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The Effects of Short-term Scapular Control Training in Overhead Athletes With Shoulder Impingement Syndrome

Primary Purpose

Shoulder Impingement Syndrome, Scapular Dyskinesis

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Scapular control training
General exercise
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring Corticospinal excitability, Transcranial magnetic stimulation, Motor control training, Scapula-focused exercise

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria (patients with shoulder impingement) :

  1. perform overhead exercise at least 4 hours a week
  2. present type I or II scapular dyskinesis at rest or moving
  3. pain at least two weeks
  4. 3 of 6 impingement test present positive

    • Neer's impingement test: arm abduction overhead with shoulder internal rotation and thumb downward. If feel pain, then positive.
    • Hawkins-Kennedy impingement Test: arm lift to horizontal plane, elbow flexion to 90 degree. Tester put force on forearm toward shoulder internal rotation. If feel pain, then positive.
    • Empty can test: shoulder abduction with thumb down, then give a resistive force toward up. If feel pain, then positive.
    • Resistive shoulder external rotation test: elbow flexion to 90 degrees and do resistive shoulder rotation. If feel pain, then positive.
    • Rotator cuff tenderness test: tester put pressure on rotator cuff. If feel pain, then positive.
    • Painful arc: perform arm elevation. If feel pain during movement, then positive.

Inclusion Criteria (healthy people) :

  1. perform overhead exercise at least 4 hours a week
  2. no any symptoms or injuries on shoulder and neck

Exclusion Criteria:

  1. Have a history of dislocation, fracture, or surgery of upper extremity
  2. A history of direct contact injury to the neck or upper extremities within the past 12 months
  3. A concussion within the past 12 months or a history of three or more concussions
  4. Brain injury and neurological impairment
  5. History of frequent headache or dizziness
  6. Contraindications to the use of transcranial magnetic stimulation (TMS), assessed with a safety screening questionnaire, including pregnancy, history of seizure, epilepsy and syncope, having cochlear implant, having medal implant and taking anti-depressant medication.

Sites / Locations

  • National Yang-Ming University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Scapular control training group

General exercise group

Healthy subject group

Arm Description

Participants in these group will be taught how to correctly movement arm overhead. And they will undergo series of movement tasks with mirror and also receive scapular-focused exercises. The difficulty of the movements protocol will increase weekly.

Participants in this group will receive a general strengthening exercise, focusing on the shoulder muscles. And the load will progressively increase weekly.

No intervention.

Outcomes

Primary Outcome Measures

Change in neurophysiological measures - Active motor threshold
Active motor threshold (AMT) will be described with the percentage (%) of maximum stimulator output (MSO).
Change in neurophysiological measures - Motor evoked potential
Motor evoked potential (MEP) will be described with millivolt (mV) at different points and with different stimulus intensity
Change in neurophysiological measures - Cortical silent period
Cortical silent period (CSP) will be measured with millisecond (ms).
Change in neurophysiological measures - Short interval cortical inhibition and short interval cortical facilitation
Short interval cortical inhibition (SICI) and short interval cortical facilitation (SICF) will be defined as percentage (%) of conditioning responses vs testing responses
Change in shoulder pain
Pain will be measured with a numerical rating scale (0-10). Zero indicates the absence of pain, while 10 represents the most intense pain possible. No unit.
Change in shoulder function
Function will be measured questionnaire, Flexilevel Scale of Shoulder Function (FLEX-SF). There are 15 questions on each difficulty version. Zero indicates the most difficulty, while 3 means the least difficulty.
Long-term change in shoulder pain
Pain will be measured with a numerical rating scale (0-10). Zero indicates the absence of pain, while 10 represents the most intense pain possible. No unit.
Long-term change in shoulder function
Function will be measured questionnaire, FLEX-SF. There are 15 questions on each

Secondary Outcome Measures

Scapular kinematics
Including anterior/posterior tilt, upward/downward rotation, and internal/external rotation in scapula plan elevation at 30°, 60°, 90°, and 120°, will be calculated and will be described with degree (°).
Scapular muscle activation
The root mean square of electromyography (EMG) data of the upper trapezius, lower trapezius, and serratus anterior will be normalized by the maximum voluntary contraction amplitude (percentage of maximal voluntary contraction, %) and calculated over three 30° increments of motion during arm elevation from 30° to 120°, including 30° - 60°, 60° - 90°, and 90° - 120°

