Intramuscular Temperature on the Echo-textural Characteristics

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Subjects
• Intervention / Treatment: Device: Muscle warm-up

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sergio Montero-Navarro, PhD; Phone Number: 67704 965426486; Email: sergio.montero@uchceu.es
• Study Contact Backup: Name: Javier Molina-Payá, PhD; Phone Number: 67804 965426486; Email: francisco.molina@uchceu.es

Study Locations

• Spain
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Recruiting
      • Sergio Montero Navarro
      • Contact: SERGIO MONTERO NAVARRO, PhD; Phone Number: 651472265; Email: sergio.montero@uchceu.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Muscle temperature; Heating the vastus lateralis of the right quadriceps using microwaves	Device: Muscle warm-up; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age (years)	Subject's age (years)	Pre-intervention
Sex (female or male)	Subject's sex (female or male)	Pre-intervention
Dominance	Dominant leg (right-left)	Pre-intervention
Body mass index	It is a measure of body fat based on height and weight that applies to adult men and women	Pre-intervention

Collaborators and Investigators

• Sponsor: Cardenal Herrera University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful 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

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: November 17, 2023
• First Submitted That Met QC Criteria: November 17, 2023
• First Posted (Actual): November 24, 2023

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: ultrasound; muscle; temperature; texture; echo intensity
• Other Study ID Numbers: CEEI23_453

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Access to identified personal information will be restricted to the principal investigator of the study/collaborators, the Research Ethics Committee and authorized personnel, when necessary to verify the data and procedures of the study, but always maintaining their confidentiality in accordance to current legislation.

The personal data of the participants, obtained during their participation in the project, will be kept for the time necessary for the development of this research, which is estimated to be 6 months, and will subsequently be destroyed, and cannot be kept without having previously been anonymized.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No