Eco-guided Neuromodulation of the Femoral Nerve on the Performance of Amateur Athletes.
17. Juli 2026 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Bedingungen
Studientyp
Interventionell
Einschreibung (Geschätzt)
23
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Jacobo Rodríguez Sanz, PhD
- Telefonnummer: +34 636-136-789
- E-Mail: jrodriguezs@uic.es
Studienorte
-
-
Barcelona
-
Sant Cugat del Vallès, Barcelona, Spanien, 08195
- Rekrutierung
- Universitat Internacional de Catalunya
-
Kontakt:
- Jacobo Rodríguez Sanz, PhD
- Telefonnummer: +34 636 136 789
- E-Mail: jrodriguezs@uic.es
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
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).
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
Andere Namen:
|
|
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.
Andere Namen:
|
|
Schein-Komparator: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Changes in squat execution velocity (m/s) measured with a linear encoder
Zeitfenster: pre-intervention, immediately after the intervention
|
pre-intervention, immediately after the intervention
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Changes in vertical jump performance (jump height) measured with the MyJump2 app.
Zeitfenster: pre-intervention, immediately after the intervention
|
pre-intervention, immediately after the intervention
|
|
Changes in quadriceps strength measured in newtons using a force gauge
Zeitfenster: pre-intervention, immediately after the intervention
|
pre-intervention, immediately after the intervention
|
|
Changes in muscle activation in microvolts (μV) measured via surface electromyography
Zeitfenster: pre-intervention, immediately after the intervention
|
pre-intervention, immediately after the intervention
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. September 2026
Primärer Abschluss (Geschätzt)
30. September 2026
Studienabschluss (Geschätzt)
30. September 2026
Studienanmeldedaten
Zuerst eingereicht
13. Juli 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
17. Juli 2026
Zuerst gepostet (Tatsächlich)
22. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
22. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
17. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CBAS-2023-19
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .