Localization of Vasculonervous Structures in Tibial Nerve Neuromodulation: a Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Tibial Distance (TD) to the tibial artery
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects over 18 years of age
排除标准
- •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
结局指标
主要结局
Tibial Distance (TD) to the tibial artery
时间窗: 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 nerve
时间窗: 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 vein
时间窗: 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
次要结局
- Cross-sectional area of the tibial nerve(Day 1)
- Cross-sectional area of the tibial vein(Day 1)
- Overlap between each structure(Day 1)
- Horizontal Tibial Distance to the tibial nerve(Day 1)
- Cross-sectional area of the tibial artery(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)
- Variability of the tibial vessels(Day 1)
研究者
Irene Lázaro Navas
Physiotherapy, PhD
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal