<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/NCT03255616</url>
  </required_header>
  <id_info>
    <org_study_id>Project_X</org_study_id>
    <nct_id>NCT03255616</nct_id>
  </id_info>
  <brief_title>Low Back Pain: Unveiling the Contribution of Motor Control Adaption Using Biomechanical Modeling and Neuroimaging</brief_title>
  <official_title>Low Back Pain: Unveiling the Contribution of Motor Control Adaption Using Biomechanical Modeling and Neuroimaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Balgrist University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Psychiatric University Hospital, Zurich</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bern University of Applied Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Balgrist University Hospital</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>
      This project aims to reveal the potential sensorimotor reorganization of sensory input in low&#xD;
      back pain patients and its association with different motor control strategies in LBP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Low back pain (LBP) is a major health issue. Treatment of chronic LBP is still a&#xD;
      major challenge due to a lack of pathophysiological understanding. Thus, understanding LBP&#xD;
      pathophysiology is a research priority. Adaptions of motor control likely play a significant&#xD;
      role in chronic or recurrent LBP because motor control is crucial for spine posture,&#xD;
      stability and movement. Different motor adaption strategies exist across individuals with LBP&#xD;
      and two phenotypes representing the opposite ends of a spectrum have been suggested; i.e.&#xD;
      &quot;tight&quot; control and &quot;loose&quot; control over trunk movement. The former would be associated with&#xD;
      reduced trunk motor variability, the later with increased trunk motor variability. This&#xD;
      conceptual framework is very useful to explain maintenance and aggravating of LBP because&#xD;
      motor control adaptations are expected to have long-term consequences, such as increased&#xD;
      spinal tissue loading, associated with degeneration of intervertebral discs and other&#xD;
      tissues. Several knowledge gaps need to be addressed to test the validity of this framework:&#xD;
      1) Do loose/tight control phenotypes indeed exist and/or do other motor control adaption&#xD;
      strategies exist? 2) Is reduced/altered paraspinal proprioceptive input associated with LBP&#xD;
      related to neuroplastic cortical changes, thereby affecting the organizational structure in&#xD;
      sensorimotor cortices and top-down trunk motor control? 3) Do psychological factors influence&#xD;
      the organizational structure in sensorimotor cortices and motor control strategies? To&#xD;
      address these knowledge gaps, the objectives of the current project are: I) To establish&#xD;
      motor control phenotypes in LBP. Proprioceptive weighting and biomechanical assessment of&#xD;
      dynamic movement tasks, including subject-specific spine kinematic variability and its&#xD;
      relationship to pain duration, negative pain-related cognitions, segmental loadings and&#xD;
      paraspinal muscle forces, will be performed. II) To test whether cortical proprioceptive maps&#xD;
      differ between healthy subjects and patients with LBP. Brain activation in response to&#xD;
      thoracolumbar vibrotactile stimulation will be interrogated using functional magnetic&#xD;
      resonance imaging data and univariate and multivariate analysis based on machine learning.&#xD;
      III) To test whether proprioceptive maps demonstrate a relationship to spine kinematic&#xD;
      patterns, pain duration and negative pain-related cognitions in LBP patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">January 17, 2023</completion_date>
  <primary_completion_date type="Actual">January 17, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood oxygenation level dependent (BOLD) responses</measure>
    <time_frame>MR assessment, 30 minutes</time_frame>
    <description>supraspinal BOLD responses induced by mechanical and vibrotactile stimulations of the back recorded by means of functional magnetic resonance imaging (fMRI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Spine kinematics</measure>
    <time_frame>Spinal kinematics assessment, 120 minutes</time_frame>
    <description>Sagittal and frontal plane lumbar and thoracic spinal curvature angles</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Spine biomechanics: muscle forces</measure>
    <time_frame>Spinal kinematics assessment, 120 minutes</time_frame>
    <description>segmental muscle forces (N/mm) during dynamic tasks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Spine biomechanics: segmental loading</measure>
    <time_frame>Spinal kinematics assessment, 120 minutes</time_frame>
    <description>segmental loading (N) during dynamic tasks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proprioceptive repositioning errors</measure>
    <time_frame>Proprioceptive assessment, 10 minutes</time_frame>
    <description>Sagittal plane repositioning errors assessed through lumbar and thoracic spinal curvature angles</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Center of pressure displacements</measure>
    <time_frame>Postural stability assessment, 20 minutes</time_frame>
    <description>Center of pressure displacements during vibrotactile stimulation while standing on a force plate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Segmental movement</measure>
    <time_frame>MR assessment, 20 minutes</time_frame>
    <description>Displacement (intervertebral angles) of the stimulated and adjacent spinal segments during mechanical pressure using dynamic T2 scans</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of movement</measure>
