Shoulder Brace on Muscle Activation and Scapular Kinematics in Patients With Shoulder Impingement Syndrome and Rounded Shoulder Posture

Shoulder Impingement Syndrome Clinical Trial

Official title:

The Effect of Shoulder Brace on Muscle Activation and Scapular Kinematics in Patients With Shoulder Impingement Syndrome and Rounded Shoulder Posture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03667833
• Other study ID #: 201805043RINC
• Status: Completed
• Phase: N/A
• Start date: September 20, 2018
• Est. completion date: October 31, 2018

Study information

• Verified date: June 2018
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background:

Rounded shoulder posture (RSP), associated with altered scapular kinematics and imbalance of muscle activation, is one of potential risks for shoulder impingement syndrome (SIS) due to alignment deviation of scapula. Evidence showed shoulder brace improved degree of RSP by postural correction. However, it is unknown whether shoulder brace with different characteristics (tension and direction) is optimal for muscle activation and scapular kinematics in patients with SIS and RSP.

Objective:

There are 4 objectives for the present study: (1) to investigate the relationships among degree of RSP, scapular kinematics and muscle activation in SIS patients with RSP; (2) to compare the effect of shoulder brace on degree of RSP, muscle balance ratios (Upper trapezius/Lower trapezius, Upper trapezius/ Serratus anterior) and scapular kinematics (upward/downward rotation, anterior/posterior tilt, external/internal rotation) during arm movements; (3) to compare the effect of two tensions of brace strap (self-comfortable and forced tension) in symptomatic impingement patients with RSP; (4) to compare the effect of two types of direction of strap (paraspinal muscle and diagonal orientation) in symptomatic impingement patients with RSP.

Design:

Patients with SIS and RSP will be recruited in this study. Participants will be randomly assigned into 2 groups (self-comfortable following forced tension and forced following self-comfortable tension groups) with 2 directions of strap in each tension wearing shoulder brace. Each patient has the assessment 2 times with 1-week interval. Pectoralis minor, acromial distance, scapular index and shoulder angle will be used to assess degree of RSP. Three-dimensional electromagnetic motion analysis and electromyography muscle activity will be used to record the scapular kinematic, absolute muscle activation and muscular balance ratios during arm movements with or without shoulder brace.

Main outcome measures:

Scapula kinematic (upward/downward rotation, anterior/posterior tilt, external/internal rotation), absolute muscle activation (Upper trapezius, Middle Trapezius, Lower trapezius, Serratus anterior) and muscle balance ratios (Upper trapezius/Lower trapezius, Upper trapezius/Serratus anterior) are main outcomes of the study.

Description:

Participants will be recruited from outpatient clinic in National Taiwan University Hospital (NTUH) and also through general announcements in social media. Subjects will be undergoing physical examinations for eligibility by a physical therapist. Thoracic kyphosis angle, one inclinometer over 1st and 2nd thoracic spines, and another inclinometer over the 12th thoracic and 1st lumbar spines in relaxed standing with adopting a natural posture of the subject, is calculated by the summation of the angle recorded by two inclinometers. Participants will sign a consent form approved by the National Taiwan University Hospital institutional review boards. Participant characteristics will be collected by the assessor including age, gender, height, weight, dominant side, involved side, VAS (Visual Analogue Scale) pain intensity during arm movements, symptom duration and shoulder function. Shoulder function will be assessed by Flexilevel Scale of Shoulder Function (FLEX-SF), a self-administered questionnaire. The questionnaire was commonly used in shoulder pain patients to assess shoulder function with sufficient psychometric properties. Lower FLEX-SF score represents limited function.

Subjects will be randomly assigned into 2 groups (self-comfortable following forced tension and forced following self-comfortable tension groups) with 2 directions of strap in each tension wearing shoulder brace. Each subject has the assessment 2 times with 1-week interval. At the first, each subject will be assessed on PMI, SI, AD and SA with and without shoulder brace in resting position. Then the surface EMG electrodes and FASTRAK kinematic sensors will be attached to the subjects. Surface EMG electrodes will be placed on upper trapezius, middle trapezius, lower trapezius and serratus anterior of involved shoulder. Three electromagnetic sensors will be attached to the sternum, the flat bony surface of the acromion and the distal humerus via Velcro straps.

Then subject will be tested wearing shoulder brace with two tensions of strap (self- comfortable/ forced) under two directions of strap (paraspinal muscle/ diagonal orientation). Strap is applied from mid-level of thoracic spinal process to mid-point of clavicle on the tested side and then pulled downward diagonally back to the thoracic spinal process and then applied the same way in the other side. In general, strap had a cross on mid-thorax and ran through mid-point of clavicle and axillary two sides. For the strap tension, length of strap will be adjusted with buckles relative to original length of figure 8 by the experimenter. Self- comfortable tension of strap will be adjusted by subject's feedback with comfortable feeling as "please feel postural correction by shoulder brace without tight pressure". Accordingly, the self-comfortable tension of strap will be increased till forced tension of strap using buckles. Direction of strap will change bilaterally as upper part of shoulder brace is fixed at 2 points of shoulder brace .

