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/NCT06010394</url>
    </required_header>
    <id_info>
      <org_study_id>Uskudar50</org_study_id>
      <nct_id>NCT06010394</nct_id>
    </id_info>
    <brief_title>Control of Edema in the Knee in Patients With Knee Osteoarthritis</brief_title>
    <official_title>Comparison of the Effectiveness of Exercise and Classical Massage in the Control of Edema in the Knee in Patients With Knee Osteoarthritis.</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 was to compare the effectiveness of exercise and classical massage in&#xD;
        the control of knee edema in patients with knee osteoarthritis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will be a prospective randomized controlled study. It is planned to include 75&#xD;
        patients with knee osteoarthritis in this study. It was categorized as osteoarthritis(OA)&#xD;
        stages according to Kellgren-Lawrence criteria. Patients were randomly divided into three&#xD;
        groups. the investigators first group is the control group (KG) and this group will receive&#xD;
        classical physical therapy with ultrasound and subcutaneous electrical nerve stimulation.&#xD;
        Exercise therapy will be applied to the second group in addition to the classical physical&#xD;
        therapy applied to the KG. The third group will be given classical massage in addition to the&#xD;
        classical physical therapy applied to the KG. The treatments to be applied to the patients&#xD;
        will be 3 sessions per week and it is planned to continue for 4 weeks. Knee edema, pain&#xD;
        severity, functional status and daily life activities will be measured at the beginning and&#xD;
        in the 4th week of the patients. The data obtained 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">November 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 15, 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>classical physical therapy, exercise therapy, classical massage</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Knee Injury and Osteoarthritis Outcome Score</measure>
      <time_frame>4 weeks</time_frame>
      <description>It is used to detect symptoms and restrictions in current work that individuals do in daily life. The test is collected under 2 main headings, consisting of 6 questions about the effect of symptoms and 8 sub-activities that question the status of the activity. The answer to each question in the test is scored between 0-5. The scores that the person gets from each question are added together and these scores are divided by 70 and multiplied by 100. High score means low quality of life.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Western Ontario and McMaster Universities Osteoarthritis Index</measure>
      <time_frame>4 weeks</time_frame>
      <description>Pain, joint stiffness and functional status; Evaluated with the Arthritis Index of Western Ontario and McMaster Universities. The scale is a disease-specific, multidimensional, self-administered health status tool used in hip or knee osteoarthritis27. It consists of 24 questions on pain, stiffness and physical disability and is approximately 10 min. can be completed in Western Ontario and McMaster Universities Osteoarthritis Index consists of 24 questions under three sub-headings. Pain consists of 5 questions, stiffness 2 questions and function 17 questions. Each sub-parameter is scored between 0-4 points. Accordingly, it is classified as pain (0-20), stiffness (0-8) and function (0-68). A high score indicates poor health, a low score indicates good health.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">75</enrollment>
    <condition>Knee Osteoarthritis</condition>
    <condition>Edema</condition>
    <condition>Edema Leg</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>commensal physiotherapy will be applied</description>
    </arm_group>
    <arm_group>
      <arm_group_label>exercise group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>exercises will be given</description>
    </arm_group>
    <arm_group>
      <arm_group_label>massage group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>massage will be done</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>conventional physiotherapy</intervention_name>
      <description>ultrasound electrotherapy cold applications</description>
      <arm_group_label>control group</arm_group_label>
      <arm_group_label>exercise group</arm_group_label>
      <arm_group_label>massage group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>exercises for the knee area</intervention_name>
      <description>range of motion exercises strengthening exercises exercises to reduce edema</description>
      <arm_group_label>exercise group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>payment oriented massage</intervention_name>
      <description>10 / 15-minute massage treatments to reduce payment</description>
      <arm_group_label>massage group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being between the ages of 30-65&#xD;
  &#xD;
            -  Patients with a diagnosis of osteoarthritis in stage 2 and stage 3 according to&#xD;
               Kellgren-Lawrence criteria(1) and also with measurable edema&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inability to continue treatment regularly&#xD;
  &#xD;
            -  situations that prevent you from doing the exercise&#xD;
  &#xD;
            -  inflammation that interferes with massage.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Enver Deniz YILDIRIM</last_name>
      <role>Study Chair</role>
      <affiliation>Uskudar University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ömer ŞEVGİN</last_name>
      <phone>+905069787535</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>Maricar N, Callaghan MJ, Parkes MJ, Felson DT, O'Neill TW. Clinical assessment of effusion in knee osteoarthritis-A systematic review. Semin Arthritis Rheum. 2016 Apr;45(5):556-63. doi: 10.1016/j.semarthrit.2015.10.004. Epub 2015 Oct 22.</citation>
      <PMID>26581486</PMID>
    </reference>
    <reference>
      <citation>Hofmann S, Kramer J, Vakil-Adli A, Aigner N, Breitenseher M. Painful bone marrow edema of the knee: differential diagnosis and therapeutic concepts. Orthop Clin North Am. 2004 Jul;35(3):321-33, ix. doi: 10.1016/j.ocl.2004.04.005.</citation>
      <PMID>15271540</PMID>
    </reference>
    <reference>
      <citation>Molfetta L, Florian A, Saviola G, Frediani B. Bone Marrow Edema: pathogenetic features. Clin Ter. 2022 Sep-Oct;173(5):434-439. doi: 10.7417/CT.2022.2459.</citation>
      <PMID>36155729</PMID>
    </reference>
    <reference>
      <citation>Kan HS, Chan PK, Chiu KY, Yan CH, Yeung SS, Ng YL, Shiu KW, Ho T. Non-surgical treatment of knee osteoarthritis. Hong Kong Med J. 2019 Apr;25(2):127-133. doi: 10.12809/hkmj187600. Epub 2019 Mar 28.</citation>
      <PMID>30919810</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 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>
    <keyword>massage</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</mesh_term>
      <mesh_term>Osteoarthritis, Knee</mesh_term>
      <mesh_term>Edema</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/NCT06010394
  org study id: Uskudar50
  nct id: NCT06010394
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study was to compare the effectiveness of exercise and classical massage in
        the control of knee edema in patients with knee osteoarthritis.
