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

NCT06196112 | Completed

• 1 other identifier: 115/23
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tibial Nerve; Healthy Volunteers

Keywords

tibial arteries; ultrasonography; Pelvic Floor Disorders; Transcutaneous Electric Nerve Stimulation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (9)

• Horizontal Tibial Distance to the tibial nerve

  Day 1

• Horizontal Tibial Distance to the tibial artery

  Day 1

• Horizontal Tibial Distance to the tibial vein

  Day 1

• Depth of the tibial nerve

  Day 1

• Cross-sectional area of the tibial nerve

  Day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing treatment at the Rehabilitation Service and among the workers of Ramón y Cajal University Hospital who meet the selection criteria

You may qualify if:

• Healthy subjects over 18 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead

Study Sites (1)

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Related Publications (1)

• 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.

  PMID: 40932423 DERIVED

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapy, PhD

Study Record Dates

• First Submitted: December 24, 2023
• First Posted: January 9, 2024
• Study Start: January 15, 2024
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

ES (1)