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/NCT06028269</url>
    </required_header>
    <id_info>
      <org_study_id>AAU031-1025976a</org_study_id>
      <nct_id>NCT06028269</nct_id>
    </id_info>
    <brief_title>The Effect of Adding Auditory Information on Head Movements in People With Non-traumatic Neck Pain</brief_title>
    <official_title>The Effect of Adding Auditory Information on Head Movements in People With Non-traumatic Neck Pain</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Aalborg University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Aalborg University</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>
        This study sets out to investigate the potential effect of auditory disturbances on human&#xD;
        movement&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Clinicians routinely investigate/test human movement but if/how this is effect by auditory&#xD;
        disturbances is unclear. This study sets out to investigate the impact of auditory&#xD;
        disturbances on head movements.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 31, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2026</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>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Range of motion</measure>
      <time_frame>During a single test session (approximately 45minutes) at day 1</time_frame>
      <description>Range of motion will be assessed during head rotations (i.e. moving the head from a neutral position to end of range in rotation before returning to the start position)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Head repositioning accuracy</measure>
      <time_frame>During a single test session (approximately 45minutes) at day 1</time_frame>
      <description>Head repositioning accuracy will be assessed as the error between the starting point and the end point following a head rotation (i.e. moving the head from a neutral position to end of range in rotation before returning to the start position) and will be repressed in degrees.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of head movement</measure>
      <time_frame>During a single test session (approximately 45minutes) at day 1</time_frame>
      <description>Quality of movement (smoothness) will be determined using calculations of jerk variance (Jerk is the time derivative of acceleration which will be measures using an inertial measurement unit. The measure will be converted to a unitless measure where higher values indicates less smooth movements), assessed during head rotations (i.e. moving the head from a neutral position to end of range in rotation before returning to the start position).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived stiffness during movement</measure>
      <time_frame>During a single test session (approximately 45minutes) at day 1</time_frame>
      <description>Participants will rate their perceived stiffness during head movement using a 0-100 numerical rating scale, where 0 = no stiffness and 100 = worst stiffness imaginable.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived difficultness of performing movement</measure>
      <time_frame>During a single test session (approximately 45minutes) at day 1</time_frame>
      <description>Participants will rate the Perceived difficultness of performing head movements using a 6-point Likert scale going from 0 = no problems, 1 = minimally difficult; 2 = somewhat difficult; 3 = fairly difficult; 4 = very difficult; 5 = unable to perform</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived neck pain intensity</measure>
      <time_frame>During a single test session (approximately 45minutes) at day 1</time_frame>
      <description>Participants will rate ant potential pain during the session using a 0-11 numeric rating scale (NRS) with 0 = no pain and 10 = worst imaginable pain</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Neck Disability Index (NDI)</measure>
      <time_frame>At the beginning of the single test session (approximately 45minutes) at day 1</time_frame>
      <description>The NDI questionnaire consists of 10 items (Domains: pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleeping, recreation) used to assess how neck pain affects your ability to manage everyday activities. Each item is score on a scale from 0-5 with a higher total score = high level of disability</description>
    </other_outcome>
    <other_outcome>
      <measure>Tampa Scale for Kinesiophobia (TSK-11)</measure>
      <time_frame>At the beginning of the single test session (approximately 45minutes) at day 1</time_frame>
      <description>The TSK-11 questionnaire consists of 11 items which is answered using a 4-point scale (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree). Score can range from 11 to 44 and a higher score indicated a greater kinesiophobia</description>
    </other_outcome>
    <other_outcome>
      <measure>Perceived area of neck pain</measure>
      <time_frame>At the beginning of the single test session (approximately 45minutes) at day 1</time_frame>
      <description>Participants will draw the area of perceived neck pain on a body chart</description>
    </other_outcome>
    <other_outcome>
      <measure>Fear Avoidance Beliefs Questionnaire-physical activity subscale (FABQpa)</measure>
      <time_frame>Time Frame: At the beginning of the single test session (approximately 45minutes) at day 1</time_frame>
