<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/NCT03006094</url>
  </required_header>
  <id_info>
    <org_study_id>242</org_study_id>
    <nct_id>NCT03006094</nct_id>
  </id_info>
  <brief_title>The Greek Version of the Chronic Pain Grade Questionnaire (CPGQ)</brief_title>
  <official_title>Validity, Reliability and Responsiveness of the Greek Version of the Chronic Pain Grade Questionnaire (CPGQ) in Chronic Hip Pain Sufferers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asklepieion Voulas General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asklepieion Voulas General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present study is to investigate and report on the psychometric properties of a&#xD;
      Greek version of the Chronic Pain Grade Questionnaire (CPGQ).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Chronic Pain Grade Questionnaire (CPGQ) is designed to evaluate overall severity of&#xD;
      chronic pain based on two dimensions, pain intensity and pain-related disability. Currently,&#xD;
      there is no reliable, valid and sensitive to change self-report instrument as brief and easy&#xD;
      to understand and complete as the CPGQ available in Greek. A culturally adapted version of&#xD;
      the CPGQ would facilitate the study of chronic pain and its implications in the Greek&#xD;
      population and allow for cross-cultural comparisons. The aim of the present study is to&#xD;
      examine the validity, reliability and responsiveness of a Greek version of the CPGQ in&#xD;
      chronic hip pain sufferers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2014</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">January 2018</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Factor analysis of the Greek version of the CPGQ</measure>
    <time_frame>At recruitment (baseline)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlations between the CPGQ items, total, subscale scores and the SF-12 PCS, MCS scores</measure>
    <time_frame>At recruitment (baseline)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cronbach's alpha values for the total scale and each subscale of the Greek version of the CPGQ</measure>
    <time_frame>At recruitment (baseline)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Intraclass correlation coefficient (ICC) values for the total scale and each sub scale of the Greek version of the CPGQ</measure>
    <time_frame>48 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in CPGQ total scale and subscale scores</measure>
    <time_frame>At recruitment (baseline) and 6 months following total hip replacement surgery</time_frame>
    <description>Recruited subjects who will undergo total hip replacement surgery will complete the Greek version of the CPGQ and report their improvement using a dichotomous variable (Yes or No improvement) six months postoperatively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients who were able to complete the Greek version of the CPGQ by themselves</measure>
    <time_frame>At recruitment (baseline)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time employed in filling out the Greek version of the CPGQ</measure>
    <time_frame>At recruitment (baseline)</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">87</enrollment>
  <condition>Chronic Hip Pain</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Orthopaedic outpatients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  chronic hip pain (persistent or recurrent hip pain for at least 12 weeks)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe systemic disease that is a constant threat to life&#xD;
&#xD;
          -  known psychiatric disorder&#xD;
&#xD;
          -  impaired cognition or dementia&#xD;
&#xD;
          -  mother language other than Greek&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>General Hospital Asklepieio Voulas</name>
      <address>
        <city>Voula</city>
        <zip>16673</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>March 4, 2018</last_update_submitted>
  <last_update_submitted_qc>March 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asklepieion Voulas General Hospital</investigator_affiliation>
    <investigator_full_name>Maria Diakomi</investigator_full_name>
    <investigator_title>MD, MSc</investigator_title>
  </responsible_party>
  <keyword>questionnaire</keyword>
  <keyword>hip</keyword>
  <keyword>pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03006094
org study id: 242
nct id: NCT03006094
lead sponsor: 
has dmc: No
The aim of the present study is to investigate and report on the psychometric properties of a
      Greek version of the Chronic Pain Grade Questionnaire (CPGQ).
The Chronic Pain Grade Questionnaire (CPGQ) is designed to evaluate overall severity of
      chronic pain based on two dimensions, pain intensity and pain-related disability. Currently,
      there is no reliable, valid and sensitive to change self-report instrument as brief and easy
      to understand and complete as the CPGQ available in Greek. A culturally adapted version of
      the CPGQ would facilitate the study of chronic pain and its implications in the Greek
      population and allow for cross-cultural comparisons. The aim of the present study is to
      examine the validity, reliability and responsiveness of a Greek version of the CPGQ in
      chronic hip pain sufferers.
observational model: Cohort
time perspective: Prospective
measure: Factor analysis of the Greek version of the CPGQ
time frame: At recruitment (baseline)
measure: Correlations between the CPGQ items, total, subscale scores and the SF-12 PCS, MCS scores
time frame: At recruitment (baseline)
measure: Cronbach's alpha values for the total scale and each subscale of the Greek version of the CPGQ
time frame: At recruitment (baseline)
measure: Intraclass correlation coefficient (ICC) values for the total scale and each sub scale of the Greek version of the CPGQ
time frame: 48 hours
measure: Change in CPGQ total scale and subscale scores
time frame: At recruitment (baseline) and 6 months following total hip replacement surgery
description: Recruited subjects who will undergo total hip replacement surgery will complete the Greek version of the CPGQ and report their improvement using a dichotomous variable (Yes or No improvement) six months postoperatively.
measure: Percentage of patients who were able to complete the Greek version of the CPGQ by themselves
time frame: At recruitment (baseline)
measure: Time employed in filling out the Greek version of the CPGQ
time frame: At recruitment (baseline)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: Asklepieion Voulas General Hospital
investigator full name: Maria Diakomi
investigator title: MD, MSc
mesh term: Chronic Pain
sharing ipd: No