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

NCT07719179 | Recruiting

• 1 other identifier: CBAS-2023-19
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers; Neuromuscular Function

Keywords

Neuromuscular Performance; Muscle Strength; Quadriceps; Percutaneous Electrical Nerve Stimulation; Sports Performance; Physiotherapy

Outcome Measures

Primary Outcomes (1)

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

  pre-intervention, immediately after the intervention

Secondary Outcomes (3)

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

  pre-intervention, immediately after the intervention

• Changes in quadriceps strength measured in newtons using a force gauge

  pre-intervention, immediately after the intervention

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

  pre-intervention, immediately after the intervention

Study Arms (5)

Theta Burst Protocol

EXPERIMENTAL

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.

Device: Theta Burst Protocol

10-10-10 Protocol

EXPERIMENTAL

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.

Device: 10-10-10 Protocol

5-55 Protocol

EXPERIMENTAL

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.

Device: 5-55 Protocol

HIB Protocol (High-Intensity Burst)

EXPERIMENTAL

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.

Device: High-Intensity Burst (HIB) Protocol

Placebo

SHAM COMPARATOR

Ultrasound-guided needle insertion at the same anatomical location without electrical stimulation. The device is manipulated to simulate treatment, but no current is delivered.

Device: Placebo

Interventions

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.

Also known as: Impulse Train Protocol

Theta Burst Protocol

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.

10-10-10 Protocol

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.

5-55 Protocol

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.

Placebo

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.

Also known as: High Intensity Burst, HIB

HIB Protocol (High-Intensity Burst)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

RECRUITING

MeSH Terms

Interventions

Clinical Protocols

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Central Study Contacts

Jacobo Rodríguez Sanz, PhD

CONTACT

+34 636-136-789; jrodriguezs@uic.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Area Director

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-07

Locations

ES (1)