Tibial NerveNCT06196112
Localization of Vasculonervous Structures in Tibial Nerve Neuromodulation: a Cross-sectional Study
An observational study of Tibial Nerve and Healthy Volunteers, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
Tibial nerve neuromodulation is an effective and widely used technique in various pelvic floor dysfunctions. There are two approaches described in scientific literature to perform this technique: transcutaneous and percutaneous. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tibial Nerve, Healthy Volunteers
- How many people
- 105 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2024to 15 Jul 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing treatment at the Rehabilitation Service and among the workers of Ramón y Cajal University Hospital who meet the selection criteria
Who may be able to join
- Healthy subjects over 18 years of age
Who cannot join
- Previous fracture of the distal end of the right tibia
- Previous vascular pathology of the distal end of the right tibia
- Previous nervous condition of the distal end of the right tibia
- Previous surgical intervention of the distal end of the right tibia
- Ongoing oncological process of the distal end of the right tibia
Trial locations and contacts
1 site in 1 country.
About this study
Tibial nerve neuromodulation is an effective and widely used technique in various pelvic floor dysfunctions. There are two approaches described in scientific literature to perform this technique: transcutaneous and percutaneous. However, there is no consensus on the execution of these techniques, as the location of the tibial nerve in relation to other anatomical structures like the tibia has not been described. The findings of this research could serve as a basis for the implementation and development of protocols aimed at improving the technique of posterior tibial neuromodulation.
Read the detailed description
Design: A cross-sectional observational study at the Physiotherapy Unit of the Ramón y Cajal University Hospital.
The main objective of this study is to determine the location and size of tibial vasculonervous structures (nerve, artery, and vein) in relation to the tibia and skin using ultrasound in healthy subjects Methods: Healthy subjects will participate, and sociodemographic data (age, sex, weight, height) will be collected. Subsequently, various measurements of the right tibial vasculonervous structures will be obtained through ultrasound A single examiner with over 5 years of experience in ultrasound will perform the measurements.
Significance of the research: Knowledge of the position and size of the tibial vasculonervous bundle could be useful to justify and standardize transcutaneous and percutaneous approaches in tibial nerve neuromodulation. This would improve the safety of the technique, avoiding adverse events resulting from the intervention
- Conditions
- Tibial Nerve, Healthy Volunteers
- Keywords
- tibial arteries, ultrasonography, Pelvic Floor Disorders, Transcutaneous Electric Nerve Stimulation
- Medical subject headings
- Pelvic Floor Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Tibial Distance (TD) to the tibial nerve
Subjects will be placed in a right lateral decubitus position on a bed. Seven marks will be made with a dermal marker from the lower edge of the right tibial malleolus, following the medial edge of the tibial bone in the cranial direction. Measurements will be taken at 2, 4, 5, 6, 8, 10, and 12 cm with respect to the lower edge of the tibial malleolus. The most superficial aspect of the tibia will be considered for the measurements.
The measurements will be performed using an ultrasound machine (ALPINIONⓒ, Seoul, South Korea, model ECUBE 8LEⓇ) with a linear probe L3-12T (frequency range 3-12 MHz), using the Rehabilitative Ultrasound Imaging (RUSI) method.
The distance will be measured using a caliper by drawing a straight line from the most medial aspect of the tibia to the most anterior aspect of the nerve, taking into consideration the outer edge of the tibial nerve wall. This will be analyzed at each of the 7 marks previously described
Measured: Day 1
Tibial Distance (TD) to the tibial artery
Subjects will be placed in a right lateral decubitus position on a bed. Seven marks will be made with a dermal marker from the lower edge of the right tibial malleolus, following the medial edge of the tibial bone in the cranial direction. Measurements will be taken at 2, 4, 5, 6, 8, 10, and 12 cm with respect to the lower edge of the tibial malleolus. The most superficial aspect of the tibia will be considered for the measurements.
The measurements will be performed using an ultrasound machine (ALPINIONⓒ, Seoul, South Korea, model ECUBE 8LEⓇ) with a linear probe L3-12T (frequency range 3-12 MHz), using the Rehabilitative Ultrasound Imaging (RUSI) method.
The distance will be measured using a caliper by drawing a straight line from the most medial aspect of the tibia to the most anterior aspect of the artery, taking into consideration the outer edge of the tibial artery wall. This will be analyzed at each of the 7 marks previously described
Measured: Day 1
Tibial Distance (TD) to the tibial vein
Subjects will be placed in a right lateral decubitus position on a bed. Seven marks will be made with a dermal marker from the lower edge of the right tibial malleolus, following the medial edge of the tibial bone in the cranial direction. Measurements will be taken at 2, 4, 5, 6, 8, 10, and 12 cm with respect to the lower edge of the tibial malleolus. The most superficial aspect of the tibia will be considered for the measurements.
