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

17 de julio de 2026 actualizado por: Jacobo Rodríguez Sanz, Universitat Internacional de Catalunya

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

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.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

23

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Jacobo Rodríguez Sanz, PhD
  • Número de teléfono: +34 636-136-789
  • Correo electrónico: jrodriguezs@uic.es

Ubicaciones de estudio

    • Barcelona
      • Sant Cugat del Vallès, Barcelona, España, 08195
        • Reclutamiento
        • Universitat Internacional de Catalunya
        • Contacto:
          • Jacobo Rodríguez Sanz, PhD
          • Número de teléfono: +34 636 136 789
          • Correo electrónico: jrodriguezs@uic.es

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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 above the motor threshold and below the pain threshold.
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 above the motor threshold and below the pain threshold.
Otros nombres:
  • Impulse Train Protocol
Experimental: 10-10-10 Protocol
The intervention consists of the bilateral, ultrasound-guided insertion of a needle for percutaneous electrical nerve stimulation (PENS). An asymmetric biphasic compensated current is applied, with a rectangular positive phase and a triangular negative phase, at a frequency of 10 Hz, pulse width of 240 µs, and an intensity above the motor threshold and below the pain threshold. Each stimulation period lasts 10 seconds, followed by 10 seconds of rest, repeated ten times.
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.
Experimental: 5-55 Protocol
Ultrasound-guided PENS protocol applying a 100 Hz stimulation for 5 s followed by 55 s of rest, repeated five times. The intensity is adjusted to a tolerable tingling sensation, below the pain threshold.
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.
Experimental: HIB Protocol (High-Intensity Burst)
Ultrasound-guided PENS protocol consisting of high-intensity bursts applied bilaterally at a current intensity close to 1000 mA, repeated three times. The intensity is set individually, approaching but not exceeding the participant's tolerance threshold.
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.
Otros nombres:
  • High Intensity Burst
  • HIB
Comparador falso: Placebo
Ultrasound-guided needle insertion at the same anatomical location without electrical stimulation. The device is manipulated to simulate treatment, but no current is delivered.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Changes in squat execution velocity (m/s) measured with a linear encoder
Periodo de tiempo: pre-intervention, immediately after the intervention
pre-intervention, immediately after the intervention

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Changes in vertical jump performance (jump height) measured with the MyJump2 app.
Periodo de tiempo: pre-intervention, immediately after the intervention
pre-intervention, immediately after the intervention
Changes in quadriceps strength measured in newtons using a force gauge
Periodo de tiempo: pre-intervention, immediately after the intervention
pre-intervention, immediately after the intervention
Changes in muscle activation in microvolts (μV) measured via surface electromyography
Periodo de tiempo: pre-intervention, immediately after the intervention
pre-intervention, immediately after the intervention

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

30 de septiembre de 2026

Finalización del estudio (Estimado)

30 de septiembre de 2026

Fechas de registro del estudio

Enviado por primera vez

13 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

17 de julio de 2026

Publicado por primera vez (Actual)

22 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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