<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/NCT03246867</url>
  </required_header>
  <id_info>
    <org_study_id>3418-GOA</org_study_id>
    <nct_id>NCT03246867</nct_id>
  </id_info>
  <brief_title>The Acute Effects of Different Stretching Methods in Individuals With Subacromial Impingement Syndrome</brief_title>
  <official_title>The Acute Effects of Different Stretching Methods on Posterior Shoulder Tightness, Pain, Joint Range of Motion, Subacromial Space and Strength in Individuals Having Subacromial Impingement Syndrome With Glenohumeral Internal Rotation Deficit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dokuz Eylul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dokuz Eylul University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate and compare the acute effects of isolytic and&#xD;
      static stretching training in individuals having subacromial impingement syndrome with&#xD;
      glenohumeral internal rotation deficit. Isolytic group will receive isolytic stretching in&#xD;
      modified cross body position. Static group will receive static stretching in modified cross&#xD;
      body position. Stretching groups will be evaluated before and just after stretching exercise.&#xD;
      Control group will receive no stretching. Control group will be evaluated for the first time&#xD;
      and then will be waited until the duration of the stretching exercise program. Afterwards,&#xD;
      second evaluation will be performed&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is no information in literature about the acute effects of isolytic stretching exercise&#xD;
      in individuals having subacromial impingement syndrome with glenohumeral internal rotation&#xD;
      deficit. The purpose of this study is to investigate and compare the acute effects of&#xD;
      isolytic and static stretching training in individuals having subacromial impingement&#xD;
      syndrome with glenohumeral internal rotation deficit.&#xD;
&#xD;
      In modified cross body position, static stretching group will perform active-assistive static&#xD;
      stretching by the physiotherapist whereas isolytic stretching group will perform&#xD;
      active-assistive isolytic stretching. Stretching exercises will be applied five times each&#xD;
      for 15 seconds. After each stretching there will be a resting period for 5 seconds. Control&#xD;
      group will receive no stretching. They will be handed a brochure about the stretching&#xD;
      techniques and its role in injury prevention. Isolytic and static stretching groups will be&#xD;
      evaluated before and just after stretching exercise. Control group will be evaluated for the&#xD;
      first time and then will be passively waited until the duration of the stretching exercise&#xD;
      program (approximately 4-5 min). Afterwards, second evaluation will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 28, 2017</start_date>
  <completion_date type="Actual">January 2, 2020</completion_date>
  <primary_completion_date type="Actual">December 15, 2019</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>
    <intervention_model_description>There are 3 groups. First group will receive isolytic stretching in modified cross body position. Second group will receive static stretching in modified cross body position. The stretching exercise will be applied five times each for 15 seconds. After each stretching there will be a resting period for 5 seconds. Control group will receive no stretching. They will be handed a brochure about the stretching techniques and its role in injury prevention. Isolytic and static stretching groups will be evaluated before and just after stretching exercise. Control group will be evaluated for the first time and then will be passively waited until the duration of the stretching exercise program (approximately 4-5 min). Afterwards, second evaluation will be performed.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>All of participants must have subacromial impingement syndrome with glenohumeral internal rotation deficit.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Shoulder internal rotation range of motion</measure>
    <time_frame>Baseline and just after stretching exercise</time_frame>
    <description>Change of shoulder internal rotation range of motion (with bubble inclinometer)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Posterior shoulder tightness</measure>
    <time_frame>Baseline and just after stretching exercise</time_frame>
    <description>Change of posterior shoulder tightness (with bubble inclinometer)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentric strength</measure>
    <time_frame>Baseline and just after stretching exercise</time_frame>
    <description>Change of trapezius muscles, rotattor cuff muscles concentric strength (in kg, with hand held dynamometer)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eccentric strength</measure>
    <time_frame>Baseline and just after stretching exercise</time_frame>
    <description>Change of shoulder abduction and external rotation eccentric strength (in kg, with hand held dynamometer)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subacromial space</measure>
    <time_frame>Baseline and just after stretching exercise</time_frame>
    <description>Change of subacromial space ( with Ultrasound)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>Baseline and just after stretching exercise</time_frame>
    <description>Change of visual analog scale score in activity and rest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shoulder external rotation range of motion</measure>
    <time_frame>Baseline and just after stretching exercise</time_frame>
    <description>Change of shoulder external rotation range of motion (with bubble inclinometer)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Subacromial Impingement Syndrome</condition>
  <condition>Glenohumeral Internal Rotation Deficit</condition>
