Healthy SubjectsNCT06145646
Intramuscular Temperature on the Echo-textural Characteristics
A study testing Muscle warm-up in people with Healthy Subjects, run by Cardenal Herrera University at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Muscle warm-up
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 30 Nov 2023to 20 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Acceptance of participation in the study.
- Healthy subjects.
- Subjects between the ages of 18 and 65.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Sergio Montero Navarro
Elche, ALICANTE, 03203
SERGIO MONTERO NAVARRO, PhD, 651472265, sergio.montero@uchceu.es
About this study
Official title: 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.
- Conditions
- Healthy Subjects
- Being tested
- Muscle warm-up
- Keywords
- muscle, temperature, texture, ultrasound, echo intensity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle warm-upDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Muscle temperature | Experimental | Heating the vastus lateralis of the right quadriceps using microwaves Receives: Device: Muscle warm-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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.)
Measured: During intervention
Muscle energy or second angular momentum.
It is a second order parameter (GLCM) that measures textural uniformity of the muscle ROI
Measured: During intervention
Muscle homogeneity.
It is a second-order parameter (GLCM) that measures the uniformity of the muscle ROI composition.
Measured: During intervention
Contrast.
It is a second-order parameter (GLCM) that measures local variations in gray levels of the muscle ROI.
Measured: During intervention
Textural Correlation.
It is a second-order parameter (GLCM) that expresses linear gray-level dependencies of the muscle ROI.
Measured: During intervention
Entropy.
It is a second-order parameter (GLCM) to measure muscle ROI disorder.
Measured: 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.
Measured: Pre-intervention
Muscle temperature (ºC).
Measurement of intramuscular temperature of the right vastus lateralis of the quadriceps (ºC)
Measured: Pre-intervention and during intervention
Secondary outcomes (4)
Age (years)
Subject's age (years)
Measured: Pre-intervention
Sex (female or male)
Subject's sex (female or male)
Measured: Pre-intervention
Dominance
Dominant leg (right-left)
Measured: Pre-intervention
Body mass index
It is a measure of body fat based on height and weight that applies to adult men and women
Measured: Pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start30 Nov 2023
- Primary completion1 Jun 2027 (estimated)
- Study completion20 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SERGIO MONTERO NAVARRO, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145646
- Sponsor's protocol ID
- CEEI23_453
- Status last verified
- Oct 2026
- First submitted
- 17 Nov 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 28126635Young 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 25787260Pillen 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 19081667Teixeira 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 24630851Pinto 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 36355345Kenny 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 at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Intramuscular Temperature on the Textural Characteristics of the B-mode Ultrasound Image.
- ClinicalTrials.gov ID
- NCT06145646
- Acronym / sponsor ID
- CEEI23_453
- Conditions
- Healthy Subjects
- Keywords
- muscle, temperature, texture, ultrasound, echo intensity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 20 Jun 2027 (estimated)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Muscle temperature | Experimental | Device: Muscle warm-upHeating the vastus lateralis of the right quadriceps using microwaves |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acceptance of participation in the study.
- Healthy subjects.
- Subjects between the ages of 18 and 65.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle warm-upPassive 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. | Device | Muscle temperature |
Primary outcome
Muscle echointensity (0-255 a.u.).
Time frame: 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.).
Time frame: 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.
Time frame: During intervention
It is a second order parameter (GLCM) that measures textural uniformity of the muscle ROI
Muscle homogeneity.
Time frame: During intervention
It is a second-order parameter (GLCM) that measures the uniformity of the muscle ROI composition.
Contrast.
Time frame: During intervention
It is a second-order parameter (GLCM) that measures local variations in gray levels of the muscle ROI.
Textural Correlation.
Time frame: During intervention
It is a second-order parameter (GLCM) that expresses linear gray-level dependencies of the muscle ROI.
Entropy.
Time frame: During intervention
It is a second-order parameter (GLCM) to measure muscle ROI disorder.
Echointensity correction factor for adipose thickness
Time frame: 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).
Time frame: Pre-intervention and during intervention
Measurement of intramuscular temperature of the right vastus lateralis of the quadriceps (ºC)
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Background: PubMed 28126635Akima 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.
- Background: PubMed 25787260Young 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.
- Background: PubMed 19081667Pillen 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.
- Background: PubMed 24630851Teixeira 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.
- Background: PubMed 36355345Pinto 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.
- Background: PubMed 12598487Kenny 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.
- 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 SpainLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle warm-up in people with Healthy Subjects, run by Cardenal Herrera University at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Javier Molina-Payá, PhD (965426486 ext. 67804, francisco.molina@uchceu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle echointensity (0-255 a.u.). (time frame: During intervention). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06145646, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026; AzTrials last refreshed its copy on 29 Oct 2026.