<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04493190</url>
  </required_header>
  <id_info>
    <org_study_id>YM108159F</org_study_id>
    <nct_id>NCT04493190</nct_id>
  </id_info>
  <brief_title>The Effects of Short-term Scapular Control Training in Overhead Athletes With Shoulder Impingement Syndrome</brief_title>
  <official_title>The Effects of Short-term Scapular Control Training on Motor Control in Overhead Athletes With Shoulder Impingement Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Yang Ming University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Yang Ming University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Subacromial impingement syndrome (SIS) is a common disorder of shoulder joint. SIS has been&#xD;
      accounted for 44-65 % of all shoulder pain. It is believed that one important contributing&#xD;
      factor is scapular dyskinesis. Patients with SIS demonstrates scapular dyskinesis, including&#xD;
      decrease in upward rotation, scapular posterior tilt, and external rotation. Altered muscle&#xD;
      activity of scapular muscles may contribute to scapular dyskinesis, such as increase in&#xD;
      activity of upper trapezius, and decrease in activity of lower trapezius and serratus&#xD;
      anterior. In addition to these changes in neuromuscular control, central nervous system may&#xD;
      be re-organized in patients with musculoskeletal disorders. Evidence has been reported that&#xD;
      center of gravity of motor mapping changes, corticospinal excitability decreases and&#xD;
      inhibition increases in patients with shoulder injuries such as instability, rotator cuff&#xD;
      tendinopathy and SIS. These corticospinal changes are believed to be related to chronicity of&#xD;
      symptoms and lack of treatment effects.&#xD;
&#xD;
      Previous studies have applied many types of treatments to SIS, such as manipulation, taping,&#xD;
      and exercises. However, most studies mainly focused on the outcomes of pain and function, few&#xD;
      studies investigated changes in neuromuscular control following treatments. Yet, no study has&#xD;
      addressed how corticospinal system changes following treatment in patient with shoulder&#xD;
      injuries. Motor skill training, which has been widely used in training healthy subjects or&#xD;
      patients with neurological disorders, has been shown to change corticospinal systems,&#xD;
      including increasing excitability and decreasing inhibition. To our knowledge, no study has&#xD;
      integrated the concepts of motor skill learning into a short-term treatment or investigated&#xD;
      the effects of motor skill training on corticospinal systems in patients with SIS. The&#xD;
      purposes of the study are to investigate the effects of short-term motor skill training on&#xD;
      pain, neuromuscular control, corticospinal system in patients with SIS, and also to&#xD;
      investigate whether changes in corticospinal parameters will be related to changes in pain,&#xD;
      function and neuromuscular control.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2, 2020</start_date>
  <completion_date type="Actual">November 26, 2021</completion_date>
  <primary_completion_date type="Actual">August 26, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in neurophysiological measures - Active motor threshold</measure>
    <time_frame>Change from baseline AMT at 6 weeks</time_frame>
    <description>Active motor threshold (AMT) will be described with the percentage (%) of maximum stimulator output (MSO).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in neurophysiological measures - Motor evoked potential</measure>
    <time_frame>Change from baseline MEP at 6 weeks</time_frame>
    <description>Motor evoked potential (MEP) will be described with millivolt (mV) at different points and with different stimulus intensity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in neurophysiological measures - Cortical silent period</measure>
    <time_frame>Change from baseline CSP at 6 weeks</time_frame>
    <description>Cortical silent period (CSP) will be measured with millisecond (ms).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in neurophysiological measures - Short interval cortical inhibition and short interval cortical facilitation</measure>
    <time_frame>Change from baseline SICI and SICF at 6 weeks</time_frame>
    <description>Short interval cortical inhibition (SICI) and short interval cortical facilitation (SICF) will be defined as percentage (%) of conditioning responses vs testing responses</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in shoulder pain</measure>
    <time_frame>Change from baseline pain at 6 weeks</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in shoulder function</measure>
    <time_frame>Change from baseline function at 6 weeks and 3 months</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Long-term change in shoulder pain</measure>
    <time_frame>Change from baseline pain at 3 months</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Long-term change in shoulder function</measure>
    <time_frame>Change from baseline pain at 3 months</time_frame>
    <description>Function will be measured questionnaire, FLEX-SF. There are 15 questions on each</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Scapular kinematics</measure>
    <time_frame>Change from baseline scapular kinematics at 6 weeks</time_frame>
    <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 (°).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scapular muscle activation</measure>
    <time_frame>Change from baseline muscle activation at 6 weeks</time_frame>
    <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°</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Shoulder Impingement Syndrome</condition>
  <condition>Scapular Dyskinesis</condition>
  <arm_group>
    <arm_group_label>Scapular control training group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>General exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will receive a general strengthening exercise, focusing on the shoulder muscles. And the load will progressively increase weekly.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy subject group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Scapular control training</intervention_name>
    <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.</description>
    <arm_group_label>Scapular control training group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>General exercise</intervention_name>
    <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.</description>
