<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/NCT03029260</url>
  </required_header>
  <id_info>
    <org_study_id>NSM01</org_study_id>
    <nct_id>NCT03029260</nct_id>
  </id_info>
  <brief_title>Effects of Nervous System Mobilization</brief_title>
  <official_title>Effect of Nervous System Mobilization on Heat, Cold and Mechanical Pain Thresholds and Lower Limb Flexibility</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aveiro University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aveiro University</source>
  <brief_summary>
    <textblock>
      This study aims to compare the effect of tension neural mobilization versus sliding neural&#xD;
      mobilization of the peroneal nerve on the heat and cold threshold, on pressure pain threshold&#xD;
      and on flexibility both in the dominant lower limb (subjected to mobilization) and the&#xD;
      non-dominant lower limb (not subjected to mobilization) in healthy young participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sixty young and healthy participants will be randomly allocated to receive tension neural&#xD;
      mobilization (n=30) or sliding neural mobilization (n=30). Data on heat threshold, cold&#xD;
      threshold, pressure pain threshold and lower limb flexibility will be collected before the&#xD;
      intervention, immediately after the intervention and at least 24h after the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</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>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Range of motion of the Straight Leg Raising test</measure>
    <time_frame>Baseline</time_frame>
    <description>The hip is raised to maximum flexion and the degree of flexion is measured with universal goniometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of motion of the Straight Leg Raising test</measure>
    <time_frame>Approximately 45 minutes after baseline measurements</time_frame>
    <description>The hip is raised to maximum flexion and the degree of flexion is measured with universal goniometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Range of motion of the Straight Leg Raising test</measure>
    <time_frame>At least 24 hours after baseline measurements</time_frame>
    <description>The hip is raised to maximum flexion and the degree of flexion is measured with universal goniometer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heat threshold</measure>
    <time_frame>Baseline</time_frame>
    <description>This is measured with a QSense instrument, which has thermode that is attached to the skin. The temperature in this thermode increases or decreases (as per the protocol being used) and the participants is holding a device to stop the temperature to increase/decrease when he/she first perceives it. The temperature perceived is the test result.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heat threshold</measure>
    <time_frame>Approximately 45 minutes after baseline measurements</time_frame>
    <description>This is measured with a QSense instrument, which has thermode that is attached to the skin. The temperature in this thermode increases or decreases (as per the protocol being used) and the participants is holding a device to stop the temperature to increase/decrease when he/she first perceives it. The temperature perceived is the test result.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heat threshold</measure>
    <time_frame>At least 24 hours after baseline measurements</time_frame>
    <description>This is measured with a QSense instrument, which has thermode that is attached to the skin. The temperature in this thermode increases or decreases (as per the protocol being used) and the participants is holding a device to stop the temperature to increase/decrease when he/she first perceives it. The temperature perceived is the test result.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cold threshold</measure>
    <time_frame>Baseline</time_frame>
    <description>This is measured with a QSense instrument, which has thermode that is attached to the skin. The temperature in this thermode increases or decreases (as per the protocol being used) and the participants is holding a device to stop the temperature to increase/decrease when he/she first perceives it. The temperature perceived is the test result.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cold threshold</measure>
    <time_frame>Approximately 45 minutes after baseline measurements</time_frame>
    <description>This is measured with a QSense instrument, which has thermode that is attached to the skin. The temperature in this thermode increases or decreases (as per the protocol being used) and the participants is holding a device to stop the temperature to increase/decrease when he/she first perceives it. The temperature perceived is the test result.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cold threshold</measure>
    <time_frame>At least 24 hours after baseline measurements</time_frame>
    <description>This is measured with a QSense instrument, which has thermode that is attached to the skin. The temperature in this thermode increases or decreases (as per the protocol being used) and the participants is holding a device to stop the temperature to increase/decrease when he/she first perceives it. The temperature perceived is the test result.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pressure pain threshold</measure>
    <time_frame>Baseline</time_frame>
    <description>This is measured using a pressure pain algometer. Pressure is made with this device against a specific body region (upper and lateral part of the dominant foot) until the participants perceives that the pressure changes to pain. The amount of pressure that the participants perceives as being painful is the test result.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pressure pain threshold</measure>
