ElastographyNCT03509337
Changes in the Ulnar Tissues by Shear-wave Elastography
An observational study of Elastography and Soft Tissue, run by Guadarrama Hospital at 1 site in Spain.
Trial summary
A single-center, observational, prospective, single cohort study with before-after design. Evaluation by shear-wave elastography, measured in kilopascals (KPa), of the muscle, tendon and cubital nerve, before and after the maneuver of putting in tension of the ulnar nerve. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Elastography, Soft Tissue, Muscle Tonus
- What is being tested?
- shear-wave elastography
- How many people
- 39 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2018to 1 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers recruited among the students of the Francisco de Vitoria University.
Who may be able to join
- Francisco de Vitoria University student.
- Age between 18 and 26 years old.
Who cannot join
- History of neuropathies in upper limbs.
- Slight neck pain in the last 6 months of traumatic origin.
- Neck pain in the last 3 months.
- episodes of moderate / severe neck pain in the last year.
- History of fracture or dislocation in the upper extremity.
- Surgical history in the upper extremity.
- Cervical symptomatology or upper limb at the present time.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in the Tension of the Flexor Carpi Ulnar Muscle With the Tensioning of the Ulnar Nerve by Shear-wave Elastography: a Pilot Study
A single-center, observational, prospective, single cohort study with before-after design. Evaluation by shear-wave elastography, measured in kilopascals (KPa), of the muscle, tendon and cubital nerve, before and after the maneuver of putting in tension of the ulnar nerve.
Read the detailed description
Once each subject has signed the informed consent document and it has been verified that the inclusion criteria are met, it will be assigned the same identification number (ID) that is related to its Clinical History (CH) by simple coding; custody of the file with the relationship of each ID with its CH will be the responsibility of the principal investigator.
Body placement: The participants will be placed in the supine position with the hips and knees bent, in such a way that the soles of the feet rest on the plane of the stretcher. the palm of the hand of the left extremity will rest on the abdomen and the head in a neutral position, with the maximum relaxation of the sternocleidomastoids.
Upper limb placement: The right extremity will be placed in abduction of 90°, the elbow to flexion of 10° and the forearm to 30° of supination. Wrist and joints metacarpophalangic (mcf), proximal interphalangeal (ifp) and distal interphalangeal (ifp) of the first three fingers in full extension. The articulations mcf, ifp, ifd of the fourth and fifth fingers in a relaxed position. In this position, the first ultrasound measurement will be taken.
Tension maneuver of the ulnar nerve: An expert researcher in mobilization of neural tissue will perform an extension of fourth and fifth finger, respecting the initial parameters that are maintained in position by the splint. To do this, he will use the index and middle of his left hand and make a contact on the palmar side of the fingers and a back pressure with the thumb on the back of the hand. Next, it will extend the fingers until the exponential resistance following the path of elastic deformation (linear resistance) of the tensioned tissues is perceived. At this time the new ultrasound record will be made.
Ultrasound records: A Toshiba ai800 ultrasound scanner (Toshiba Medical Corporation, Japan) with a multifrequency linear probe plt-1005bt 14l5 (5-14 Mhz) will be used. The identification number (ID) registered in the ultrasound will correspond to the participant number.
The same researcher, with experience in the acquisition and management of medical images, will perform the ultrasound and in-line measurements of the images obtained.
The ultrasound will be obtained in a pre and post-median situation after the neural tension put on by the expert investigator in manual therapy and a label will be consigned in the images indicating if the acquisition was "pre" or "post".
To perform the acquisition of the images the probe wil be positioned on the skin of the forearm with minimal pressure and with angulation such that there is no anisotropy. The anatomical region where the myotendinous junction of the flexor carpi ulnaris muscle and the ulnar nerve is observed will be searched transversally. the parameters of emission power, general gain, depth of the image, position of the focus and frequency of emission will be adapted to obtain a quality image. The protocol will be the following:
- 2d image in transverse plane.
