Localization of Vasculonervous Structures in Tibial Nerve Neuromodulation: a Cross-sectional Study

Healthy Volunteers Clinical Trial

Official title:

Localization of Vasculonervous Structures in Tibial Nerve Neuromodulation: a Cross-sectional Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06196112
• Other study ID #: 115/23
• Status: Recruiting
• Start date: January 15, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: January 2024
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Contact: Irene Lázaro Navas, PhD
• Phone: +34699327333
• Email: ilazaron[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy subjects over 18 years of age

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Healthy Volunteers
• Tibial Nerve

Locations

Country	Name	City	State
Spain	Hospital Universitario Ramón y Cajal	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 1
Primary	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	Day 1
Primary	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	Day 1
Secondary	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	Day 1
Secondary	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	Day 1
Secondary	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	Day 1
Secondary	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	Day 1
Secondary	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	Day 1
Secondary	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	Day 1
Secondary	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	Day 1
Secondary	Overlap between each structure	The overlap between the tibial nerve, artery, and vein will be described at each of the 7 marks previously mentioned	Day 1
Secondary	Variability of the tibial vessels	The number of arteries and veins present will be recorded at each of the 7 marks previously described	Day 1