Percutaneous Peripheral Nerve Stimulation and Performance

December 4, 2020 updated by: César Fernández-de-las-Peñas, Universidad Rey Juan Carlos

Effects of Percutaneous Peripheral Nerve Stimulation on Physical Performance in Soccer Players

Percutaneous Peripheral Nerve Stimulation is a relative new intervention applied by physical therapists. Although it has been hypothesized that this technique could improve pain and function, no studies have investigated changes in physical performance in soccer players. This study will evaluate changes in physical performance after the application of Percutaneous Peripheral Nerve Stimulation in a sample of healthy soccer players.

Study Overview

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • César Fernández-de-las-Peñas
    • Rest Of The World
      • Alcorcon, Rest Of The World, Spain, 28922
        • César Fernández-de-las-Peñas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Semiprofessional soccer player
  • No symptoms or injury in the lower extremity previous 6 months
  • Training frequency of at least 3 days a week plus soccer game

Exclusion Criteria:

  • fear to needles
  • presence of pain or any musculoskeletal disease
  • previous surgery in the lower extremity
  • underlying medical conditions, e.g., diabetes, hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Percutaneous Peripheral Nerve Stimulation

Participants assigned to this group will received two sessions (once per week) of ultrasound guided Percutaneous Peripheral Nerve Stimulation targeting the femoral nerve. We will apply a biphasic compensated electrical current at a frequency of 10 Hz, a pulse width of 240 µs and intensity allowed over a pain-free motor threshold (muscle contraction). Each participant will receive 10 repetitions of 10 seconds each one with 10 seconds rest- period between series (total treatment session 1.40 min).

After that participants will walk during 3 minutes.

Participants assigned to this group will received two sessions (once per week) of ultrasound guided Percutaneous Peripheral Nerve Stimulation targeting the femoral nerve.
Placebo Comparator: Control
Participants in the control group will walk during 5 minutes, without receiving any intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Contra-Movement Jump between baseline and follow-up periods
Time Frame: Baseline and immediately after each session and 1 month after the last treatment session
The jump will start in an upright position with participants hands in their waists. They will perform a vertical jump after a fast down countermovement. During the knees and hips flexion, the trunk will remain the most upright as possible. The jump is measured using a Chronopump-Boscosystem DIN-A2 contact platform obtaining a jump reliable and valid height in centimeters
Baseline and immediately after each session and 1 month after the last treatment session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Squat Performance Speed between baseline and follow-up periods
Time Frame: Baseline and immediately after each session and 1 month after the last treatment session
The Speed4Lift device will be used. Squats will be performed using a 20kg olympic bar with two 20kg discs in each side. Participants will place the bar over their shoulders in a 90º triple-flexion position. The measurements will be performed during the concentric contraction phase of the squat
Baseline and immediately after each session and 1 month after the last treatment session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2020

Primary Completion (Actual)

November 25, 2020

Study Completion (Actual)

December 4, 2020

Study Registration Dates

First Submitted

June 4, 2020

First Submitted That Met QC Criteria

June 11, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

December 8, 2020

Last Update Submitted That Met QC Criteria

December 4, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • URJC-UAX-02-2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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