xml: <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/NCT05989490</url>
    </required_header>
    <id_info>
      <org_study_id>Intensity vs. Hypoalgesia</org_study_id>
      <nct_id>NCT05989490</nct_id>
    </id_info>
    <brief_title>The Effect of Stretching Intensity on Pain Sensitivity</brief_title>
    <official_title>The Effect of Stretching Intensity on Pain Sensitivity</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University College of Northern Denmark</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Bispebjerg Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Copenhagen</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Research Unit of General Practice, Aalborg</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University College of Northern Denmark</source>
    <oversight_info>
      <has_dmc>No</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>
        The primary objective of this study is to determine the immediate efficiency of stretching&#xD;
        intensity on regional and distant pain sensitivity in healthy subjects. It is hypothesized&#xD;
        that the analgesic effect of stretching may be linked with the intensity of stretching in a&#xD;
        dose-response relationship.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 20, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</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>This was a randomized, repeated-measures cross-over study. The interventions consist of two different stretching protocols (e.g., stretching to the point of discomfort and stretching to the point of pain). Subjects were randomized to one of two groups (pain first or discomfort first). Both groups underwent a static stretch protocol consisting of four bouts of thirty-second constant-angle static stretching of the knee flexors with a 20-second rest period between bouts. Subjects were instructed to keep the limb relaxed as the lower leg was passively moved towards extension to the point of discomfort and the point of pain.</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>Participants were blinded to the results of all measurements and naïve to research hypotheses.&#xD;
  The investigator was blinded to the results of all measurements.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Pressure pain thresholds</measure>
      <time_frame>Pressure pain thresholds were measured as a baseline just prior to the induction of stretching to the point of pain and stretching to the point of discomfort</time_frame>
      <description>Pressure pain thresholds was measures using a handheld pressure algometer</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pressure pain thresholds</measure>
      <time_frame>Pressure pain thresholds were measured immediately after stretching</time_frame>
      <description>Pressure pain thresholds was measures using a handheld pressure algometer</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Knee extension range of motion</measure>
      <time_frame>Passive knee extension range of motion was measured as a baseline just prior to the induction of stretching to the point of pain and stretching to the point of discomfort</time_frame>
      <description>Passively induced knee extension range of motion was measured using the Biodex system 4 pro isokinetic dynamometer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Knee extension range of motion</measure>
      <time_frame>Passive knee extension range of motion was measured immediately after stretching</time_frame>
      <description>Passively induced knee extension range of motion was measured using the Biodex system 4 pro isokinetic dynamometer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Passive resistive torque</measure>
      <time_frame>Passive resistive torque was measured as a baseline just prior to the induction of stretching to the point of pain and stretching to the point of discomfort</time_frame>
      <description>Passive resistive torque was measured using the Biodex system 4 pro isokinetic dynamometer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Passive resistive torque</measure>
      <time_frame>Passive resistive torque was measured immediately after stretching</time_frame>
      <description>Passive resistive torque was measured using the Biodex system 4 pro isokinetic dynamometer</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">31</enrollment>
    <condition>Pain Threshold</condition>
    <condition>Stretching</condition>
    <condition>Pain Sensitivity</condition>
    <condition>Range of Motion</condition>
    <arm_group>
      <arm_group_label>Static stretching to the point of pain</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The participants are assigned to four bouts of static stretching of the right knee flexors with a 20-second rest period between bouts 20 to the point of pain.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Static stretching to the point of discomfort</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The participants are assigned to four bouts of static stretching of the right knee flexors with a 20-second rest period between bouts 20 to the point of discomfort.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Static stretching</intervention_name>
      <description>The participants are assigned to four bouts of static stretching of the right knee flexors with a 20-second rest period between bouts 20 to the point of discomfort and to the point of pain.</description>
      <arm_group_label>Static stretching to the point of discomfort</arm_group_label>
      <arm_group_label>Static stretching to the point of pain</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy men and women aged 18-55 years are recruited. As part of the screening,&#xD;
               volunteers will also be asked to indicate known medical issues or diseases.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants are included if they have no known medical conditions such as; cognitive&#xD;
