<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/NCT03260361</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/16/8235</org_study_id>
    <nct_id>NCT03260361</nct_id>
  </id_info>
  <brief_title>Hypnosis and MEOPA in Regional Painful Syndrome Complex</brief_title>
  <acronym>ProHKM-SDRC</acronym>
  <official_title>Combined Therapy of Hypnosis Kinesitherapy and MEOPA in Patients With Regional Painful Syndrome Complex</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</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>
      Relation between hypnosis and MEOPA on algodystrophy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 6, 2017</start_date>
  <completion_date type="Actual">December 7, 2022</completion_date>
  <primary_completion_date type="Actual">November 7, 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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain intensity measure using visual analogical ladder (EVA)</measure>
    <time_frame>3 weeks</time_frame>
    <description>pain intensity is determined by patient himself on a visual analogical ladder created by Huskisson</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>QDSA ( Saint Antoine Pain Questions)</measure>
    <time_frame>3 weeks</time_frame>
    <description>description of the type of pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF36 (Short Form (36) Health Survey)</measure>
    <time_frame>3 weeks</time_frame>
    <description>quality of life appreciation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HADs</measure>
    <time_frame>3 weeks</time_frame>
    <description>Hospital Anxiety and Depression Scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Algodystrophy of Hand</condition>
  <arm_group>
    <arm_group_label>Hypnosis Kinesitherapy and MEOPA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>combined therapy of Hypnosis Kinesitherapy and MEOPA (HKM)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>usual practice</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>physiopathology and treatments</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hypnosis, kinesitherapy, MEOPA</intervention_name>
    <description>classical intervention</description>
    <arm_group_label>Hypnosis Kinesitherapy and MEOPA</arm_group_label>
    <other_name>Hypnosis Kinesitherapy and MEOPA (HKM)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual practice</intervention_name>
    <description>Usual practice with treatments and physio</description>
    <arm_group_label>usual practice</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Regional Painful Syndrome Complex&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  deaf people&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martine QUINTARD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Croix du Sud</name>
      <address>
        <city>Quint Fonsegrives</city>
        <zip>31130</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Oerlemans HM, Oostendorp RA, de Boo T, Perez RS, Goris RJ. Signs and symptoms in complex regional pain syndrome type I/reflex sympathetic dystrophy: judgment of the physician versus objective measurement. Clin J Pain. 1999 Sep;15(3):224-32. doi: 10.1097/00002508-199909000-00010.</citation>
    <PMID>10524476</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>August 22, 2023</last_update_submitted>
  <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 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>Reflex Sympathetic Dystrophy</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/NCT03260361
org study id: RC31/16/8235
nct id: NCT03260361
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Relation between hypnosis and MEOPA on algodystrophy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Pain intensity measure using visual analogical ladder (EVA)
time frame: 3 weeks
description: pain intensity is determined by patient himself on a visual analogical ladder created by Huskisson
measure: QDSA ( Saint Antoine Pain Questions)
time frame: 3 weeks
description: description of the type of pain
measure: SF36 (Short Form (36) Health Survey)
time frame: 3 weeks
description: quality of life appreciation
measure: HADs
time frame: 3 weeks
description: Hospital Anxiety and Depression Scale
arm group label: Hypnosis Kinesitherapy and MEOPA
arm group type: Experimental
description: combined therapy of Hypnosis Kinesitherapy and MEOPA (HKM)
arm group label: usual practice
arm group type: Other
description: physiopathology and treatments
intervention type: Other
intervention name: Hypnosis, kinesitherapy, MEOPA
description: classical intervention
arm group label: Hypnosis Kinesitherapy and MEOPA
other name: Hypnosis Kinesitherapy and MEOPA (HKM)
intervention type: Other
intervention name: Usual practice
description: Usual practice with treatments and physio
arm group label: usual practice
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Martine QUINTARD
role: Principal Investigator
affiliation: University Hospital, Toulouse
facility: 
facility: 
country: France
citation: Oerlemans HM, Oostendorp RA, de Boo T, Perez RS, Goris RJ. Signs and symptoms in complex regional pain syndrome type I/reflex sympathetic dystrophy: judgment of the physician versus objective measurement. Clin J Pain. 1999 Sep;15(3):224-32. doi: 10.1097/00002508-199909000-00010.
PMID: 10524476
responsible party type: Sponsor
mesh term: Reflex Sympathetic Dystrophy
sharing ipd: No