<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/NCT04417855</url>
  </required_header>
  <id_info>
    <org_study_id>G-Sensor</org_study_id>
    <nct_id>NCT04417855</nct_id>
  </id_info>
  <brief_title>Lumbar Kinematics in People With the Low Back Pain</brief_title>
  <official_title>The Effect of Lumbar Disc Herniation on the Kinematics in Lumbo-pelvic Region During Daily Living Activities.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wroclaw University of Health and Sport Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wroclaw University of Health and Sport Sciences</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 study evaluates the effect of lumbar disc herniation on kinematics in the lumbopelvic&#xD;
      region during daily living activities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lumbar disc herniation (LDH) is one of the causes of low back pain and contributes to&#xD;
      increasing the socio-economic problem. Depending on the reason for the dysfunction, various&#xD;
      classifications describing the level of advancement are used. The literature on the subject&#xD;
      commonly uses the division into protrusion and extrusion of the intervertebral disc, as&#xD;
      approved by the American Society of Neuroradiology.&#xD;
&#xD;
      The lumbopelvic kinematics, including gait and daily living activities, can be affected by&#xD;
      the LDH: protrusion or extrusion. This pathology may be different due to the direction of&#xD;
      disc migration: centre, left, right or all mentioned. Therefore, we believe that from the&#xD;
      different direction of the disc migration the different symptoms can be observed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 8, 2020</start_date>
  <completion_date type="Actual">August 4, 2020</completion_date>
  <primary_completion_date type="Actual">July 20, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Timed Up and Go test (TUG)</measure>
    <time_frame>5 minutes</time_frame>
    <description>The sensor mounted on the belt in lumbar 2nd (L2) vertebra. Following data will be obtained:&#xD;
Spatio-temporal parameters standing phase, sitting phase and rotations, trunk kinematics (flexion and/or extension angle) will be collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>6-meter walking test</measure>
    <time_frame>5 minutes</time_frame>
    <description>The sensor mounted on the belt in lumbar 5th (L5) vertebra. Following data will be obtained:&#xD;
Total distance travelled general spatio-temporal parameters, variation in spatio-temporal parameters during the 6 minutes walking, pelvis kinematics</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oswestry Disability Index (ODI)</measure>
    <time_frame>15 minutes</time_frame>
    <description>The Oswestry Disability Index (ODI) is a valid and reliable assessment tool used by clinicians and researchers to quantify disability for low back pain. The self-completed questionnaire contains ten sections concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel.&#xD;
For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. After completing, the score is calculated by by summing scores from all sections (total maximum points=50). Total results are calculated as a percentage. The higher the score, the subject's condition is worse.&#xD;
The results are interpreted as follows:&#xD;
0% to 20%: minimal disability 21%-40%: moderate disability 41%-60%: severe disability 61%-80%: crippled 81%-100%:These patients are either bed-bound or exaggerating their symptoms.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Lumbar Disc Herniation</condition>
  <condition>Protrusion</condition>
  <condition>Extrusion of Migrated Disc</condition>
  <condition>Hernia</condition>
  <arm_group>
    <arm_group_label>LDH</arm_group_label>
    <description>Group of symptomatic individuals with LDH confirmed in MRI.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Group of asymptomatic individuals with no LDH.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>G-Walk</intervention_name>
    <description>Every individual will be examined with a non-invasive &quot;G-Walk&quot; device which is a sensor mounted on a belt and fasten on individuals' lumbar spine region during two test activities: Timed up and go and 6-meter walk tests. Data collection will include kinematic parameters. Oswestry Disability Index (ODI) score will also be collected.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>LDH</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Primary care clinic, students&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  disc disease located in the lumbar region of the spine confirmed in the MRI&#xD;
&#xD;
          -  subacute stage of the disease&#xD;
&#xD;
          -  age 18-35 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  advanced degenerative-deformation changes of the spine&#xD;
&#xD;
          -  previous fracture of the spine&#xD;
&#xD;
          -  neurologic deficits in lower limbs or pelvis&#xD;
&#xD;
          -  spondylolisthesis&#xD;
&#xD;
          -  transitional vertebra&#xD;
&#xD;
          -  rheumatic diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>theMedicine</name>
      <address>
        <city>Wrocław</city>
        <state>Dolnośląskie</state>
        <zip>50-305</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <reference>
    <citation>Shahvarpour A, Gagnon D, Preuss R, Henry SM, Lariviere C. Trunk postural balance and low back pain: Reliability and relationship with clinical changes following a lumbar stabilization exercise program. Gait Posture. 2018 Mar;61:375-381. doi: 10.1016/j.gaitpost.2018.02.006. Epub 2018 Feb 9.</citation>
    <PMID>29448220</PMID>
  </reference>
  <reference>
    <citation>Kuwahara W, Kurumadani H, Tanaka N, Nakanishi K, Nakamura H, Ishii Y, Ueda A, Deie M, Adachi N, Sunagawa T. Correlation between spinal and pelvic movements during gait and aggravation of low back pain by gait loading in lumbar spinal stenosis patients. J Orthop Sci. 2019 Mar;24(2):207-213. doi: 10.1016/j.jos.2018.09.002. Epub 2018 Oct 12.</citation>
    <PMID>30322623</PMID>
  </reference>
  <reference>
    <citation>Kuai S, Zhou W, Liao Z, Ji R, Guo D, Zhang R, Liu W. Influences of lumbar disc herniation on the kinematics in multi-segmental spine, pelvis, and lower extremities during five activities of daily living. BMC Musculoskelet Disord. 2017 May 25;18(1):216. doi: 10.1186/s12891-017-1572-7.</citation>
    <PMID>28545560</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>August 9, 2020</last_update_submitted>
  <last_update_submitted_qc>August 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wroclaw University of Health and Sport Sciences</investigator_affiliation>
    <investigator_full_name>Tomasz Kuligowski</investigator_full_name>
    <investigator_title>dr Tomasz Kuligowski</investigator_title>
  </responsible_party>
  <keyword>degenerative disc disease</keyword>
  <keyword>protrusion</keyword>
  <keyword>extrusion</keyword>
  <keyword>gait</keyword>
  <keyword>kinematics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intervertebral Disc Displacement</mesh_term>
    <mesh_term>Hernia</mesh_term>
  </condition_browse>
  <!-- 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/NCT04417855
org study id: G-Sensor
nct id: NCT04417855
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effect of lumbar disc herniation on kinematics in the lumbopelvic
      region during daily living activities.
