<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/NCT04434183</url>
  </required_header>
  <id_info>
    <org_study_id>851</org_study_id>
    <nct_id>NCT04434183</nct_id>
  </id_info>
  <brief_title>Comparison of the Effects of Home Exercise and Isokinetic Exercise Program in Subacromial Impingement Syndrome Patients</brief_title>
  <official_title>Comparison of the Effects of Home Exercise Program and Isokinetic Exercise Program on Pain, Muscle Strength, Functionality, Sense of Proprioception and Quality of Life in Subacromial Impingement Syndrome Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate and compare the effects of home exercise program and&#xD;
      isokinetic exercise program on pain, muscle strength, functionality, proprioception sensation&#xD;
      and quality of life in patients with subacromial impingement syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study was designed prospectively. A total of 50 patients with subacromial impingement&#xD;
      syndrome according to clinical and MRI findings with shoulder pain for at least 3 months were&#xD;
      included in the study. Patients were randomly divided into two groups. The first group&#xD;
      (isokinetic exercise group, n = 25) was given isokinetic exercise. The second group(home&#xD;
      exercise group, n=25) was given home exercise program. Patients were evaluated before and&#xD;
      after treatment and 3 months after the end of treatment. In the evaluation, VAS, Shoulder&#xD;
      Pain and Disability Index, Constant Murley Scoring, Shoulder Disability Questionnaire, Health&#xD;
      Assessment Questionnaire, Pittsburgh Sleep Quality Index, Humic Norm II isokinetic device&#xD;
      were used. At statistically evaluation of data Student T Test and Mann Whitney U tests were&#xD;
      used. In qualitative datas comparison Ki-Kare Test was used. Significance was evaluated at&#xD;
      the level of p&amp;lt; 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 30, 2018</start_date>
  <completion_date type="Actual">November 30, 2018</completion_date>
  <primary_completion_date type="Actual">November 30, 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of shoulder examination findings</measure>
    <time_frame>3 months</time_frame>
    <description>The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment shoulder examination findings. The investigators used to painful arc test consisting of 13 questions that scored from zero to ten.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of shoulder functions</measure>
    <time_frame>3 months</time_frame>
    <description>The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment shoulder functions and muscle strenght. The investigators used to Constant-Murley functional evaluate scale consisting of four parameters that scored from zero to one hundered.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of muscle strenght</measure>
    <time_frame>3 months</time_frame>
    <description>The investigators evaluated it with isokinetic cybex dynamometer. The isokinetic cybex dynamometer assessments using newton-meter for muscle strenght and angle degree for velocity measurements.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of quality of life</measure>
    <time_frame>3 months</time_frame>
    <description>The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment quality of life values with Pittsburg sleep quality index. The Pittsburg sleep quality index consisting of 23 questions that scored from zero to three.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of sense of proprioseption</measure>
    <time_frame>3 months</time_frame>
    <description>The investigators evaluated it with isokinetic cybex dynamometer. The isokinetic cybex dynamometer assessments using angle degree for sense of position.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of shoulder pain</measure>
    <time_frame>3 months</time_frame>
    <description>The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment for shoulder pain. The investigators used to visual analog score for pain that scored from zero to ten.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of shoulder disability</measure>
    <time_frame>3 months</time_frame>
    <description>The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment for shoulder disability. The investigators used to shoulder disability questionnare consisting of 16 questions that scored yes or no. Calculation; score = [Yes counts / (Yes counts + No counts)]x100. The score seems, zero point is maximal fine health and 100 points (maximal point) is poor health.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of physical health situation</measure>
    <time_frame>3 months</time_frame>
    <description>The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment for physical health situation. The investigators used to health evaluated inventory. The inventroy consisting of 20 questions that scored from zero to three per question. Zero point is maximal fine health and 60 points are maximal poor health.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Home Exercise</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>isokinetic exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The group (isokinetic exercise group, n = 25) was given isokinetic exercise.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>home exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The group(home exercise group, n=25) was given home exercise program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Exercises of rehabilitation</intervention_name>
    <description>Compare and evaluate of the effects of the routin physical medicine and rehabilitation programs in impingement patients</description>
    <arm_group_label>home exercise</arm_group_label>
    <arm_group_label>isokinetic exercise</arm_group_label>
    <other_name>Isokinetic cybex dynamometer</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Shoulder pain and functional disability at least 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Instability of shoulder, Stage 2-3 adhesive capsulitis, tendinitis or bursitis,&#xD;
             cervical radiculopathy, underwent surgery, norological diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>OMER KURU, FULL PROF</last_name>
    <role>Study Chair</role>
    <affiliation>Prof. Dr. Cemil Tascıoglu City Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Prof Dr Cemil Tascioglu City Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34384</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/14578662/</url>
    <description>Subacromial Impingement Syndrome: Pathogenesis, Clinical Features, and Examination Methods</description>
  </link>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/18509791/?from_single_result=Campbell+RS%2C+Dunn+A%3A+External+impingement+of+the+shoulder.</url>
    <description>External Impingement of the Shoulder</description>
  </link>
  <results_reference>
    <citation>Akman S, Kucukkaya M. [Subacromial impingement syndrome: pathogenesis, clinical features, and examination methods]. Acta Orthop Traumatol Turc. 2003;37 Suppl 1:27-34. Turkish.</citation>
    <PMID>14578662</PMID>
  </results_reference>
  <results_reference>
    <citation>Campbell RS, Dunn A. External impingement of the shoulder. Semin Musculoskelet Radiol. 2008 Jun;12(2):107-26. doi: 10.1055/s-2008-1078699.</citation>
    <PMID>18509791</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization</investigator_affiliation>
    <investigator_full_name>Sevgi Atar</investigator_full_name>
    <investigator_title>Administrative Director of PMR Clinic</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Impingement Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>December 26, 2020</submitted>
    <returned>January 19, 2021</returned>
  </pending_results>
  <!-- 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/NCT04434183
org study id: 851
nct id: NCT04434183
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The aim of this study is to evaluate and compare the effects of home exercise program and
      isokinetic exercise program on pain, muscle strength, functionality, proprioception sensation
      and quality of life in patients with subacromial impingement syndrome.
