Health TrialsbyHealthPanel

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

ConditionsHealthy VolunteersNeuromuscular Function
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorUniversitat Internacional de Catalunya

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Crossover

Treatments tested in this trial

  • Theta Burst Protocol

    Device

    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.

  • 10-10-10 Protocol

    Device

    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.

  • 5-55 Protocol

    Device

    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.

  • Placebo

    Device

    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.

  • High-Intensity Burst (HIB) Protocol

    Device

    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.

Treatment groups

23 Participants
are divided into 5 treatment groups
Group A: Theta Burst ProtocolExperimental treatment 1 intervention
Group B: 10-10-10 ProtocolExperimental treatment 1 intervention
Group C: 5-55 ProtocolExperimental treatment 1 intervention
Group D: HIB Protocol (High-Intensity Burst)Experimental treatment 1 intervention
Group E: PlaceboSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes in squat execution velocity (m/s) measured with a linear encoder

Time frame
pre-intervention, immediately after the intervention

Secondary outcomes

1

Changes in vertical jump performance (jump height) measured with the MyJump2 app.

Time frame
pre-intervention, immediately after the intervention
2

Changes in quadriceps strength measured in newtons using a force gauge

Time frame
pre-intervention, immediately after the intervention
3

Changes in muscle activation in microvolts (μV) measured via surface electromyography

Time frame
pre-intervention, immediately after the intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitat Internacional de Catalunya

Lead sponsor

Source ClinicalTrials.gov
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