<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/NCT02254694</url>
  </required_header>
  <id_info>
    <org_study_id>SNCTP000000049</org_study_id>
    <nct_id>NCT02254694</nct_id>
  </id_info>
  <brief_title>The Influence of High Heeled Shoes on the Sagittal Balance of the Spine and Whole Body</brief_title>
  <official_title>The Influence of High Heeled Shoes on the Sagittal Balance of the Spine and Whole Body</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the influence of high heeled shoes on the&#xD;
      sagittal balance of the spine and the whole body.&#xD;
&#xD;
      The investigators hypothesize that wearing high heeled shoes leads to a hyperlordosis of the&#xD;
      cervical spine, a decrease of thoracic kyphosis, hyperlordosis of the lumbar spine and a&#xD;
      posterior tilt of the pelvis resulting in a posterior shift of the body's center of gravity.&#xD;
      This would be an explanation for the increased prevalence of back pain in individuals&#xD;
      frequently wearing high heels.&#xD;
&#xD;
      In order to assess these changes, differences in the two following outcome parameters will be&#xD;
      measured on a standing lateral EOS-radiograph of the whole body - barefoot and with high&#xD;
      heeled shoes: spino-sacral angle (primary) and meatus plumb line (secondary) .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Female volunteers (age ≥ 21 years) that are not frequent user of high heeled shoes (i.e. not&#xD;
      longer than 6 hours/month with heels &gt; 3 cm) will be included. Exclusion criteria are osseous&#xD;
      metastases, missing written informed consent, cognitive inability to consent on their own,&#xD;
      and pregnancy. Based on own preliminary studies, a sample size of 19 (+3 to anticipate drop&#xD;
      outs) patients is aimed for.&#xD;
&#xD;
      After obtaining informed consent, the participants will be interviewed with special regard to&#xD;
      their age, gender, height, weight, shoe size, past medical history, occupational and&#xD;
      recreational activities, and duration and frequency of wearing high heeled shoes.&#xD;
&#xD;
      A clinical examination of the spine and pelvis will be performed as well as a pregnancy urine&#xD;
      test.&#xD;
&#xD;
      Standing lateral EOS-radiographs (http://www.eos-imaging.com/) of the whole body will be&#xD;
      taken - once barefoot and once with high heeled shoes (heel height 9 cm).&#xD;
&#xD;
      All data acquisition is going to be performed during a single session, participants will not&#xD;
      be followed up.&#xD;
&#xD;
      The following parameters will be assessed on the radiographs: presence and number of (healed)&#xD;
      fractures, osseous metastases, sagittal C7 plumb line, meatus plumb line, cervical lordosis,&#xD;
      thoracic kyphosis, lumbar lordosis, spino- sacral angle as described by Roussouly et al.&#xD;
      (2006), pelvic incidence, pelvic tilt.&#xD;
&#xD;
      For statistical analysis, all data will be collected in a statistic software file (SPSS.&#xD;
      21.0, SPSS Inc, Chicago, Illinois). After testing for normal distribution, these differences&#xD;
      in means of the primary and secondary outcome parameters between the barefoot and the high&#xD;
      heeled radiograph will be assessed using a paired Student's T-test or non-parametric tests.&#xD;
      The level of significance is p &lt; 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>spino-sacral angle</measure>
    <time_frame>1 day</time_frame>
    <description>&quot;spino-sacral angle&quot; measured on the lateral EOS-radiograph of the whole body as described in: &quot;Classification of the normal variation in the sagittal alignment of the human lumbar spine and pelvis in the standing position.&quot; Roussouly P, Gollogly S, Berthonnaud E, Dimnet J. Spine (Phila Pa 1976). 2005 Feb 1;30(3):346-53.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>meatus plumb line</measure>
    <time_frame>1 day</time_frame>
    <description>plumb line from the meatus acusticus in relation to the calcaneal tuberosity on the lateral radiograph of the whole body</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Back Pain</condition>
  <arm_group>
    <arm_group_label>high heeled shoes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>see detailed description</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>high heeled shoes</intervention_name>
    <description>see detailed study description</description>
    <arm_group_label>high heeled shoes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  not frequent user of high heeled shoes (i.e. not longer than 6 hours/month with heels&#xD;
             &gt; 3 cm)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  osseous metastases&#xD;
&#xD;
          -  missing written informed consent&#xD;
&#xD;
          -  cognitive inability to consent on their own&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clément ML Werner, MD, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Zurich, Klinik für Unfallchirurgie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinik für Unfallchirurgie, University Hospital Zurich</name>
      <address>
        <city>Zurich</city>
        <state>ZH</state>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <results_reference>
    <citation>Opila KA, Wagner SS, Schiowitz S, Chen J. Postural alignment in barefoot and high-heeled stance. Spine (Phila Pa 1976). 1988 May;13(5):542-7. doi: 10.1097/00007632-198805000-00018.</citation>
    <PMID>3187700</PMID>
  </results_reference>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>May 27, 2015</last_update_submitted>
  <last_update_submitted_qc>May 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sagittal balance</keyword>
  <keyword>posture</keyword>
  <keyword>lumbar lordosis</keyword>
  <keyword>high heeled shoes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</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/NCT02254694
org study id: SNCTP000000049
nct id: NCT02254694
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the influence of high heeled shoes on the
      sagittal balance of the spine and the whole body.