Full Information

First Posted
June 29, 2020
Last Updated
April 5, 2022
Sponsor
National Yang Ming University
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1. Study Identification

Unique Protocol Identification Number
NCT04493190
Brief Title
The Effects of Short-term Scapular Control Training in Overhead Athletes With Shoulder Impingement Syndrome
Official Title
The Effects of Short-term Scapular Control Training on Motor Control in Overhead Athletes With Shoulder Impingement Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
August 26, 2021 (Actual)
Study Completion Date
November 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University

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
Subacromial impingement syndrome (SIS) is a common disorder of shoulder joint. SIS has been accounted for 44-65 % of all shoulder pain. It is believed that one important contributing factor is scapular dyskinesis. Patients with SIS demonstrates scapular dyskinesis, including decrease in upward rotation, scapular posterior tilt, and external rotation. Altered muscle activity of scapular muscles may contribute to scapular dyskinesis, such as increase in activity of upper trapezius, and decrease in activity of lower trapezius and serratus anterior. In addition to these changes in neuromuscular control, central nervous system may be re-organized in patients with musculoskeletal disorders. Evidence has been reported that center of gravity of motor mapping changes, corticospinal excitability decreases and inhibition increases in patients with shoulder injuries such as instability, rotator cuff tendinopathy and SIS. These corticospinal changes are believed to be related to chronicity of symptoms and lack of treatment effects. Previous studies have applied many types of treatments to SIS, such as manipulation, taping, and exercises. However, most studies mainly focused on the outcomes of pain and function, few studies investigated changes in neuromuscular control following treatments. Yet, no study has addressed how corticospinal system changes following treatment in patient with shoulder injuries. Motor skill training, which has been widely used in training healthy subjects or patients with neurological disorders, has been shown to change corticospinal systems, including increasing excitability and decreasing inhibition. To our knowledge, no study has integrated the concepts of motor skill learning into a short-term treatment or investigated the effects of motor skill training on corticospinal systems in patients with SIS. The purposes of the study are to investigate the effects of short-term motor skill training on pain, neuromuscular control, corticospinal system in patients with SIS, and also to investigate whether changes in corticospinal parameters will be related to changes in pain, function and neuromuscular control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome, Scapular Dyskinesis
Keywords
Corticospinal excitability, Transcranial magnetic stimulation, Motor control training, Scapula-focused exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Scapular control training group
Arm Type
Experimental
Arm Description
Participants in these group will be taught how to correctly movement arm overhead. And they will undergo series of movement tasks with mirror and also receive scapular-focused exercises. The difficulty of the movements protocol will increase weekly.
Arm Title
General exercise group
Arm Type
Experimental
Arm Description
Participants in this group will receive a general strengthening exercise, focusing on the shoulder muscles. And the load will progressively increase weekly.
Arm Title
Healthy subject group
Arm Type
No Intervention
Arm Description
No intervention.
Intervention Type
Procedure
Intervention Name(s)
Scapular control training
Intervention Description
Participants in this group will learn how to maintain normal scapular position at first. Then they will progress to moving arm with good scapular control with mirror. Afterward, participants will undergo movements protocol which give different directions of arm movements while keeping scapula in a good alignment. They will also receive scapular-focused exercises. The difficulty of the movement protocol will increase weekly. They will be trained three times per week for 6 weeks with an average duration of 30 min per session.
Intervention Type
Procedure
Intervention Name(s)
General exercise
Intervention Description
Participants in this group will receive a general shoulder strengthening with theraband or dumbbell. Load will increase weekly. They will be trained three times per week for 6 weeks with an average duration of 30 min per session.
Primary Outcome Measure Information:
Title
Change in neurophysiological measures - Active motor threshold
Description
Active motor threshold (AMT) will be described with the percentage (%) of maximum stimulator output (MSO).
Time Frame
