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Completed

NCT Number: NCT06196112

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

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Key information

Conditions

Tibial Nerve Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Healthy Volunteers Male Urogenital Diseases Pelvic Floor Disorders Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Horizontal Tibial Distance to the tibial nerve

    Time frame: Day 1

    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

  2. Horizontal Tibial Distance to the tibial artery

    Time frame: Day 1

    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

  3. Horizontal Tibial Distance to the tibial vein

    Time frame: Day 1

    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

  4. Depth of the tibial nerve

    Time frame: Day 1

    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

  5. Cross-sectional area of the tibial nerve

    Time frame: Day 1

    The cross-sectional area of the nerve will be measured at each of the 7 marks described above using the ultrasound

  6. Cross-sectional area of the tibial artery

    Time frame: Day 1

    The cross-sectional area of the artery will be measured at each of the 7 marks described above using the ultrasound

  7. Cross-sectional area of the tibial vein

    Time frame: Day 1

    The cross-sectional area of the vein will be measured at each of the 7 marks described above using the ultrasound

  8. Overlap between each structure

    Time frame: Day 1

    The overlap between the tibial nerve, artery, and vein will be described at each of the 7 marks previously mentioned

  9. Variability of the tibial vessels

    Time frame: Day 1

    The number of arteries and veins present will be recorded at each of the 7 marks previously described

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 9, 2024
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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