      <description>The FABQpa subscale consists of 4 items which are used to assess the participants beliefs on how physical activity can affect their pain. The items are scored on a 7-point scale with 0 = Completely disagree and 6 = Completely agree. Score ranges from 0-24 with a higher score indicating higher fear avoidance beliefs with regards to physical activity</description>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">44</enrollment>
    <condition>Healthy</condition>
    <condition>Neck Pain</condition>
    <arm_group>
      <arm_group_label>Sound 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A sound will be played while moving the head</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sound 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A sound (different from Sound 1) will be played while moving the head</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No Sound</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No sound will be played while moving the head</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Smartphone playing a sound</intervention_name>
      <description>A sound will be played from a portable device (smartphone) during movement</description>
      <arm_group_label>Sound 1</arm_group_label>
      <arm_group_label>Sound 2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Control group:&#xD;
  &#xD;
          Inclusion Criteria (Control):&#xD;
  &#xD;
            -  Able to speak, read and understand Danish/English&#xD;
  &#xD;
          Exclusion Criteria (Control):&#xD;
  &#xD;
            -  Pain from the neck or shoulder area during the past 6 months&#xD;
  &#xD;
            -  Experience of delayed onset muscle soreness (DOMS) during the week leading up to the&#xD;
               test session&#xD;
  &#xD;
            -  Former surgery in neck or shoulder&#xD;
  &#xD;
            -  Current or previous chronic or recurrent pain condition that could affect the results&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Drug addiction defined as the use of cannabis, opioids or other drugs&#xD;
  &#xD;
            -  Previous neurologic, musculoskeletal or mental illnesses that could affect the results&#xD;
  &#xD;
            -  Regular use of analgesics&#xD;
  &#xD;
            -  Abnormally disrupted sleep in the last 24 hours preceding the experiment&#xD;
  &#xD;
            -  Lack of ability to cooperate&#xD;
  &#xD;
          Neck pain group:&#xD;
  &#xD;
          Inclusion Criteria (Neck Pain):&#xD;
  &#xD;
            -  Idiopathic neck pain&#xD;
  &#xD;
            -  Able to speak, read and understand Danish/English&#xD;
  &#xD;
            -  Reduced/painful active range of motion of the head and/or painful reaction to&#xD;
               palpation of the neck at the time of inclusion&#xD;
  &#xD;
          Exclusion Criteria (Neck Pain):&#xD;
  &#xD;
            -  Experience of DOMS during the week leading up to the test session&#xD;
  &#xD;
            -  Former surgery in neck or shoulder&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Drug addiction defined as the use of cannabis, opioids or other drugs&#xD;
  &#xD;
            -  Previous neurologic, musculoskeletal (other than neck pain) or mental illnesses that&#xD;
               could affect the results&#xD;
  &#xD;
            -  Abnormally disrupted sleep in the 24 hours preceding the experiment&#xD;
  &#xD;
            -  Lack of ability to cooperate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Steffan WM Christensen, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Aalborg University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Steffan WM Christensen, PhD</last_name>
      <phone>(+45) 99408889</phone>
      <email>stc@hst.aau.dk</email>
    </overall_contact>
    <location>
      <facility>
        <name>FysioDanmark Aalborg</name>
        <address>
          <city>Aalborg</city>
          <zip>9000</zip>
          <country>Denmark</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Dept. Of Health Science and Technology, Aalborg University</name>
        <address>
          <city>Gistrup</city>
          <zip>9260</zip>
          <country>Denmark</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Aalborg University</investigator_affiliation>
      <investigator_full_name>Steffan Wittrup Christensen</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>Neck pain</keyword>
    <keyword>Kinematics</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neck Pain</mesh_term>
    </condition_browse>
    <!-- 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/NCT06028269
  org study id: AAU031-1025976a
  nct id: NCT06028269
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study sets out to investigate the potential effect of auditory disturbances on human
        movement
  Clinicians routinely investigate/test human movement but if/how this is effect by auditory
        disturbances is unclear. This study sets out to investigate the impact of auditory
        disturbances on head movements.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Basic Science
  masking: Single (Participant)
  measure: Range of motion
  time frame: During a single test session (approximately 45minutes) at day 1
  description: Range of motion will be assessed during head rotations (i.e. moving the head from a neutral position to end of range in rotation before returning to the start position)
  measure: Head repositioning accuracy
  time frame: During a single test session (approximately 45minutes) at day 1
  description: Head repositioning accuracy will be assessed as the error between the starting point and the end point following a head rotation (i.e. moving the head from a neutral position to end of range in rotation before returning to the start position) and will be repressed in degrees.