The measurements will be performed using an ultrasound machine (ALPINIONⓒ, Seoul, South Korea, model ECUBE 8LEⓇ) with a linear probe L3-12T (frequency range 3-12 MHz), using the Rehabilitative Ultrasound Imaging (RUSI) method.
The distance will be measured using a caliper by drawing a straight line from the most medial aspect of the tibia to the most anterior aspect of the vein, taking into consideration the outer edge of the tibial vein wall. This will be analyzed at each of the 7 marks previously described
Measured: Day 1
Secondary outcomes (9)
Horizontal Tibial Distance to the tibial nerve
The horizontal distance will be collected by drawing a perpendicular line with the caliper from the most medial aspect of the tibia to the most anterior aspect of the nerve, taking into consideration the outer edge of the tibial nerve wall. The measurement will be taken at each of the 7 marks previously described. This measurement will allow for an extrapolation in the implementation of percutaneous techniques
Measured: Day 1
Horizontal Tibial Distance to the tibial artery
The horizontal distance will be collected by drawing a perpendicular line with the caliper from the most medial aspect of the tibia to the most anterior aspect of the artery tibial, taking into consideration the outer edge of the tibial artery wall. The measurement will be taken at each of the 7 marks previously described. This measurement will allow for an extrapolation in the implementation of percutaneous techniques
Measured: Day 1
Horizontal Tibial Distance to the tibial vein
The horizontal distance will be collected by drawing a perpendicular line with the caliper from the most medial aspect of the tibia to the most anterior aspect of the vein, taking into consideration the outer edge of the tibial vein wall. The measurement will be taken at each of the 7 marks previously described. This measurement will allow for an extrapolation in the implementation of percutaneous techniques
Measured: Day 1
Depth of the tibial nerve
Using the ultrasound machine and considering a caliper perpendicular from the most superficial aspect of the skin to the most superficial aspect of the epineurium at each of the 7 previously described marks
Measured: Day 1
Cross-sectional area of the tibial nerve
The cross-sectional area of the nerve will be measured at each of the 7 marks described above using the ultrasound
Measured: Day 1
Cross-sectional area of the tibial artery
The cross-sectional area of the artery will be measured at each of the 7 marks described above using the ultrasound
Measured: Day 1
Cross-sectional area of the tibial vein
The cross-sectional area of the vein will be measured at each of the 7 marks described above using the ultrasound
Measured: Day 1
Overlap between each structure
The overlap between the tibial nerve, artery, and vein will be described at each of the 7 marks previously mentioned
Measured: Day 1
Variability of the tibial vessels
The number of arteries and veins present will be recorded at each of the 7 marks previously described
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start15 Jan 2024
- Primary completion15 Jul 2024
- Study completion15 Jul 2024
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 Tibial NerveStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irene Lázaro Navas, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196112
- Sponsor's protocol ID
- 115/23
- Status last verified
- Aug 2024
- First submitted
- 24 Dec 2023
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lazaro-Navas I, Cervera-Cano M, Pecos-Martin D, Lopez-Gonzalez L, Valcarcel-Linares D. Ultrasound Evaluation of Tibial Vasculonervous Structures for Tibial Nerve Neuromodulation: A Cross-Sectional Study. Neuromodulation. 2025 Dec;28(8):1318-1326. doi: 10.1016/j.neurom.2025.07.010. Epub 2025 Sep 11.
PubMed 40932423
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Localization of Vasculonervous Structures in Tibial Nerve Neuromodulation: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06196112
- Acronym / sponsor ID
- 115/23
- Conditions
- Tibial Nerve, Healthy Volunteers
- Keywords
- tibial arteries, ultrasonography, Pelvic Floor Disorders, Transcutaneous Electric Nerve Stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 9 Jan 2024 (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.
Tibial nerve neuromodulation is an effective and widely used technique in various pelvic floor dysfunctions. There are two approaches described in scientific literature to perform this technique: transcutaneous and percutaneous. However, there is no consensus on the execution of these techniques, as the location of the tibial nerve in relation to other anatomical structures like the tibia has not been described. The findings of this research could serve as a basis for the implementation and development of protocols aimed at improving the technique of posterior tibial neuromodulation.
Detailed description
Design: A cross-sectional observational study at the Physiotherapy Unit of the Ramón y Cajal University Hospital.
The main objective of this study is to determine the location and size of tibial vasculonervous structures (nerve, artery, and vein) in relation to the tibia and skin using ultrasound in healthy subjects Methods: Healthy subjects will participate, and sociodemographic data (age, sex, weight, height) will be collected. Subsequently, various measurements of the right tibial vasculonervous structures will be obtained through ultrasound A single examiner with over 5 years of experience in ultrasound will perform the measurements.
