Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06145646

Intramuscular Temperature on the Echo-textural Characteristics

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Healthy Subjects

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sergio Montero Navarro

Elche, Alicante, 03203, Spain

Location status: Recruiting

Location contact

SERGIO MONTERO NAVARRO, PhD

CONTACT

[email protected]

651472265

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acceptance of participation in the study.
  • Healthy subjects.
  • Subjects between the ages of 18 and 65.

Exclusion criteria

  • Have known neurological, cardiovascular, metabolic or orthopedic conditions that prevent them from participating in the study.
  • Present metal implants in the heating area.
  • Wear a pacemaker.
  • Perform physical activity during the 48 hours prior to data collection.
  • Contraindications of dry needling such as: Belonephobia, history of abnormal reaction to the puncture or injection, anticoagulant treatment or thrombocytopenia, lymphedema over the area of intervention, severely compromised immune system, vascular diseases, diabetes mellitus, pregnancy, epilepsy, allergy to metals or that the intervention area has wounds, scars, tattoos, or stains.

Treatment and study plan

Muscle warm-up

Device

Passive heating of the vastus lateralis of the right quadriceps will be performed using a microwave device. The device will be set at a power of 150 W and a distance of 10-15 cm from the skin surface for 20 minutes with the purpose of increasing local muscle temperature to 40 ºC.

Primary outcomes

  1. Muscle echointensity (0-255 a.u.).

    Time frame: During intervention

    Muscle echointensity is calculated by the mean gray level value of the muscle Range of Interest (ROI). (0-255 a.u.)

  2. Muscle echovariance (0-255 a.u.).

    Time frame: During intervention

    The echovariance is determined by the relationship between the standard deviation and the average pixel intensity obtained from the histogram of the muscle ROI. (0-255 a.u.)

  3. Muscle energy or second angular momentum.

    Time frame: During intervention

    It is a second order parameter (GLCM) that measures textural uniformity of the muscle ROI

  4. Muscle homogeneity.

    Time frame: During intervention

    It is a second-order parameter (GLCM) that measures the uniformity of the muscle ROI composition.

  5. Contrast.

    Time frame: During intervention

    It is a second-order parameter (GLCM) that measures local variations in gray levels of the muscle ROI.

  6. Textural Correlation.

    Time frame: During intervention

    It is a second-order parameter (GLCM) that expresses linear gray-level dependencies of the muscle ROI.

  7. Entropy.

    Time frame: During intervention

    It is a second-order parameter (GLCM) to measure muscle ROI disorder.

  8. Echointensity correction factor for adipose thickness

    Time frame: Pre-intervention

    The measurement of subcutaneous adipose thickness will be carried out through the average of the distance from the skin to the aponeurosis coinciding with the superficial interface of the muscle and with different pressures of the probe on the skin. This measure will be used to develop a correction factor that allows compensating the influence of this variable on echogenicity and echotexture, standardizing the results.

  9. Muscle temperature (ºC).

    Time frame: Pre-intervention and during intervention

    Measurement of intramuscular temperature of the right vastus lateralis of the quadriceps (ºC)

Secondary outcomes

  1. Age (years)

    Time frame: Pre-intervention

    Subject's age (years)

  2. Sex (female or male)

    Time frame: Pre-intervention

    Subject's sex (female or male)

  3. Dominance

    Time frame: Pre-intervention

    Dominant leg (right-left)

  4. Body mass index

    Time frame: Pre-intervention

    It is a measure of body fat based on height and weight that applies to adult men and women

Study contacts

Contact information is provided by the study sponsor or research team.

Javier Molina-Payá, PhD

CONTACT

[email protected]

965426486 ext. 67804

Sergio Montero-Navarro, PhD

CONTACT

[email protected]

965426486 ext. 67704

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Registry information

Official study title

Influence of Intramuscular Temperature on the Textural Characteristics of the B-mode Ultrasound Image.

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 24, 2023
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.