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/NCT06037824</url>
    </required_header>
    <id_info>
      <org_study_id>IFMK01</org_study_id>
      <nct_id>NCT06037824</nct_id>
    </id_info>
    <brief_title>Compressive Cryotherapy Versus Conventional Cryotherapy After Total Knee Arthroplasty</brief_title>
    <official_title>Influence of Compressive Cryotherapy Compared to Conventional Cryotherapy on Articular, Trophic and Functional Recovery After Total Knee Arthroplasty: a Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institut de Formation en Masso-Kinésithérapie Saint Michel</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Institut de Formation en Masso-Kinésithérapie Saint Michel</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>
        In the postoperative period of a total knee arthroplasty, subjects present limitations of&#xD;
        articular amplitudes, swelling, pain and functional limitations. Functional rehabilitation is&#xD;
        unanimously recommended, including the use of cryotherapy. However, there is no consensus&#xD;
        regarding the methods of application of cryotherapy. Thus the objective of the study is to&#xD;
        compare 2 cryotherapy techniques associated with a classic rehabilitation on the improvement&#xD;
        of mobility, swelling, pain and functional parameters. The 2 cryotherapies were a compressive&#xD;
        cryotherapy and a so-called classic cryotherapy by cold pack.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2019</start_date>
    <completion_date type="Actual">June 30, 2023</completion_date>
    <primary_completion_date type="Actual">March 22, 2022</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>Single (Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>knee range of motion</measure>
      <time_frame>Day 1-Day 8-Day 15-Day 21</time_frame>
      <description>Measurement of passive flexion and active extension with a goniometer</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Knee perimetry</measure>
      <time_frame>Day 1-Day 8-Day 15-Day 21</time_frame>
      <description>A perimetry measurement with a tape measure was carried out</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Swelling</measure>
      <time_frame>Day 1-Day 8-Day 15-Day 21</time_frame>
      <description>Swelling has been measured with the &quot;fluctuation test&quot;: the examiner placed his thumb and fingers on either side of the lower part of the patella, while with his other hand, he positioned himself at the level of the upper part of the sub quadriceps fornix. The fingers of the cranial hand exerted light pressure to mobilize the fluid from the quadriceps fornix. The test was positive if the fingers or thumb were pushed back by the effusion.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain at rest and on exertion</measure>
      <time_frame>Day 1-Day 8-Day 15-Day 21</time_frame>
      <description>Pain assessment was based on the use of the Verbal Numerical Scale (NVS). The examiner asked the subject to quantify their pain on a scale ranging from 0 to 10 (0 corresponding to no pain and 10 to unbearable pain). Pain assessment was carried out at rest and during exercise during the rehabilitation sessions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>6min walking test</measure>
      <time_frame>Day 1-Day 8-Day 15-Day 21</time_frame>
      <description>The instructions were to cover the greatest distance possible for 6 minutes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>KOOS score (Knee injury and Osteoarthritis Outcome Score)</measure>
      <time_frame>Day 1-Day 8-Day 15-Day 21</time_frame>
      <description>Only the 17 items of the questionnaire dealing with &quot;quality of life&quot; were considered in this study. Subjects had to complete the questions</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>Knee Arthropathy</condition>
    <condition>Cryotherapy Effect</condition>
    <arm_group>
      <arm_group_label>Experimental Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group received classic rehabilitation* + compressive cryotherapy&#xD;
  * classic rehabilitation include passive and active of mobilization of knee and patella, treat arthrogenic muscular inhibition, learn to lock the quadriceps, progressive muscular strengthening of the periarticular muscles of the knee, stretching of the quadriceps and the posterior muscular chain, proprioceptive exercises with bi- and unipodal balance, transfer of support and resumption of the walking pattern.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>This group received classic rehabilitation* + classic cryotherapy&#xD;
  *classic rehabilitation include passive and active of mobilization of knee and patella, treat arthrogenic muscular inhibition, learn to lock the quadriceps, progressive muscular strengthening of the periarticular muscles of the knee, stretching of the quadriceps and the posterior muscular chain, proprioceptive exercises with bi- and unipodal balance, transfer of support and resumption of the walking pattern.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>cryotherapy</intervention_name>
      <description>cryotherapy was added to rehabilitation*. One group received compressive cryotherapy and the other conventional cold pack cryotherapy.&#xD;
  * rehabilitation includes (=&quot;classic rehabilitation&quot;) passive and active of mobilization of knee and patella, treat arthrogenic muscular inhibition, learn to lock the quadriceps, progressive muscular strengthening of the periarticular muscles of the knee, stretching of the quadriceps and the posterior muscular chain, proprioceptive exercises with bi- and unipodal balance, transfer of support and resumption of the walking pattern.</description>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_label>Experimental Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Volunteers&#xD;
