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

Primary Purpose

Shoulder Impingement Syndrome

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Shoulder brace
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring Shoulder Brace

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

shoulder brace with comfortable tension

shoulder brace with forced tension

Arm Description

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".

Forced tension, the self-comfortable tension of strap will be increased till forced tension of strap using buckles.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
August 16, 2018
Last Updated
December 17, 2018
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03667833
Brief Title
Shoulder Brace on Muscle Activation and Scapular Kinematics in Patients With Shoulder Impingement Syndrome and Rounded Shoulder Posture
Official Title
The Effect of Shoulder Brace on Muscle Activation and Scapular Kinematics in Patients With Shoulder Impingement Syndrome and Rounded Shoulder Posture
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome
Keywords
Shoulder Brace

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
shoulder brace with comfortable tension
Arm Type
Experimental
Arm Description
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".
Arm Title
shoulder brace with forced tension
Arm Type
Experimental
Arm Description
Forced tension, the self-comfortable tension of strap will be increased till forced tension of strap using buckles.
Intervention Type
Other
Intervention Name(s)
Shoulder brace
Intervention Description
Shoulder brace is a designed elastic strap to correct scapula alignment in different characteristics such as tension and direction of force.
Primary Outcome Measure Information:
Title
Scapular kinematics
Description
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.
Time Frame
1 year
Title
Surface Electromyography of shoulder muscle
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Pectoralis minor index (PMI)
Description
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.
Time Frame
1 year
Title
Acromial distance (AD)
Description
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.
Time Frame
1 year
Title
Scapular index (SI)
Description
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.
Time Frame
1 year
Title
Shoulder angle (SA)
Description
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.
Time Frame
1 year
Title
Self-reported flexilevel scale of shoulder function (FLEX-SF)
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 2 of the following 5 impingement signs Neer's impingement test; Hawkins-Kennedy impingement test; Empty can test; External resisted test; 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Jenq Lin, Phd
Organizational Affiliation
School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
Official's Role
Study Chair
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

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

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