               impairments, neurological, orthopaedic, or neuromuscular problems that might affect&#xD;
               the somatosensory system or preclude stretching exercises or range of motion testing&#xD;
               at the knee.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Morten P Støve, Pt. Msc</last_name>
      <role>Principal Investigator</role>
      <affiliation>University College of Northern Denmark and Center for General Practice, Aalborg University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Morten P Støve, PT. Msc.</last_name>
      <phone>0045 72691004</phone>
      <email>mps@ucn.dk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Allan Riis, PT. Ph.D.</last_name>
      <phone>+4572691310</phone>
      <email>alr@ucn.dk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University College of Northern Denmark</name>
        <address>
          <city>Aalborg</city>
          <zip>9220</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Morten Pallisgaard Støve, Msc.</last_name>
        <phone>72691004</phone>
        <email>mps@ucn.dk</email>
      </contact>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypersensitivity</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Data is made available upon request.</ipd_description>
      <ipd_access_criteria>Access is granted on reasonable request</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05989490
  org study id: Intensity vs. Hypoalgesia
  nct id: NCT05989490
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The primary objective of this study is to determine the immediate efficiency of stretching
        intensity on regional and distant pain sensitivity in healthy subjects. It is hypothesized
        that the analgesic effect of stretching may be linked with the intensity of stretching in a
        dose-response relationship.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: This was a randomized, repeated-measures cross-over study. The interventions consist of two different stretching protocols (e.g., stretching to the point of discomfort and stretching to the point of pain). Subjects were randomized to one of two groups (pain first or discomfort first). Both groups underwent a static stretch protocol consisting of four bouts of thirty-second constant-angle static stretching of the knee flexors with a 20-second rest period between bouts. Subjects were instructed to keep the limb relaxed as the lower leg was passively moved towards extension to the point of discomfort and the point of pain.
  primary purpose: Basic Science
  masking: Double (Participant, Investigator)
  masking description: Participants were blinded to the results of all measurements and naïve to research hypotheses.
  The investigator was blinded to the results of all measurements.
  measure: Pressure pain thresholds
  time frame: Pressure pain thresholds were measured as a baseline just prior to the induction of stretching to the point of pain and stretching to the point of discomfort
  description: Pressure pain thresholds was measures using a handheld pressure algometer
  measure: Pressure pain thresholds
  time frame: Pressure pain thresholds were measured immediately after stretching
  description: Pressure pain thresholds was measures using a handheld pressure algometer
  measure: Knee extension range of motion
  time frame: Passive knee extension range of motion was measured as a baseline just prior to the induction of stretching to the point of pain and stretching to the point of discomfort
  description: Passively induced knee extension range of motion was measured using the Biodex system 4 pro isokinetic dynamometer
  measure: Knee extension range of motion
  time frame: Passive knee extension range of motion was measured immediately after stretching
  description: Passively induced knee extension range of motion was measured using the Biodex system 4 pro isokinetic dynamometer
  measure: Passive resistive torque
  time frame: Passive resistive torque was measured as a baseline just prior to the induction of stretching to the point of pain and stretching to the point of discomfort
  description: Passive resistive torque was measured using the Biodex system 4 pro isokinetic dynamometer
  measure: Passive resistive torque
  time frame: Passive resistive torque was measured immediately after stretching
  description: Passive resistive torque was measured using the Biodex system 4 pro isokinetic dynamometer
  arm group label: Static stretching to the point of pain
  arm group type: Experimental
  description: The participants are assigned to four bouts of static stretching of the right knee flexors with a 20-second rest period between bouts 20 to the point of pain.
  arm group label: Static stretching to the point of discomfort
  arm group type: Experimental
  description: The participants are assigned to four bouts of static stretching of the right knee flexors with a 20-second rest period between bouts 20 to the point of discomfort.
  intervention type: Other
  intervention name: Static stretching
  description: The participants are assigned to four bouts of static stretching of the right knee flexors with a 20-second rest period between bouts 20 to the point of discomfort and to the point of pain.
  arm group label: Static stretching to the point of discomfort
  arm group label: Static stretching to the point of pain
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Morten P Støve, Pt. Msc
  role: Principal Investigator
  affiliation: University College of Northern Denmark and Center for General Practice, Aalborg University
  last name: Morten P Støve, PT. Msc.
  phone: 0045 72691004
  email: mps@ucn.dk
  last name: Allan Riis, PT. Ph.D.
  phone: +4572691310
  email: alr@ucn.dk
  facility: 
  status: Recruiting
  contact: 
  country: Denmark
  responsible party type: Sponsor
  mesh term: Hypersensitivity
  sharing ipd: Yes
  ipd description: Data is made available upon request.
  ipd access criteria: Access is granted on reasonable request