<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/NCT03246698</url>
  </required_header>
  <id_info>
    <org_study_id>3413-GOA</org_study_id>
    <nct_id>NCT03246698</nct_id>
  </id_info>
  <brief_title>The Effect of Isolytic and Static Stretching Training in Individuals With Subacromial Impingement Syndrome</brief_title>
  <official_title>The Effect of Isolytic and Static Stretching Training 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 effect of isolytic and static&#xD;
      stretching training in individuals having subacromial impingement syndrome with glenohumeral&#xD;
      internal rotation deficit. Isolytic group will receive isolytic stretching in modified cross&#xD;
      body stretching position and standard physiotherapy program. Static group will receive static&#xD;
      stretching in modified cross body stretching position and standard physiotherapy program.&#xD;
      Control group will receive only standard physiotherapy program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The effectiveness of static stretching on various parameters such as range of motion or pain&#xD;
      is studied and proved in literature. Static stretching in cross body position was also found&#xD;
      helpful for improving shoulder range of motion with some disadvantages. In modified cross&#xD;
      body position, the patient is positioned in a more advantageous way for him/her. Usually this&#xD;
      stretching is done as active-assistive static stretching with the physiotherapist. Proof is&#xD;
      still needed for the effectiveness of active-assistive static stretching in modified cross&#xD;
      body position. Furthermore, there is no research about the effect of isolytic stretching&#xD;
      which is relatively new technique compare to static stretches in subacromial impingement&#xD;
      syndrome. In isolytic stretching, when the patient contracts the agonist muscle group with&#xD;
      20% muscle force active-assistive streching in agonist muscle group by the physiotherapist at&#xD;
      the same time is done for 2-4 seconds. A fast isolytic stretching is applied in order to&#xD;
      break the fibrous tissue. Our purpose is to investigate and compare the effect of isolytic&#xD;
      and static stretching training in individuals having subacromial impingement syndrome with&#xD;
      glenohumeral internal rotation deficit . Stretching groups will receive either isolytic or&#xD;
      static stretching in modified cross body stretching position and standard physiotherapy&#xD;
      program. There is a control group. Control group will receive only standard physiotherapy&#xD;
      program. Standard physiotherapy program includes TENS, hotpack, posture and strengthening&#xD;
      training program. Treatment program will last four times a week (4-4-4-3) for four weeks, 15&#xD;
      sessions in total.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 28, 2017</start_date>
  <completion_date type="Actual">July 20, 2019</completion_date>
  <primary_completion_date type="Actual">June 20, 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 stretching position and standard physiotherapy program. Second group will receive static stretching in modified cross body stretching position and standard physiotherapy program. Control group will receive only standard physiotherapy program. In standard physiotherapy program, there are TENS, hotpack, posture and strengthening training program. Treatment program will last four weeks.</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 4 weeks</time_frame>
    <description>Change of shoulder internal rotation range of motion (with bubble inclinometer)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glenohumeral internal rotation deficit</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Change of difference in shoulder internal rotation range of motion between the affected and non-affected shoulder (with bubble inclinometer)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Posterior shoulder tightness</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Change of posterior shoulder tightness (with bubble inclinometer)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shoulder external rotation range of motion</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Change of shoulder external rotation range of motion (with bubble inclinometer)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shoulder total rotational range of motion</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Change of shoulder total rotational range of motion (Sum of the internal and external rotation motion)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resting and activitiy pain in shoulder</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Change of visual analog scale score in activity and rest pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subacromial space</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Change of subacromial space at arm resting at the side (0°), and at 60° of scapular plane elevation (with Ultrasound)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Supraspinatus tendon thickness</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Change of supraspinatus tendon thickness (with Ultrasound)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentric strength</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Change of rotattor cuff muscles concentric strength (in kg, with hand held dynamometer)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eccentric strength</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Change of shoulder abduction eccentric strength (in kg, with hand held dynamometer)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shoulder Function</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Change of Modified Constant-Murley Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upper extremity function</measure>
    <time_frame>Baseline and 4 weeks</time_frame>
    <description>Change of disabilities of the arm, shoulder, and hand (Quick-DASH) score</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Subacromial Impingement Syndrome</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. Additionally they will receive standard physiotherapy.</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.&#xD;
Additionally they will receive standard physiotherapy.</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 only standard physiotherapy.</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. Isolytic stretching exercises will perform four times a week for four weeks. It's obligatory to receive at least 15 sessions in total. They will also receive standard physiotherapy program four times a week for four week, 15 sessions in total.</description>
    <arm_group_label>Isolytic stretching group</arm_group_label>
    <other_name>Standard physiotherapy</other_name>
  </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. Static stretching exercises will perform four times a week for four weeks. It's obligatory to receive at least 15 sessions in total. They will also receive standard physiotherapy program four times a week for four week, 15 sessions in total.</description>
    <arm_group_label>Static stretching group</arm_group_label>
    <other_name>Standard physiotherapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>They will receive only standard physiotherapy program, four times a week for four weeks, 15 sessions in total.</description>
    <arm_group_label>Control group</arm_group_label>
    <other_name>Standard physiotherapy</other_name>
  </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;
          -  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 and cervical 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;
&#xD;
          -  Neck and shoulder pain with active/passive cervical spine movement&#xD;
&#xD;
          -  A diagnosis of chest deformity or scoliosis&#xD;
&#xD;
          -  Regularly performing posterior shoulder stretching exercises&#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>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>
        <state>Balçova</state>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2022</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>July 14, 2022</last_update_submitted>
  <last_update_submitted_qc>July 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2022</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>Shoulder pain</keyword>
  <keyword>Physical therapy</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>Ultrasonography</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03246698
org study id: 3413-GOA
nct id: NCT03246698
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 effect 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 stretching position and standard physiotherapy program. Static group will receive static
      stretching in modified cross body stretching position and standard physiotherapy program.