Then subjects will be tested and familiarized with the arm movement with and without shoulder brace. To ensure that each subject perform arm movements at a standard speed, a metronome will be set as one beat per second. Subjects will be asked to elevate and lower arm by following three beats, respectively. Each subject will do task three times with or without shoulder brace in each session. After one week from the first assessment, each subject will be assessed again under another condition of strap tension according to their assignment groups.

Maximum voluntary isometric contraction (MVIC) of the subject will be collected after the testing session to prevent fatigue of the scapular muscles. The MVIC for upper trapezius muscle will be measured during resisted shoulder flexion. The subjects will be seated with shoulder flexion 90 degrees and resistance will be applied on the distal arm. For measuring MVIC of middle trapezius muscle, the subjects will lie prone with testing arm at 90 degrees of abduction. For measuring MVIC of lower trapezius muscle, the subjects will lie prone with testing arm at 120 degrees of abduction in line with muscle fibers. Resistances will be applied to against further elevation. For measuring MVIC of serratus anterior muscle, the subjects will be seated with arm elevated at 135 degrees. Resistances will be applied to distal upper arm against further elevation. The MVICs will be collected for 5 seconds for 3 trials, with a 1- minute rest interval between each trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• At least 2 of the following 5 impingement signs

1. Neer's impingement test;

2. Hawkins-Kennedy impingement test;

3. Empty can test;

4. External resisted test;

5. Pain during rotator cuff palpation

• Acromial distance higher than 2.6 cm.

Exclusion Criteria:

• History of shoulder dislocation, fracture, shoulder surgery, or direct contact injury to the neck or upper extremities within the past 3 months

• Glenohumeral joint instability (apprehension test or sulcus sign)

• Neurological disorders (thoracic outlet syndrome or pectoralis minor syndrome)

• Pain (VAS>5) during the experimental tasks

• Excessive thoracic kyphosis higher than 50 degrees

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Shoulder Impingement Syndrome
• Syndrome

Intervention

Other:
• Shoulder brace
Shoulder brace is a designed elastic strap to correct scapula alignment in different characteristics such as tension and direction of force.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scapular kinematics	This study will follow the ISB guidelines for constructing a shoulder joint coordinate system. Scapular orientation relative to the thorax will be described using a Euler angle sequence of rotation about Zs (protraction/retraction), rotation about Y's (downward /upward rotation), and rotation about X"s (posterior/anterior tipping).; Unit of measure is degree.	1 year
Primary	Surface Electromyography of shoulder muscle	The mean sEMG amplitude of each muscle reported as a percentage of MVIC will be used to describe the activity of upper trapezius, middle trapezius, lower trapezius and serratus anterior muscle.; Unit of measure is percentage of maximal voluntary isometric contraction.	1 year
Secondary	Pectoralis minor index (PMI)	PMI is used to measure the length of the PM. The subjects will be seated erect with their test arms by side. Forearm position is neutral with hand in resting position. The measurement of PM muscle length is from the medial-inferior angle of the coracoid process to the sternocostal junction of the inferior aspect of the fourth rib with a caliper. The PMI is calculated by dividing he resting muscle length by the subject's height and multiplying by 100.; Unit of measurement is percentage because length and height have been divided each other.	1 year
Secondary	Acromial distance (AD)	Acromial distance is defined as the distance from table to border of lateral-inferior acromion when subjects are in supine position with shoulder in neutral position (Host HH, 1995). A score? 2.6 cm will be defined as RSP.	1 year
Secondary	Scapular index (SI)	SI was determined by measuring the distance from the mid-point of the sternal notch (SN) to the medial aspect of the coracoid process (CP) and the horizontal distance from the posterolateral angle of the acromion (PLA) to the thoracic spine (TS) with a soft tape measure. The subjects will be seated in upright position with their test arms by side (Borstad JD, 2006). The SI is calculated by dividing the SN-CP length by the PLA-TS length and multiplying by 100.; PMI is used to measure the length of the PM. The subjects will be seated erect with their test arms by side. Forearm position is neutral with hand in resting position. The measurement of PM muscle length is from the medial-inferior angle of the coracoid process to the sternocostal junction of the inferior aspect of the fourth rib with a caliper. The PMI is calculated by dividing he resting muscle length by the subject's height and multiplying by 100.; Unit of measurement is percentage because length have been divided each other.	1 year
Secondary	Shoulder angle (SA)	The angle formed at the intersection of the line between the midpoint of the humerus and spinous process of C7 and the horizontal line through the midpoint of the acromial process, reflects anterior translation of shoulder in sagittal plane.	1 year
Secondary	Self-reported flexilevel scale of shoulder function (FLEX-SF)	The selection of the FLEX-SF scale to assess shoulder function and disability in this study is based on its entire continuum assessment of shoulder functions and appropriate psychometric properties of reliability, validity, and responsiveness to clinical change. In this scale, respondents answer a single question that grossly classifies their level of function as low, medium, or high. They then respond to only the items that target their level of function. Scores will be recorded from 1, with the most limited function, to 50, without any limited function in the subject.; Unit of measurement is purely score.	1 year