    <time_frame>Medical assessment, 5 minutes</time_frame>
    <description>score of the Tampa Scale of Kinesiphobia (TSK) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear Avoidance Beliefs</measure>
    <time_frame>Medical assessment, 5 minutes</time_frame>
    <description>scores of the Fear Aovidance Beliefs questionnaire (FABQ) in low back pain patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of disability</measure>
    <time_frame>Medical assessment, 3 minutes</time_frame>
    <description>scores of the Oswestry Disability Index (ODI) in low back pain patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain characteristics</measure>
    <time_frame>Medical assessment, 1 minutes</time_frame>
    <description>Pain quality assessment using the PainDETECT questionnaire in low back pain patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perception of the back</measure>
    <time_frame>Medical assessment, 2 minutes</time_frame>
    <description>Assessment of self-perception of the back using the Fremantle Back Awareness Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State and Trait anxiety</measure>
    <time_frame>Medical assessment, 2 minutes</time_frame>
    <description>scores of state and trait anxiety (STAI) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived harmfulness of back stressing movements</measure>
    <time_frame>Medical assessment, 15 minutes</time_frame>
    <description>Assessment of the perceived harmfulness of back stressing movements using the electronic version of the PHODA questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Healthy subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Spine kinematics assessment during daily activities and brain responses to thoracolumbar mechanical and vibrotactile stimulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low back pain patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Spine kinematics assessment during daily activities and brain responses to thoracolumbar mechanical and vibrotactile stimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>mechanical stimulation</intervention_name>
    <description>mechanical non-painful low- and high pressure stimuli to thoracolumbar segments of healthy subjects and low back pain patients</description>
    <arm_group_label>Healthy subjects</arm_group_label>
    <arm_group_label>Low back pain patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>vibrotactile stimulation</intervention_name>
    <description>non-painful vibrotactile stimulation within a frequency range between 20-150Hz to thoracolumbar segments of healthy subjects and low back pain patients</description>
    <arm_group_label>Healthy subjects</arm_group_label>
    <arm_group_label>Low back pain patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria healthy subjects:&#xD;
&#xD;
          -  Aged between 18 and 60&#xD;
&#xD;
          -  Written informed consent after being informed&#xD;
&#xD;
        Inclusion criteria low back pain patients:&#xD;
&#xD;
          -  Aged between 18 and 60&#xD;
&#xD;
          -  Low back pain for more than 1 week&#xD;
&#xD;
        Exclusion criteria healthy subjects:&#xD;
&#xD;
          -  Consumption of alcohol, drugs, analgesics within the last 24 h&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  acute and/or low recurrent back pain within the last 3 months&#xD;
&#xD;
          -  Prior spine surgery&#xD;
&#xD;
          -  Other chronic pain condition&#xD;
&#xD;
          -  history of psychiatric or neurological disorders&#xD;
&#xD;
          -  MR-contraindications&#xD;
&#xD;
          -  Body mass index (BMI) &gt; 30 kg/m2&#xD;
&#xD;
        Exclusion criteria low back pain patients:&#xD;
&#xD;
          -  Consumption of alcohol, drugs, analgesics within the last 24 h&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Specific causes for the back pain (ruled out by the clinician)&#xD;
&#xD;
          -  Prior spine surgery&#xD;
&#xD;
          -  History of psychiatric or neurological disorders&#xD;
&#xD;
          -  MR-contraindications&#xD;
&#xD;
          -  Body mass index (BMI) &gt; 30 kg/m2&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Meier, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Balgrist University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Balgrist University Hospital</name>
      <address>
        <city>Zürich</city>
        <zip>8008</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>January 17, 2023</last_update_submitted>
  <last_update_submitted_qc>January 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Balgrist University Hospital</investigator_affiliation>
    <investigator_full_name>Michael Meier</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>It is planned to share the fMRI dataset in BIDS format on &quot;openfmri.org&quot;</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/NCT03255616
org study id: Project_X
nct id: NCT03255616
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This project aims to reveal the potential sensorimotor reorganization of sensory input in low
      back pain patients and its association with different motor control strategies in LBP.
Background: Low back pain (LBP) is a major health issue. Treatment of chronic LBP is still a
      major challenge due to a lack of pathophysiological understanding. Thus, understanding LBP
      pathophysiology is a research priority. Adaptions of motor control likely play a significant
      role in chronic or recurrent LBP because motor control is crucial for spine posture,
      stability and movement. Different motor adaption strategies exist across individuals with LBP
      and two phenotypes representing the opposite ends of a spectrum have been suggested; i.e.