      The investigators hypothesize that wearing high heeled shoes leads to a hyperlordosis of the
      cervical spine, a decrease of thoracic kyphosis, hyperlordosis of the lumbar spine and a
      posterior tilt of the pelvis resulting in a posterior shift of the body's center of gravity.
      This would be an explanation for the increased prevalence of back pain in individuals
      frequently wearing high heels.

      In order to assess these changes, differences in the two following outcome parameters will be
      measured on a standing lateral EOS-radiograph of the whole body - barefoot and with high
      heeled shoes: spino-sacral angle (primary) and meatus plumb line (secondary) .
Female volunteers (age ≥ 21 years) that are not frequent user of high heeled shoes (i.e. not
      longer than 6 hours/month with heels > 3 cm) will be included. Exclusion criteria are osseous
      metastases, missing written informed consent, cognitive inability to consent on their own,
      and pregnancy. Based on own preliminary studies, a sample size of 19 (+3 to anticipate drop
      outs) patients is aimed for.

      After obtaining informed consent, the participants will be interviewed with special regard to
      their age, gender, height, weight, shoe size, past medical history, occupational and
      recreational activities, and duration and frequency of wearing high heeled shoes.

      A clinical examination of the spine and pelvis will be performed as well as a pregnancy urine
      test.

      Standing lateral EOS-radiographs (http://www.eos-imaging.com/) of the whole body will be
      taken - once barefoot and once with high heeled shoes (heel height 9 cm).

      All data acquisition is going to be performed during a single session, participants will not
      be followed up.

      The following parameters will be assessed on the radiographs: presence and number of (healed)
      fractures, osseous metastases, sagittal C7 plumb line, meatus plumb line, cervical lordosis,
      thoracic kyphosis, lumbar lordosis, spino- sacral angle as described by Roussouly et al.
      (2006), pelvic incidence, pelvic tilt.

      For statistical analysis, all data will be collected in a statistic software file (SPSS.
      21.0, SPSS Inc, Chicago, Illinois). After testing for normal distribution, these differences
      in means of the primary and secondary outcome parameters between the barefoot and the high
      heeled radiograph will be assessed using a paired Student's T-test or non-parametric tests.
      The level of significance is p < 0.05.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: spino-sacral angle
time frame: 1 day
description: "spino-sacral angle" measured on the lateral EOS-radiograph of the whole body as described in: "Classification of the normal variation in the sagittal alignment of the human lumbar spine and pelvis in the standing position." Roussouly P, Gollogly S, Berthonnaud E, Dimnet J. Spine (Phila Pa 1976). 2005 Feb 1;30(3):346-53.
measure: meatus plumb line
time frame: 1 day
description: plumb line from the meatus acusticus in relation to the calcaneal tuberosity on the lateral radiograph of the whole body
arm group label: high heeled shoes
arm group type: Experimental
description: see detailed description
intervention type: Other
intervention name: high heeled shoes
description: see detailed study description
arm group label: high heeled shoes
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Clément ML Werner, MD, Prof
role: Principal Investigator
affiliation: University of Zurich, Klinik für Unfallchirurgie
facility: 
country: Switzerland
citation: Opila KA, Wagner SS, Schiowitz S, Chen J. Postural alignment in barefoot and high-heeled stance. Spine (Phila Pa 1976). 1988 May;13(5):542-7. doi: 10.1097/00007632-198805000-00018.
PMID: 3187700
responsible party type: Sponsor
mesh term: Back Pain