    <time_frame>Approximately 45 minutes after baseline measurements</time_frame>
    <description>This is measured using a pressure pain algometer. Pressure is made with this device against a specific body region (upper and lateral part of the dominant foot) until the participants perceives that the pressure changes to pain. The amount of pressure that the participants perceives as being painful is the test result.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pressure pain threshold</measure>
    <time_frame>At least 24 hours after baseline measurements</time_frame>
    <description>This is measured using a pressure pain algometer. Pressure is made with this device against a specific body region (upper and lateral part of the dominant foot) until the participants perceives that the pressure changes to pain. The amount of pressure that the participants perceives as being painful is the test result.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Healthy Individuals</condition>
  <arm_group>
    <arm_group_label>Neural mobilization - tension</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>It is anticipated that 30 participants will be in this group. They will receive tension type neural mobilization of the peroneal nerve in the dominant limb. This will consist of positioning the lower limb with inversion and plantar flexion of the ankle, extension of the knee and maximum flexion of the hip without pain. A physiotherapists will move the hip from this maximum position of flexion in direction to extension (for example if the participants reaches 80º of flexion the mobilization will be between 40º and 80º of flexion). Each participant will receive four series of 10 mobilizations with 1 minute rest between series.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neural mobilization - sliding</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>It is anticipated that 30 participants will be in this group. They will receive sliding neural mobilization of the peroneal nerve in the dominant limb. Each participant will receive four series of 10 mobilizations with 1 minute rest between series of the following combination of movement: from ankle dorsiflexion, knee extension and hip extension to ankle plantarflexion, knee and hip flexion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neural mobilization - tension.</intervention_name>
    <description>Neural mobilization in tension consists of using combinations of joint movement known to maximize the tension and lengthening of peripheral nervous structures.&#xD;
The intervention will be delivered in one session only.</description>
    <arm_group_label>Neural mobilization - tension</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neural mobilization - gliding</intervention_name>
    <description>Gliding neural mobilization consists of using combinations of joint movement known to maximize the movement of the peripheral nerves in relation to adjacent structures.&#xD;
The intervention will be delivered in one session only.</description>
    <arm_group_label>Neural mobilization - sliding</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  naïve to nervous system mobilization;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any surgery or trauma in the previous 6 months; neurological, cardiorespiratory or&#xD;
             rheumatic pathology; cancer.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anabela Silva, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of aveiro</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School of Health Sciences</name>
      <address>
        <city>Aveiro</city>
        <zip>3810-193</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>April 4, 2018</last_update_submitted>
  <last_update_submitted_qc>April 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aveiro University</investigator_affiliation>
    <investigator_full_name>Anabela G Silva</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03029260
org study id: NSM01
nct id: NCT03029260
lead sponsor: 
This study aims to compare the effect of tension neural mobilization versus sliding neural
      mobilization of the peroneal nerve on the heat and cold threshold, on pressure pain threshold
      and on flexibility both in the dominant lower limb (subjected to mobilization) and the
      non-dominant lower limb (not subjected to mobilization) in healthy young participants.
Sixty young and healthy participants will be randomly allocated to receive tension neural
      mobilization (n=30) or sliding neural mobilization (n=30). Data on heat threshold, cold
      threshold, pressure pain threshold and lower limb flexibility will be collected before the
      intervention, immediately after the intervention and at least 24h after the intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Range of motion of the Straight Leg Raising test
time frame: Baseline
description: The hip is raised to maximum flexion and the degree of flexion is measured with universal goniometer
measure: Range of motion of the Straight Leg Raising test
time frame: Approximately 45 minutes after baseline measurements
description: The hip is raised to maximum flexion and the degree of flexion is measured with universal goniometer
measure: Range of motion of the Straight Leg Raising test
time frame: At least 24 hours after baseline measurements
description: The hip is raised to maximum flexion and the degree of flexion is measured with universal goniometer
measure: Heat threshold
time frame: Baseline
description: This is measured with a QSense instrument, which has thermode that is attached to the skin. The temperature in this thermode increases or decreases (as per the protocol being used) and the participants is holding a device to stop the temperature to increase/decrease when he/she first perceives it. The temperature perceived is the test result.
