Intramuscular Temperature on the Echo-textural Characteristics

Sponsor

Cardenal Herrera University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06145646

Collaborator

(none)

Enrollment

Arm

2.1

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Device: Muscle warm-up	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Nov 30, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Muscle echointensity (0-255 a.u.). [During intervention]
Muscle echointensity is calculated by the mean gray level value of the muscle Range of Interest (ROI). (0-255 a.u.)
Muscle echovariance (0-255 a.u.). [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.)
Muscle energy or second angular momentum. [During intervention]
It is a second order parameter (GLCM) that measures textural uniformity of the muscle ROI
Muscle homogeneity. [During intervention]
It is a second-order parameter (GLCM) that measures the uniformity of the muscle ROI composition.
Contrast. [During intervention]
It is a second-order parameter (GLCM) that measures local variations in gray levels of the muscle ROI.
Textural Correlation. [During intervention]
It is a second-order parameter (GLCM) that expresses linear gray-level dependencies of the muscle ROI.
Entropy. [During intervention]
It is a second-order parameter (GLCM) to measure muscle ROI disorder.
Echointensity correction factor for adipose thickness [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.
Muscle temperature (ºC). [Pre-intervention and during intervention]
Measurement of intramuscular temperature of the right vastus lateralis of the quadriceps (ºC)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.