Knee TemperatureNCT07559734
Evaluation of Thermographic Images of Healthy Volunteers for the Analysis of Physiological Knee Temperature
An observational study of Knee Temperature, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Knee Temperature
- What is being tested?
- Knee thermography
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 2 Feb 2024to 30 Dec 2025
- 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 35 years
- All sexes
- Adult
Study population: healthy volunteers
Who may be able to join
- 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
Who cannot join
- 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;
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The study plans to enroll 60 patients-30 women and 30 men-aged 18 to 35 with no history of previous surgery or chronic knee pain. Once informed consent has been obtained from the healthy volunteer, the volunteer will wait for 10 minutes while seated in a temperature-controlled room set at 25°C. A thermographic assessment will then be performed using a FLIRT1020 thermal imaging camera. Images will be captured from the anteroposterior, right lateral, left lateral, and posteroanterior views. The patient will then perform a knee flexion-extension exercise against resistance for 2 minutes using a 2-kg ankle weight. The speed of this exercise will be constant for all subjects, with one repetition per second per leg. Following this exercise, four additional thermographic images identical to the first set will be acquired. Baseline thermographic assessments will be performed at the end of the exercise, and at 2, 5, and 10 minutes after the end of the exercise. Once the images have been acquired, they will be analyzed using ResearchIR software. Regions of interest within the knee will then be defined, and the temperature distribution across the various images will be analyzed, along with how this distribution changes following physical exertion.
- Conditions
- Knee Temperature
- Being tested
- Knee thermography
- Keywords
- healthy volunteers, thermography, Knee thermography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee thermographyOther
All 60 patients will undergo thermographic evaluation of the knees
What is being measured
The primary outcome is the main question the study is designed to answer.
Total knee temperature
The average skin temperature of the entire knee will be measured, along with the minimum and maximum temperatures
Measured: 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.
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start2 Feb 2024
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Knee TemperatureStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessandro Di Martino, MD, Principal investigator, IRCCS Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559734
- Sponsor's protocol ID
- Thermo-Young
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27217931Merla 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.
PubMed 19798579Lahiri 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.
PubMed 32288544Ramirez-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.
PubMed 35309080Ahn 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.
PubMed 35083899Umapathy 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.
PubMed 31821162Bardhan 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.
PubMed 30706334Formenti 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.
PubMed 27264889Priego 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.
PubMed 25660627Vujcic 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.
PubMed 1768161Menard 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.
PubMed 7370847Denoble 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.
PubMed 21151853Neves 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.
PubMed 29108552
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Thermographic Images of Healthy Volunteers for the Analysis of Physiological Knee Temperature
- ClinicalTrials.gov ID
- NCT07559734
- Acronym / sponsor ID
- Thermo-Young
- Conditions
- Knee Temperature
- Keywords
- healthy volunteers, thermography, Knee thermography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 30 Apr 2026 (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.
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.
Detailed description
The study plans to enroll 60 patients-30 women and 30 men-aged 18 to 35 with no history of previous surgery or chronic knee pain. Once informed consent has been obtained from the healthy volunteer, the volunteer will wait for 10 minutes while seated in a temperature-controlled room set at 25°C. A thermographic assessment will then be performed using a FLIRT1020 thermal imaging camera. Images will be captured from the anteroposterior, right lateral, left lateral, and posteroanterior views. The patient will then perform a knee flexion-extension exercise against resistance for 2 minutes using a 2-kg ankle weight. The speed of this exercise will be constant for all subjects, with one repetition per second per leg. Following this exercise, four additional thermographic images identical to the first set will be acquired. Baseline thermographic assessments will be performed at the end of the exercise, and at 2, 5, and 10 minutes after the end of the exercise. Once the images have been acquired, they will be analyzed using ResearchIR software. Regions of interest within the knee will then be defined, and the temperature distribution across the various images will be analyzed, along with how this distribution changes following physical exertion.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Age groups
- Adult
- Study population
- healthy volunteers
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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;
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 |
|---|---|---|
| Knee thermographyAll 60 patients will undergo thermographic evaluation of the knees | Other | – |
Primary outcome
Total knee temperature
Time frame: baseline
The average skin temperature of the entire knee will be measured, along with the minimum and maximum temperatures
Temperature of the knee regions of interest
Time frame: baseline
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.
Tegner Activity Level Scale
Time frame: baseline
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.
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 30 Apr 2026.
- Background: PubMed 27217931Fernandes 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.
- Background: PubMed 19798579Merla 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.
- Background: PubMed 32288544Lahiri 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.
- Background: PubMed 35309080Ramirez-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.
- Background: PubMed 35083899Ahn 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.
- Background: PubMed 31821162Umapathy 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.
- Background: PubMed 30706334Bardhan 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.
- Background: PubMed 27264889Formenti 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.
- Background: PubMed 25660627Priego 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.
- Background: PubMed 1768161Vujcic 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.
- Background: PubMed 7370847Menard 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.
- Background: PubMed 21151853Denoble 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.
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Compassion
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.
Alessandro Di Martino, MD principal investigator
IRCCS Istituto Ortopedico Rizzoli
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 Knee Temperature, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 13 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 30 Apr 2026. 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 Italy. 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?
Total knee temperature (time frame: baseline). The study lists 3 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 NCT07559734, which also lists 13 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 30 Apr 2026.