<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/NCT03784144</url>
  </required_header>
  <id_info>
    <org_study_id>HSanJose</org_study_id>
    <nct_id>NCT03784144</nct_id>
  </id_info>
  <brief_title>Effect of the Cognitive Strategy During Trunk Muscle Endurance in Patients With Lumbar Hernia Surgery</brief_title>
  <official_title>Effect of the Cognitive Strategy During Trunk Muscle Endurance in Patients With Lumbar Hernia Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital San José, Chile</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Clínico La Florida</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital San José, Chile</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Muscle endurance will be evaluated on two exercises: Biering-Sorensen Test and Prone Plank&#xD;
      Test. Each test will be assessed in different days following a randomized order.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients will be encouraged to achieve the maximum time to task failure, stopped only by&#xD;
      muscular fatigue or pain precluding to maintain the position. Each exercise will perform&#xD;
      under two conditions.&#xD;
&#xD;
      On the control condition, the patients will perform both tests without any cognitive&#xD;
      condition, while on the experimental condition they will be instructed to perform both tests&#xD;
      while performing a mathematical subtracting task (starting at 300, by sevens).&#xD;
&#xD;
      The starting condition will be randomly assigned with a 5-minute rest prior to the next&#xD;
      condition. Time to task failure and pain perception using a visual analog scale will be&#xD;
      assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 3, 2018</start_date>
  <completion_date type="Actual">January 22, 2019</completion_date>
  <primary_completion_date type="Actual">January 7, 2019</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Each test will be assessed in different days following a randomized order.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to task failure</measure>
    <time_frame>through study completion, an average of 2 week</time_frame>
    <description>Time in seconds from 0 to failure, where higher values represent a best muscle endurance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain evaluation</measure>
    <time_frame>through study completion, an average of 2 week</time_frame>
    <description>Pain will be measured by the Visual Analog Scale for pain (VAS) from 0 to 10, where higher values represent a worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Interference: Kinesiophobia</measure>
    <time_frame>through study completion, an average of 2 week</time_frame>
    <description>Kinesiophobia will be evaluated by Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation. Gómez-Pérez, López-Martínez y Ruiz-Párraga, 2011). Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Low Back Pain</condition>
  <condition>Disk Herniated Lumbar</condition>
  <arm_group>
    <arm_group_label>Cognitive Strategy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Performing a mathematical subtracting task (starting at 300, by sevens)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients will perform both tests without any cognitive condition</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Biering-Sorensen Test and Prone Plank Test</intervention_name>
    <description>All patients will be encouraged to achieve the maximum time to task failure, stopped only by muscular fatigue or pain precluding to maintain the position.</description>
    <arm_group_label>Cognitive Strategy</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 20-50 years.&#xD;
&#xD;
          -  Surgery of lumbar discectomy or lumbar arthrodesis with at least 3 months of&#xD;
             evolution.&#xD;
&#xD;
          -  Acceptance to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of previous surgery in the lower extremities.&#xD;
&#xD;
          -  Recent trauma (&lt;6 months).&#xD;
&#xD;
          -  Use of corticosteroids.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Cauda equina syndrome.&#xD;
&#xD;
          -  Marrow-level lesions.&#xD;
&#xD;
          -  Progressive neurological involvement.&#xD;
&#xD;
          -  History of rheumatological diseases.&#xD;
&#xD;
          -  Inability to perform the test measurement.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Clínico La Florida</name>
      <address>
        <city>Santiago</city>
        <zip>8150215</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <reference>
    <citation>Gomez-Perez L, Lopez-Martinez AE, Ruiz-Parraga GT. Psychometric Properties of the Spanish Version of the Tampa Scale for Kinesiophobia (TSK). J Pain. 2011 Apr;12(4):425-35. doi: 10.1016/j.jpain.2010.08.004.</citation>
    <PMID>20926355</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital San José, Chile</investigator_affiliation>
    <investigator_full_name>Carlos Cruz Montecinos</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Muscle endurance</keyword>
  <keyword>Biering-Sorensen Test</keyword>
  <keyword>Prone Plank Test.</keyword>
  <keyword>Dual task</keyword>
  <keyword>time to failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Muscle endurance will be evaluated on two exercises: Biering-Sorensen Test and Prone Plank Test.</ipd_description>
  </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/NCT03784144
org study id: HSanJose
nct id: NCT03784144
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Muscle endurance will be evaluated on two exercises: Biering-Sorensen Test and Prone Plank
      Test. Each test will be assessed in different days following a randomized order.
All patients will be encouraged to achieve the maximum time to task failure, stopped only by
      muscular fatigue or pain precluding to maintain the position. Each exercise will perform
      under two conditions.

      On the control condition, the patients will perform both tests without any cognitive
      condition, while on the experimental condition they will be instructed to perform both tests
      while performing a mathematical subtracting task (starting at 300, by sevens).

      The starting condition will be randomly assigned with a 5-minute rest prior to the next
      condition. Time to task failure and pain perception using a visual analog scale will be
      assessed.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Each test will be assessed in different days following a randomized order.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Time to task failure
time frame: through study completion, an average of 2 week
description: Time in seconds from 0 to failure, where higher values represent a best muscle endurance.
measure: Pain evaluation
time frame: through study completion, an average of 2 week
description: Pain will be measured by the Visual Analog Scale for pain (VAS) from 0 to 10, where higher values represent a worse outcome.
measure: Pain Interference: Kinesiophobia
time frame: through study completion, an average of 2 week
description: Kinesiophobia will be evaluated by Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation. Gómez-Pérez, López-Martínez y Ruiz-Párraga, 2011). Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).
arm group label: Cognitive Strategy
arm group type: Experimental
description: Performing a mathematical subtracting task (starting at 300, by sevens)
arm group label: Control
arm group type: Active Comparator
description: The patients will perform both tests without any cognitive condition
intervention type: Diagnostic Test
intervention name: Biering-Sorensen Test and Prone Plank Test
description: All patients will be encouraged to achieve the maximum time to task failure, stopped only by muscular fatigue or pain precluding to maintain the position.
arm group label: Cognitive Strategy
arm group label: Control
criteria: 
gender: All
gender based: Yes
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: No
facility: 
country: Chile
citation: Gomez-Perez L, Lopez-Martinez AE, Ruiz-Parraga GT. Psychometric Properties of the Spanish Version of the Tampa Scale for Kinesiophobia (TSK). J Pain. 2011 Apr;12(4):425-35. doi: 10.1016/j.jpain.2010.08.004.
PMID: 20926355
responsible party type: Principal Investigator
investigator affiliation: Hospital San José, Chile
investigator full name: Carlos Cruz Montecinos
investigator title: Principal Investigator
mesh term: Low Back Pain
sharing ipd: No
ipd description: Muscle endurance will be evaluated on two exercises: Biering-Sorensen Test and Prone Plank Test.