<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/NCT03298490</url>
  </required_header>
  <id_info>
    <org_study_id>2017-73</org_study_id>
    <nct_id>NCT03298490</nct_id>
  </id_info>
  <brief_title>Reliability, Validity Of The Turkish Version Of The Back Performance Scale</brief_title>
  <official_title>Reliability, Validity Of The Turkish Version Of The Back Performance Scale</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gazi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gazi University</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>
      In this study, we performed the validity and reliability of the Turkish version of Back&#xD;
      Performance Scale.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Low back pain (LBP) is defined as the pain that occurs in the area between the lower border&#xD;
      of the scapula and the buttocks and sometimes radiates to the lower extremities. In the&#xD;
      community, lower back pain is the second most common health problem after cold. 15% of LBP&#xD;
      cases are chronic. Appropriate use of assessment questionnaires is one of the most important&#xD;
      steps in the evaluation of the functional level of the patient and in deciding on an&#xD;
      effective treatment protocol. The purpose of study is to determine the Turkish version,&#xD;
      validity and reliability of Back Performance Scale. 180 patients with chronic low back pain&#xD;
      were included in the study. Test-retest and internal consistency analysis were conducted to&#xD;
      determine the reliability of the questionnaire. Test-retest results evaluated using the&#xD;
      Intraclass Correlation Coefficient method.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 5, 2017</start_date>
  <completion_date type="Actual">November 18, 2017</completion_date>
  <primary_completion_date type="Actual">October 5, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Roland Morris disability questionnaire</measure>
    <time_frame>10 minute</time_frame>
    <description>Roland Morris Disability Questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oswestry Low Back Pain Disability Questionnaire</measure>
    <time_frame>10 minute</time_frame>
    <description>The Oswestry Disability Index (ODI) has become one of the principal condition-specific outcome measures used in the management of spinal disorders</description>
  </secondary_outcome>
  <enrollment type="Actual">180</enrollment>
  <condition>Low Back Pain</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with chronic back pain between the ages of 18-65&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Having a low back pain&#xD;
&#xD;
          -  Literate persons&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cancer disease&#xD;
&#xD;
          -  Trauma&#xD;
&#xD;
          -  Pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>seyit çıtaker</last_name>
    <role>Study Chair</role>
    <affiliation>gazi üniversity</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gazi University</name>
      <address>
        <city>Ankara</city>
        <zip>06500</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>October 3, 2019</last_update_submitted>
  <last_update_submitted_qc>October 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gazi University</investigator_affiliation>
    <investigator_full_name>GÖKHAN MARAŞ</investigator_full_name>
    <investigator_title>Research assistant</investigator_title>
  </responsible_party>
  <keyword>validity</keyword>
  <keyword>reliability</keyword>
  <keyword>low back pain</keyword>
  <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>
  <!-- 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/NCT03298490
org study id: 2017-73
nct id: NCT03298490
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, we performed the validity and reliability of the Turkish version of Back
      Performance Scale.
Low back pain (LBP) is defined as the pain that occurs in the area between the lower border
      of the scapula and the buttocks and sometimes radiates to the lower extremities. In the
      community, lower back pain is the second most common health problem after cold. 15% of LBP
      cases are chronic. Appropriate use of assessment questionnaires is one of the most important
      steps in the evaluation of the functional level of the patient and in deciding on an
      effective treatment protocol. The purpose of study is to determine the Turkish version,
      validity and reliability of Back Performance Scale. 180 patients with chronic low back pain
      were included in the study. Test-retest and internal consistency analysis were conducted to
      determine the reliability of the questionnaire. Test-retest results evaluated using the
      Intraclass Correlation Coefficient method.
observational model: Case-Only
time perspective: Prospective
measure: Roland Morris disability questionnaire
time frame: 10 minute
description: Roland Morris Disability Questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice.
measure: Oswestry Low Back Pain Disability Questionnaire
time frame: 10 minute
description: The Oswestry Disability Index (ODI) has become one of the principal condition-specific outcome measures used in the management of spinal disorders
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: seyit çıtaker
role: Study Chair
affiliation: gazi üniversity
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Gazi University
investigator full name: GÖKHAN MARAŞ
investigator title: Research assistant
mesh term: Back Pain
mesh term: Low Back Pain