  measure: Quality of head movement
  time frame: During a single test session (approximately 45minutes) at day 1
  description: Quality of movement (smoothness) will be determined using calculations of jerk variance (Jerk is the time derivative of acceleration which will be measures using an inertial measurement unit. The measure will be converted to a unitless measure where higher values indicates less smooth movements), assessed during head rotations (i.e. moving the head from a neutral position to end of range in rotation before returning to the start position).
  measure: Perceived stiffness during movement
  time frame: During a single test session (approximately 45minutes) at day 1
  description: Participants will rate their perceived stiffness during head movement using a 0-100 numerical rating scale, where 0 = no stiffness and 100 = worst stiffness imaginable.
  measure: Perceived difficultness of performing movement
  time frame: During a single test session (approximately 45minutes) at day 1
  description: Participants will rate the Perceived difficultness of performing head movements using a 6-point Likert scale going from 0 = no problems, 1 = minimally difficult; 2 = somewhat difficult; 3 = fairly difficult; 4 = very difficult; 5 = unable to perform
  measure: Perceived neck pain intensity
  time frame: During a single test session (approximately 45minutes) at day 1
  description: Participants will rate ant potential pain during the session using a 0-11 numeric rating scale (NRS) with 0 = no pain and 10 = worst imaginable pain
  measure: Neck Disability Index (NDI)
  time frame: At the beginning of the single test session (approximately 45minutes) at day 1
  description: The NDI questionnaire consists of 10 items (Domains: pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleeping, recreation) used to assess how neck pain affects your ability to manage everyday activities. Each item is score on a scale from 0-5 with a higher total score = high level of disability
  measure: Tampa Scale for Kinesiophobia (TSK-11)
  time frame: At the beginning of the single test session (approximately 45minutes) at day 1
  description: The TSK-11 questionnaire consists of 11 items which is answered using a 4-point scale (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree). Score can range from 11 to 44 and a higher score indicated a greater kinesiophobia
  measure: Perceived area of neck pain
  time frame: At the beginning of the single test session (approximately 45minutes) at day 1
  description: Participants will draw the area of perceived neck pain on a body chart
  measure: Fear Avoidance Beliefs Questionnaire-physical activity subscale (FABQpa)
  time frame: Time Frame: At the beginning of the single test session (approximately 45minutes) at day 1
  description: The FABQpa subscale consists of 4 items which are used to assess the participants beliefs on how physical activity can affect their pain. The items are scored on a 7-point scale with 0 = Completely disagree and 6 = Completely agree. Score ranges from 0-24 with a higher score indicating higher fear avoidance beliefs with regards to physical activity
  arm group label: Sound 1
  arm group type: Experimental
  description: A sound will be played while moving the head
  arm group label: Sound 2
  arm group type: Experimental
  description: A sound (different from Sound 1) will be played while moving the head
  arm group label: No Sound
  arm group type: No Intervention
  description: No sound will be played while moving the head
  intervention type: Device
  intervention name: Smartphone playing a sound
  description: A sound will be played from a portable device (smartphone) during movement
  arm group label: Sound 1
  arm group label: Sound 2
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Steffan WM Christensen, PhD
  role: Principal Investigator
  affiliation: Aalborg University
  last name: Steffan WM Christensen, PhD
  phone: (+45) 99408889
  email: stc@hst.aau.dk
  facility: 
  facility: 
  country: Denmark
  responsible party type: Principal Investigator
  investigator affiliation: Aalborg University
  investigator full name: Steffan Wittrup Christensen
  investigator title: Associate Professor
  mesh term: Neck Pain