xml: <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/NCT05996510</url>
    </required_header>
    <id_info>
      <org_study_id>BursaYIEAH</org_study_id>
      <nct_id>NCT05996510</nct_id>
    </id_info>
    <brief_title>Suprascapular Notch Cross-sectional Area Measured by Ultrasonography</brief_title>
    <official_title>Investigation of the Relationship Between Suprascapular Notch Cross-sectional Area Measured by Ultrasonography and Disease Activity in Subacromial Impingement Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bursa Yüksek İhtisas Education and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bursa Yüksek İhtisas Education and Research Hospital</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>
        Chronic shoulder pain is one of the most common diseases affecting the quality of life today.&#xD;
        Although there are multiple causes, one of the most common causes is shoulder impingement&#xD;
        syndrome.&#xD;
  &#xD;
        Ultrasound can be used for diagnosis in patients whose treatment is difficult due to its&#xD;
        complex structure. While the supraspinatus muscle, tendon and shoulder joint are the regions&#xD;
        that are usually evaluated, the visualization of the Suprascapular notch is usually observed&#xD;
        during injection. The connection between the suprascapular notch and the shoulder joint has&#xD;
        been demonstrated in different studies.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study, the investigation of the relationship between the measurements of the&#xD;
        suprascapular nerve and the suprascapular notch, which the investigators observed in our&#xD;
        clinical ultrasound applications, and the disease activity intended.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 10, 2023</start_date>
    <completion_date type="Anticipated">October 11, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 10, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Suprascapular notch cross-sectional area measurement</measure>
      <time_frame>baseline</time_frame>
      <description>The area under the suprascapular notch and the superior transverse scapular ligament is measured using the cross-sectional area measurement method.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Visual Analogue Scale</measure>
      <time_frame>baseline</time_frame>
      <description>Visual Analog Scale was used for pain. Pain intensity was measured using 0-10 cm visual analogue scale (VAS). The findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Shoulder Pain and Disability Index (SPADI)</measure>
      <time_frame>baseline</time_frame>
      <description>The Shoulder Pain and Disability Index (SPADI) is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with activity of daily livings requiring the use of the upper extremities. The pain subscale has 5-items and the Disability subscale has 8-items.To score either version of the SPADI, the total score is calculated by averaging the pain and disability subscale scores to find a score out of 100. On this scale, 0 represents less disability while 100 represents greatest disability</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Shoulder Pain</condition>
    <condition>Shoulder Impingement Syndrome</condition>
    <arm_group>
      <arm_group_label>diseased shoulder</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>sturdy shoulder</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>ultrasound</intervention_name>
      <description>Shoulder ultrasound is performed using a linear ultrasound probe. The area under the suprascapular notch and the superior transverse scapular ligament is measured using the cross-sectional area measurement method.</description>
      <arm_group_label>diseased shoulder</arm_group_label>
      <arm_group_label>sturdy shoulder</arm_group_label>
      <other_name>shoulder ultrasound</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  chronic shoulder pain&#xD;
  &#xD;
            -  35-65 years&#xD;
  &#xD;
            -  who agreed to participate in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  . Lymphoproliferative diseases and other neoplasms&#xD;
  &#xD;
            -  .Uncontrolled arterial hypertension&#xD;
  &#xD;
            -  Metabolic syndrome&#xD;
  &#xD;
            -  Uncontrolled diabetes mellitus&#xD;
  &#xD;
            -  Mental retardation&#xD;
  &#xD;
            -  Antidepressant use&#xD;
  &#xD;
            -  Autoimmune diseases&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>korgün ökmen</last_name>
      <role>Study Chair</role>
      <affiliation>Bursa Yuksek Ihtisas Training and Research Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Lale altan inceoğlu, phd</last_name>
      <role>Study Chair</role>
      <affiliation>uludağ university faculty of medicine</affiliation>
    </overall_official>
    <overall_official>
      <last_name>ugur ertem, M.D.</last_name>
      <role>Study Chair</role>
      <affiliation>uludağ university faculty of medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Burcu Ökmen, Assoc.Phd.MD</last_name>
      <phone>+905057081020</phone>
      <email>burcumetinokmen@gmail.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Bursa Yüksek İhtisas Education and Research Hospital</investigator_affiliation>
      <investigator_full_name>Dr. Burcu Metin Ökmen</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Shoulder Pain</mesh_term>
      <mesh_term>Shoulder Impingement Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05996510
  org study id: BursaYIEAH
  nct id: NCT05996510
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Chronic shoulder pain is one of the most common diseases affecting the quality of life today.
        Although there are multiple causes, one of the most common causes is shoulder impingement
        syndrome.
  
        Ultrasound can be used for diagnosis in patients whose treatment is difficult due to its
        complex structure. While the supraspinatus muscle, tendon and shoulder joint are the regions
        that are usually evaluated, the visualization of the Suprascapular notch is usually observed
        during injection. The connection between the suprascapular notch and the shoulder joint has
        been demonstrated in different studies.
  In this study, the investigation of the relationship between the measurements of the
        suprascapular nerve and the suprascapular notch, which the investigators observed in our
        clinical ultrasound applications, and the disease activity intended.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Suprascapular notch cross-sectional area measurement
  time frame: baseline
  description: The area under the suprascapular notch and the superior transverse scapular ligament is measured using the cross-sectional area measurement method.
  measure: Visual Analogue Scale
  time frame: baseline
  description: Visual Analog Scale was used for pain. Pain intensity was measured using 0-10 cm visual analogue scale (VAS). The findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.
  measure: Shoulder Pain and Disability Index (SPADI)
  time frame: baseline
  description: The Shoulder Pain and Disability Index (SPADI) is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with activity of daily livings requiring the use of the upper extremities. The pain subscale has 5-items and the Disability subscale has 8-items.To score either version of the SPADI, the total score is calculated by averaging the pain and disability subscale scores to find a score out of 100. On this scale, 0 represents less disability while 100 represents greatest disability
  arm group label: diseased shoulder
  arm group type: Active Comparator
  arm group label: sturdy shoulder
  arm group type: Active Comparator
  intervention type: Device
  intervention name: ultrasound
  description: Shoulder ultrasound is performed using a linear ultrasound probe. The area under the suprascapular notch and the superior transverse scapular ligament is measured using the cross-sectional area measurement method.
  arm group label: diseased shoulder
  arm group label: sturdy shoulder
  other name: shoulder ultrasound
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: korgün ökmen
  role: Study Chair
  affiliation: Bursa Yuksek Ihtisas Training and Research Hospital
  last name: Lale altan inceoğlu, phd
  role: Study Chair
  affiliation: uludağ university faculty of medicine
  last name: ugur ertem, M.D.
  role: Study Chair
  affiliation: uludağ university faculty of medicine
  last name: Burcu Ökmen, Assoc.Phd.MD
  phone: +905057081020
  email: burcumetinokmen@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: Bursa Yüksek İhtisas Education and Research Hospital
  investigator full name: Dr. Burcu Metin Ökmen
  investigator title: Principal Investigator
  mesh term: Shoulder Pain
  mesh term: Shoulder Impingement Syndrome
  mesh term: Syndrome
  sharing ipd: No