xml: <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/NCT06006351</url>
    </required_header>
    <id_info>
      <org_study_id>Uskudar54</org_study_id>
      <nct_id>NCT06006351</nct_id>
    </id_info>
    <brief_title>Efficiency of Hypervolt Device Application in the Treatment of Shoulder Impingement Syndrome</brief_title>
    <official_title>Comparison of the Effects of Exercise and Hypervolt Device Application on Pain, Muscle Strength and Normal Joint Movement in the Treatment of Shoulder Impingement Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Uskudar University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Uskudar University</source>
    <oversight_info>
      <has_dmc>No</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 aim of this study is to compare the effects of exercise and Hypervolt Device on pain,&#xD;
        muscle strength and normal joint movement in the treatment of shoulder impingement syndrome.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study was planned as a randomized controlled trial. The study sample will be divided into&#xD;
        two groups by simple randomization method. Only exercise will be applied to 30 individuals&#xD;
        diagnosed with shoulder impingement in the first group of the study. In the second group, 30&#xD;
        individuals with shoulder impingement diagnosis will be given a Hypervolt Device in addition&#xD;
        to the exercise. Disabilities of the Arm, Shoulder and Hand Questionnaire, Visual Analog&#xD;
        Scale and Lawton Daily Living Activities Questionnaire will be applied to the participants&#xD;
        before and after the treatment. The obtained data will be analyzed statistically.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2023</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>Exercise therapy and Applying a Hypervolt massager</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Disabilities of the Arm, Shoulder and Hand Questionnaire</measure>
      <time_frame>12 weeks</time_frame>
      <description>It was developed to evaluate functional status and symptoms by focusing on physical function in upper extremity injuries. According to the results of the survey; a result from 0-100 is obtained from each part; 0-no apology 100-maximum apology.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Lawton Activities of Daily Living Scale</measure>
      <time_frame>12 weeks</time_frame>
      <description>It is a questionnaire consisting of eight questions, including information about using the telephone, preparing food, shopping, doing daily household chores, washing clothes, getting on a transportation vehicle, using medicines and managing money. If the individual does the activities independently, three points, two points if he does it with help, and one point if he cannot do it at all. In Lawton Activities of Daily Living Scale; 0-8 points are classified as &quot;dependent&quot;, 9-16 points as &quot;semi-dependent&quot;, 17-24 points as &quot;independent&quot;.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Shoulder Impingement</condition>
    <arm_group>
      <arm_group_label>control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>classical physiotherapy protocol will be applied.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Massage</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In addition to the classical physiotherapy protocol, a Hypervolt Device will be applied.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Physiotherapy</intervention_name>
      <description>manual therapy stretching exercises strengthening exercises electrotherapy applications</description>
      <arm_group_label>Massage</arm_group_label>
      <arm_group_label>control</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Hypervolt Device</intervention_name>
      <description>The painful area will be applied with a massage tool, and the frequency and mode of the tool will be adjusted in a way that does not disturb the patient.</description>
      <arm_group_label>Massage</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being between the ages of 18-50.&#xD;
  &#xD;
            -  Having a Visual Analogue Scale (VAS) value of 5 or higher.&#xD;
  &#xD;
            -  Having a history of shoulder pain for at least 1 month.&#xD;
  &#xD;
            -  Volunteer to participate in research.&#xD;
  &#xD;
            -  Having been diagnosed with Shoulder Impingement.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having cognitive, mental or psychological problems.&#xD;
  &#xD;
            -  Having a condition that prevents him from exercising.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tuba KARACA</last_name>
      <role>Study Chair</role>
      <affiliation>Uskudar University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>ömer şevgin</last_name>
      <phone>+90506 978 75 35</phone>
      <email>omer.sevgin@uskudar.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Uskudar university</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ömer Şevgin</last_name>
        <email>omer.sevgin@uskudar.edu.tr</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Consigliere P, Haddo O, Levy O, Sforza G. Subacromial impingement syndrome: management challenges. Orthop Res Rev. 2018 Oct 23;10:83-91. doi: 10.2147/ORR.S157864. eCollection 2018.</citation>
      <PMID>30774463</PMID>
    </reference>
    <reference>
      <citation>Ellenbecker TS, Cools A. Rehabilitation of shoulder impingement syndrome and rotator cuff injuries: an evidence-based review. Br J Sports Med. 2010 Apr;44(5):319-27. doi: 10.1136/bjsm.2009.058875.</citation>
      <PMID>20371557</PMID>
    </reference>
    <reference>
      <citation>Marik TL, Roll SC. Effectiveness of Occupational Therapy Interventions for Musculoskeletal Shoulder Conditions: A Systematic Review. Am J Occup Ther. 2017 Jan/Feb;71(1):7101180020p1-7101180020p11. doi: 10.5014/ajot.2017.023127.</citation>
      <PMID>28027039</PMID>
    </reference>
    <reference>
      <citation>Gebremariam L, Hay EM, van der Sande R, Rinkel WD, Koes BW, Huisstede BM. Subacromial impingement syndrome--effectiveness of physiotherapy and manual therapy. Br J Sports Med. 2014 Aug;48(16):1202-8. doi: 10.1136/bjsports-2012-091802. Epub 2013 Nov 11.</citation>
      <PMID>24217037</PMID>
    </reference>
    <reference>
      <citation>Steuri R, Sattelmayer M, Elsig S, Kolly C, Tal A, Taeymans J, Hilfiker R. Effectiveness of conservative interventions including exercise, manual therapy and medical management in adults with shoulder impingement: a systematic review and meta-analysis of RCTs. Br J Sports Med. 2017 Sep;51(18):1340-1347. doi: 10.1136/bjsports-2016-096515. Epub 2017 Jun 19.</citation>
      <PMID>28630217</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Uskudar University</investigator_affiliation>
      <investigator_full_name>Dr. Öğr. Üyesi Ömer Şevgin</investigator_full_name>
      <investigator_title>Asst.Prof.Dr.</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>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06006351
  org study id: Uskudar54
  nct id: NCT06006351
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to compare the effects of exercise and Hypervolt Device on pain,
        muscle strength and normal joint movement in the treatment of shoulder impingement syndrome.
