<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/NCT04409756</url>
  </required_header>
  <id_info>
    <org_study_id>20181106/4</org_study_id>
    <nct_id>NCT04409756</nct_id>
  </id_info>
  <brief_title>Shoulder Rating Questionnaire in Turkish</brief_title>
  <official_title>Validity and Reliability of the Turkish Version of the Shoulder Rating Questionnaire</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Betül Tepeli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ufuk University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Namik Kemal 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>
      The purpose of this study is to determine the Turkish version of the Shoulder Rating&#xD;
      Questionnaire (SRQ) and assign reliability and validity in Turkish patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Shoulder pain is one of the common musculoskeletal disorders. A self- administered&#xD;
      patient-based questionnaire has an important role for evaluate shoulder disabilities and also&#xD;
      it is helpful for assess the treatment success.The purpose of this study is to determine the&#xD;
      Turkish version of the Shoulder Rating Questionnaire (SRQ) and assign reliability and&#xD;
      validity in Turkish patients.The Turkish version of the Shoulder Rating Questionnaire (SRQ-T)&#xD;
      will be applied to patients after translation from English into Turkish. 122 patients will be&#xD;
      participate to the study. Patients who were over 18 years with various shoulder pain&#xD;
      complaints will be included into the study. The patients with mixed-type pain, cancer pain,&#xD;
      headache, substance abuse, severe depression and fibromyalgia syndrome will be excluded. The&#xD;
      musculoskeletal and neurological examinations of the patients will be performed. The Turkish&#xD;
      version of the Shoulder Rating Questionnaire (SRQ-T) and Disabilities of arm, shoulder,&#xD;
      hands-T (DASH-T) will be applied to all patients.&#xD;
&#xD;
      SRQ-T and DASH-T will be collected in two sessions with at last three days between the&#xD;
      sessions for pre-assessment and post-assessment. Reliability of SRQ-T questionnaire will be&#xD;
      tested by internal consistency and test-retest reliability. Internal consistency will be&#xD;
      evaluated by determining intraclass correlation coefficient (ICC) with 95% confidence&#xD;
      interval, ranged between 0 and 1.&#xD;
&#xD;
      To determine the internal consistency of the five domains of SRQ-T, Cronbach's alfa&#xD;
      coefficient will be computed for both pre- and post-assessment of the questionnaire. The&#xD;
      test-retest method with Wilcoxon Signed Rank Test will be used to determine reliability of&#xD;
      SRQ-T and its domains. Then, Spearman correlation coefficients will be used to assess the&#xD;
      discriminant validity of SRQ-T for evaluation of shoulder pain. The Spearman correlation&#xD;
      coefficient score more than 0.70 will be accepted for reliability&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">March 1, 2019</completion_date>
  <primary_completion_date type="Actual">March 1, 2019</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>reliability of SRQ-T questionnaire</measure>
    <time_frame>through study completion, an average of 1 month</time_frame>
    <description>Reliability of SRQ-T questionnaire will be tested by internal consistency and test-retest reliability. Internal consistency will be evaluated by determining intraclass correlation coefficient (ICC) with 95% confidence interval, ranged between 0 and 1.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">122</enrollment>
  <condition>Shoulder Pain</condition>
  <arm_group>
    <arm_group_label>postassessment of the SRQ-T test</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>the SRQ -T will be obtained to all patients three days after the first assessment</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>shoulder rating questionnaire</intervention_name>
    <description>to investigate reliability of turkish version of shoulder rating questionnaire</description>
    <arm_group_label>postassessment of the SRQ-T test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who were over 18 years with various shoulder pain complaints&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patients with mixed-type pain, cancer pain, headache, substance abuse, severe&#xD;
             depression and fibromyalgia syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Betül Tepeli</last_name>
    <role>Study Director</role>
    <affiliation>private balkan hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Betül Tepeli</name>
      <address>
        <city>Kırklareli</city>
        <state>Lüleburgaz</state>
        <zip>39750</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>L'Insalata JC, Warren RF, Cohen SB, Altchek DW, Peterson MG. A self-administered questionnaire for assessment of symptoms and function of the shoulder. J Bone Joint Surg Am. 1997 May;79(5):738-48.</citation>
    <PMID>9160947</PMID>
  </results_reference>
  <results_reference>
    <citation>Vermeulen HM, Boonman DC, Schuller HM, Obermann WR, van Houwelingen HC, Rozing PM, Vliet Vlieland TP. Translation, adaptation and validation of the Shoulder Rating Questionnaire (SRQ) into the Dutch language. Clin Rehabil. 2005 May;19(3):300-11. doi: 10.1191/0269215505cr811oa.</citation>
    <PMID>15859531</PMID>
  </results_reference>
  <results_reference>
    <citation>Paul A, Lewis M, Shadforth MF, Croft PR, Van Der Windt DA, Hay EM. A comparison of four shoulder-specific questionnaires in primary care. Ann Rheum Dis. 2004 Oct;63(10):1293-9. doi: 10.1136/ard.2003.012088.</citation>
    <PMID>15361390</PMID>
  </results_reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>May 29, 2020</last_update_submitted>
  <last_update_submitted_qc>May 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Namik Kemal University</investigator_affiliation>
    <investigator_full_name>Betül Tepeli</investigator_full_name>
    <investigator_title>Department of Physical Medicine And Rehabilitation, Private Balkan Hospital,Principal Investigator,</investigator_title>
  </responsible_party>
  <keyword>Disability Evaluation</keyword>
  <keyword>Shoulder Pain</keyword>
  <keyword>Shoulder Validation Studies</keyword>
  <keyword>Outcome measures</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder 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/NCT04409756
org study id: 20181106/4
nct id: NCT04409756
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine the Turkish version of the Shoulder Rating
      Questionnaire (SRQ) and assign reliability and validity in Turkish patients.