measure: Heat threshold
time frame: Approximately 45 minutes after baseline measurements
description: This is measured with a QSense instrument, which has thermode that is attached to the skin. The temperature in this thermode increases or decreases (as per the protocol being used) and the participants is holding a device to stop the temperature to increase/decrease when he/she first perceives it. The temperature perceived is the test result.
measure: Heat threshold
time frame: At least 24 hours after baseline measurements
description: This is measured with a QSense instrument, which has thermode that is attached to the skin. The temperature in this thermode increases or decreases (as per the protocol being used) and the participants is holding a device to stop the temperature to increase/decrease when he/she first perceives it. The temperature perceived is the test result.
measure: Cold threshold
time frame: Baseline
description: This is measured with a QSense instrument, which has thermode that is attached to the skin. The temperature in this thermode increases or decreases (as per the protocol being used) and the participants is holding a device to stop the temperature to increase/decrease when he/she first perceives it. The temperature perceived is the test result.
measure: Cold threshold
time frame: Approximately 45 minutes after baseline measurements
description: This is measured with a QSense instrument, which has thermode that is attached to the skin. The temperature in this thermode increases or decreases (as per the protocol being used) and the participants is holding a device to stop the temperature to increase/decrease when he/she first perceives it. The temperature perceived is the test result.
measure: Cold threshold
time frame: At least 24 hours after baseline measurements
description: This is measured with a QSense instrument, which has thermode that is attached to the skin. The temperature in this thermode increases or decreases (as per the protocol being used) and the participants is holding a device to stop the temperature to increase/decrease when he/she first perceives it. The temperature perceived is the test result.
measure: Pressure pain threshold
time frame: Baseline
description: This is measured using a pressure pain algometer. Pressure is made with this device against a specific body region (upper and lateral part of the dominant foot) until the participants perceives that the pressure changes to pain. The amount of pressure that the participants perceives as being painful is the test result.
measure: Pressure pain threshold
time frame: Approximately 45 minutes after baseline measurements
description: This is measured using a pressure pain algometer. Pressure is made with this device against a specific body region (upper and lateral part of the dominant foot) until the participants perceives that the pressure changes to pain. The amount of pressure that the participants perceives as being painful is the test result.
measure: Pressure pain threshold
time frame: At least 24 hours after baseline measurements
description: This is measured using a pressure pain algometer. Pressure is made with this device against a specific body region (upper and lateral part of the dominant foot) until the participants perceives that the pressure changes to pain. The amount of pressure that the participants perceives as being painful is the test result.
arm group label: Neural mobilization - tension
arm group type: Experimental
description: It is anticipated that 30 participants will be in this group. They will receive tension type neural mobilization of the peroneal nerve in the dominant limb. This will consist of positioning the lower limb with inversion and plantar flexion of the ankle, extension of the knee and maximum flexion of the hip without pain. A physiotherapists will move the hip from this maximum position of flexion in direction to extension (for example if the participants reaches 80º of flexion the mobilization will be between 40º and 80º of flexion). Each participant will receive four series of 10 mobilizations with 1 minute rest between series.
arm group label: Neural mobilization - sliding
arm group type: Active Comparator
description: It is anticipated that 30 participants will be in this group. They will receive sliding neural mobilization of the peroneal nerve in the dominant limb. Each participant will receive four series of 10 mobilizations with 1 minute rest between series of the following combination of movement: from ankle dorsiflexion, knee extension and hip extension to ankle plantarflexion, knee and hip flexion.
intervention type: Other
intervention name: Neural mobilization - tension.
description: Neural mobilization in tension consists of using combinations of joint movement known to maximize the tension and lengthening of peripheral nervous structures.
The intervention will be delivered in one session only.
arm group label: Neural mobilization - tension
intervention type: Other
intervention name: Neural mobilization - gliding
description: Gliding neural mobilization consists of using combinations of joint movement known to maximize the movement of the peripheral nerves in relation to adjacent structures.
The intervention will be delivered in one session only.
arm group label: Neural mobilization - sliding
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Anabela Silva, PhD
role: Principal Investigator
affiliation: University of aveiro
facility: 
country: Portugal
responsible party type: Principal Investigator
investigator affiliation: Aveiro University
investigator full name: Anabela G Silva
investigator title: Dr
sharing ipd: No