ultrasonography (US) and magnetic resonance imaging (MRI) can aid in confirming the diagnosis and assessing severity, MRI is costly and less accessible, and US shows poor correlation with clinical symptoms. Consequently, diagnosis largely relies on clinical examination and medical history. Infrared thermography (IT) has emerged as a potential alternative imaging technique, offering a low-cost, reliable, and non-invasive method to detect thermal asymmetries indicative of underlying pathologies. Technological advancements have enhanced the precision of IT, reducing the thermal asymmetry threshold from 2-3 ºC in the 1970s to 0.5 ºC in current knee assessments. First-order statistics, such as mean gray intensity, and second-order features based on the gray-level co-occurrence matrix (GLCM), have been extensively used in medical image analysis, including IT, to quantify structural and textural characteristics. The size of the region of interest (ROI) is also a critical factor in thermal and texture analyses, as it can influence sensitivity and diagnostic accuracy. Given these considerations, the objectives of this study were: (1) to evaluate differences in thermal and GLCM-based textural features between athletes with PT and healthy controls; (2) to compare the diagnostic performance of IT and GLCM features applied to thermographic images; and (3) to identify the most appropriate ROI size for optimal characterization of PT using both thermal and textural analysis.
- Being tested
- thermal images (IT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thermal images (IT)Diagnostic test
The IT images were recorded with an OPTRIS PI 450 IRT camera coupled to Optris PI Connect Software (Germany). The IRT camera has a Noise Equivalent Temperature Difference <40 mK with 38º x 29º FOV, a wide range of temperature from -20°C to +100°C, spectrum range of 7.5-13 μm, focal plane array sensor size of 382 × 288 pixels, emissivity set at 0.98 and a measurement uncertainty of ± 2% of the overall temperature reading. The size of the capture frame will be 55.4 × 40.63 cm (1.5 mm/px).
| Study group | Role | What they receive |
|---|---|---|
| athletes with unilateral PT | diagnosed through a combination of clinical criteria, specific functional tests, and ultrasound evaluation. Additional inclusion criteria for this group include a symptom evolution time of more than 3 months, a VISA-P score of less than 80, and the performance of a differential diagnosis to rule out other potential causes of anterior knee pain Receives: Diagnostic Test: thermal images (IT) | |
| healthy volunteer athletes | recruited under the inclusion criteria of no previous history of PT and a VISA-P score of 100 Receives: Diagnostic Test: thermal images (IT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Textural analysis based on the Gray-Level Co-occurrence Matrix (GLCM)
GLCM relies on the angular relationship between neighboring pixels and the distance between them. relies on the angular relationship between neighboring pixels and the distance between them.
Measured: baseline
Energy or angular second moment (ASM)
ASM Measures the uniformity or regularity in the distribution of image values. Higher values indicate greater uniformity in the image.
Measured: baseline
Homogeneity or inverse difference moment (IDM)
IDM reflects the homogeneity of image composition, associated with pixel pairs. Homogeneous images with minimal variations produce high IDM values
Measured: baseline
Contrast (CON)
CON represents the degree of local variations in gray levels within the image.If the variation increases, the contrast increases.
Measured: baseline
Textural correlation (TCOR)
TCOR expresses linear dependencies between gray levels in the image. Regions with similar gray levels tend to exhibit higher values.
Measured: baseline
Entropy (ENT)
Indicates the level of disorder within the image. Homogeneous images result in lower entropy values
Measured: baseline
Secondary outcomes (4)
Age (years)
Measured: baseline
Sex
Measured: baseline
Body Mass index (BMI)
kg/m²
Measured: baseline
time of evolution (months)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Aug 2025
- Primary completion20 Aug 2025
- Study completion19 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellar TendinopathyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 54 participants (actual)
- Target duration
- 1 Day
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
- NCT07095738
- Sponsor's protocol ID
- CE111803
- Status last verified
- Sep 2025
- First submitted
- 23 Jul 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data associated with this paper will be available in the Zenodo repository
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Textural Analysis and Effect of ROI Size on Infrared Thermography in Athletes With Patellar Tendinopathy. A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT07095738
- Acronym / sponsor ID
- CE111803
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 20 Aug 2025 (actual)
- Study completion
- 19 Sep 2025 (actual)
- First posted
- 31 Jul 2025 (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.