  This study will be a prospective randomized controlled study. It is planned to include 75
        patients with knee osteoarthritis in this study. It was categorized as osteoarthritis(OA)
        stages according to Kellgren-Lawrence criteria. Patients were randomly divided into three
        groups. the investigators first group is the control group (KG) and this group will receive
        classical physical therapy with ultrasound and subcutaneous electrical nerve stimulation.
        Exercise therapy will be applied to the second group in addition to the classical physical
        therapy applied to the KG. The third group will be given classical massage in addition to the
        classical physical therapy applied to the KG. The treatments to be applied to the patients
        will be 3 sessions per week and it is planned to continue for 4 weeks. Knee edema, pain
        severity, functional status and daily life activities will be measured at the beginning and
        in the 4th week of the patients. The data obtained will be analyzed statistically.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: classical physical therapy, exercise therapy, classical massage
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Knee Injury and Osteoarthritis Outcome Score
  time frame: 4 weeks
  description: It is used to detect symptoms and restrictions in current work that individuals do in daily life. The test is collected under 2 main headings, consisting of 6 questions about the effect of symptoms and 8 sub-activities that question the status of the activity. The answer to each question in the test is scored between 0-5. The scores that the person gets from each question are added together and these scores are divided by 70 and multiplied by 100. High score means low quality of life.
  measure: Western Ontario and McMaster Universities Osteoarthritis Index
  time frame: 4 weeks
  description: Pain, joint stiffness and functional status; Evaluated with the Arthritis Index of Western Ontario and McMaster Universities. The scale is a disease-specific, multidimensional, self-administered health status tool used in hip or knee osteoarthritis27. It consists of 24 questions on pain, stiffness and physical disability and is approximately 10 min. can be completed in Western Ontario and McMaster Universities Osteoarthritis Index consists of 24 questions under three sub-headings. Pain consists of 5 questions, stiffness 2 questions and function 17 questions. Each sub-parameter is scored between 0-4 points. Accordingly, it is classified as pain (0-20), stiffness (0-8) and function (0-68). A high score indicates poor health, a low score indicates good health.
  arm group label: control group
  arm group type: Active Comparator
  description: commensal physiotherapy will be applied
  arm group label: exercise group
  arm group type: Experimental
  description: exercises will be given
  arm group label: massage group
  arm group type: Experimental
  description: massage will be done
  intervention type: Other
  intervention name: conventional physiotherapy
  description: ultrasound electrotherapy cold applications
  arm group label: control group
  arm group label: exercise group
  arm group label: massage group
  intervention type: Other
  intervention name: exercises for the knee area
  description: range of motion exercises strengthening exercises exercises to reduce edema
  arm group label: exercise group
  intervention type: Other
  intervention name: payment oriented massage
  description: 10 / 15-minute massage treatments to reduce payment
  arm group label: massage group
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Enver Deniz YILDIRIM
  role: Study Chair
  affiliation: Uskudar University
  last name: Ömer ŞEVGİN
  phone: +905069787535
  email: omer.sevgin@uskudar.edu.tr
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Maricar N, Callaghan MJ, Parkes MJ, Felson DT, O'Neill TW. Clinical assessment of effusion in knee osteoarthritis-A systematic review. Semin Arthritis Rheum. 2016 Apr;45(5):556-63. doi: 10.1016/j.semarthrit.2015.10.004. Epub 2015 Oct 22.
  PMID: 26581486
  citation: Hofmann S, Kramer J, Vakil-Adli A, Aigner N, Breitenseher M. Painful bone marrow edema of the knee: differential diagnosis and therapeutic concepts. Orthop Clin North Am. 2004 Jul;35(3):321-33, ix. doi: 10.1016/j.ocl.2004.04.005.
  PMID: 15271540
  citation: Molfetta L, Florian A, Saviola G, Frediani B. Bone Marrow Edema: pathogenetic features. Clin Ter. 2022 Sep-Oct;173(5):434-439. doi: 10.7417/CT.2022.2459.
  PMID: 36155729
  citation: Kan HS, Chan PK, Chiu KY, Yan CH, Yeung SS, Ng YL, Shiu KW, Ho T. Non-surgical treatment of knee osteoarthritis. Hong Kong Med J. 2019 Apr;25(2):127-133. doi: 10.12809/hkmj187600. Epub 2019 Mar 28.
  PMID: 30919810
  responsible party type: Principal Investigator
  investigator affiliation: Uskudar University
  investigator full name: Dr. Öğr. Üyesi Ömer Şevgin
  investigator title: Asst. Prof. Dr.
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee
  mesh term: Edema
  sharing ipd: No