Eco-guided Neuromodulation of the Femoral Nerve on the Performance of Amateur Athletes.

Официальное название

Effectiveness of Eco-guided Neuromodulation of the Femoral Nerve on the Performance of Amateur Athletes. Randomized Controlled Crossover Clinical Trial

Обзор

This randomized crossover study aims to evaluate whether different percutaneous electrical nerve stimulation (PENS) protocols produce changes in neuromuscular performance in healthy adults. PENS involves the ultrasound-guided application of an electrical current through a needle to modulate motor neuron excitability. Each participant will undergo five intervention sessions: (1) a long-term potentiation (LTP)-based protocol with impulse trains, (2) a 10 Hz protocol with 10 s stimulation and 10 s rest repeated ten times, (3) a 5-55 protocol with 100 Hz stimulation for 5 s followed by 55 s rest repeated five times, (4) a high-intensity burst (HIB) protocol applied at a high current intensity close to 1000 mA and repeated three times, and (5) a placebo condition. All interventions will be applied bilaterally by an experienced physiotherapist under ultrasound guidance, with a two-week washout between sessions. The objective of this trial is to assess whether these stimulation patterns produce measurable changes in squat execution velocity, jump performance, and quadriceps strength. The findings may help identify the most effective stimulation strategy for enhancing neuromuscular performance.

Вмешательства

• Устройство Theta Burst Protocol
  The intervention consists of the bilateral, ultrasound-guided insertion of a needle for percutaneous electrical nerve stimulation (PENS), following a theta-burst pattern designed to produce long-term potentiation-like effects. An asymmetric biphasic compensated current with a rectangular positive phase and a triangular negative phase is applied at a frequency of 100 Hz for 5 seconds, followed by 55 seconds of rest, repeated five times. The pulse width is 240 µs, and the intensity is maintained a
• Устройство 10-10-10 Protocol
  Percutaneous electrical nerve stimulation (PENS) applied under ultrasound guidance at 10 Hz, consisting of 10 seconds of stimulation followed by 10 seconds of rest, repeated ten times. The current intensity is adjusted to produce visible muscle contraction without pain.
• Устройство 5-55 Protocol
  Percutaneous electrical nerve stimulation (PENS) applied under ultrasound guidance at 100 Hz for 5 seconds, followed by 55 seconds of rest, repeated five times. The current intensity is adjusted to elicit a mild tingling sensation while remaining below the pain threshold.
• Устройство Placebo
  A sham PENS procedure involving ultrasound-guided needle insertion at the same anatomical site without electrical stimulation. The device is manipulated to simulate treatment, but no current is delivered. Participants are informed they might not feel any sensation during the session.
• Устройство High-Intensity Burst (HIB) Protocol
  Percutaneous electrical nerve stimulation (PENS) applied under ultrasound guidance using high-intensity bursts delivered bilaterally at a current intensity close to 1000 mA, repeated three times. The stimulation intensity is individually adjusted to approach but not exceed the participant's tolerance threshold.

Первичные конечные точки

• Changes in squat execution velocity (m/s) measured with a linear encoder [Срок оценки: pre-intervention, immediately after the intervention]

Вторичные конечные точки (3)

• Changes in vertical jump performance (jump height) measured with the MyJump2 app. [Срок оценки: pre-intervention, immediately after the intervention]
• Changes in quadriceps strength measured in newtons using a force gauge [Срок оценки: pre-intervention, immediately after the intervention]
• Changes in muscle activation in microvolts (μV) measured via surface electromyography [Срок оценки: pre-intervention, immediately after the intervention]

Критерии участия

Критерии включения

• Athletes aged between 18 and 30 years.
• Familiarized with performing barbell back squats using an Olympic bar.
• Engaged in regular training at least three times per week during the last six months.
• Able to perform squat and jump tests safely.
• Provided written informed consent to participate in the study.

Критерии исключения

• Sports injury within the last two months or current inability to perform physical activity.
• Inability to understand or follow the instructions provided by the therapist.
• Participation in another research study during the same period.
• Belonephobia (fear of needles).
• Ongoing medical or pharmacological treatment that could interfere with neuromuscular performance (e.g., anticonvulsants, antidepressants, or similar medications).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Universitat Internacional de Catalunya — Sant Cugat del Vallès

Идентификаторы

NCT: NCT07719179 · CBAS-2023-19

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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