<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/NCT04418063</url>
  </required_header>
  <id_info>
    <org_study_id>GIRD-Ahtl-FMUI</org_study_id>
    <nct_id>NCT04418063</nct_id>
  </id_info>
  <brief_title>Glenohumeral Internal Rotation Deficit in Non-pitcher Overhead Athletic Athletes: Case Series Analysis of Athletes</brief_title>
  <acronym>GIRDAhtlFMUI</acronym>
  <official_title>Glenohumeral Internal Rotation Deficit in Non-pitcher Overhead Athletic Athletes: Case Series Analysis of Athletes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indonesia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indonesia 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 observational case series the investigators would like to investigate wether or not&#xD;
      the strenuous activity exerted on over head athletic athletes (ie. javelin throwers, discus&#xD;
      throwers) may incite injury on their shoulders.&#xD;
&#xD;
      The investigators understood that these athletes had to perform repeated throwing motions and&#xD;
      yet reports on their effects are very limited. This condition in the long run may contribute&#xD;
      to injury and affecting performance of the athletes.&#xD;
&#xD;
      The investigators found that these relationships have not been looked at closely by others&#xD;
      and largely overshadowed by athletes in other fields; such injury patterns had been described&#xD;
      in details in baseball pitchers but not in other athletes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Description of protocol:&#xD;
&#xD;
      In this study, the investigators would recruit athletes from the national athletics&#xD;
      federation training in our city.&#xD;
&#xD;
      Data collection:&#xD;
&#xD;
      History taking:&#xD;
&#xD;
        -  complaints of shoulder stiffness&#xD;
&#xD;
        -  need for prolonged warm-up&#xD;
&#xD;
        -  pain&#xD;
&#xD;
        -  discomfort relating to the shoulders&#xD;
&#xD;
      Physical examination:&#xD;
&#xD;
        -  Bilateral shoulder range of motion (internal and external rotation)&#xD;
&#xD;
        -  Posterior shoulder flexibility test (denotes internal rotation deficit)&#xD;
&#xD;
        -  Scapular malpositioning, inferior medial border prominence, coracoid pain and&#xD;
           malposition and dyskinesis of scapular movement (SICK) scapula rating&#xD;
&#xD;
      Notes: measurements are taken by at least two investigators separately and compared to ensure&#xD;
      accuracy.&#xD;
&#xD;
      Results are presented in a table and analysed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2020</start_date>
  <completion_date type="Anticipated">October 2020</completion_date>
  <primary_completion_date type="Anticipated">October 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Glenohumeral internal rotation deficit</measure>
    <time_frame>1 day</time_frame>
    <description>A deficit of &gt;20 degrees between dominant and non-dominant shoulder</description>
  </primary_outcome>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Shoulder Injuries</condition>
  <condition>Shoulder Syndrome</condition>
  <condition>Injury;Sports</condition>
  <condition>Sport Injury</condition>
  <eligibility>
    <study_pop>
      <textblock>
        National athletic athletes that performed overhead throwing motion in their sports that&#xD;
        meet the inclusion criteria within our city.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Performed overhead throwing motions in their athletic skills&#xD;
&#xD;
          -  Athletes have competed in regional and national level&#xD;
&#xD;
          -  Undergoing active training&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Apparent anatomical deformity&#xD;
&#xD;
          -  Sustaining injury(ies)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Andri Lubis, MD, PhD</last_name>
    <phone>+62 8161177078</phone>
    <email>andri_lubis@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rizky Wisnubaroto, MD</last_name>
    <phone>+6281905874209</phone>
    <email>rizky.wisnubaroto@gmail.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Burkhart SS, Morgan CD, Kibler WB. The disabled throwing shoulder: spectrum of pathology Part I: pathoanatomy and biomechanics. Arthroscopy. 2003 Apr;19(4):404-20. doi: 10.1053/jars.2003.50128.</citation>
    <PMID>12671624</PMID>
  </reference>
  <reference>
    <citation>Burkhart SS, Morgan CD, Kibler WB. The disabled throwing shoulder: spectrum of pathology Part III: The SICK scapula, scapular dyskinesis, the kinetic chain, and rehabilitation. Arthroscopy. 2003 Jul-Aug;19(6):641-61. doi: 10.1016/s0749-8063(03)00389-x. No abstract available.</citation>
    <PMID>12861203</PMID>
  </reference>
  <reference>
    <citation>Keller RA, De Giacomo AF, Neumann JA, Limpisvasti O, Tibone JE. Glenohumeral Internal Rotation Deficit and Risk of Upper Extremity Injury in Overhead Athletes: A Meta-Analysis and Systematic Review. Sports Health. 2018 Mar/Apr;10(2):125-132. doi: 10.1177/1941738118756577. Epub 2018 Jan 30.</citation>
    <PMID>29381423</PMID>
  </reference>
  <results_reference>
    <citation>Rose MB, Noonan T. Glenohumeral internal rotation deficit in throwing athletes: current perspectives. Open Access J Sports Med. 2018 Mar 19;9:69-78. doi: 10.2147/OAJSM.S138975. eCollection 2018.</citation>
    <PMID>29593438</PMID>
  </results_reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>May 31, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>September 6, 2020</last_update_submitted>
  <last_update_submitted_qc>September 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indonesia University</investigator_affiliation>
    <investigator_full_name>Andri Maruli Tua Lubis</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>shoulder</keyword>
  <keyword>glenohumeral internal rotation deficit</keyword>
  <keyword>throwing athletic athlete</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Athletic Injuries</mesh_term>
    <mesh_term>Shoulder Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>There is a plan to make IPD and related data dictionaries available.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>The IPD will become available starting 6 months after publication.</ipd_time_frame>
    <ipd_access_criteria>The information will be shared electronically via email to other researchers after review by the principal investigator.</ipd_access_criteria>
  </patient_data>
  <pending_results>
    <submitted>February 9, 2021</submitted>
    <returned>February 26, 2021</returned>
    <submitted>August 25, 2021</submitted>
    <returned>September 20, 2021</returned>
  </pending_results>
  <!-- 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/NCT04418063
org study id: GIRD-Ahtl-FMUI
nct id: NCT04418063
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this observational case series the investigators would like to investigate wether or not
      the strenuous activity exerted on over head athletic athletes (ie. javelin throwers, discus
      throwers) may incite injury on their shoulders.