Significance of the research: Knowledge of the position and size of the tibial vasculonervous bundle could be useful to justify and standardize transcutaneous and percutaneous approaches in tibial nerve neuromodulation. This would improve the safety of the technique, avoiding adverse events resulting from the intervention
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing treatment at the Rehabilitation Service and among the workers of Ramón y Cajal University Hospital who meet the selection criteria
Key inclusion criteria (1 listed)
- Healthy subjects over 18 years of age
Key exclusion criteria (5 listed)
- Previous fracture of the distal end of the right tibia
- Previous vascular pathology of the distal end of the right tibia
- Previous nervous condition of the distal end of the right tibia
- Previous surgical intervention of the distal end of the right tibia
- Ongoing oncological process of the distal end of the right tibia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tibial Distance (TD) to the tibial nerve
Time frame: Day 1
Subjects will be placed in a right lateral decubitus position on a bed. Seven marks will be made with a dermal marker from the lower edge of the right tibial malleolus, following the medial edge of the tibial bone in the cranial direction. Measurements will be taken at 2, 4, 5, 6, 8, 10, and 12 cm with respect to the lower edge of the tibial malleolus. The most superficial aspect of the tibia will be considered for the measurements. The measurements will be performed using an ultrasound machine (ALPINIONⓒ, Seoul, South Korea, model ECUBE 8LEⓇ) with a linear probe L3-12T (frequency range 3-12 MHz), using the Rehabilitative Ultrasound Imaging (RUSI) method. The distance will be measured using a caliper by drawing a straight line from the most medial aspect of the tibia to the most anterior aspect of the nerve, taking into consideration the outer edge of the tibial nerve wall. This will be analyzed at each of the 7 marks previously described
Tibial Distance (TD) to the tibial artery
Time frame: Day 1
Subjects will be placed in a right lateral decubitus position on a bed. Seven marks will be made with a dermal marker from the lower edge of the right tibial malleolus, following the medial edge of the tibial bone in the cranial direction. Measurements will be taken at 2, 4, 5, 6, 8, 10, and 12 cm with respect to the lower edge of the tibial malleolus. The most superficial aspect of the tibia will be considered for the measurements. The measurements will be performed using an ultrasound machine (ALPINIONⓒ, Seoul, South Korea, model ECUBE 8LEⓇ) with a linear probe L3-12T (frequency range 3-12 MHz), using the Rehabilitative Ultrasound Imaging (RUSI) method. The distance will be measured using a caliper by drawing a straight line from the most medial aspect of the tibia to the most anterior aspect of the artery, taking into consideration the outer edge of the tibial artery wall. This will be analyzed at each of the 7 marks previously described
Tibial Distance (TD) to the tibial vein
Time frame: Day 1
Subjects will be placed in a right lateral decubitus position on a bed. Seven marks will be made with a dermal marker from the lower edge of the right tibial malleolus, following the medial edge of the tibial bone in the cranial direction. Measurements will be taken at 2, 4, 5, 6, 8, 10, and 12 cm with respect to the lower edge of the tibial malleolus. The most superficial aspect of the tibia will be considered for the measurements. The measurements will be performed using an ultrasound machine (ALPINIONⓒ, Seoul, South Korea, model ECUBE 8LEⓇ) with a linear probe L3-12T (frequency range 3-12 MHz), using the Rehabilitative Ultrasound Imaging (RUSI) method. The distance will be measured using a caliper by drawing a straight line from the most medial aspect of the tibia to the most anterior aspect of the vein, taking into consideration the outer edge of the tibial vein wall. This will be analyzed at each of the 7 marks previously described
9 secondary outcomes
Horizontal Tibial Distance to the tibial nerve
Time frame: Day 1
Horizontal Tibial Distance to the tibial artery
Time frame: Day 1
Horizontal Tibial Distance to the tibial vein
Time frame: Day 1
Depth of the tibial nerve
Time frame: Day 1
Cross-sectional area of the tibial nerve
Time frame: Day 1
Cross-sectional area of the tibial artery
Time frame: Day 1
Cross-sectional area of the tibial vein
Time frame: Day 1
Overlap between each structure
Time frame: Day 1
Variability of the tibial vessels
Time frame: Day 1
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 28 Aug 2024.
- Derived from this study: PubMed 40932423Lazaro-Navas I, Cervera-Cano M, Pecos-Martin D, Lopez-Gonzalez L, Valcarcel-Linares D. Ultrasound Evaluation of Tibial Vasculonervous Structures for Tibial Nerve Neuromodulation: A Cross-Sectional Study. Neuromodulation. 2025 Dec;28(8):1318-1326. doi: 10.1016/j.neurom.2025.07.010. Epub 2025 Sep 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tibial Nerve and Healthy Volunteers, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal 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 1 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: finished, as of the sponsor's last update on 28 Aug 2024. 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?
Tibial Distance (TD) to the tibial nerve (time frame: Day 1). The study lists 3 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 NCT06196112, 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 28 Aug 2024.