Lumbar disc herniation (LDH) is one of the causes of low back pain and contributes to
      increasing the socio-economic problem. Depending on the reason for the dysfunction, various
      classifications describing the level of advancement are used. The literature on the subject
      commonly uses the division into protrusion and extrusion of the intervertebral disc, as
      approved by the American Society of Neuroradiology.

      The lumbopelvic kinematics, including gait and daily living activities, can be affected by
      the LDH: protrusion or extrusion. This pathology may be different due to the direction of
      disc migration: centre, left, right or all mentioned. Therefore, we believe that from the
      different direction of the disc migration the different symptoms can be observed.
observational model: Cohort
time perspective: Cross-Sectional
measure: Timed Up and Go test (TUG)
time frame: 5 minutes
description: The sensor mounted on the belt in lumbar 2nd (L2) vertebra. Following data will be obtained:
Spatio-temporal parameters standing phase, sitting phase and rotations, trunk kinematics (flexion and/or extension angle) will be collected.
measure: 6-meter walking test
time frame: 5 minutes
description: The sensor mounted on the belt in lumbar 5th (L5) vertebra. Following data will be obtained:
Total distance travelled general spatio-temporal parameters, variation in spatio-temporal parameters during the 6 minutes walking, pelvis kinematics
measure: Oswestry Disability Index (ODI)
time frame: 15 minutes
description: The Oswestry Disability Index (ODI) is a valid and reliable assessment tool used by clinicians and researchers to quantify disability for low back pain. The self-completed questionnaire contains ten sections concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel.
For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. After completing, the score is calculated by by summing scores from all sections (total maximum points=50). Total results are calculated as a percentage. The higher the score, the subject's condition is worse.
The results are interpreted as follows:
0% to 20%: minimal disability 21%-40%: moderate disability 41%-60%: severe disability 61%-80%: crippled 81%-100%:These patients are either bed-bound or exaggerating their symptoms.
arm group label: LDH
description: Group of symptomatic individuals with LDH confirmed in MRI.
arm group label: Control
description: Group of asymptomatic individuals with no LDH.
intervention type: Diagnostic Test
intervention name: G-Walk
description: Every individual will be examined with a non-invasive "G-Walk" device which is a sensor mounted on a belt and fasten on individuals' lumbar spine region during two test activities: Timed up and go and 6-meter walk tests. Data collection will include kinematic parameters. Oswestry Disability Index (ODI) score will also be collected.
arm group label: Control
arm group label: LDH
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Poland
citation: Shahvarpour A, Gagnon D, Preuss R, Henry SM, Lariviere C. Trunk postural balance and low back pain: Reliability and relationship with clinical changes following a lumbar stabilization exercise program. Gait Posture. 2018 Mar;61:375-381. doi: 10.1016/j.gaitpost.2018.02.006. Epub 2018 Feb 9.
PMID: 29448220
citation: Kuwahara W, Kurumadani H, Tanaka N, Nakanishi K, Nakamura H, Ishii Y, Ueda A, Deie M, Adachi N, Sunagawa T. Correlation between spinal and pelvic movements during gait and aggravation of low back pain by gait loading in lumbar spinal stenosis patients. J Orthop Sci. 2019 Mar;24(2):207-213. doi: 10.1016/j.jos.2018.09.002. Epub 2018 Oct 12.
PMID: 30322623
citation: Kuai S, Zhou W, Liao Z, Ji R, Guo D, Zhang R, Liu W. Influences of lumbar disc herniation on the kinematics in multi-segmental spine, pelvis, and lower extremities during five activities of daily living. BMC Musculoskelet Disord. 2017 May 25;18(1):216. doi: 10.1186/s12891-017-1572-7.
PMID: 28545560
responsible party type: Principal Investigator
investigator affiliation: Wroclaw University of Health and Sport Sciences
investigator full name: Tomasz Kuligowski
investigator title: dr Tomasz Kuligowski
mesh term: Intervertebral Disc Displacement
mesh term: Hernia