- 2d image in longitudinal plane.
- Shear-wave elastography in longitudinal plane.
- Measurement of the images: They will be carried out off-line using the elastography software of the team itself once all the participants have been explored. three regions of interest (ROIs) adjacent to each other will be established in the body of the ulnar nerve, three in the distal area of the flexor carpi ulnaris muscle and three in the tendinous body of the same muscle. The size of the ROI should include the entire body of the mentioned structures.
- The average value of the three ROIs will be written down in units of pressure (KPa).
- Conditions
- Elastography, Soft Tissue, Muscle Tonus
- Being tested
- shear-wave elastography
- Keywords
- Elastography, Nervous tissue, Muscle tonus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shear-wave elastographyDiagnostic test
Measurement by shear-wave elastography of the nerve, muscle and ulnar tendon before and after the tension of the ulnar nerve
What is being measured
The primary outcome is the main question the study is designed to answer.
elastographic soft tissue tension (KPa)
Tension (KPa) in the nerve, muscle and ulnar tendon measured by elastography shear-wave before and after putting the ulnar nerve in tension
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start1 May 2018
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ElastographyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guadarrama Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Francisco de Vitoria
- Responsible party
- Principal investigator, J. Nicolas Cuenca Zaldivar, Guadarrama Hospital
- Investigators
- J. Nicolas Cuenca Zaldivar, Principal investigator, Guadarrama Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509337
- Sponsor's protocol ID
- 3.0
- Status last verified
- Aug 2018
- First submitted
- 17 Apr 2018
- Last updated
- 4 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The statistical analysis plan and the analytical code will be available in .html and .rmd format as well as the file with the raw data.
Publications
Alvarez-Gonzalez J, Digerolamo G, Cuenca-Zaldivar N, Vicente-Campos D, Sanchez-Jorge S, Keough E, Pilat A. Epimuscular myofascial force transmission between nerve and myotendinous unit: A shear-wave elastography study. J Bodyw Mov Ther. 2024 Oct;40:1349-1355. doi: 10.1016/j.jbmt.2024.07.050. Epub 2024 Jul 22.
PubMed 39593456
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in the Tension of the Flexor Carpi Ulnar Muscle With the Tensioning of the Ulnar Nerve by Shear-wave Elastography: a Pilot Study
- ClinicalTrials.gov ID
- NCT03509337
- Acronym / sponsor ID
- 3.0
- Conditions
- Elastography, Soft Tissue, Muscle Tonus
- Keywords
- Elastography, Nervous tissue, Muscle tonus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Guadarrama HospitalUniversity, hospital or other
- Collaborators
- Universidad Francisco de Vitoria
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 26 Apr 2018 (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.
A single-center, observational, prospective, single cohort study with before-after design. Evaluation by shear-wave elastography, measured in kilopascals (KPa), of the muscle, tendon and cubital nerve, before and after the maneuver of putting in tension of the ulnar nerve.
Detailed description
Once each subject has signed the informed consent document and it has been verified that the inclusion criteria are met, it will be assigned the same identification number (ID) that is related to its Clinical History (CH) by simple coding; custody of the file with the relationship of each ID with its CH will be the responsibility of the principal investigator.
Body placement: The participants will be placed in the supine position with the hips and knees bent, in such a way that the soles of the feet rest on the plane of the stretcher. the palm of the hand of the left extremity will rest on the abdomen and the head in a neutral position, with the maximum relaxation of the sternocleidomastoids.
Upper limb placement: The right extremity will be placed in abduction of 90°, the elbow to flexion of 10° and the forearm to 30° of supination. Wrist and joints metacarpophalangic (mcf), proximal interphalangeal (ifp) and distal interphalangeal (ifp) of the first three fingers in full extension. The articulations mcf, ifp, ifd of the fourth and fifth fingers in a relaxed position. In this position, the first ultrasound measurement will be taken.
