Status Approved
First Submitted Date
2019/10/25
Registered Date
2019/11/06
Last Updated Date
2020/01/14
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
| CRIS Registration Number |
KCT0004429 |
|---|---|
| Unique Protocol ID | 1041386-201910-HR-41-01 |
| Public/Brief Title | Effects of intended scapular posterior tilt motion on electromyography activities of trapezius muscles |
| Scientific Title | Effects of intended scapular posterior tilt motion on electromyography activities of trapezius muscles |
| 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
| Board Approval Status | Submitted approval |
|---|---|
| Board Approval Number | 1041386-201910-HR-41-01 |
| Approval Date | 2019-10-11 |
| Institutional Review Board Name | Pukyong National University Institutional Review Board |
| Institutional Review Board Address | 45, Yongso-ro, Nam-gu, Busan |
| Institutional Review Board Telephone | 051-629-5223 |
| Data Monitoring Committee | No |
3. Contact Details
| Contact Person for Principal Investigator / Scientific Queries | |
|---|---|
| Name | Sooyong Kim |
| Title | Staff |
| Telephone | +82-55-360-4214 |
| Affiliation | Pusan National University Yangsan Hospital |
| Address | Mulgeum-eup, Yangsan-si, Gyeongsangnam-do |
| Contact Person for Public Queries | |
| Name | Minhyeok Kang |
| Title | Assistant Professor |
| Telephone | +82-55-751-8292 |
| Affiliation | International University of Korea |
| Address | 965, Dongbu-ro, Jinju-si, Gyeongsangnam-do |
| Contact Person for Updating Information | |
| Name | Minhyeok Kang |
| Title | Assistant Professor |
| Telephone | +82-55-751-8292 |
| Affiliation | International University of Korea |
| Address | 965, Dongbu-ro, Jinju-si, Gyeongsangnam-do |
4. Status
| Study Site | Single | |
|---|---|---|
| Overall Recruitment Status | Completed | |
| Date of First Enrollment | 2019-11-20 Actual | |
| Target Number of Participant | 18 | |
| Primary Completion Date | 2019-11-27 , Actual | |
| Study Completion Date | 2019-11-27 , Actual | |
| Recruitment Status by Participating Study Site 1 | ||
| Name of Study | Pukyung National University | |
| Recruitment Status | Completed | |
| Date of First Enrollment | 2019-11-20 , | |
5. Source of Monetary / Material Support
| 1. Source of Monetary/Material Support | |
|---|---|
| Organization Name | National Research Foundation |
| Organization Type | Others |
| Project ID | 2018R1C1B5085529 |
6. Sponsor Organization
| 1. Sponsor Organization | |
|---|---|
| Organization Name | Pukyung National University |
| Organization Type | University |
7. Study Summary
| Lay Summary | ■ Background and purpose Abnormal scapular alignments lead to various shoulder injuries. Weakness of lower trapezius is a crucial factor for abnormal scapular alignments. Thus, to prevent and treat shoulder injuries, strengthening exercise of lower trapezius is important. Primary functional actions of lower trapezius are scapular adduction, upward rotation, and posterior tilt. However, previous studies performed shoulder horizontal abduction exercise, strengthening exercise of lower trapezius, focusing on only scapular adduction and upward rotation. Therefore, the purpose of this study is to identify the effects of intended scapular posterior tilt on electromyography activities of trapezius muscles during shoulder horizontal abduction. ■ Subjects 18 healthy adults without shoulder pain ■ Exercises - Shoulder horizontal abduction: Subjects perform shoulder horizontal abduction with 125° of shoulder abduction and shoulder external rotation. - Active scapular posterior tilt training: Subjects pull away acromion backward. - Shoulder horizontal abduction with intended scapular posterior tilt: Subjects perform shoulder horizontal abduction with 125° of shoulder abduction, shoulder external rotation, and intended scapualr posterior tilt - Shoulder horizontal abduction with intended scapular posterior tilt and trunk extension: Subjects performed shoulder horizontal abduction with intended scapular posterior tilt and then trunk extension. ■ Measures - Muscle activity (upper trapezius, middle trapezius, lower trapezius, upper trapezius/middle trapezius ratio, upper trapezius/lower trapezius ratio) - Scapular posterior tilt angle ■ Hypothesis Considering the actions of lower trapezius, we hypothesized that intended scapular posterior tilt motion would increase lower trapezius muscle activity and selective lower trapezius muscle activation during shoulder horizontal abduction. |
|---|
8. Study Design
| Study Type | Interventional Study |