The study was designed prospectively. A total of 50 patients with subacromial impingement
      syndrome according to clinical and MRI findings with shoulder pain for at least 3 months were
      included in the study. Patients were randomly divided into two groups. The first group
      (isokinetic exercise group, n = 25) was given isokinetic exercise. The second group(home
      exercise group, n=25) was given home exercise program. Patients were evaluated before and
      after treatment and 3 months after the end of treatment. In the evaluation, VAS, Shoulder
      Pain and Disability Index, Constant Murley Scoring, Shoulder Disability Questionnaire, Health
      Assessment Questionnaire, Pittsburgh Sleep Quality Index, Humic Norm II isokinetic device
      were used. At statistically evaluation of data Student T Test and Mann Whitney U tests were
      used. In qualitative datas comparison Ki-Kare Test was used. Significance was evaluated at
      the level of p&lt; 0.05.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Assessment of shoulder examination findings
time frame: 3 months
description: The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment shoulder examination findings. The investigators used to painful arc test consisting of 13 questions that scored from zero to ten.
measure: Assessment of shoulder functions
time frame: 3 months
description: The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment shoulder functions and muscle strenght. The investigators used to Constant-Murley functional evaluate scale consisting of four parameters that scored from zero to one hundered.
measure: Assessment of muscle strenght
time frame: 3 months
description: The investigators evaluated it with isokinetic cybex dynamometer. The isokinetic cybex dynamometer assessments using newton-meter for muscle strenght and angle degree for velocity measurements.
measure: Assessment of quality of life
time frame: 3 months
description: The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment quality of life values with Pittsburg sleep quality index. The Pittsburg sleep quality index consisting of 23 questions that scored from zero to three.
measure: Assessment of sense of proprioseption
time frame: 3 months
description: The investigators evaluated it with isokinetic cybex dynamometer. The isokinetic cybex dynamometer assessments using angle degree for sense of position.
measure: Assessment of shoulder pain
time frame: 3 months
description: The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment for shoulder pain. The investigators used to visual analog score for pain that scored from zero to ten.
measure: Assessment of shoulder disability
time frame: 3 months
description: The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment for shoulder disability. The investigators used to shoulder disability questionnare consisting of 16 questions that scored yes or no. Calculation; score = [Yes counts / (Yes counts + No counts)]x100. The score seems, zero point is maximal fine health and 100 points (maximal point) is poor health.
measure: Assessment of physical health situation
time frame: 3 months
description: The investigators evaluated to pre-treatment, intermediate post-treatment, and late post-treatment for physical health situation. The investigators used to health evaluated inventory. The inventroy consisting of 20 questions that scored from zero to three per question. Zero point is maximal fine health and 60 points are maximal poor health.
arm group label: isokinetic exercise
arm group type: Active Comparator
description: The group (isokinetic exercise group, n = 25) was given isokinetic exercise.
arm group label: home exercise
arm group type: Active Comparator
description: The group(home exercise group, n=25) was given home exercise program.
intervention type: Device
intervention name: Exercises of rehabilitation
description: Compare and evaluate of the effects of the routin physical medicine and rehabilitation programs in impingement patients
arm group label: home exercise
arm group label: isokinetic exercise
other name: Isokinetic cybex dynamometer
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: OMER KURU, FULL PROF
role: Study Chair
affiliation: Prof. Dr. Cemil Tascıoglu City Hospital
facility: 
country: Turkey
url: https://pubmed.ncbi.nlm.nih.gov/14578662/
description: Subacromial Impingement Syndrome: Pathogenesis, Clinical Features, and Examination Methods
url: https://pubmed.ncbi.nlm.nih.gov/18509791/?from_single_result=Campbell+RS%2C+Dunn+A%3A+External+impingement+of+the+shoulder.
description: External Impingement of the Shoulder
citation: Akman S, Kucukkaya M. [Subacromial impingement syndrome: pathogenesis, clinical features, and examination methods]. Acta Orthop Traumatol Turc. 2003;37 Suppl 1:27-34. Turkish.
PMID: 14578662
citation: Campbell RS, Dunn A. External impingement of the shoulder. Semin Musculoskelet Radiol. 2008 Jun;12(2):107-26. doi: 10.1055/s-2008-1078699.
PMID: 18509791
responsible party type: Principal Investigator
investigator affiliation: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
investigator full name: Sevgi Atar
investigator title: Administrative Director of PMR Clinic
mesh term: Shoulder Impingement Syndrome
sharing ipd: No
submitted: December 26, 2020
returned: January 19, 2021