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
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
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 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
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
1. Source of Monetary/Material Support | |
---|---|
Organization Name | Yonsei University |
Organization Type | University |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
---|---|
Organization Name | Yonsei University |
Organization Type | University |
7. Study Summary
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 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
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)
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
Result Registered | No |
---|
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
---|---|
Time of Sharing | 2021. 12 |
Way of Sharing | Available on Request
(yhi940929@naver.com) |
TOP
BOTTOM
화면 최하단으로 이동