Tension maneuver of the ulnar nerve: An expert researcher in mobilization of neural tissue will perform an extension of fourth and fifth finger, respecting the initial parameters that are maintained in position by the splint. To do this, he will use the index and middle of his left hand and make a contact on the palmar side of the fingers and a back pressure with the thumb on the back of the hand. Next, it will extend the fingers until the exponential resistance following the path of elastic deformation (linear resistance) of the tensioned tissues is perceived. At this time the new ultrasound record will be made.
Ultrasound records: A Toshiba ai800 ultrasound scanner (Toshiba Medical Corporation, Japan) with a multifrequency linear probe plt-1005bt 14l5 (5-14 Mhz) will be used. The identification number (ID) registered in the ultrasound will correspond to the participant number.
The same researcher, with experience in the acquisition and management of medical images, will perform the ultrasound and in-line measurements of the images obtained.
The ultrasound will be obtained in a pre and post-median situation after the neural tension put on by the expert investigator in manual therapy and a label will be consigned in the images indicating if the acquisition was "pre" or "post".
To perform the acquisition of the images the probe wil be positioned on the skin of the forearm with minimal pressure and with angulation such that there is no anisotropy. The anatomical region where the myotendinous junction of the flexor carpi ulnaris muscle and the ulnar nerve is observed will be searched transversally. the parameters of emission power, general gain, depth of the image, position of the focus and frequency of emission will be adapted to obtain a quality image. The protocol will be the following:
- 2d image in transverse plane.
- 2d image in longitudinal plane.
- Shear-wave elastography in longitudinal plane.
- Measurement of the images: They will be carried out off-line using the elastography software of the team itself once all the participants have been explored. three regions of interest (ROIs) adjacent to each other will be established in the body of the ulnar nerve, three in the distal area of the flexor carpi ulnaris muscle and three in the tendinous body of the same muscle. The size of the ROI should include the entire body of the mentioned structures.
- The average value of the three ROIs will be written down in units of pressure (KPa).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers recruited among the students of the Francisco de Vitoria University.
Key inclusion criteria (2 listed)
- Francisco de Vitoria University student.
- Age between 18 and 26 years old.
Key exclusion criteria (7 listed)
- History of neuropathies in upper limbs.
- Slight neck pain in the last 6 months of traumatic origin.
- Neck pain in the last 3 months.
- episodes of moderate / severe neck pain in the last year.
- History of fracture or dislocation in the upper extremity.
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 |
|---|---|---|
| shear-wave elastographyMeasurement by shear-wave elastography of the nerve, muscle and ulnar tendon before and after the tension of the ulnar nerve | Diagnostic test | – |
Primary outcome
elastographic soft tissue tension (KPa)
Time frame: 1 day
Tension (KPa) in the nerve, muscle and ulnar tendon measured by elastography shear-wave before and after putting the ulnar nerve in tension
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
- Derived from this study: PubMed 39593456Alvarez-Gonzalez J, Digerolamo G, Cuenca-Zaldivar N, Vicente-Campos D, Sanchez-Jorge S, Keough E, Pilat A. Epimuscular myofascial force transmission between nerve and myotendinous unit: A shear-wave elastography study. J Bodyw Mov Ther. 2024 Oct;40:1349-1355. doi: 10.1016/j.jbmt.2024.07.050. Epub 2024 Jul 22.
- Individual participant dataSharing planned: Yes. The statistical analysis plan and the analytical code will be available in .html and .rmd format as well as the file with the raw data.
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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. This study is not recruiting at the moment.
J. Nicolas Cuenca Zaldivar principal investigator
Guadarrama Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elastography and Soft Tissue, run by Guadarrama Hospital 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 4 Sep 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
elastographic soft tissue tension (KPa) (time frame: 1 day). 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 NCT03509337, which also lists 1 linked publication.
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 4 Sep 2018.