  The study was planned as a randomized controlled trial. The study sample will be divided into
        two groups by simple randomization method. Only exercise will be applied to 30 individuals
        diagnosed with shoulder impingement in the first group of the study. In the second group, 30
        individuals with shoulder impingement diagnosis will be given a Hypervolt Device in addition
        to the exercise. Disabilities of the Arm, Shoulder and Hand Questionnaire, Visual Analog
        Scale and Lawton Daily Living Activities Questionnaire will be applied to the participants
        before and after the treatment. The obtained data will be analyzed statistically.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Exercise therapy and Applying a Hypervolt massager
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Disabilities of the Arm, Shoulder and Hand Questionnaire
  time frame: 12 weeks
  description: It was developed to evaluate functional status and symptoms by focusing on physical function in upper extremity injuries. According to the results of the survey; a result from 0-100 is obtained from each part; 0-no apology 100-maximum apology.
  measure: Lawton Activities of Daily Living Scale
  time frame: 12 weeks
  description: It is a questionnaire consisting of eight questions, including information about using the telephone, preparing food, shopping, doing daily household chores, washing clothes, getting on a transportation vehicle, using medicines and managing money. If the individual does the activities independently, three points, two points if he does it with help, and one point if he cannot do it at all. In Lawton Activities of Daily Living Scale; 0-8 points are classified as "dependent", 9-16 points as "semi-dependent", 17-24 points as "independent".
  arm group label: control
  arm group type: Active Comparator
  description: classical physiotherapy protocol will be applied.
  arm group label: Massage
  arm group type: Experimental
  description: In addition to the classical physiotherapy protocol, a Hypervolt Device will be applied.
  intervention type: Other
  intervention name: Physiotherapy
  description: manual therapy stretching exercises strengthening exercises electrotherapy applications
  arm group label: Massage
  arm group label: control
  intervention type: Other
  intervention name: Hypervolt Device
  description: The painful area will be applied with a massage tool, and the frequency and mode of the tool will be adjusted in a way that does not disturb the patient.
  arm group label: Massage
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: Tuba KARACA
  role: Study Chair
  affiliation: Uskudar University
  last name: ömer şevgin
  phone: +90506 978 75 35
  email: omer.sevgin@uskudar.edu.tr
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Consigliere P, Haddo O, Levy O, Sforza G. Subacromial impingement syndrome: management challenges. Orthop Res Rev. 2018 Oct 23;10:83-91. doi: 10.2147/ORR.S157864. eCollection 2018.
  PMID: 30774463
  citation: Ellenbecker TS, Cools A. Rehabilitation of shoulder impingement syndrome and rotator cuff injuries: an evidence-based review. Br J Sports Med. 2010 Apr;44(5):319-27. doi: 10.1136/bjsm.2009.058875.
  PMID: 20371557
  citation: Marik TL, Roll SC. Effectiveness of Occupational Therapy Interventions for Musculoskeletal Shoulder Conditions: A Systematic Review. Am J Occup Ther. 2017 Jan/Feb;71(1):7101180020p1-7101180020p11. doi: 10.5014/ajot.2017.023127.
  PMID: 28027039
  citation: Gebremariam L, Hay EM, van der Sande R, Rinkel WD, Koes BW, Huisstede BM. Subacromial impingement syndrome--effectiveness of physiotherapy and manual therapy. Br J Sports Med. 2014 Aug;48(16):1202-8. doi: 10.1136/bjsports-2012-091802. Epub 2013 Nov 11.
  PMID: 24217037
  citation: Steuri R, Sattelmayer M, Elsig S, Kolly C, Tal A, Taeymans J, Hilfiker R. Effectiveness of conservative interventions including exercise, manual therapy and medical management in adults with shoulder impingement: a systematic review and meta-analysis of RCTs. Br J Sports Med. 2017 Sep;51(18):1340-1347. doi: 10.1136/bjsports-2016-096515. Epub 2017 Jun 19.
  PMID: 28630217
  responsible party type: Principal Investigator
  investigator affiliation: Uskudar University
  investigator full name: Dr. Öğr. Üyesi Ömer Şevgin
  investigator title: Asst.Prof.Dr.
  mesh term: Shoulder Impingement Syndrome
  sharing ipd: No