<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/NCT02230007</url>
  </required_header>
  <id_info>
    <org_study_id>2013-000065-37</org_study_id>
    <secondary_id>12AOI02</secondary_id>
    <nct_id>NCT02230007</nct_id>
  </id_info>
  <brief_title>Contribution of the MEOPA in the Physiotherapy Care of Painful Articular Steepness Among Elderly</brief_title>
  <official_title>Contribution of the MEOPA in the Physiotherapy Care of Painful Articular Steepness Among Elderly</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nice</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nice</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The MEOPA is used to obtain an analgesia of the short-term painful acts. To the population of&#xD;
      elderly patients, the therapeutic resources to control the passing pain require in their&#xD;
      manipulation a certain caution and are not divested of side effects badly tolerated at this&#xD;
      age. An alternative in the opioid presents all its interest. The MEOPA is here an alternative&#xD;
      of choice in the care of these pains, in particular in case of pre-existent cognitive&#xD;
      achievement, of polypathologies or of polymédication.&#xD;
&#xD;
      The gas MEOPA administered to the mask could thus be an effective additive in the&#xD;
      physiotherapy treatment of the elderly person.&#xD;
&#xD;
      The main objective is to Assess the efficacy , in terms of recovery of the hip and knee joint&#xD;
      articular amplitude, of 3 sessions of reeducation using MEOPA versus standard reeducation&#xD;
      within a population of elderly patients presenting a pain during the physiotherapy treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2013</start_date>
  <completion_date type="Anticipated">July 2015</completion_date>
  <primary_completion_date type="Anticipated">May 2015</primary_completion_date>
  <phase>Phase 4</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>% of recovery of the hip and knee joint articular amplitude</measure>
    <time_frame>5 days</time_frame>
    <description>% of recovery of the hip and knee joint articular amplitude during 5 days after 3 sessions of reeducation using MEOPA versus standard reeducation within a population of elderly patients presenting a pain during the physiotherapy treatment; measure % of recovery of the hip and knee joint articular amplitude two times : before the beginning of the session of reeducation and at the end of the session</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure of the pain</measure>
    <time_frame>5 days</time_frame>
    <description>Patient answer a questionnaire on his pain at the beginning of each session of reeducation (5 sessions)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients'satisfaction</measure>
    <time_frame>End of the period of care (up to 5 days)</time_frame>
    <description>Patient answer a questionnaire on this satisfaction at the end of the period of care of the protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physiotherapists'satisfaction</measure>
    <time_frame>End of all the period of care (up to 5 days)</time_frame>
    <description>Physiotherapists answer a questionnaire on this satisfaction of the use of the MEOPA</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">64</enrollment>
  <condition>Pain Management and Care</condition>
  <arm_group>
    <arm_group_label>MEOPA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ENTONOX (MEOPA)gas Duration of treatment of a subject according to the protocol: 60 MINUTES Inhalation use</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Without MEOPA</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Physiotherapit care without MEOPA</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MEOPA</intervention_name>
    <description>3 sessions of reeducation using MEOPA</description>
    <arm_group_label>MEOPA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female aged 65 years old or more&#xD;
&#xD;
          -  Patients having a prescription for physiotherapy&#xD;
&#xD;
          -  Absence of contraindication to MEOPA&#xD;
&#xD;
          -  Patients whose initial assessment show a passive articular deficit of at least a joint&#xD;
             of hip or the knee and whose painful assessment is ≥ 5 or ≥ 2 during mobilisation on&#xD;
             the validated scale Algoplus&#xD;
&#xD;
          -  Patients whose reeducation project established by the physiotherapist&#xD;
&#xD;
          -  Patients having agreed to participate in the study and having signed the consent&#xD;
&#xD;
          -  Subjects affiliated to the social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient requiring a ventilation in pure oxygen&#xD;
&#xD;
          -  Patient with a consciousness deterioration preventing his cooperation&#xD;
&#xD;
          -  Care under MEOPA during the period of the protocol and during the month which precedes&#xD;
&#xD;
          -  Increase of the dosage of morphine of less than 48 hours Patient under guardianship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Véronique Mailland, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire de Nice</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Véronique MAILLAND, MD</last_name>
    <phone>0033 4 92034397</phone>
    <email>mailland-putegnat@chu-nice.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Pôle de Gérontologie Hôpital de Cimiez CHU de Nice</name>
      <address>
        <city>Nice</city>
        <zip>06000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Véronique MAILLAND, MD</last_name>
      <phone>+33 4 92 03 43 97</phone>
      <email>mailland-putegnat.v@chu-nice.fr</email>
    </contact>
    <investigator>
      <last_name>Véronique MAILLAND, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Nice</name>
      <address>
        <city>Nice</city>
        <zip>06003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Véronique MAILLAND, MD</last_name>
      <phone>0033 4 92034397</phone>
      <email>mailland-putegnat@chu-nice.fr</email>
    </contact>
    <investigator>
      <last_name>Véronique MAILLAND, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>May 7, 2013</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>September 2, 2014</last_update_submitted>
  <last_update_submitted_qc>September 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02230007
org study id: 2013-000065-37
secondary id: 12AOI02
nct id: NCT02230007
lead sponsor: 
has dmc: No
The MEOPA is used to obtain an analgesia of the short-term painful acts. To the population of
      elderly patients, the therapeutic resources to control the passing pain require in their
      manipulation a certain caution and are not divested of side effects badly tolerated at this
      age. An alternative in the opioid presents all its interest. The MEOPA is here an alternative
      of choice in the care of these pains, in particular in case of pre-existent cognitive
      achievement, of polypathologies or of polymédication.

      The gas MEOPA administered to the mask could thus be an effective additive in the
      physiotherapy treatment of the elderly person.

      The main objective is to Assess the efficacy , in terms of recovery of the hip and knee joint
      articular amplitude, of 3 sessions of reeducation using MEOPA versus standard reeducation
      within a population of elderly patients presenting a pain during the physiotherapy treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: % of recovery of the hip and knee joint articular amplitude
time frame: 5 days
description: % of recovery of the hip and knee joint articular amplitude during 5 days after 3 sessions of reeducation using MEOPA versus standard reeducation within a population of elderly patients presenting a pain during the physiotherapy treatment; measure % of recovery of the hip and knee joint articular amplitude two times : before the beginning of the session of reeducation and at the end of the session
measure: Measure of the pain
time frame: 5 days
description: Patient answer a questionnaire on his pain at the beginning of each session of reeducation (5 sessions)
measure: Patients'satisfaction
time frame: End of the period of care (up to 5 days)
description: Patient answer a questionnaire on this satisfaction at the end of the period of care of the protocol.
measure: Physiotherapists'satisfaction
time frame: End of all the period of care (up to 5 days)
description: Physiotherapists answer a questionnaire on this satisfaction of the use of the MEOPA
arm group label: MEOPA
arm group type: Experimental
description: ENTONOX (MEOPA)gas Duration of treatment of a subject according to the protocol: 60 MINUTES Inhalation use
arm group label: Without MEOPA
arm group type: No Intervention
description: Physiotherapit care without MEOPA
intervention type: Drug
intervention name: MEOPA
description: 3 sessions of reeducation using MEOPA
arm group label: MEOPA
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Véronique Mailland, MD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire de Nice
last name: Véronique MAILLAND, MD
phone: 0033 4 92034397
email: mailland-putegnat@chu-nice.fr
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor