Clinical trial NCT06145646: Intramuscular Temperature on the Echo-textural Characteristics
Official title: Influence of Intramuscular Temperature on the Textural Characteristics of the B-mode Ultrasound Image.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Subjects
Keywords: muscle
temperature
texture
ultrasound
echo intensity
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2023-11-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Muscle echointensity (0-255 a.u.).
timeFrame: During intervention
measure: Muscle echovariance (0-255 a.u.).
timeFrame: During intervention
measure: Muscle energy or second angular momentum.
timeFrame: During intervention
measure: Muscle homogeneity.
timeFrame: During intervention
measure: Contrast.
timeFrame: During intervention
measure: Textural Correlation.
timeFrame: During intervention
measure: Entropy.
timeFrame: During intervention
measure: Echointensity correction factor for adipose thickness
timeFrame: Pre-intervention
measure: Muscle temperature (ºC).
timeFrame: Pre-intervention and during intervention
Secondary outcomes:
measure: Age (years)
timeFrame: Pre-intervention
measure: Sex (female or male)
timeFrame: Pre-intervention
measure: Dominance
timeFrame: Pre-intervention
measure: Body mass index
timeFrame: Pre-intervention
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Sergio Montero Navarro
state: Alicante
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.