Patellar tendinopathy (PT) is a common knee disorder, particularly among elite athletes, with a reported prevalence of approximately 14.2%. Athletes affected by PT may experience persistent pain, functional impairment, reduced quality of life, decreased physical performance, and even premature career termination. Diagnosing PT remains challenging due to the absence of a gold standard diagnostic method. Although imaging techniques such as ultrasonography (US) and magnetic resonance imaging (MRI) can aid in confirming the diagnosis and assessing severity, MRI is costly and less accessible, and US shows poor correlation with clinical symptoms. Consequently, diagnosis largely relies on clinical examination and medical history. Infrared thermography (IT) has emerged as a potential alternative imaging technique, offering a low-cost, reliable, and non-invasive method to detect thermal asymmetries indicative of underlying pathologies. Technological advancements have enhanced the precision of IT, reducing the thermal asymmetry threshold from 2-3 ºC in the 1970s to 0.5 ºC in current knee assessments. First-order statistics, such as mean gray intensity, and second-order features based on the gray-level co-occurrence matrix (GLCM), have been extensively used in medical image analysis, including IT, to quantify structural and textural characteristics. The size of the region of interest (ROI) is also a critical factor in thermal and texture analyses, as it can influence sensitivity and diagnostic accuracy. Given these considerations, the objectives of this study were: (1) to evaluate differences in thermal and GLCM-based textural features between athletes with PT and healthy controls; (2) to compare the diagnostic performance of IT and GLCM features applied to thermographic images; and (3) to identify the most appropriate ROI size for optimal characterization of PT using both thermal and textural analysis.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| athletes with unilateral PT | – | Diagnostic Test: thermal images (IT)diagnosed through a combination of clinical criteria, specific functional tests, and ultrasound evaluation. Additional inclusion criteria for this group include a symptom evolution time of more than 3 months, a VISA-P score of less than 80, and the performance of a differential diagnosis to rule out other potential causes of anterior knee pain |
| healthy volunteer athletes | – | Diagnostic Test: thermal images (IT)recruited under the inclusion criteria of no previous history of PT and a VISA-P score of 100 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All participants will be instructed not to engage in physical exercise; not to drink alcohol, coffee, or energy drinks 12 hours prior to measurements; not to smoke in the 6 hours prior to measurements; not to apply creams or lotions to their legs to avoid altering skin emissivity; to report any medication or treatments they were taking; and to try to avoid altering their rest and meal habits. These requirements minimise the influence of individual extrinsic factors on the IT results.
Key inclusion criteria (5 listed)
- Specific functional tests.
- Ultrasound evaluation.
- Symptom evolution time of more than 3 months.
- A VISA-P score of less than 80.
- The performance of a differential diagnosis to rule out other potential causes of anterior knee pain.
Key exclusion criteria (2 listed)
- Lower limb pathology.
- Nerve or vascular disorder, or skin lesion in the knee area that could alter thermal information in the patellar tendon region.
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 |
|---|---|---|
| thermal images (IT)The IT images were recorded with an OPTRIS PI 450 IRT camera coupled to Optris PI Connect Software (Germany). The IRT camera has a Noise Equivalent Temperature Difference <40 mK with 38º x 29º FOV, a wide range of temperature from -20°C to +100°C, spectrum range of 7.5-13 μm, focal plane array sensor size of 382 × 288 pixels, emissivity set at 0.98 and a measurement uncertainty of ± 2% of the overall temperature reading. The size of the capture frame will be 55.4 × 40.63 cm (1.5 mm/px). | Diagnostic test | athletes with unilateral PT, healthy volunteer athletes |
Primary outcome
Textural analysis based on the Gray-Level Co-occurrence Matrix (GLCM)
Time frame: baseline
GLCM relies on the angular relationship between neighboring pixels and the distance between them. relies on the angular relationship between neighboring pixels and the distance between them.
Energy or angular second moment (ASM)
Time frame: baseline
ASM Measures the uniformity or regularity in the distribution of image values. Higher values indicate greater uniformity in the image.
Homogeneity or inverse difference moment (IDM)
Time frame: baseline
IDM reflects the homogeneity of image composition, associated with pixel pairs. Homogeneous images with minimal variations produce high IDM values
Contrast (CON)
Time frame: baseline
CON represents the degree of local variations in gray levels within the image.If the variation increases, the contrast increases.
Textural correlation (TCOR)
Time frame: baseline
TCOR expresses linear dependencies between gray levels in the image. Regions with similar gray levels tend to exhibit higher values.
Entropy (ENT)
Time frame: baseline
Indicates the level of disorder within the image. Homogeneous images result in lower entropy values
4 secondary outcomes
Age (years)
Time frame: baseline
Sex
Time frame: baseline
Body Mass index (BMI)
Time frame: baseline
time of evolution (months)
Time frame: baseline
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 24 Sep 2025.
- Group investigationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The data associated with this paper will be available in the Zenodo repository
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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?
An observational study of Patellar Tendinopathy and Diagnostic Accuracy, 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 5 inclusion and 2 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 24 Sep 2025. 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?
Textural analysis based on the Gray-Level Co-occurrence Matrix (GLCM) (time frame: baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2025.