Evaluation of Thermographic Images of Healthy Volunteers for the Analysis of Physiological Knee Temperature
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total knee temperature
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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;
结局指标
主要结局
Total knee temperature
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点