<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/NCT03806322</url>
  </required_header>
  <id_info>
    <org_study_id>MU2019VT</org_study_id>
    <nct_id>NCT03806322</nct_id>
  </id_info>
  <brief_title>A Better Way to Decrease Knee Swelling in Patients With Knee Osteoarthritis</brief_title>
  <official_title>A Better Way to Decrease Knee Swelling in Patients With Knee Osteoarthritis: A Single-Blind Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marmara University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Marmara University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, we compared the effects of intermittent pneumatic compression along with&#xD;
      conventional treatment and cold-pack treatment along with conventional treatment on clinical&#xD;
      outcomes in patients with knee osteoarthritis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2011</start_date>
  <completion_date type="Actual">June 1, 2012</completion_date>
  <primary_completion_date type="Actual">May 31, 2012</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Knee Swelling</measure>
    <time_frame>3 minutes</time_frame>
    <description>Knee swelling was measured with a tape measure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain Intensity</measure>
    <time_frame>3 minutes</time_frame>
    <description>A Visual Analogue Scale was used to measure pain intensity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Range of Motion</measure>
    <time_frame>3 minutes</time_frame>
    <description>A universal goniometer was used to measure range of knee flexion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle Strength</measure>
    <time_frame>10 minutes</time_frame>
    <description>A digital dynamometer (J-TECH Power Track II Commander, USA) was used to measure quadriceps femoris and hamstring muscle strength.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Status</measure>
    <time_frame>10 minutes</time_frame>
    <description>The Western Ontario and McMaster Universities Arthritis (WOMAC) Index was used to evaluate pain, stiffness and physical function.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">89</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>Cold-pack Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and cold packs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intermittent Pneumatic Compression</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The second group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and intermittent pneumatic compression</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intermittent Pneumatic Compression</intervention_name>
    <description>The group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and intermittent pneumatic compression.</description>
    <arm_group_label>Intermittent Pneumatic Compression</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cold-pack</intervention_name>
    <description>The group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and cold packs.</description>
    <arm_group_label>Cold-pack Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients diagnosed with knee OA according to the criteria of the American College of&#xD;
        Rheumatology (ACR), and were considered as stage 2 and 3 according to Kellgren-Lawrence&#xD;
        criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion criteria were previous knee surgery, malignancy, circulation disorder, and&#xD;
        conditions preventing exercise or causing muscle weakness, pregnancy, diagnosis of mental&#xD;
        disorder, scar tissue, or metal implants.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</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/NCT03806322
org study id: MU2019VT
nct id: NCT03806322
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In this study, we compared the effects of intermittent pneumatic compression along with
      conventional treatment and cold-pack treatment along with conventional treatment on clinical
      outcomes in patients with knee osteoarthritis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Knee Swelling
time frame: 3 minutes
description: Knee swelling was measured with a tape measure.
measure: Pain Intensity
time frame: 3 minutes
description: A Visual Analogue Scale was used to measure pain intensity.
measure: Range of Motion
time frame: 3 minutes
description: A universal goniometer was used to measure range of knee flexion.
measure: Muscle Strength
time frame: 10 minutes
description: A digital dynamometer (J-TECH Power Track II Commander, USA) was used to measure quadriceps femoris and hamstring muscle strength.
measure: Functional Status
time frame: 10 minutes
description: The Western Ontario and McMaster Universities Arthritis (WOMAC) Index was used to evaluate pain, stiffness and physical function.
arm group label: Cold-pack Group
arm group type: Experimental
description: One group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and cold packs
arm group label: Intermittent Pneumatic Compression
arm group type: Experimental
description: The second group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and intermittent pneumatic compression
intervention type: Other
intervention name: Intermittent Pneumatic Compression
description: The group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and intermittent pneumatic compression.
arm group label: Intermittent Pneumatic Compression
intervention type: Other
intervention name: Cold-pack
description: The group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and cold packs.
arm group label: Cold-pack Group
criteria: 
gender: All
minimum age: 35 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No