      Control group will receive only standard physiotherapy program.
The effectiveness of static stretching on various parameters such as range of motion or pain
      is studied and proved in literature. Static stretching in cross body position was also found
      helpful for improving shoulder range of motion with some disadvantages. In modified cross
      body position, the patient is positioned in a more advantageous way for him/her. Usually this
      stretching is done as active-assistive static stretching with the physiotherapist. Proof is
      still needed for the effectiveness of active-assistive static stretching in modified cross
      body position. Furthermore, there is no research about the effect of isolytic stretching
      which is relatively new technique compare to static stretches in subacromial impingement
      syndrome. In isolytic stretching, when the patient contracts the agonist muscle group with
      20% muscle force active-assistive streching in agonist muscle group by the physiotherapist at
      the same time is done for 2-4 seconds. A fast isolytic stretching is applied in order to
      break the fibrous tissue. Our purpose is to investigate and compare the effect of isolytic
      and static stretching training in individuals having subacromial impingement syndrome with
      glenohumeral internal rotation deficit . Stretching groups will receive either isolytic or
      static stretching in modified cross body stretching position and standard physiotherapy
      program. There is a control group. Control group will receive only standard physiotherapy
      program. Standard physiotherapy program includes TENS, hotpack, posture and strengthening
      training program. Treatment program will last four times a week (4-4-4-3) for four weeks, 15
      sessions in total.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: There are 3 groups. First group will receive isolytic stretching in modified cross body stretching position and standard physiotherapy program. Second group will receive static stretching in modified cross body stretching position and standard physiotherapy program. Control group will receive only standard physiotherapy program. In standard physiotherapy program, there are TENS, hotpack, posture and strengthening training program. Treatment program will last four weeks.
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 4 weeks
description: Change of shoulder internal rotation range of motion (with bubble inclinometer)
measure: Glenohumeral internal rotation deficit
time frame: Baseline and 4 weeks
description: Change of difference in shoulder internal rotation range of motion between the affected and non-affected shoulder (with bubble inclinometer)
measure: Posterior shoulder tightness
time frame: Baseline and 4 weeks
description: Change of posterior shoulder tightness (with bubble inclinometer)
measure: Shoulder external rotation range of motion
time frame: Baseline and 4 weeks
description: Change of shoulder external rotation range of motion (with bubble inclinometer)
measure: Shoulder total rotational range of motion
time frame: Baseline and 4 weeks
description: Change of shoulder total rotational range of motion (Sum of the internal and external rotation motion)
measure: Resting and activitiy pain in shoulder
time frame: Baseline and 4 weeks
description: Change of visual analog scale score in activity and rest pain
measure: Subacromial space
time frame: Baseline and 4 weeks
description: Change of subacromial space at arm resting at the side (0°), and at 60° of scapular plane elevation (with Ultrasound)
measure: Supraspinatus tendon thickness
time frame: Baseline and 4 weeks
description: Change of supraspinatus tendon thickness (with Ultrasound)
measure: Concentric strength
time frame: Baseline and 4 weeks
description: Change of rotattor cuff muscles concentric strength (in kg, with hand held dynamometer)
measure: Eccentric strength
time frame: Baseline and 4 weeks
description: Change of shoulder abduction eccentric strength (in kg, with hand held dynamometer)
measure: Shoulder Function
time frame: Baseline and 4 weeks
description: Change of Modified Constant-Murley Score
measure: Upper extremity function
time frame: Baseline and 4 weeks
description: Change of disabilities of the arm, shoulder, and hand (Quick-DASH) score
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. Additionally they will receive standard physiotherapy.
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.
Additionally they will receive standard physiotherapy.
arm group label: Control group
arm group type: Active Comparator
description: The participants in this group will receive only standard physiotherapy.
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. Isolytic stretching exercises will perform four times a week for four weeks. It's obligatory to receive at least 15 sessions in total. They will also receive standard physiotherapy program four times a week for four week, 15 sessions in total.
arm group label: Isolytic stretching group
other name: Standard physiotherapy
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. Static stretching exercises will perform four times a week for four weeks. It's obligatory to receive at least 15 sessions in total. They will also receive standard physiotherapy program four times a week for four week, 15 sessions in total.
arm group label: Static stretching group
other name: Standard physiotherapy
intervention type: Other
intervention name: Control group
description: They will receive only standard physiotherapy program, four times a week for four weeks, 15 sessions in total.
arm group label: Control group
other name: Standard physiotherapy
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: 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
sharing ipd: No