Intramuscular Temperature on the Echo-textural Characteristics

NCT06145646 | Recruiting

• 1 other identifier: CEEI23_453
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Subjects

Keywords

muscle; temperature; texture; ultrasound; echo intensity

Outcome Measures

Primary Outcomes (9)

• Muscle echointensity (0-255 a.u.).

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

  During intervention

• Muscle echovariance (0-255 a.u.).

  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.)

  During intervention

• Muscle energy or second angular momentum.

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

  During intervention

• Muscle homogeneity.

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

  During intervention

• Contrast.

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

  During intervention

• Textural Correlation.

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

  During intervention

• Entropy.

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

  During intervention

• Echointensity correction factor for adipose thickness

  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.

  Pre-intervention

• Muscle temperature (ºC).

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

  Pre-intervention and during intervention

Secondary Outcomes (4)

• Age (years)

  Pre-intervention

• Sex (female or male)

  Pre-intervention

• Dominance

  Pre-intervention

• Body mass index

  Pre-intervention

Study Arms (1)

Muscle temperature

EXPERIMENTAL

Heating the vastus lateralis of the right quadriceps using microwaves

Device: Muscle warm-up

Interventions

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.

Muscle temperature

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardenal Herrera University: lead

Study Sites (1)

Sergio Montero Navarro

Elche, Alicante, 03203, Spain

RECRUITING

Related Publications (6)

• Akima H, Yoshiko A, Tomita A, Ando R, Saito A, Ogawa M, Kondo S, Tanaka NI. Relationship between quadriceps echo intensity and functional and morphological characteristics in older men and women. Arch Gerontol Geriatr. 2017 May-Jun;70:105-111. doi: 10.1016/j.archger.2017.01.014. Epub 2017 Jan 20.

  PMID: 28126635 BACKGROUND

• Young HJ, Jenkins NT, Zhao Q, Mccully KK. Measurement of intramuscular fat by muscle echo intensity. Muscle Nerve. 2015 Dec;52(6):963-71. doi: 10.1002/mus.24656. Epub 2015 Sep 7.

  PMID: 25787260 BACKGROUND

• Pillen S, Tak RO, Zwarts MJ, Lammens MM, Verrijp KN, Arts IM, van der Laak JA, Hoogerbrugge PM, van Engelen BG, Verrips A. Skeletal muscle ultrasound: correlation between fibrous tissue and echo intensity. Ultrasound Med Biol. 2009 Mar;35(3):443-6. doi: 10.1016/j.ultrasmedbio.2008.09.016. Epub 2008 Dec 10.

  PMID: 19081667 BACKGROUND

• Teixeira CA, Alvarenga AV, Cortela G, von Kruger MA, Pereira WC. Feasibility of non-invasive temperature estimation by the assessment of the average gray-level content of B-mode images. Ultrasonics. 2014 Aug;54(6):1692-702. doi: 10.1016/j.ultras.2014.02.021. Epub 2014 Mar 1.

  PMID: 24630851 BACKGROUND

• Pinto MD, Silveira Pinto R, Nosaka K, Blazevich AJ. Do Intramuscular Temperature and Fascicle Angle Affect Ultrasound Echo Intensity Values? Med Sci Sports Exerc. 2023 Apr 1;55(4):740-750. doi: 10.1249/MSS.0000000000003082. Epub 2022 Nov 8.

  PMID: 36355345 BACKGROUND

• Kenny GP, Reardon FD, Zaleski W, Reardon ML, Haman F, Ducharme MB. Muscle temperature transients before, during, and after exercise measured using an intramuscular multisensor probe. J Appl Physiol (1985). 2003 Jun;94(6):2350-7. doi: 10.1152/japplphysiol.01107.2002. Epub 2003 Feb 21.

  PMID: 12598487 BACKGROUND

Related Links

• Description The University CEU-Cardenal Herrera is th first private university in the Valencian Community. It belongs to the Foundation San Pablo - CEU and is the leading educational organization in Spain with three Universities all over Spain

Central Study Contacts

Javier Molina-Payá, PhD

CONTACT

965426486; francisco.molina@uchceu.es

Sergio Montero-Navarro, PhD

CONTACT

965426486; sergio.montero@uchceu.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 24, 2023
• Study Start: November 30, 2023
• Primary Completion: February 1, 2026
• Study Completion: April 20, 2026
• Last Updated: January 22, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)