<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04427553</url>
  </required_header>
  <id_info>
    <org_study_id>URJC-UAX-02-2020</org_study_id>
    <nct_id>NCT04427553</nct_id>
  </id_info>
  <brief_title>Percutaneous Peripheral Nerve Stimulation and Performance</brief_title>
  <official_title>Effects of Percutaneous Peripheral Nerve Stimulation on Physical Performance in Soccer Players</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Rey Juan Carlos</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Rey Juan Carlos</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Percutaneous Peripheral Nerve Stimulation is a relative new intervention applied by physical&#xD;
      therapists. Although it has been hypothesized that this technique could improve pain and&#xD;
      function, no studies have investigated changes in physical performance in soccer players.&#xD;
      This study will evaluate changes in physical performance after the application of&#xD;
      Percutaneous Peripheral Nerve Stimulation in a sample of healthy soccer players.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2020</start_date>
  <completion_date type="Actual">December 4, 2020</completion_date>
  <primary_completion_date type="Actual">November 25, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Contra-Movement Jump between baseline and follow-up periods</measure>
    <time_frame>Baseline and immediately after each session and 1 month after the last treatment session</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Squat Performance Speed between baseline and follow-up periods</measure>
    <time_frame>Baseline and immediately after each session and 1 month after the last treatment session</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Sports Physical Therapy</condition>
  <arm_group>
    <arm_group_label>Percutaneous Peripheral Nerve Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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).&#xD;
After that participants will walk during 3 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants in the control group will walk during 5 minutes, without receiving any intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Percutaneous Peripheral Nerve Stimulation</intervention_name>
    <description>Participants assigned to this group will received two sessions (once per week) of ultrasound guided Percutaneous Peripheral Nerve Stimulation targeting the femoral nerve.</description>
    <arm_group_label>Percutaneous Peripheral Nerve Stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control Group</intervention_name>
    <description>No intervention</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Semiprofessional soccer player&#xD;
&#xD;
          -  No symptoms or injury in the lower extremity previous 6 months&#xD;
&#xD;
          -  Training frequency of at least 3 days a week plus soccer game&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  fear to needles&#xD;
&#xD;
          -  presence of pain or any musculoskeletal disease&#xD;
&#xD;
          -  previous surgery in the lower extremity&#xD;
&#xD;
          -  underlying medical conditions, e.g., diabetes, hypertension&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>César Fernández-de-las-Peñas</name>
      <address>
        <city>Alcorcón</city>
        <state>Madrid</state>
        <zip>28922</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>César Fernández-de-las-Peñas</name>
      <address>
        <city>Alcorcon</city>
        <state>Rest Of The World</state>
        <zip>28922</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>December 4, 2020</last_update_submitted>
  <last_update_submitted_qc>December 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Rey Juan Carlos</investigator_affiliation>
    <investigator_full_name>César Fernández-de-las-Peñas</investigator_full_name>
    <investigator_title>Full proffessor</investigator_title>
  </responsible_party>
  <keyword>Percutaneous Peripheral Nerve Stimulation</keyword>
  <keyword>Performance</keyword>
  <keyword>Soccer</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04427553
org study id: URJC-UAX-02-2020
nct id: NCT04427553
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: 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
description: 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
measure: 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
description: 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
arm group label: Percutaneous Peripheral Nerve Stimulation
arm group type: Experimental
description: 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.
arm group label: Control
arm group type: Placebo Comparator
description: Participants in the control group will walk during 5 minutes, without receiving any intervention
intervention type: Device
intervention name: Percutaneous Peripheral Nerve Stimulation
description: Participants assigned to this group will received two sessions (once per week) of ultrasound guided Percutaneous Peripheral Nerve Stimulation targeting the femoral nerve.
arm group label: Percutaneous Peripheral Nerve Stimulation
intervention type: Other
intervention name: Control Group
description: No intervention
arm group label: Control
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Rey Juan Carlos
investigator full name: César Fernández-de-las-Peñas
investigator title: Full proffessor