  <arm_group>
    <arm_group_label>Isolytic stretching group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants in this group will receive isolytic stretching in modified cross body position.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Static stretching group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants in this group will receive static stretching in modified cross body position.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The participants in this group will receive no stretching. They will only be evaluated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Isolytic stretching group</intervention_name>
    <description>In modified cross body position, isolytic stretching exercises will perform five times each for 15 seconds. After each stretching patient will rest for 5 seconds. When the patient contracts the agonist muscle group with 20% muscle force, the agonist muscle group is stretched at the same time for 2-4 seconds. Afterwards active-assistive stretching is done. Evaluations will be done before and just after stretching exercise.</description>
    <arm_group_label>Isolytic stretching group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Static stretching group</intervention_name>
    <description>In modified cross body position, active-assistive static stretching exercises will be performed 5 times each for 15 seconds. This stretching exercise is performed 5 times with 5 seconds intervals. Evaluations will be done before and just after stretching exercise.</description>
    <arm_group_label>Static stretching group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>Control group will receive no stretching. They will be handed a brochure about the stretching techniques and its role in injury prevention. Control group will be evaluated for the first time and then will be passively waited until the duration of the stretching exercise program (approximately 4-5 min). Afterwards, second evaluation will be performed.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of subacromial impingement syndrome&#xD;
&#xD;
          -  Glenohumeral internal rotation range of motion of the affected shoulder should be less&#xD;
             than other shoulder and bilateral shoulder internal rotation range of motion&#xD;
             difference should be ≥15 º&#xD;
&#xD;
          -  Pain with resisted arm elevation or external rotation as well as a minimum of 3 of 5&#xD;
             positive subacromial impingement syndrome tests, painful arc, pain or weakness with&#xD;
             resisted external rotation, Neer, Hawkins and Jobe tests .&#xD;
&#xD;
          -  Ability to complete the entire study procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  An inability to elevate the involved arm greater than 140 degree in the scapular plane&#xD;
&#xD;
          -  A 50% limitation of passive shoulder range of motion in &gt;2 planes of motion&#xD;
&#xD;
          -  Pain &gt;7/10&#xD;
&#xD;
          -  A history of fracture to the shoulder girdle&#xD;
&#xD;
          -  Systemic musculoskeletal disease&#xD;
&#xD;
          -  History of shoulder surgery,&#xD;
&#xD;
          -  Glenohumeral instability (positive apprehension, relocation or positive sulcus test)&#xD;
             or positive findings for a full thickness rotator cuff tear (positive lag sign,&#xD;
             positive drop arm test or marked weakness with shoulder external rotation)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sevgi Sevi YESILYAPRAK, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Dokuz Eylul University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Damla GULPINAR, MS</last_name>
    <role>Study Director</role>
    <affiliation>Izmir Katip Celebi University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mehmet ERDURAN, MD</last_name>
    <role>Study Director</role>
    <affiliation>Dokuz Eylul University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cem OZCAN, MD</last_name>
    <role>Study Director</role>
    <affiliation>Izmır Katip Celebi University Atatürk Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dokuz Eylül University</name>
      <address>
        <city>İzmir</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>February 20, 2020</last_update_submitted>
  <last_update_submitted_qc>February 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dokuz Eylul University</investigator_affiliation>
    <investigator_full_name>Halime Ezgi TÜRKSAN</investigator_full_name>
    <investigator_title>Research Assistant</investigator_title>
  </responsible_party>
  <keyword>isolytic stretching</keyword>
  <keyword>static stretching</keyword>
  <keyword>Glenohumeral Internal Rotation Deficit</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/NCT03246867
org study id: 3418-GOA
nct id: NCT03246867
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate and compare the acute effects of isolytic and
      static stretching training in individuals having subacromial impingement syndrome with
      glenohumeral internal rotation deficit. Isolytic group will receive isolytic stretching in
      modified cross body position. Static group will receive static stretching in modified cross
      body position. Stretching groups will be evaluated before and just after stretching exercise.
      Control group will receive no stretching. Control group will be evaluated for the first time
      and then will be waited until the duration of the stretching exercise program. Afterwards,
      second evaluation will be performed
There is no information in literature about the acute effects of isolytic stretching exercise
      in individuals having subacromial impingement syndrome with glenohumeral internal rotation
      deficit. The purpose of this study is to investigate and compare the acute effects of
      isolytic and static stretching training in individuals having subacromial impingement
      syndrome with glenohumeral internal rotation deficit.

