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

NCT03667833 | Completed

• 1 other identifier: 201805043RINC
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Impingement Syndrome

Keywords

Shoulder Brace

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Pectoralis minor index (PMI)

  1 year

• Acromial distance (AD)

  1 year

• Scapular index (SI)

  1 year

• Shoulder angle (SA)

  1 year

• Self-reported flexilevel scale of shoulder function (FLEX-SF)

  1 year

Study Arms (2)

shoulder brace with comfortable tension

EXPERIMENTAL

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".

Other: Shoulder brace

shoulder brace with forced tension

EXPERIMENTAL

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

Other: Shoulder brace

Interventions

Shoulder brace OTHER

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

shoulder brace with comfortable tension; shoulder brace with forced tension

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Study Officials

• Jin Jenq Lin, Phd

  School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: September 12, 2018
• Study Start: September 20, 2018
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-06

Locations

TW (1)