      "tight" control and "loose" control over trunk movement. The former would be associated with
      reduced trunk motor variability, the later with increased trunk motor variability. This
      conceptual framework is very useful to explain maintenance and aggravating of LBP because
      motor control adaptations are expected to have long-term consequences, such as increased
      spinal tissue loading, associated with degeneration of intervertebral discs and other
      tissues. Several knowledge gaps need to be addressed to test the validity of this framework:
      1) Do loose/tight control phenotypes indeed exist and/or do other motor control adaption
      strategies exist? 2) Is reduced/altered paraspinal proprioceptive input associated with LBP
      related to neuroplastic cortical changes, thereby affecting the organizational structure in
      sensorimotor cortices and top-down trunk motor control? 3) Do psychological factors influence
      the organizational structure in sensorimotor cortices and motor control strategies? To
      address these knowledge gaps, the objectives of the current project are: I) To establish
      motor control phenotypes in LBP. Proprioceptive weighting and biomechanical assessment of
      dynamic movement tasks, including subject-specific spine kinematic variability and its
      relationship to pain duration, negative pain-related cognitions, segmental loadings and
      paraspinal muscle forces, will be performed. II) To test whether cortical proprioceptive maps
      differ between healthy subjects and patients with LBP. Brain activation in response to
      thoracolumbar vibrotactile stimulation will be interrogated using functional magnetic
      resonance imaging data and univariate and multivariate analysis based on machine learning.
      III) To test whether proprioceptive maps demonstrate a relationship to spine kinematic
      patterns, pain duration and negative pain-related cognitions in LBP patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Blood oxygenation level dependent (BOLD) responses
time frame: MR assessment, 30 minutes
description: supraspinal BOLD responses induced by mechanical and vibrotactile stimulations of the back recorded by means of functional magnetic resonance imaging (fMRI)
measure: Spine kinematics
time frame: Spinal kinematics assessment, 120 minutes
description: Sagittal and frontal plane lumbar and thoracic spinal curvature angles
measure: Spine biomechanics: muscle forces
time frame: Spinal kinematics assessment, 120 minutes
description: segmental muscle forces (N/mm) during dynamic tasks
measure: Spine biomechanics: segmental loading
time frame: Spinal kinematics assessment, 120 minutes
description: segmental loading (N) during dynamic tasks
measure: Proprioceptive repositioning errors
time frame: Proprioceptive assessment, 10 minutes
description: Sagittal plane repositioning errors assessed through lumbar and thoracic spinal curvature angles
measure: Center of pressure displacements
time frame: Postural stability assessment, 20 minutes
description: Center of pressure displacements during vibrotactile stimulation while standing on a force plate
measure: Segmental movement
time frame: MR assessment, 20 minutes
description: Displacement (intervertebral angles) of the stimulated and adjacent spinal segments during mechanical pressure using dynamic T2 scans
measure: Fear of movement
time frame: Medical assessment, 5 minutes
description: score of the Tampa Scale of Kinesiphobia (TSK) questionnaire
measure: Fear Avoidance Beliefs
time frame: Medical assessment, 5 minutes
description: scores of the Fear Aovidance Beliefs questionnaire (FABQ) in low back pain patients
measure: Level of disability
time frame: Medical assessment, 3 minutes
description: scores of the Oswestry Disability Index (ODI) in low back pain patients
measure: Pain characteristics
time frame: Medical assessment, 1 minutes
description: Pain quality assessment using the PainDETECT questionnaire in low back pain patients
measure: Perception of the back
time frame: Medical assessment, 2 minutes
description: Assessment of self-perception of the back using the Fremantle Back Awareness Questionnaire
measure: State and Trait anxiety
time frame: Medical assessment, 2 minutes
description: scores of state and trait anxiety (STAI) questionnaire
measure: Perceived harmfulness of back stressing movements
time frame: Medical assessment, 15 minutes
description: Assessment of the perceived harmfulness of back stressing movements using the electronic version of the PHODA questionnaire
arm group label: Healthy subjects
arm group type: Experimental
description: Spine kinematics assessment during daily activities and brain responses to thoracolumbar mechanical and vibrotactile stimulation
arm group label: Low back pain patients
arm group type: Experimental
description: Spine kinematics assessment during daily activities and brain responses to thoracolumbar mechanical and vibrotactile stimulation
intervention type: Other
intervention name: mechanical stimulation
description: mechanical non-painful low- and high pressure stimuli to thoracolumbar segments of healthy subjects and low back pain patients
arm group label: Healthy subjects
arm group label: Low back pain patients
intervention type: Other
intervention name: vibrotactile stimulation
description: non-painful vibrotactile stimulation within a frequency range between 20-150Hz to thoracolumbar segments of healthy subjects and low back pain patients
arm group label: Healthy subjects
arm group label: Low back pain patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Meier, PhD
role: Principal Investigator
affiliation: Balgrist University Hospital
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Balgrist University Hospital
investigator full name: Michael Meier
investigator title: Principal Investigator
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: Undecided
ipd description: It is planned to share the fMRI dataset in BIDS format on "openfmri.org"