      The investigators understood that these athletes had to perform repeated throwing motions and
      yet reports on their effects are very limited. This condition in the long run may contribute
      to injury and affecting performance of the athletes.

      The investigators found that these relationships have not been looked at closely by others
      and largely overshadowed by athletes in other fields; such injury patterns had been described
      in details in baseball pitchers but not in other athletes.
Description of protocol:

      In this study, the investigators would recruit athletes from the national athletics
      federation training in our city.

      Data collection:

      History taking:

        -  complaints of shoulder stiffness

        -  need for prolonged warm-up

        -  pain

        -  discomfort relating to the shoulders

      Physical examination:

        -  Bilateral shoulder range of motion (internal and external rotation)

        -  Posterior shoulder flexibility test (denotes internal rotation deficit)

        -  Scapular malpositioning, inferior medial border prominence, coracoid pain and
           malposition and dyskinesis of scapular movement (SICK) scapula rating

      Notes: measurements are taken by at least two investigators separately and compared to ensure
      accuracy.

      Results are presented in a table and analysed.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: Glenohumeral internal rotation deficit
time frame: 1 day
description: A deficit of >20 degrees between dominant and non-dominant shoulder
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Andri Lubis, MD, PhD
phone: +62 8161177078
email: andri_lubis@yahoo.com
last name: Rizky Wisnubaroto, MD
phone: +6281905874209
email: rizky.wisnubaroto@gmail.com
citation: Burkhart SS, Morgan CD, Kibler WB. The disabled throwing shoulder: spectrum of pathology Part I: pathoanatomy and biomechanics. Arthroscopy. 2003 Apr;19(4):404-20. doi: 10.1053/jars.2003.50128.
PMID: 12671624
citation: Burkhart SS, Morgan CD, Kibler WB. The disabled throwing shoulder: spectrum of pathology Part III: The SICK scapula, scapular dyskinesis, the kinetic chain, and rehabilitation. Arthroscopy. 2003 Jul-Aug;19(6):641-61. doi: 10.1016/s0749-8063(03)00389-x. No abstract available.
PMID: 12861203
citation: Keller RA, De Giacomo AF, Neumann JA, Limpisvasti O, Tibone JE. Glenohumeral Internal Rotation Deficit and Risk of Upper Extremity Injury in Overhead Athletes: A Meta-Analysis and Systematic Review. Sports Health. 2018 Mar/Apr;10(2):125-132. doi: 10.1177/1941738118756577. Epub 2018 Jan 30.
PMID: 29381423
citation: Rose MB, Noonan T. Glenohumeral internal rotation deficit in throwing athletes: current perspectives. Open Access J Sports Med. 2018 Mar 19;9:69-78. doi: 10.2147/OAJSM.S138975. eCollection 2018.
PMID: 29593438
responsible party type: Principal Investigator
investigator affiliation: Indonesia University
investigator full name: Andri Maruli Tua Lubis
investigator title: Principal Investigator
mesh term: Wounds and Injuries
mesh term: Athletic Injuries
mesh term: Shoulder Injuries
sharing ipd: Yes
ipd description: There is a plan to make IPD and related data dictionaries available.
ipd info type: Study Protocol
ipd time frame: The IPD will become available starting 6 months after publication.
ipd access criteria: The information will be shared electronically via email to other researchers after review by the principal investigator.
submitted: February 9, 2021
returned: February 26, 2021
submitted: August 25, 2021
returned: September 20, 2021