Change from baseline AMT at 6 weeks
Title
Change in neurophysiological measures - Motor evoked potential
Description
Motor evoked potential (MEP) will be described with millivolt (mV) at different points and with different stimulus intensity
Time Frame
Change from baseline MEP at 6 weeks
Title
Change in neurophysiological measures - Cortical silent period
Description
Cortical silent period (CSP) will be measured with millisecond (ms).
Time Frame
Change from baseline CSP at 6 weeks
Title
Change in neurophysiological measures - Short interval cortical inhibition and short interval cortical facilitation
Description
Short interval cortical inhibition (SICI) and short interval cortical facilitation (SICF) will be defined as percentage (%) of conditioning responses vs testing responses
Time Frame
Change from baseline SICI and SICF at 6 weeks
Title
Change in shoulder pain
Description
Pain will be measured with a numerical rating scale (0-10). Zero indicates the absence of pain, while 10 represents the most intense pain possible. No unit.
Time Frame
Change from baseline pain at 6 weeks
Title
Change in shoulder function
Description
Function will be measured questionnaire, Flexilevel Scale of Shoulder Function (FLEX-SF). There are 15 questions on each difficulty version. Zero indicates the most difficulty, while 3 means the least difficulty.
Time Frame
Change from baseline function at 6 weeks and 3 months
Title
Long-term change in shoulder pain
Description
Pain will be measured with a numerical rating scale (0-10). Zero indicates the absence of pain, while 10 represents the most intense pain possible. No unit.
Time Frame
Change from baseline pain at 3 months
Title
Long-term change in shoulder function
Description
Function will be measured questionnaire, FLEX-SF. There are 15 questions on each
Time Frame
Change from baseline pain at 3 months
Secondary Outcome Measure Information:
Title
Scapular kinematics
Description
Including anterior/posterior tilt, upward/downward rotation, and internal/external rotation in scapula plan elevation at 30°, 60°, 90°, and 120°, will be calculated and will be described with degree (°).
Time Frame
Change from baseline scapular kinematics at 6 weeks
Title
Scapular muscle activation
Description
The root mean square of electromyography (EMG) data of the upper trapezius, lower trapezius, and serratus anterior will be normalized by the maximum voluntary contraction amplitude (percentage of maximal voluntary contraction, %) and calculated over three 30° increments of motion during arm elevation from 30° to 120°, including 30° - 60°, 60° - 90°, and 90° - 120°
Time Frame
Change from baseline muscle activation at 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (patients with shoulder impingement) : perform overhead exercise at least 4 hours a week present type I or II scapular dyskinesis at rest or moving pain at least two weeks 3 of 6 impingement test present positive Neer's impingement test: arm abduction overhead with shoulder internal rotation and thumb downward. If feel pain, then positive. Hawkins-Kennedy impingement Test: arm lift to horizontal plane, elbow flexion to 90 degree. Tester put force on forearm toward shoulder internal rotation. If feel pain, then positive. Empty can test: shoulder abduction with thumb down, then give a resistive force toward up. If feel pain, then positive. Resistive shoulder external rotation test: elbow flexion to 90 degrees and do resistive shoulder rotation. If feel pain, then positive. Rotator cuff tenderness test: tester put pressure on rotator cuff. If feel pain, then positive. Painful arc: perform arm elevation. If feel pain during movement, then positive. Inclusion Criteria (healthy people) : perform overhead exercise at least 4 hours a week no any symptoms or injuries on shoulder and neck Exclusion Criteria: Have a history of dislocation, fracture, or surgery of upper extremity A history of direct contact injury to the neck or upper extremities within the past 12 months A concussion within the past 12 months or a history of three or more concussions Brain injury and neurological impairment History of frequent headache or dizziness Contraindications to the use of transcranial magnetic stimulation (TMS), assessed with a safety screening questionnaire, including pregnancy, history of seizure, epilepsy and syncope, having cochlear implant, having medal implant and taking anti-depressant medication.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yin-Liang Lin, PhD
Organizational Affiliation
National Yang Ming University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Yang-Ming University
City
Taipei
ZIP/Postal Code
112
Country
Taiwan

12. IPD Sharing Statement

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The Effects of Short-term Scapular Control Training in Overhead Athletes With Shoulder Impingement Syndrome

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