|---|---|
| Study Purpose | Prevention |
| Phase | Not applicable |
| Intervention Model | Single Group |
| Blinding/Masking | Open |
| Allocation | Not Applicable |
| Intervention Type | Others |
| Intervention Description | ■ Shoulder horizontal abduction - Subjects place shoulder at 125° of shoulder abduction with shoulder external rotation. - Subjects performed shoulder horizontal abduction and maintain end-position for 5 second, and repeat three times. ■ Active scapular posterior tilt training - Subjects perform active scapular posterior tilt training (pull away acromion backward) for 5 minutes - An examiner monitor compensatory movements such as scapular adduction without scapular posterior tilt and scapular downward rotation. ■ Shoulder horizontal abduction with intended scapular posterior tilt - After active scapular posterior tilt training, subjects place shoulder at 125° of shoulder abduction with shoulder external rotation. - Subjects perform intended scapluar posterior tilt and then shoulder horizontal abduction. - Subjects maintain end-position for 5 seconds and repeat three times. ■ Shoulder horizontal abduction with intended scapular posterior tilt and trunk extension - After active scapular posterior tilt training, subjects place shoulder at 125° of shoulder abduction with shoulder external rotation. - Subjects perform intended scapluar posterior tilt and then shoulder horizontal abduction. - Subjects raise their chest approximately 10 cm from 7th cervical spinous process. - Subjects maintain end-position for 5 seconds and repeat three times. |
| Number of Arms | 1 |
| Arm 1 |
Arm Label Exercise group |
|
Target Number of Participant 18 |
|
|
Arm Type Experimental |
|
|
Arm Description 1) Shoulder horizontal abduction - Subjects place shoulder at 125° of shoulder abduction with shoulder external rotation. - Subjects performed shoulder horizontal abduction and maintain end-position for 5 second, and repeat three times. 2) Active scapular posterior tilt training - Subjects perform active scapular posterior tilt training (pull away acromion backward) for 5 minutes - An examiner monitor compensatory movements such as scapular adduction without scapular posterior tilt and scapular downward rotation. 3) Shoulder horizontal abduction with intended scapular posterior tilt - After active scapular posterior tilt training, subjects place shoulder at 125° of shoulder abduction with shoulder external rotation. - Subjects perform intended scapluar posterior tilt and then shoulder horizontal abduction. - Subjects maintain end-position for 5 seconds and repeat three times. 4) Shoulder horizontal abduction with intended scapular posterior tilt and trunk extension - After active scapular posterior tilt training, subjects place shoulder at 125° of shoulder abduction with shoulder external rotation. - Subjects perform intended scapluar posterior tilt and then shoulder horizontal abduction. - Subjects raise their chest approximately 10 cm from 7th cervical spinous process. - Subjects maintain end-position for 5 seconds and repeat three times. |
9. Subject Eligibility
| Condition(s)/Problem(s) |
* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M75.4)Impingement syndrome of shoulder Shoulder Impingement Syndrome |
|---|---|
| Rare Disease | No |
| Inclusion Criteria |
Gender Both |
|
Age 18Year~60Year |
|
|
Description Healthy adults |
|
| Exclusion Criteria |
Individuals who have history of diagnosis for tendinitis, adhesive capsulitis, or subacromial impingement, |
| Healthy Volunteers | Yes |
10. Outcome Measure(s)
| Type of Primary Outcome | Efficacy | |
|---|---|---|
| Primary Outcome(s) 1 | ||
| Outcome | Muscle activity (upper trapezius, middle trapezius, lower trapezius, upper trapezius/middle trapezius ratio, upper trapezius/lower trapezius ratio) |
|
| Timepoint | During each shoulder horizontal abduction exercise (shoulder horizontal abduction, shoulder horizontal abduction with intended scapular posterior tilt, shoulder horizontal abduction with intended scapular posterior tilt and trunk extension) |
|
| Secondary Outcome(s) 1 | ||
| Outcome | Scapular posterior tilt angle |
|
| Timepoint | Prone with 125° of shoulder abduction and shouler external rotation with and without intended scapular posterior tilt |
|
11. Study Results and Publication
| Result Registered | No |
|---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
| Sharing Statement | Not provided at time of Registration |
|---|
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