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RecruitingNCT06145646Updated Oct 20, 2026

Intramuscular Temperature on the Echo-textural Characteristics

An interventional study of Muscle warm-up in Healthy Subjects, sponsored by Cardenal Herrera University. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Cardenal Herrera University · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Nov 2023; still recruiting 2 years 11 months later.
Updated Oct 20, 2026Primary completion movedStudy completion moved+2 moreGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Subjects

Keywords

  • muscle
  • temperature
  • texture
  • ultrasound
  • echo intensity
03

In context

Lead sponsor

Cardenal Herrera University is the lead sponsor of 108 studies on the registry; 22 are open to participants now.

Browse Cardenal Herrera University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Muscle temperature

    Heating the vastus lateralis of the right quadriceps using microwaves

    Device: Muscle warm-up

Interventions

  • DeviceMuscle 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.

06

What researchers measure

Primary outcomes

  1. 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.)

    Time frame: During intervention

  2. 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.)

    Time frame: During intervention

  3. Muscle energy or second angular momentum.

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

    Time frame: During intervention

  4. Muscle homogeneity.

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

    Time frame: During intervention

  5. Contrast.

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

    Time frame: During intervention

  6. Textural Correlation.

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

    Time frame: During intervention

  7. Entropy.

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

    Time frame: During intervention

  8. 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.

    Time frame: Pre-intervention

  9. Muscle temperature (ºC).

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

    Time frame: Pre-intervention and during intervention

Secondary outcomes

  1. Age (years)

    Subject's age (years)

    Time frame: Pre-intervention

  2. Sex (female or male)

    Subject's sex (female or male)

    Time frame: Pre-intervention

  3. Dominance

    Dominant leg (right-left)

    Time frame: Pre-intervention

  4. Body mass index

    It is a measure of body fat based on height and weight that applies to adult men and women

    Time frame: Pre-intervention

07

Study locations

1 of 1 sites recruiting
  • Sergio Montero Navarro
    Elche, ALICANTE 03203, Spain
    Recruiting
08

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 12598487 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — 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.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Nov 2023 (actual). Primary completion is estimated for Jun 2027, 42 months after the start.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 20, 2026: primary completion Feb 2026 → Jun 2027 and completion Apr 2026 → Jun 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Nov 17, 2023
First posted
Nov 24, 2023
StartActual
Nov 30, 2023
Primary completionEst.
Jun 1, 2027was Feb 2026
CompletionEst.
Jun 20, 2027was Apr 2026
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added, 1 site removed
Show site
  • Sergio Montero Navarro · Elche, Spain
Show 1 removed
  • Sergio Montero Navarro · Elche, Spain
Oct 20, 2026
Primary completion
Feb 1, 2026→Jun 1, 2027
Oct 20, 2026
Study completion
Apr 20, 2026→Jun 20, 2027
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    1 site added, 1 site removed
    Show site
    • Sergio Montero Navarro · Elche, Spain
    Show 1 removed
    • Sergio Montero Navarro · Elche, Spain
    Primary completion Feb 1, 2026→Jun 1, 2027
    Study completion Apr 20, 2026→Jun 20, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06145646
Lead sponsor
Cardenal Herrera University
Responsible party
SERGIO MONTERO NAVARRO (Principal Investigator, Cardenal Herrera University) — Principal investigator
First posted
Nov 24, 2023
Start date
Nov 30, 2023
Primary completion
Jun 1, 2027 (estimated)
Completion
Jun 20, 2027 (estimated)
Last update
Oct 20, 2026

Study contacts

Javier Molina-Payá, PhD
Contact
francisco.molina@uchceu.es
965426486 ext. 67804
Sergio Montero-Navarro, PhD
Contact
sergio.montero@uchceu.es
965426486 ext. 67704

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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