NCT07095738

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2025

Completed
Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

19 days

First QC Date

July 23, 2025

Last Update Submit

September 19, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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

    baseline

  • Contrast (CON)

    CON represents the degree of local variations in gray levels within the image.If the variation increases, the contrast increases.

    baseline

  • Textural correlation (TCOR)

    TCOR expresses linear dependencies between gray levels in the image. Regions with similar gray levels tend to exhibit higher values.

    baseline

  • Entropy (ENT)

    Indicates the level of disorder within the image. Homogeneous images result in lower entropy values

    baseline

Secondary Outcomes (4)

  • Age (years)

    baseline

  • Sex

    baseline

  • Body Mass index (BMI)

    baseline

  • time of evolution (months)

    baseline

Study Arms (2)

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

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

Diagnostic Test: thermal images (IT)

Interventions

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).

athletes with unilateral PThealthy volunteer athletes

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Lower limb pathology.
  • Nerve or vascular disorder, or skin lesion in the knee area that could alter thermal information in the patellar tendon region.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ceu Cardenal Herrera University

Elche, Alicante, 03204, Spain

Location

Related Links

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

July 23, 2025

First Posted

July 31, 2025

Study Start

August 1, 2025

Primary Completion

August 20, 2025

Study Completion

September 19, 2025

Last Updated

September 24, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

The data associated with this paper will be available in the Zenodo repository

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
baseline

Locations