Evaluation of Thermographic Images of Healthy Volunteers for the Analysis of Physiological Knee Temperature

NCT07559734 | Completed

• 1 other identifier: Thermo-Young
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The Thermo-Young study is a a cross-sectional observational study of healthy volunteers of both sexes. This study aims to assess the temperature of various areas of the knee using thermographic imaging. The aim of the study is to analyze thermographic images of the knees of healthy volunteers in order to establish reference values for the field, while examining the influence of gender and physical exercise on these values.

Conditions

Knee Temperature

Keywords

healthy volunteers; thermography; Knee thermography

Outcome Measures

Primary Outcomes (3)

• Total knee temperature

  The average skin temperature of the entire knee will be measured, along with the minimum and maximum temperatures

  baseline

• Temperature of the knee regions of interest

  The average skin temperature will be measured, along with the minimum and maximum temperatures of the regions of interest on the knee, divided into the medial, lateral, patellar, and suprapatellar areas.

  baseline

• Tegner Activity Level Scale

  t allows for the estimation of a subject's level of physical activity using a score ranging from 0 to 10, where 0 represents "inability" and 10 represents "participation in competitive sports, such as soccer at the national or international level." This score is the most commonly used measure to assess the level of physical activity in patients with knee disorders. In the study, the Tegner Score will be completed directly by the investigator through an interview.

  baseline

Interventions

Knee thermography OTHER

All 60 patients will undergo thermographic evaluation of the knees

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

healthy volunteers

You may qualify if:

• Male or female patients aged 18 to 35;
• No history of previous surgery on either knee;
• No history of direct or indirect trauma to either knee in the preceding six months;
• Absence of knee symptoms (VAS pain score of 0) and no history of acute or chronic knee pain in either knee;
• BMI between 18.5 kg/m² and 30.0 kg/m²

You may not qualify if:

• Consumption of hot beverages or alcohol within 4 hours prior to the measurement;
• Use of anti-inflammatory medications within 48 hours prior;
• No strenuous physical activity within 48 hours prior to the thermographic evaluation;
• No history of cardiovascular disease;
• Skin inflammation in the knee area;
• Chronic ligament injuries to the knee;
• Advanced cartilage lesions according to the Outerbridge classification (Grade IV);
• Incorrect axial alignment of the lower limb;
• Local or systemic infection;
• Systemic administration of corticosteroids or immunosuppressive drugs within 30 days prior to the measurement;
• history of rheumatoid arthritis, inflammatory arthritis, or autoimmune diseases;
• neurological disorders or conditions that may compromise the research protocol;
• pregnancy.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (13)

• Fernandes Ade A, Amorim PR, Brito CJ, Sillero-Quintana M, Bouzas Marins JC. Regional Skin Temperature Response to Moderate Aerobic Exercise Measured by Infrared Thermography. Asian J Sports Med. 2016 Mar 1;7(1):e29243. doi: 10.5812/asjsm.29243. eCollection 2016 Mar.

  PMID: 27217931 BACKGROUND

• Merla A, Mattei PA, Di Donato L, Romani GL. Thermal imaging of cutaneous temperature modifications in runners during graded exercise. Ann Biomed Eng. 2010 Jan;38(1):158-63. doi: 10.1007/s10439-009-9809-8. Epub 2009 Oct 2.

  PMID: 19798579 BACKGROUND

• Lahiri BB, Bagavathiappan S, Jayakumar T, Philip J. Medical applications of infrared thermography: A review. Infrared Phys Technol. 2012 Jul;55(4):221-235. doi: 10.1016/j.infrared.2012.03.007. Epub 2012 Apr 13.

  PMID: 32288544 BACKGROUND

• Ramirez-GarciaLuna JL, Bartlett R, Arriaga-Caballero JE, Fraser RDJ, Saiko G. Infrared Thermography in Wound Care, Surgery, and Sports Medicine: A Review. Front Physiol. 2022 Mar 3;13:838528. doi: 10.3389/fphys.2022.838528. eCollection 2022.

  PMID: 35309080 BACKGROUND

• Ahn SM, Chun JH, Hong S, Lee CK, Yoo B, Oh JS, Kim YG. The Value of Thermal Imaging for Knee Arthritis: A Single-Center Observational Study. Yonsei Med J. 2022 Feb;63(2):141-147. doi: 10.3349/ymj.2022.63.2.141.

  PMID: 35083899 BACKGROUND

• Umapathy S, Thulasi R, Gupta N, Sivanadhan S. Thermography and colour Doppler ultrasound: a potential complementary diagnostic tool in evaluation of rheumatoid arthritis in the knee region. Biomed Tech (Berl). 2020 May 26;65(3):289-299. doi: 10.1515/bmt-2019-0051.

  PMID: 31821162 BACKGROUND

• Bardhan S, Bhowmik MK. 2-Stage classification of knee joint thermograms for rheumatoid arthritis prediction in subclinical inflammation. Australas Phys Eng Sci Med. 2019 Mar;42(1):259-277. doi: 10.1007/s13246-019-00726-9. Epub 2019 Jan 31.

  PMID: 30706334 BACKGROUND

• Formenti D, Ludwig N, Trecroci A, Gargano M, Michielon G, Caumo A, Alberti G. Dynamics of thermographic skin temperature response during squat exercise at two different speeds. J Therm Biol. 2016 Jul;59:58-63. doi: 10.1016/j.jtherbio.2016.04.013. Epub 2016 May 10.

  PMID: 27264889 BACKGROUND

• Priego Quesada JI, Carpes FP, Bini RR, Salvador Palmer R, Perez-Soriano P, Cibrian Ortiz de Anda RM. Relationship between skin temperature and muscle activation during incremental cycle exercise. J Therm Biol. 2015 Feb;48:28-35. doi: 10.1016/j.jtherbio.2014.12.005. Epub 2014 Dec 13.

  PMID: 25660627 BACKGROUND

• Vujcic M, Nedeljkovic R. Thermography in the detection and follow up of chondromalacia patellae. Ann Rheum Dis. 1991 Dec;50(12):921-5. doi: 10.1136/ard.50.12.921.

  PMID: 1768161 BACKGROUND

• Menard HA, Paquette D. Skin temperature of the knee: an unrecognized physical sign of inflammatory disease of the knee. Can Med Assoc J. 1980 Feb 23;122(4):439-40. No abstract available.

  PMID: 7370847 BACKGROUND

• Denoble AE, Hall N, Pieper CF, Kraus VB. Patellar skin surface temperature by thermography reflects knee osteoarthritis severity. Clin Med Insights Arthritis Musculoskelet Disord. 2010 Oct 15;3:69-75. doi: 10.4137/CMAMD.S5916.

  PMID: 21151853 BACKGROUND

• Neves EB, Salamunes ACC, de Oliveira RM, Stadnik AMW. Effect of body fat and gender on body temperature distribution. J Therm Biol. 2017 Dec;70(Pt B):1-8. doi: 10.1016/j.jtherbio.2017.10.017. Epub 2017 Oct 27.

  PMID: 29108552 BACKGROUND

Study Officials

• Alessandro Di Martino, MD

  IRCCS Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 30, 2026
• Study Start: February 2, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

IT (1)