    <arm_group_label>General exercise group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (patients with shoulder impingement) :&#xD;
&#xD;
          1. perform overhead exercise at least 4 hours a week&#xD;
&#xD;
          2. present type I or II scapular dyskinesis at rest or moving&#xD;
&#xD;
          3. pain at least two weeks&#xD;
&#xD;
          4. 3 of 6 impingement test present positive&#xD;
&#xD;
               -  Neer's impingement test: arm abduction overhead with shoulder internal rotation&#xD;
                  and thumb downward. If feel pain, then positive.&#xD;
&#xD;
               -  Hawkins-Kennedy impingement Test: arm lift to horizontal plane, elbow flexion to&#xD;
                  90 degree. Tester put force on forearm toward shoulder internal rotation. If feel&#xD;
                  pain, then positive.&#xD;
&#xD;
               -  Empty can test: shoulder abduction with thumb down, then give a resistive force&#xD;
                  toward up. If feel pain, then positive.&#xD;
&#xD;
               -  Resistive shoulder external rotation test: elbow flexion to 90 degrees and do&#xD;
                  resistive shoulder rotation. If feel pain, then positive.&#xD;
&#xD;
               -  Rotator cuff tenderness test: tester put pressure on rotator cuff. If feel pain,&#xD;
                  then positive.&#xD;
&#xD;
               -  Painful arc: perform arm elevation. If feel pain during movement, then positive.&#xD;
&#xD;
        Inclusion Criteria (healthy people) :&#xD;
&#xD;
          1. perform overhead exercise at least 4 hours a week&#xD;
&#xD;
          2. no any symptoms or injuries on shoulder and neck&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have a history of dislocation, fracture, or surgery of upper extremity&#xD;
&#xD;
          2. A history of direct contact injury to the neck or upper extremities within the past 12&#xD;
             months&#xD;
&#xD;
          3. A concussion within the past 12 months or a history of three or more concussions&#xD;
&#xD;
          4. Brain injury and neurological impairment&#xD;
&#xD;
          5. History of frequent headache or dizziness&#xD;
&#xD;
          6. Contraindications to the use of transcranial magnetic stimulation (TMS), assessed with&#xD;
             a safety screening questionnaire, including pregnancy, history of seizure, epilepsy&#xD;
             and syncope, having cochlear implant, having medal implant and taking anti-depressant&#xD;
             medication.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yin-Liang Lin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Yang Ming University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Yang-Ming University</name>
      <address>
        <city>Taipei</city>
        <zip>112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>April 5, 2022</last_update_submitted>
  <last_update_submitted_qc>April 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Yang Ming University</investigator_affiliation>
    <investigator_full_name>Yin-Liang Lin</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Corticospinal excitability</keyword>
  <keyword>Transcranial magnetic stimulation</keyword>
  <keyword>Motor control training</keyword>
  <keyword>Scapula-focused exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Impingement Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04493190
org study id: YM108159F
nct id: NCT04493190
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in neurophysiological measures - Active motor threshold
time frame: Change from baseline AMT at 6 weeks
description: Active motor threshold (AMT) will be described with the percentage (%) of maximum stimulator output (MSO).
measure: Change in neurophysiological measures - Motor evoked potential
time frame: Change from baseline MEP at 6 weeks
description: Motor evoked potential (MEP) will be described with millivolt (mV) at different points and with different stimulus intensity
measure: Change in neurophysiological measures - Cortical silent period
time frame: Change from baseline CSP at 6 weeks
description: Cortical silent period (CSP) will be measured with millisecond (ms).
measure: Change in neurophysiological measures - Short interval cortical inhibition and short interval cortical facilitation
time frame: Change from baseline SICI and SICF at 6 weeks
description: Short interval cortical inhibition (SICI) and short interval cortical facilitation (SICF) will be defined as percentage (%) of conditioning responses vs testing responses
measure: Change in shoulder pain
time frame: Change from baseline pain at 6 weeks
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.
measure: Change in shoulder function
time frame: Change from baseline function at 6 weeks and 3 months
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.
measure: Long-term change in shoulder pain
time frame: Change from baseline pain at 3 months
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.
measure: Long-term change in shoulder function
time frame: Change from baseline pain at 3 months
description: Function will be measured questionnaire, FLEX-SF. There are 15 questions on each
measure: Scapular kinematics
time frame: Change from baseline scapular kinematics at 6 weeks
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 (°).
measure: Scapular muscle activation
time frame: Change from baseline muscle activation at 6 weeks
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°
arm group label: Scapular control training group
arm group type: Experimental
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 group label: General exercise group
arm group type: Experimental
description: Participants in this group will receive a general strengthening exercise, focusing on the shoulder muscles. And the load will progressively increase weekly.
arm group label: Healthy subject group
arm group type: No Intervention
description: No intervention.
intervention type: Procedure
intervention name: Scapular control training
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.
arm group label: Scapular control training group
intervention type: Procedure
intervention name: General exercise
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.
arm group label: General exercise group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yin-Liang Lin, PhD
role: Principal Investigator
affiliation: National Yang Ming University
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Yang Ming University
investigator full name: Yin-Liang Lin
investigator title: Assistant Professor
mesh term: Shoulder Impingement Syndrome
mesh term: Syndrome
mesh term: Rotator Cuff Injuries