      In modified cross body position, static stretching group will perform active-assistive static
      stretching by the physiotherapist whereas isolytic stretching group will perform
      active-assistive isolytic stretching. Stretching exercises will be applied five times each
      for 15 seconds. After each stretching there will be a resting period for 5 seconds. Control
      group will receive no stretching. They will be handed a brochure about the stretching
      techniques and its role in injury prevention. Isolytic and static stretching groups will be
      evaluated before and just after stretching exercise. Control group will be evaluated for the
      first time and then will be passively waited until the duration of the stretching exercise
      program (approximately 4-5 min). Afterwards, second evaluation will be performed.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: There are 3 groups. First group will receive isolytic stretching in modified cross body position. Second group will receive static stretching in modified cross body position. The stretching exercise will be applied five times each for 15 seconds. After each stretching there will be a resting period for 5 seconds. Control group will receive no stretching. They will be handed a brochure about the stretching techniques and its role in injury prevention. Isolytic and static stretching groups will be evaluated before and just after stretching exercise. Control group will be evaluated for the first time and then will be passively waited until the duration of the stretching exercise program (approximately 4-5 min). Afterwards, second evaluation will be performed.
primary purpose: Treatment
masking: Single (Participant)
masking description: All of participants must have subacromial impingement syndrome with glenohumeral internal rotation deficit.
measure: Shoulder internal rotation range of motion
time frame: Baseline and just after stretching exercise
description: Change of shoulder internal rotation range of motion (with bubble inclinometer)
measure: Posterior shoulder tightness
time frame: Baseline and just after stretching exercise
description: Change of posterior shoulder tightness (with bubble inclinometer)
measure: Concentric strength
time frame: Baseline and just after stretching exercise
description: Change of trapezius muscles, rotattor cuff muscles concentric strength (in kg, with hand held dynamometer)
measure: Eccentric strength
time frame: Baseline and just after stretching exercise
description: Change of shoulder abduction and external rotation eccentric strength (in kg, with hand held dynamometer)
measure: Subacromial space
time frame: Baseline and just after stretching exercise
description: Change of subacromial space ( with Ultrasound)
measure: Pain
time frame: Baseline and just after stretching exercise
description: Change of visual analog scale score in activity and rest
measure: Shoulder external rotation range of motion
time frame: Baseline and just after stretching exercise
description: Change of shoulder external rotation range of motion (with bubble inclinometer)
arm group label: Isolytic stretching group
arm group type: Experimental
description: The participants in this group will receive isolytic stretching in modified cross body position.
arm group label: Static stretching group
arm group type: Experimental
description: The participants in this group will receive static stretching in modified cross body position.
arm group label: Control group
arm group type: Active Comparator
description: The participants in this group will receive no stretching. They will only be evaluated.
intervention type: Other
intervention name: Isolytic stretching group
description: In modified cross body position, isolytic stretching exercises will perform five times each for 15 seconds. After each stretching patient will rest for 5 seconds. When the patient contracts the agonist muscle group with 20% muscle force, the agonist muscle group is stretched at the same time for 2-4 seconds. Afterwards active-assistive stretching is done. Evaluations will be done before and just after stretching exercise.
arm group label: Isolytic stretching group
intervention type: Other
intervention name: Static stretching group
description: In modified cross body position, active-assistive static stretching exercises will be performed 5 times each for 15 seconds. This stretching exercise is performed 5 times with 5 seconds intervals. Evaluations will be done before and just after stretching exercise.
arm group label: Static stretching group
intervention type: Other
intervention name: Control group
description: Control group will receive no stretching. They will be handed a brochure about the stretching techniques and its role in injury prevention. Control group will be evaluated for the first time and then will be passively waited until the duration of the stretching exercise program (approximately 4-5 min). Afterwards, second evaluation will be performed.
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sevgi Sevi YESILYAPRAK, PhD
role: Study Director
affiliation: Dokuz Eylul University
last name: Damla GULPINAR, MS
role: Study Director
affiliation: Izmir Katip Celebi University
last name: Mehmet ERDURAN, MD
role: Study Director
affiliation: Dokuz Eylul University
last name: Cem OZCAN, MD
role: Study Director
affiliation: Izmır Katip Celebi University Atatürk Training and Research Hospital
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Dokuz Eylul University
investigator full name: Halime Ezgi TÜRKSAN
investigator title: Research Assistant
mesh term: Shoulder Impingement Syndrome
mesh term: Syndrome
mesh term: Rotator Cuff Injuries