Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619001677190
Ethics application status
Approved
Date submitted
16/09/2019
Date registered
29/11/2019
Date last updated
6/11/2020
Date data sharing statement initially provided
29/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The study of lower trapezius muscle when performing shoulder forward lift in prone and varying pelvic tilts quadruped positions.
Scientific title
Surface electromyographic analysis of the lower trapezius muscle activation during shoulder diagonal flexion performed in the prone and quadruped positions, and the influence of pelvic position during the quadruped shoulder diagonal flexion.
Secondary ID [1] 299300 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower trapezius muscle activation variations 314428 0
Condition category
Condition code
Musculoskeletal 312772 312772 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Electromyographic (EMG) data will be collected during manual muscle testing performed by the subject with their dominant arm, to acquire maximal voluntary isometric contraction (MVIC) of the serratus anterior (SA), upper trapezius (UT) and lower trapezius (LT) muscle.

For the electrodes placement, the skin will be shaved if required and wiped with isopropyl alcohol to reduce skin impedance. For the UT, the shoulder was abducted 90°. Two electrodes were positioned parallel to the UT fibres, 1 electrode superior-medial, and 1 inferior-lateral at 2 cm apart, and at a distance one-half away from the spinous process C7 and the lateral acromion tip. For the LT, the shoulder was flexed into 90° and electrodes were angled obliquely. 1 electrode was placed superiorly and 1 inferiorly, 5cm inferior-medially from the root of the spine of scapula. For the SA, electrodes were vertically positioned at the mid-axillary of ribs 6 to 8.

In manual muscle testing, the SA will be tested with the shoulder in 125° flexion. Resistance is applied above the elbow and at the inferior angle of the scapula attempting to de-rotate the scapula. The subject seats tall without back support. The UT will be tested with resistance given to shoulder abduction at 90° with simultaneous resistance to the head after the neck is first side-bent to the same side, rotated to the opposite side, and then extended. The LT will be tested in the prone position. The subject’s arm is raised diagonally overhead with shoulder in 145°abduction, in line with the LT fibres. Resistance is applied distal to the elbow.

The isometric contraction will be held for 6 seconds with maximal effort against manual resistance until muscular failure. The first and last second of EMG data will be removed. Only the remaining 4 seconds are used. Each test is performed for 3 repetitions with 2 mins intervals between them. The EMG values from each muscle during the shoulder flexion exercise in prone and quadruped will be normalized as a percentage of the highest EMG value that the muscle produced during the MVIC. The EMG data from exercises will be expressed as a percentage MVIC (%MVIC).

Prone:
The subject is positioned in prone on a plinth. The humerus was aligned diagonally overhead with shoulder abduction of 145° using a goniometer. The angle is maintained using a metal bar. The forearm is kept in neutral. The subject placed their non-dominant hand under the forehead to stabilize the neck and thoracic spine. A cable rope, attached to a 22.5kg load on the floor, is wrapped 5cm above the radial styloid process of the dominant arm which hangs off the plinth. The maximum length of the rope is adjusted according to the distance between the floor and the final position of the arm in shoulder diagonal flexion, where the medial epicondyle is in line with the subject’s earlobe. When instructed, the subject lifts the dominant arm with elbow in extension against the resistance, to achieve maximal isometric contraction of the tested muscles.

Quadruped:
The participants begin in kneeling position on a plinth with both hands and knees in equal weight bearing. The hips, arms and knees were flexed at 90°. The shoulder girdles were directly above the hands. The fingers pointed forward with the hands at shoulder width apart. The shins were flat on the floor and the feet in plantarflexion. The subject will assume one of the three pelvic positions (neutral, full anterior pelvic tilt, full posterior pelvic tilt) before the shoulder of the dominant arm is diagonal flexed. A similar method for loaded resistance in the prone position will be used for each quadruped shoulder diagonal flexion exercise.

All exercises were performed with maximal isometric effort for 5 seconds. The participants repeat each exercise a second time after a 15-minute rest period on the same day for test-retest reliability of the recorded EMG.
Intervention code [1] 315573 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321395 0
MVIC of lower trapezius muscle will be collected using non-invasive EMG. Thereafter, participants perform resisted isometric contraction of shoulder diagonal arm lift in prone and quadruped positions to obtain EMG amplitude. The EMG amplitude will be normalised with the MVIC recording (!MVIC).
Timepoint [1] 321395 0
Baseline
Primary outcome [2] 322095 0
MVIC of upper trapezius muscle will be collected using non-invasive EMG. Thereafter, participants perform resisted isometric contraction of shoulder diagonal arm lift in prone and quadruped positions to obtain EMG amplitude. The EMG amplitude will be normalised with the MVIC recording (!MVIC).
Timepoint [2] 322095 0
Baseline
Secondary outcome [1] 374864 0
MVIC of serratus anterior muscle will be collected using non-invasive EMG. Thereafter, participants perform resisted isometric contraction of shoulder diagonal arm lift in prone and quadruped positions to obtain EMG amplitude. The EMG amplitude will be normalised with the MVIC recording (!MVIC).
Timepoint [1] 374864 0
Baseline

Eligibility
Key inclusion criteria
1. Subjects are included if they are able to understand English.
2. At least 21 years old.
3. Healthy adults with no medical conditions.
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Self-reported musculoskeletal injury and conditions or surgery to the upper and lower extremities, pelvis and the spine.
2. A history of neuromuscular disease, condition or presence of neurological deficits in the upper and lower extremities, pelvis and spine.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
21/10/2019
Date of last participant enrolment
Anticipated
16/12/2019
Actual
26/10/2019
Date of last data collection
Anticipated
30/12/2019
Actual
26/10/2019
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 21860 0
Singapore
State/province [1] 21860 0

Funding & Sponsors
Funding source category [1] 303823 0
University
Name [1] 303823 0
Singapore Institute of Technology
Country [1] 303823 0
Singapore
Primary sponsor type
University
Name
Singapore Institute of Technology
Address
10 Dover Drive, S138683
Country
Singapore
Secondary sponsor category [1] 303949 0
None
Name [1] 303949 0
Address [1] 303949 0
Country [1] 303949 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304337 0
Singapore Institute of Technology - Institutional Review Board
Ethics committee address [1] 304337 0
Ethics committee country [1] 304337 0
Singapore
Date submitted for ethics approval [1] 304337 0
Approval date [1] 304337 0
16/09/2019
Ethics approval number [1] 304337 0
2019123

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96594 0
Mr Boon Chong Kwok
Address 96594 0
Singapore Institute of Technology, 10 Dover Dr, S138683.
Country 96594 0
Singapore
Phone 96594 0
+65 96916703
Fax 96594 0
Email 96594 0
[email protected]
Contact person for public queries
Name 96595 0
Boon Chong Kwok
Address 96595 0
Singapore Institute of Technology, 10 Dover Dr, S138683.
Country 96595 0
Singapore
Phone 96595 0
+65 96916703
Fax 96595 0
Email 96595 0
[email protected]
Contact person for scientific queries
Name 96596 0
Boon Chong Kwok
Address 96596 0
Singapore Institute of Technology, 10 Dover Dr, S138683.
Country 96596 0
Singapore
Phone 96596 0
+65 96916703
Fax 96596 0
Email 96596 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Personal Data Protection Act requirements in Singapore.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4815Ethical approval    378384-(Uploaded-16-09-2019-14-29-29)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.