  &#xD;
            -  First-line Total Knee Arthroplasty on an indication of knee osteoarthritis diagnosed&#xD;
               by radio-clinical examination&#xD;
  &#xD;
            -  Between D3 and D10 postoperatively&#xD;
  &#xD;
            -  Age &lt; 90 years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Intolerance to cryotherapy or compression,&#xD;
  &#xD;
            -  Occurrence of complications secondary to surgery,&#xD;
  &#xD;
            -  Withdrawal of consent,&#xD;
  &#xD;
            -  Non-compliance with the rehabilitation protocol (content and dosage of sessions).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Hôpital de la Porte Verte</name>
        <address>
          <city>Versailles</city>
          <state>Yvelines</state>
          <zip>78000</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</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>Joint Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06037824
  org study id: IFMK01
  nct id: NCT06037824
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In the postoperative period of a total knee arthroplasty, subjects present limitations of
        articular amplitudes, swelling, pain and functional limitations. Functional rehabilitation is
        unanimously recommended, including the use of cryotherapy. However, there is no consensus
        regarding the methods of application of cryotherapy. Thus the objective of the study is to
        compare 2 cryotherapy techniques associated with a classic rehabilitation on the improvement
        of mobility, swelling, pain and functional parameters. The 2 cryotherapies were a compressive
        cryotherapy and a so-called classic cryotherapy by cold pack.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Care Provider)
  measure: knee range of motion
  time frame: Day 1-Day 8-Day 15-Day 21
  description: Measurement of passive flexion and active extension with a goniometer
  measure: Knee perimetry
  time frame: Day 1-Day 8-Day 15-Day 21
  description: A perimetry measurement with a tape measure was carried out
  measure: Swelling
  time frame: Day 1-Day 8-Day 15-Day 21
  description: Swelling has been measured with the "fluctuation test": the examiner placed his thumb and fingers on either side of the lower part of the patella, while with his other hand, he positioned himself at the level of the upper part of the sub quadriceps fornix. The fingers of the cranial hand exerted light pressure to mobilize the fluid from the quadriceps fornix. The test was positive if the fingers or thumb were pushed back by the effusion.
  measure: Pain at rest and on exertion
  time frame: Day 1-Day 8-Day 15-Day 21
  description: Pain assessment was based on the use of the Verbal Numerical Scale (NVS). The examiner asked the subject to quantify their pain on a scale ranging from 0 to 10 (0 corresponding to no pain and 10 to unbearable pain). Pain assessment was carried out at rest and during exercise during the rehabilitation sessions.
  measure: 6min walking test
  time frame: Day 1-Day 8-Day 15-Day 21
  description: The instructions were to cover the greatest distance possible for 6 minutes
  measure: KOOS score (Knee injury and Osteoarthritis Outcome Score)
  time frame: Day 1-Day 8-Day 15-Day 21
  description: Only the 17 items of the questionnaire dealing with "quality of life" were considered in this study. Subjects had to complete the questions
  arm group label: Experimental Group
  arm group type: Experimental
  description: This group received classic rehabilitation* + compressive cryotherapy
  * classic rehabilitation include passive and active of mobilization of knee and patella, treat arthrogenic muscular inhibition, learn to lock the quadriceps, progressive muscular strengthening of the periarticular muscles of the knee, stretching of the quadriceps and the posterior muscular chain, proprioceptive exercises with bi- and unipodal balance, transfer of support and resumption of the walking pattern.
  arm group label: Control Group
  arm group type: Active Comparator
  description: This group received classic rehabilitation* + classic cryotherapy
  *classic rehabilitation include passive and active of mobilization of knee and patella, treat arthrogenic muscular inhibition, learn to lock the quadriceps, progressive muscular strengthening of the periarticular muscles of the knee, stretching of the quadriceps and the posterior muscular chain, proprioceptive exercises with bi- and unipodal balance, transfer of support and resumption of the walking pattern.
  intervention type: Other
  intervention name: cryotherapy
  description: cryotherapy was added to rehabilitation*. One group received compressive cryotherapy and the other conventional cold pack cryotherapy.
  * rehabilitation includes (="classic rehabilitation") passive and active of mobilization of knee and patella, treat arthrogenic muscular inhibition, learn to lock the quadriceps, progressive muscular strengthening of the periarticular muscles of the knee, stretching of the quadriceps and the posterior muscular chain, proprioceptive exercises with bi- and unipodal balance, transfer of support and resumption of the walking pattern.
  arm group label: Control Group
  arm group label: Experimental Group
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 90 Years
  healthy volunteers: No
  facility: 
  country: France
  responsible party type: Sponsor
  mesh term: Joint Diseases
  sharing ipd: Undecided