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Recruiting NCT06145646

Intramuscular Temperature on the Echo-textural Characteristics

No phase Interventional Healthy Subjects

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In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Muscle warm-up.
Who it may be relevant to
Registry conditions: Healthy Subjects. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Muscle echointensity (0-255 a.u.). [Time frame: During intervention]
  • Muscle echovariance (0-255 a.u.). [Time frame: During intervention]
  • Muscle energy or second angular momentum. [Time frame: During intervention]
  • Muscle homogeneity. [Time frame: During intervention]
  • Contrast. [Time frame: During intervention]
  • Textural Correlation. [Time frame: During intervention]
  • Entropy. [Time frame: During intervention]
  • Echointensity correction factor for adipose thickness [Time frame: Pre-intervention]
  • Muscle temperature (ºC). [Time frame: Pre-intervention and during intervention]
Secondary outcome measures (4)
  • Age (years) [Time frame: Pre-intervention]
  • Sex (female or male) [Time frame: Pre-intervention]
  • Dominance [Time frame: Pre-intervention]
  • Body mass index [Time frame: Pre-intervention]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Spain · 1 center
  • Sergio Montero Navarro — Elche

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT06145646 · CEEI23_453

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