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Intramuscular Temperature on the Echo-textural Characteristics

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated January 22, 2026 (before its estimated February 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Primary completion date: Dec 1, 2023 to Feb 1, 2026
    • Study completion date: Dec 1, 2025 to Apr 20, 2026
    v6
  2. Minor Study completion date: Dec 1, 2024 to Dec 1, 2025v5
  3. Minor Study completion date: Jun 1, 2024 to Dec 1, 2024v4
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Study completion date: Feb 1, 2024 to Jun 1, 2024
    v3
  5. Minor Eligibility criteria revisedv2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Echointensity and echotexture have been used as a physiological marker for changes in skeletal muscle quality and structure caused by physical training, low activity, ageing and some neuromuscular disorders. However, there are some influencing factors on muscle echo-intensity and echotexture, such as temperature, which may not be taken into account when performing an ultrasound assessment and may alter the results. This study aims to investigate the effects of muscle temperature on echointensity and other 2nd order echotextures variables such as homogeneity, contrast, correlation and entropy of muscle tissue, in order to gain a better understanding of this correlation and minimise its influence, which would allow greater precision in the use of muscle ultrasound as a diagnostic tool. The methodology of this study includes firstly the acquisition of ultrasound images of the vastus lateralis muscle. This acquisition will be performed during the continuous recording of muscle temperature, carried out during a passive cooling process after 20 min of heating using microwave equipment. In addition, to standardise the results, a correction factor will be calculated to compensate for the influence of subcutaneous adipose tissue thickness on echogenicity and echotexture.
Trial Details
NCT Number NCT06145646
Lead Sponsor Cardenal Herrera University
Conditions
(from sponsor)
Healthy Subjects
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov