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Acromiohumeral distance and shoulder internal rotation angle during the modified empty can test in healthy people

Status Approved

  • First Submitted Date

    2021/03/18

  • Registered Date

    2021/03/25

  • Last Updated Date

    2021/03/18

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0006023
    Unique Protocol ID 1041849-202103-BM-031-02
    Public/Brief Title Comparison of the acromiohumeral distance and internal rotation angle during three shoulder impingement syndrome tests
    Scientific Title Acromiohumeral distance and shoulder internal rotation angle during the modified empty can test in healthy people
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 1041849-202103-BM-031-02
    Approval Date 2021-03-17
    Institutional Review Board Name Yonsei University Wonju Institutional Review Board
    Institutional Review Board Address 1, Yeonsedae-gil, Heungeop-myeon, Wonju-si, Gangwon-do
    Institutional Review Board Telephone 033-760-5247
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name oh-yun Kwon
    Title Prof.
    Telephone +82-33-760-5238
    Affiliation Yonsei University
    Address Yonsei University, 1 Yonseidae-gil, Wonju, Gangwon-do, 26493, Korea
    Contact Person for Public Queries
    Name hwa-ik Yoo
    Title BPT
    Telephone +82-2-760-5238
    Affiliation Yonsei University
    Address Yonsei University, 1 Yonseidae-gil, Wonju, Gangwon-do, 26493, Korea
    Contact Person for Updating Information
    Name hwa-ik Yoo
    Title BPT
    Telephone +82-2-760-5238
    Affiliation Yonsei University
    Address Yonsei University, 1 Yonseidae-gil, Wonju, Gangwon-do, 26493, Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-03-20 Anticipated
    Target Number of Participant 20
    Primary Completion Date 2021-04-20 , Anticipated
    Study Completion Date 2021-09-16 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Yonsei University
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-03-20 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Yonsei University
    Organization Type University
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Yonsei University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Subacromial pain syndrome (SAPS) is the most common diagnosis of shoulder pain (Juel and Natvig, 2014; Van der Windt et al., 1995), frequently termed a shoulder impingement syndrome (Braman et al., 2014; Ostor et al., 2005). Traditionally, SAPS was believed to be due to impinging the subacromial structures beneath the acromion through the reduction of the subacromial space. However, recently, some authors have suggested that there was no relationship between the reduction of the subacromial space and an etiologic mechanism for the SAPS (Kalra et al., 2010; Park et al., 2020; Timmons et al., 2013). The poor diagnostic accuracy for the clinical shoulder impingement tests is one of the possible reasons why still conflicting results of studies on the difference in subacromial space between people with and without SAPS were showed (Hegedus et al., 2012; Michener et al., 2009).The width of the subacromial space has been quantified by acromiohumeral distance (AHD). The AHD is defined as the linear distance between inferior border of the acromion and humerus. It is theorized that the AHD should be decreased when the glenohumeral joint rotates internally, such as EC test, due to nearing between the greater tuberosity of the humerus and the acromion (De Wilde et al., 2003; Roberts et al., 2002). Moreover, compared to the FC test, increasing scapular internal rotation and anterior tipping associated with decreased subacromial space were observed during EC test (Thigpen et al., 2006). However, in contrast, Timmons et al. (2013) reported that no significant differences in the AHD between EC and FC test were found. Also, although they investigated the scapular movement to find kinematic factor that may affect the AHD, however, the differences in scapular movement between EC and FC test did not seem to affect the AHD (Timmons et al., 2013). Therefore, differential factor between two tests is still unclear and this may affect diagnostic accuracy for evaluating SAPS.The direction of the thumb (downward or upward) has been widely used to instruct the glenohumeral rotation (internal rotation or neutral position) during EC and FC test (Holtby and Razmjou, 2004; Kelly et al., 2010; Michener et al., 2009; Ostor et al., 2005; Robert-Lachaine et al., 2015; Thigpen et al., 2006; Timmons et al., 2013). However, during thumb moving downwardly from the neutral position, the combination of the forearm pronation and the thumb motion could make them achieve the EC testing position even without sufficient GHIR. Therefore, these compensatory movements could limit the GHIR during EC so that there was no significant difference in the AHD between EC and FC, consequently, may increase the false negative in EC (type Ⅱ error). However, no studies have determined the actual range of motion (ROM) of GHIR during EC (thumb pointing down). Furthermore, no studies have controlled this potential compensatory movement during EC and FC.The ulnohumeral joint, classified as an uniaxial hinge joint, allows 1 degree of freedom (flexion-extension) (Magee, 2014). As a result, the forearm rotational movement does not affect to the ulnohumeral joint while glenohumeral rotation is related with the ulna because of the anatomical connection between the trochlea of the humerus and the trochlear notch of the ulna. Thus, the landmark of ulna, such as olecranon process, could be more accurate instruction for glenohumeral rotation when compared with the thumb. Therefore, the purpose of this study was to compare (1) the GHIR angle between conventional EC (with thumb direction) and modified EC (with olecranon direction), and (2) the AHD during FC, conventional EC, and modified EC. We hypothesized that the GHIR angle would demonstrate greater value in modified EC than conventional EC. We also hypothesized that, among the three testing protocols (FC vs. conventional EC vs. modified EC), the AHD would be the smallest value during modified EC, compared with FC and conventional EC.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Cohort
    Time Perspective Cross-sectional  
    Target Number of Participant 20
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Healthy people without shoulder pain in previous 6 months, age 20-30

    Cohort/Group Description

    Subjects were excluded if they reported (1) shoulder pain, (2) systemic, neurological, and musculoskeletal disease, (3) history of upper extremity injury or surgery, and (4) positive sign on any of the SAPS tests (empty can, pain, or weakness with resisted external rotation, Neer, Hawkins tests, and painful arc).
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    Subjects were recruited from the university campus
    Sampling Method
    Non-probability sampling
    Condition(s)/Problem(s) * (M00-M99)Diseases of the musculoskeletal system and connective tissue 
       (M75.1)Rotator cuff syndrome 

    Healthy people without shoulder pain
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~30Year

    Description

    Subjects were included if they were 20-30 years without shoulder pain in the previous 6 months,
    Exclusion Criteria
    Subjects were excluded if they reported (1) shoulder pain, (2) systemic, neurological, and musculoskeletal disease, (3) history of upper extremity injury or surgery, and (4) positive sign on any of the SAPS tests (empty can, pain, or weakness with resisted external rotation, Neer, Hawkins tests, and painful arc).
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Not applicable
    Primary Outcome(s) 1
    Outcome
    acromiohumeral distance
    Timepoint
    during observation (cross-sectional)
    Secondary Outcome(s) 1
    Outcome
    shoulder internal rotation angle
    Timepoint
    during observation (cross-sectional)
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Yes
    Time of Sharing 2021. 12
    Way of Sharing Available on Request
    (yhi940929@naver.com)
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