An observational study in Amputees, Amputation and Amputation Stump, sponsored by Baskent University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-10.
Sponsored by Baskent University · Observational
The goal of this observational study is to compare thermographic values in the knee region of the healthy extremity and the amputated extremity and learn about the relationship between thermographic value and pain in the knee region of the amputated extremity. The main questions it aims to answer are:
With amputation, anatomical and vascular changes occur in the distal part of the remaining limb. At this point, for individuals with amputation at the transtibial level, the knee joint in the amputated extremity is of critical importance as it is the most distal joint. While there is evidence that thermal changes observed in the knee region may be related to possible degeneration or pathological processes, there is not enough research on the amputee population. Considering that individuals who have undergone lower extremity amputation are at greater risk than the general population for many health problems and considering the current evidence, we think that the evaluation of skin temperature, which is an indicator of cutaneous circulation, may be an important indicator in taking precautions for degenerative knee diseases. With the planned study, lower extremity temperature profiles and their relationship with knee pain will be evaluated for the first time during the post-amputation period. Thermal infrared non-contact thermometer, which is non-invasive, cheap and easy to apply, will be used for the first time in lower extremity temperature measurements of amputees.
Objectives of the study,
81 studies on the registry are indexed under Neovascularization, Pathologic; 7 are open to participants now.
This study's enrollment of 21 is below the median of 50 across 23 observational studies indexed under Neovascularization, Pathologic.
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Individuals with unilateral transitibial amputation
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Exclusion Criteria:
Skin Temperature
In both knees, 3 measurements will be taken at the center of the patella, the tibialis anterior muscle trunk (10 cm distal to the tibial tubercle and 2 cm lateral to the anterior border of the tibia) and distal to the limb. Room temperature will be recorded simultaneously. Measurements will be recorded in Celsius. The study will follow the recently published 15-point TISEM consensus statement on the measurement of human Tsk. Within the scope of the study, temperature measurements will be performed using a Medisana 48620 Infrared Non-Contact Thermometer (MEDISANA, FTN, Hilden, Germany).
Time frame: 30 minutes
Knee Pain
The presence of pain in both knees, pain intensity and localization of pain will be questioned. To determine the presence of pain sensation in the knee region of the patients, the presence or absence of pain sensation in the knee of the intact and amputated extremity will be questioned. In the presence of pain sensation, the 'Visual Analog Scale' will be used to assess the severity of pain in the intact knee and the amputated knee. For pain intensity assessment with the Visual Analog Scale, a 10 cm long line is drawn. The starting and ending points of the line are numbered 0 and 10. Individuals are asked to mark the intensity of the pain they feel on the scale, indicating that a value of 0 indicates absence of pain and a value of 10 indicates unbearable severe pain. The area marked by the individuals is then measured with a ruler and recorded as pain intensity.
Time frame: 10 minutes
Phantom Sensation and Phantom Pain
The presence of phantom limb sensation will be questioned. If there is phantom limb sensation, individuals will be asked to describe their phantom limb sensation with open-ended questions and to provide information about the position of their limbs (fixed or mobile, in anatomical position or in anatomically impossible position), and whether they feel shortening/shrinking or any other condition in their limbs and the presence of telescope phenomenon will be questioned. The presence or absence of phantom pain will be questioned. If phantom pain is experienced, individuals will be asked to provide information about the area of pain, the frequency/type of pain and to complete the "Short Form Mc-Gill Pain Scale (SF-MPQ)". The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.
Time frame: 20 minutes
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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