Shoulder pain is one of the common musculoskeletal disorders. A self- administered
      patient-based questionnaire has an important role for evaluate shoulder disabilities and also
      it is helpful for assess the treatment success.The purpose of this study is to determine the
      Turkish version of the Shoulder Rating Questionnaire (SRQ) and assign reliability and
      validity in Turkish patients.The Turkish version of the Shoulder Rating Questionnaire (SRQ-T)
      will be applied to patients after translation from English into Turkish. 122 patients will be
      participate to the study. Patients who were over 18 years with various shoulder pain
      complaints will be included into the study. The patients with mixed-type pain, cancer pain,
      headache, substance abuse, severe depression and fibromyalgia syndrome will be excluded. The
      musculoskeletal and neurological examinations of the patients will be performed. The Turkish
      version of the Shoulder Rating Questionnaire (SRQ-T) and Disabilities of arm, shoulder,
      hands-T (DASH-T) will be applied to all patients.

      SRQ-T and DASH-T will be collected in two sessions with at last three days between the
      sessions for pre-assessment and post-assessment. Reliability of SRQ-T questionnaire will be
      tested by internal consistency and test-retest reliability. Internal consistency will be
      evaluated by determining intraclass correlation coefficient (ICC) with 95% confidence
      interval, ranged between 0 and 1.

      To determine the internal consistency of the five domains of SRQ-T, Cronbach's alfa
      coefficient will be computed for both pre- and post-assessment of the questionnaire. The
      test-retest method with Wilcoxon Signed Rank Test will be used to determine reliability of
      SRQ-T and its domains. Then, Spearman correlation coefficients will be used to assess the
      discriminant validity of SRQ-T for evaluation of shoulder pain. The Spearman correlation
      coefficient score more than 0.70 will be accepted for reliability
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: reliability of SRQ-T questionnaire
time frame: through study completion, an average of 1 month
description: Reliability of SRQ-T questionnaire will be tested by internal consistency and test-retest reliability. Internal consistency will be evaluated by determining intraclass correlation coefficient (ICC) with 95% confidence interval, ranged between 0 and 1.
arm group label: postassessment of the SRQ-T test
arm group type: Other
description: the SRQ -T will be obtained to all patients three days after the first assessment
intervention type: Other
intervention name: shoulder rating questionnaire
description: to investigate reliability of turkish version of shoulder rating questionnaire
arm group label: postassessment of the SRQ-T test
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Betül Tepeli
role: Study Director
affiliation: private balkan hospital
facility: 
country: Turkey
citation: L'Insalata JC, Warren RF, Cohen SB, Altchek DW, Peterson MG. A self-administered questionnaire for assessment of symptoms and function of the shoulder. J Bone Joint Surg Am. 1997 May;79(5):738-48.
PMID: 9160947
citation: Vermeulen HM, Boonman DC, Schuller HM, Obermann WR, van Houwelingen HC, Rozing PM, Vliet Vlieland TP. Translation, adaptation and validation of the Shoulder Rating Questionnaire (SRQ) into the Dutch language. Clin Rehabil. 2005 May;19(3):300-11. doi: 10.1191/0269215505cr811oa.
PMID: 15859531
citation: Paul A, Lewis M, Shadforth MF, Croft PR, Van Der Windt DA, Hay EM. A comparison of four shoulder-specific questionnaires in primary care. Ann Rheum Dis. 2004 Oct;63(10):1293-9. doi: 10.1136/ard.2003.012088.
PMID: 15361390
responsible party type: Sponsor-Investigator
investigator affiliation: Namik Kemal University
investigator full name: Betül Tepeli
investigator title: Department of Physical Medicine And Rehabilitation, Private Balkan Hospital,Principal Investigator,
mesh term: Shoulder Pain
sharing ipd: No