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Isometric Shoulder Protraction Strength and Muscle Activity of Pectoralis Major and Serratus Anterior in Supine- and Sitting- Positions

Status Approved

  • First Submitted Date

    2017/07/24

  • Registered Date

    2017/09/22

  • Last Updated Date

    2017/08/24

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
    KCT0002474
    Unique Protocol ID INJE 2017-03-004-001
    Public/Brief Title Comparison of muscle activity between serratus anterior and pectoralis major during shoulder isometric strength test
    Scientific Title Isometric Shoulder Protraction Strength and Muscle Activity of Pectoralis Major and Serratus Anterior in Supine- and Sitting- Positions
    Acronym ISPSAPM
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number INJE 2017-03-004-001
    Approval Date 2017-05-02
    Institutional Review Board Name Inje University Ethics Committe for Human Investigations
    Institutional Review Board Address
    Institutional Review Board Telephone
    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 Jae-seop Oh
    Title proffessor
    Telephone +82-55-320-3679
    Affiliation Inje University
    Address Seong-san-gwan 511,197, Inje-ro, Gimhae-si, Gyeongsangnam-do, Republic of Korea
    Contact Person for Public Queries
    Name Jun-seok Kim
    Title researcher
    Telephone +82-55-320-3849
    Affiliation Inje University
    Address Il-gang-won 703,197, Inje-ro, Gimhae-si, Gyeongsangnam-do, Republic of Korea
    Contact Person for Updating Information
    Name Jun-seok Kim
    Title researcher
    Telephone +82-55-320-3849
    Affiliation Inje University
    Address Il-gang-won 703,197, Inje-ro, Gimhae-si, Gyeongsangnam-do, Republic of 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 Recruiting
    Date of First Enrollment 2017-08-28 Anticipated
    Target Number of Participant 18
    Primary Completion Date 2017-12-31 , Anticipated
    Study Completion Date 2017-12-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Inje University
    Recruitment Status Recruiting
    Date of First Enrollment 2017-08-28 ,
  • 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 Inje University
    Organization Type University
    Project ID 20170065
  • 6. Sponsor Organization

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

    Study Summary Information
    Lay Summary
    <Purpose>
    ● the purpose of this study was to examine the isometric strength of the SA muscle and EMG activity of the SA and PM muscles during measurement of isometric protraction strength.
    
    <BACKGROUND>
    - Measurements isolating serratus anterior (SA) from pectoralis major (PM) muscle activity and strengthening the SA during isometric shoulder protraction have been considered primary goals in regaining functional motion and stability of the scapula.
    - In previous studies examining the optimal position for measuring SA muscle activity in motions related to scapular upward rotation of >120–150° of shoulder flexion, a sitting position was found to produce greater electromyographic (EMG) activity in the SA than straight shoulder protraction
    - however, many patients with shoulder impingement or rotator cuff tears may be able to exercise with a low load and range of motion in shoulder flexion as long as the painful arc of motion is avoided. For this reason, many authors have recommended scapular protraction in a different position, with shoulder flexion at 90°, for SA strengthening exercises in the earlier stages of a rehabilitation program
    - It is also important to consider the optimal position to measure shoulder protraction strength, which may also be needed to derive the appropriate muscle strength and activity of the SA in the absence of pain.
    - it remains unclear whether the designated muscle, i.e., the SA, in a given scapular MMT makes a greater contribution than the PM muscle during isometric protraction in different positions under the specified MMT.
    - No reported study has investigated isometric protraction strength when MMTs are performed, and none has compared SA and PM activity.
    
    <Hypothesis>
    - SA muscle activity and shoulder isometric protraction stregnth is greater and PM activity is lower in sitting position than conditions in supine position 
    
    <METHODS>
    In total, 18 healthy subjects performed isometric shoulder protraction in supine and sitting positions with 90° shoulder flexion. Surface electromyography (EMG) data of the SA and PM muscles and SA strength were examined simultaneously using fixed-based instrumentation, custom designed for measuring the force of isometric shoulder protraction.
  • 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 Case-only
    Time Perspective Cross-sectional  
    Target Number of Participant 18
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    a single group

    Cohort/Group Description

    In a single group, the shoulder isometric protraction strength, the muscle activity of serratus anterior and pectoralis major are measured respectively in the supine-lying position and the sitting position.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    healthy male volunteers who attending Inje University in Gimhae
    
    Sampling Method
    The sampling method is non-probablitic methods for selecting males. The sample size is determined from previous studies (Ekstrom et al., 2005) that showed significant differences in muscle activity of the SA between different positions. The power analysis indicate that at least six subjects would be required to achieve a power of 0.96 with an effect size of 1.93 at a significance level of 0.05.
    Condition(s)/Problem(s)    Not Applicable-Etc 
    Rare Disease No
    Inclusion Criteria

    Gender

    Male

    Age

    20Year~35Year

    Description

    - right handed 
    - free from past or current shoulder pain
    - no limit on the full range of motion for the shoulder joint
    Exclusion Criteria
    Subjects who had a history of shoulder surgery or disorder, such as tendonitis, adhesive capsulitis, impingement, or a neurological disorder involving long thoracic nerve injury were excluded
    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
    shoulder isometric protraction strength
    Timepoint
    supine position and sitting position
    Secondary Outcome(s) 1
    Outcome
    muscle activity of serratus anterior
    Timepoint
    supine position and sitting position
    Secondary Outcome(s) 2
    Outcome
    muscle activity of pectoralis major
    Timepoint
    supine position and sitting position
  • 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
  • 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 Not provided at time of Registration
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