Clinical trial NCT06196112: Localization of Vasculonervous Structures in Tibial Nerve Neuromodulation: a Cross-sectional Study
Official title: Localization of Vasculonervous Structures in Tibial Nerve Neuromodulation: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tibial Nerve
Healthy Volunteers
Keywords: tibial arteries
ultrasonography
Pelvic Floor Disorders
Transcutaneous Electric Nerve Stimulation
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Tibial Distance (TD) to the tibial nerve
timeFrame: Day 1
measure: Tibial Distance (TD) to the tibial artery
timeFrame: Day 1
measure: Tibial Distance (TD) to the tibial vein
timeFrame: Day 1
Secondary outcomes:
measure: Horizontal Tibial Distance to the tibial nerve
timeFrame: Day 1
measure: Horizontal Tibial Distance to the tibial artery
timeFrame: Day 1
measure: Horizontal Tibial Distance to the tibial vein
timeFrame: Day 1
measure: Depth of the tibial nerve
timeFrame: Day 1
measure: Cross-sectional area of the tibial nerve
timeFrame: Day 1
measure: Cross-sectional area of the tibial artery
timeFrame: Day 1
measure: Cross-sectional area of the tibial vein
timeFrame: Day 1
measure: Overlap between each structure
timeFrame: Day 1
measure: Variability of the tibial vessels
timeFrame: Day 1
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
Study officials:
References: