<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/NCT02995941</url>
  </required_header>
  <id_info>
    <org_study_id>2016-61</org_study_id>
    <nct_id>NCT02995941</nct_id>
  </id_info>
  <brief_title>Shoulder Symptom Irritability Scale: A Single-Blinded Observational Study</brief_title>
  <acronym>SSIS</acronym>
  <official_title>Shoulder Symptom Irritability: A Single-Blinded Observational Study of Reliability and Construct Validity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Luke's Hospital and Health Network, Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Arcadia University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nova Southeastern University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Luke's Hospital and Health Network, Pennsylvania</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the reliability and use of the shoulder symptom&#xD;
      irritability classification system for the purposes of determining an appropriate treatment&#xD;
      intensity to better help people with shoulder pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background Physical therapists regularly make decisions regarding intervention intensity&#xD;
      based upon pathoanatomy, symptom irritability, and impairment identification, but the&#xD;
      reliability and validity of classifying patients by symptom irritability is unknown.&#xD;
&#xD;
      Purpose Examine the reliability and use of the shoulder symptom irritability classification&#xD;
      system for the purposes of determining an appropriate treatment intensity.&#xD;
&#xD;
      Design Prospective repeated-measures single-blinded design to determine reliability and a&#xD;
      cross-sectional design will be utilized to aid in determining construct validity.&#xD;
&#xD;
      Methods Twenty-five (25) raters will be trained to make paired ratings in 90 subjects with&#xD;
      primary complaints of shoulder pain. Raters will record the shoulder symptom irritability&#xD;
      level and also select the appropriate intervention intensities for the subjects. Raters will&#xD;
      also be asked to choose anticipated interventions for subjects.&#xD;
&#xD;
      Data Analysis Prevalence-adjusted, bias-adjusted Kappa for ordinal scales (PABAK-OS) will be&#xD;
      the primary measure of reliability. Dependent upon the distribution of the data, other forms&#xD;
      of Kappa may be utilized to analyze the data most appropriately. To determine differences in&#xD;
      reliability between groups with and without clinical specialization, an independent t test&#xD;
      will be utilized with α = 0.05. Lastly, analysis of variance with post-hoc analysis will be&#xD;
      used to compare functional disability across different levels of irritability.&#xD;
&#xD;
      Significance This study addresses key gaps in the understanding of symptom irritability and&#xD;
      how it relates to clinical decision making. It is expected that symptom irritability should&#xD;
      logically drive intervention selection and intensity of rehabilitation interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Reliability of Shoulder Symptom Irritability Scale</measure>
    <time_frame>Day 1 of data collection for each subject</time_frame>
    <description>Two different raters will individually rate the shoulder symptom irritability of each patient. Raters will be blinded to the other's rating.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Focus On Therapeutic Outcomes (FOTO) Functional Score</measure>
    <time_frame>Day 1 of data collection for each subject</time_frame>
    <description>The FOTO functional scale for shoulder disorders27 has a standard error of the mean (SEM) of 1. with a minimal detectable change with 95% confidence (MDC95) of 3.60-10.88 functional score units.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Penn Shoulder Score (PSS)</measure>
    <time_frame>Day 1 of data collection for each subject</time_frame>
    <description>The Penn Shoulder Score (PSS)has demonstrated good test-retest reliability (ICC2,1 = 0.94) with a SEM90 of 8.5. The MDC90 is 12.1, and the minimal clinically important difference (MCID) was found to be 11.4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>American Shoulder and Elbow Surgeons (ASES) Shoulder Score</measure>
    <time_frame>Day 1 of data collection for each subject</time_frame>
    <description>The ASES Shoulder Score has demonstrated good to excellent test-retest reliability (ICC = 0.61-0.96) with an SEM of 6.7. The MDC95 is 11.2,32 and the MCID was found to be 12.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numeric Pain Rating scale</measure>
    <time_frame>Day 1 of data collection for each subject</time_frame>
    <description>The Numeric Pain Rating Scale (NPRS) has demonstrated good reliability (ICC2,1=0.74)and responsiveness (MDC = 2.5, MCID = 1.1) in subjects with shoulder pain34 and excellent reliability in an upper extremity orthopaedic population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervention intensity</measure>
    <time_frame>Day 1 of data collection for each subject</time_frame>
    <description>This project will analyze intervention choices from the primary raters for each of the 90 subjects utilizing PABAK-OS for correlation and independent t-test for group differences. It is expected that those subjects with high irritability will be prescribed interventions aimed at minimizing the physical stress to the affected tissue(s), while those subjects with low irritability will be prescribed interventions at a higher intensity to address the physical impairments.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">138</enrollment>
  <condition>Shoulder Pain</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Raters</arm_group_label>
    <description>No interventions will be administered. Raters will be state licensed as physical therapists working as outpatient physical therapists in the St. Luke's University Health Network.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>No interventions will be administered as a component of this study. Patients will be recruited from a convenience sample of consecutive patients presenting for physical therapy consultation for shoulder pain.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Raters will be recruited from outpatient physical therapists in the St. Luke's University&#xD;
        Health Network.&#xD;
&#xD;
        Patient subjects will be recruited from a convenience sample of consecutive patients&#xD;
        presenting for physical therapy consultation for shoulder pain.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Rater Group&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  State licensure as a physical therapist and regular clinical practice with patients&#xD;
             with shoulder disorders, defined as a minimum of 500 clinical hours per year in an&#xD;
             orthopaedic setting with &gt;10% of patients with shoulder disorders&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not meeting inclusion criteria&#xD;
&#xD;
        Patient Group&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Presenting with a chief complaint of shoulder pain, not extending to the neck, for&#xD;
             outpatient physical therapy consultation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Illiteracy in English and age less than 18 years. Additionally, subjects will be&#xD;
             excluded from the study if they present with pain or symptoms distal to elbow, have&#xD;
             had shoulder surgery on the symptomatic side in the past year, if active or passive&#xD;
             cervical spine ROM reproduces shoulder pain, have a positive Spurling's test, or if&#xD;
             they are unable to complete the patient reported functional questionnaires&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alicia Fernandez-Fernandez, DPT, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Nova Southeastern University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stephen M Kareha, DPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Luke's Hospital and Health Network, Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Physical Therapy at St. Luke's - Washington</name>
      <address>
        <city>Washington</city>
        <state>New Jersey</state>
        <zip>07882</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physical Therapy at St. Luke's - Hamilton</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physical Therapy at St. Luke's - West End Medical Center</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physical Therapy at St. Luke's - Bath</name>
      <address>
        <city>Bath</city>
        <state>Pennsylvania</state>
        <zip>18014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physical Therapy at St. Luke's - St. Luke's North</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physical Therapy at St. Luke's - Sports Medicine and Rehab Center</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physical Therapy at St. Luke's - Center Valley</name>
      <address>
        <city>Center Valley</city>
        <state>Pennsylvania</state>
        <zip>18034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physical Therapy at St. Luke's - Forks</name>
      <address>
        <city>Easton</city>
        <state>Pennsylvania</state>
        <zip>18040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physical Therapy at St. Luke's - Anderson</name>
      <address>
        <city>Easton</city>
        <state>Pennsylvania</state>
        <zip>18045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physical Therapy at St. Luke's - Emmaus</name>
      <address>
        <city>Emmaus</city>
        <state>Pennsylvania</state>
        <zip>18049</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physical Therapy at St. Luke's - Hellertown</name>
      <address>
        <city>Hellertown</city>
        <state>Pennsylvania</state>
        <zip>18015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physical Therapy at St. Luke's - Macungie</name>
      <address>
        <city>Macungie</city>
        <state>Pennsylvania</state>
        <zip>18062</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physical Therapy at St. Luke's - Northampton</name>
      <address>
        <city>Northampton</city>
        <state>Pennsylvania</state>
        <zip>18067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physical Therapy at St. Luke's - Orefield</name>
      <address>
        <city>Orefield</city>
        <state>Pennsylvania</state>
        <zip>18069</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physical Therapy at St. Luke's - Quakertown</name>
      <address>
        <city>Quakertown</city>
        <state>Pennsylvania</state>
        <zip>18951</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physical Therapy at St. Luke's - Stroudsburg</name>
      <address>
        <city>Stroudsburg</city>
        <state>Pennsylvania</state>
        <zip>18360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physical Therapy at St. Luke's - Wind Gap</name>
      <address>
        <city>Wind Gap</city>
        <state>Pennsylvania</state>
        <zip>18091</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://youtu.be/a-QiJ5-bKKQ</url>
    <description>Shoulder Symptom Irritability Scale Rater Training</description>
  </link>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 10, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>September 17, 2019</last_update_submitted>
  <last_update_submitted_qc>September 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Luke's Hospital and Health Network, Pennsylvania</investigator_affiliation>
    <investigator_full_name>Stephen Kareha, DPT</investigator_full_name>
    <investigator_title>Director, Orthopaedic Physical Therapy Residency</investigator_title>
  </responsible_party>
  <keyword>reliability</keyword>
  <keyword>validity</keyword>
  <keyword>classification</keyword>
  <keyword>irritability</keyword>
  <keyword>symptom</keyword>
  <keyword>intensity</keyword>
  <keyword>intervention</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>
  <study_docs>
    <study_doc>
      <doc_type>Study Protocol</doc_type>
      <doc_url>https://drive.google.com/file/d/0BzDEuj8l-dI1QkZSRUtyZGJ0RG8/view?usp=sharing</doc_url>
    </study_doc>
    <study_doc>
      <doc_type>Individual Participant Data Set</doc_type>
      <doc_url>https://drive.google.com/file/d/0BzDEuj8l-dI1VEppLWVOb2Jhd00/view?usp=sharing</doc_url>
      <doc_comment>Patient Group Data Forms</doc_comment>
    </study_doc>
    <study_doc>
      <doc_type>Individual Participant Data Set</doc_type>
      <doc_url>https://drive.google.com/file/d/0BzDEuj8l-dI1cHJFWkpKQmEweEU/view?usp=sharing</doc_url>
      <doc_comment>Rater Group Data Form</doc_comment>
    </study_doc>
  </study_docs>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 31, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT02995941/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT02995941
org study id: 2016-61
nct id: NCT02995941
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to examine the reliability and use of the shoulder symptom
      irritability classification system for the purposes of determining an appropriate treatment
      intensity to better help people with shoulder pain.
Background Physical therapists regularly make decisions regarding intervention intensity
      based upon pathoanatomy, symptom irritability, and impairment identification, but the
      reliability and validity of classifying patients by symptom irritability is unknown.

      Purpose Examine the reliability and use of the shoulder symptom irritability classification
      system for the purposes of determining an appropriate treatment intensity.

      Design Prospective repeated-measures single-blinded design to determine reliability and a
      cross-sectional design will be utilized to aid in determining construct validity.

      Methods Twenty-five (25) raters will be trained to make paired ratings in 90 subjects with
      primary complaints of shoulder pain. Raters will record the shoulder symptom irritability
      level and also select the appropriate intervention intensities for the subjects. Raters will
      also be asked to choose anticipated interventions for subjects.

      Data Analysis Prevalence-adjusted, bias-adjusted Kappa for ordinal scales (PABAK-OS) will be
      the primary measure of reliability. Dependent upon the distribution of the data, other forms
      of Kappa may be utilized to analyze the data most appropriately. To determine differences in
      reliability between groups with and without clinical specialization, an independent t test
      will be utilized with α = 0.05. Lastly, analysis of variance with post-hoc analysis will be
      used to compare functional disability across different levels of irritability.

      Significance This study addresses key gaps in the understanding of symptom irritability and
      how it relates to clinical decision making. It is expected that symptom irritability should
      logically drive intervention selection and intensity of rehabilitation interventions.
observational model: Cohort
time perspective: Cross-Sectional
measure: Reliability of Shoulder Symptom Irritability Scale
time frame: Day 1 of data collection for each subject
description: Two different raters will individually rate the shoulder symptom irritability of each patient. Raters will be blinded to the other's rating.
measure: Focus On Therapeutic Outcomes (FOTO) Functional Score
time frame: Day 1 of data collection for each subject
description: The FOTO functional scale for shoulder disorders27 has a standard error of the mean (SEM) of 1. with a minimal detectable change with 95% confidence (MDC95) of 3.60-10.88 functional score units.
measure: Penn Shoulder Score (PSS)
time frame: Day 1 of data collection for each subject
description: The Penn Shoulder Score (PSS)has demonstrated good test-retest reliability (ICC2,1 = 0.94) with a SEM90 of 8.5. The MDC90 is 12.1, and the minimal clinically important difference (MCID) was found to be 11.4.
measure: American Shoulder and Elbow Surgeons (ASES) Shoulder Score
time frame: Day 1 of data collection for each subject
description: The ASES Shoulder Score has demonstrated good to excellent test-retest reliability (ICC = 0.61-0.96) with an SEM of 6.7. The MDC95 is 11.2,32 and the MCID was found to be 12.0.
measure: Numeric Pain Rating scale
time frame: Day 1 of data collection for each subject
description: The Numeric Pain Rating Scale (NPRS) has demonstrated good reliability (ICC2,1=0.74)and responsiveness (MDC = 2.5, MCID = 1.1) in subjects with shoulder pain34 and excellent reliability in an upper extremity orthopaedic population.
measure: Intervention intensity
time frame: Day 1 of data collection for each subject
description: This project will analyze intervention choices from the primary raters for each of the 90 subjects utilizing PABAK-OS for correlation and independent t-test for group differences. It is expected that those subjects with high irritability will be prescribed interventions aimed at minimizing the physical stress to the affected tissue(s), while those subjects with low irritability will be prescribed interventions at a higher intensity to address the physical impairments.
arm group label: Raters
description: No interventions will be administered. Raters will be state licensed as physical therapists working as outpatient physical therapists in the St. Luke's University Health Network.
arm group label: Patients
description: No interventions will be administered as a component of this study. Patients will be recruited from a convenience sample of consecutive patients presenting for physical therapy consultation for shoulder pain.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alicia Fernandez-Fernandez, DPT, PhD
role: Study Chair
affiliation: Nova Southeastern University
last name: Stephen M Kareha, DPT
role: Principal Investigator
affiliation: St. Luke's Hospital and Health Network, Pennsylvania
facility: 
facility: 
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country: United States
url: https://youtu.be/a-QiJ5-bKKQ
description: Shoulder Symptom Irritability Scale Rater Training
responsible party type: Principal Investigator
investigator affiliation: St. Luke's Hospital and Health Network, Pennsylvania
investigator full name: Stephen Kareha, DPT
investigator title: Director, Orthopaedic Physical Therapy Residency
mesh term: Shoulder Pain
sharing ipd: No
study doc: 
study doc: 
study doc: 
provided document: 