<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/NCT03289078</url>
  </required_header>
  <id_info>
    <org_study_id>9846</org_study_id>
    <nct_id>NCT03289078</nct_id>
  </id_info>
  <brief_title>Evaluation of Functional Improvement After Spa Therapy in Fontcaude Center</brief_title>
  <acronym>FONTCAUDE</acronym>
  <official_title>Evaluation of Functional Improvement After Spa Therapy in Fontcaude Center, for Knee Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>FONTCAUDE's Vichy SPA center, Juvignac</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      Evaluation of functional improvement after spa therapy in Fontcaude center, for knee&#xD;
      osteoarthritis Background. Knee osteoarthritis is the first indication of spa therapy in&#xD;
      rheumatology. This therapeutic represents a non pharmacological treatment and is recommended&#xD;
      by OARSI.&#xD;
&#xD;
      In order to obtain agreement for spa therapy, the center Fontcaude, needs to show clinical&#xD;
      improvement for patients, as demonstrated in the Thermarthrose study. This center is near&#xD;
      Montpellier and could improve patients localised in this area.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods: randomised prospective clinical trial of patients with knee osteoarthritis.&#xD;
&#xD;
      The spa therapy group received 18 days of therapy over 3 weeks. Patients in the control group&#xD;
      received 18 days of therapy over 3 weeks after the 6-month follow-up visit.&#xD;
&#xD;
      Follow-up was at 3 and 6 months, by a visit to the examination.&#xD;
&#xD;
      The hypothesis of our study is to demonstrate clinical improvement at six months. The main&#xD;
      endpoint is the number of patients achieving minimal clinically important improvement (MCII)&#xD;
      at 6 months, defi ned as ≥19.9 mm on the visual analogue pain scale and/or ≥9.1 points in a&#xD;
      normalised Western Ontario and McMaster Universities osteoarthritis index function score.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No financing&#xD;
  </why_stopped>
  <start_date type="Anticipated">October 2017</start_date>
  <completion_date type="Anticipated">October 2020</completion_date>
  <primary_completion_date type="Anticipated">April 2020</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Achievement of minimal clinically important improvement (MCII) at 6 months</measure>
    <time_frame>30 months</time_frame>
    <description>The main endpoint is the number of patients achieving minimal clinically important improvement (MCII) at 6 months, defined as ≥19.9 mm on the visual analogue pain scale and/or ≥9.1 points in a normalised Western Ontario and McMaster Universities osteoart</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Achievement of minimal clinically important improvement (MCII) at 3 months</measure>
    <time_frame>30 months</time_frame>
    <description>The second outcome measure is the number of patients achieving minimal clinically important improvement (MCII) at 3 months, defi ned as ≥19.9 mm on the visual analogue pain scale and/or ≥9.1 points in a normalised Western Ontario and McMaster Universities osteoarthritis index function score, and also the safety.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Thermal care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Spa Treatment realised daily 6 days a week during 18 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Spa Treatment</intervention_name>
    <description>The spa treatments will be realised daily 6 days a week and during 18 days. The care will be provided is : Swimming pool of mobilization by physical therapist (20 minutes daily, Cataplasms (10 minutes daily), Shower in the jet (10 minutes daily), Shower under affusion (10 minutes daily)</description>
    <arm_group_label>Thermal care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Patient aged 40 to 75 years with radiologic and gonarthrosis radiologic et painful&#xD;
             gonarthrosis, unilateral ou bilateral, whatever is the radiographic stage&#xD;
&#xD;
          -  Patient presenting a EVA ≥3 with a corresponding radiology at least of 1year&#xD;
&#xD;
          -  Patient affiliated with a social security system&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Realization of a water cure in the last 6 months&#xD;
&#xD;
          -  Infiltration of the knee of less than 3 months&#xD;
&#xD;
          -  Impossibility to sign the informed consent or which for reasons geographical, social&#xD;
             or psychological could not be regularly followed,&#xD;
&#xD;
          -  Person major placed under guardianship or trusteeship,&#xD;
&#xD;
          -  Private person of freedom by court or administrative order, nobody being the object of&#xD;
             a legal protective measure,&#xD;
&#xD;
          -  Patient already included in an interventional clinical protocol,&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Contraindication in the water cure:&#xD;
&#xD;
               -  Severe change of the general state or debilitating afflictions&#xD;
&#xD;
               -  Acute affections and pushed acute(sharp) of the chronic affections&#xD;
&#xD;
               -  Grave cardiac insufficiency, unstable arterial high blood pressure&#xD;
&#xD;
               -  Severe renal or hepatic insufficiency&#xD;
&#xD;
               -  Not healed cutaneous hurts&#xD;
&#xD;
               -  Contagious or evolutionary diseases&#xD;
&#xD;
               -  Evolutionary Cancers&#xD;
&#xD;
               -  Current immunomodulator or immunosupressor Treatment, waves of inflammation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Isabel TAVARES, PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Montpellier</affiliation>
  </overall_official>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>May 11, 2021</last_update_submitted>
  <last_update_submitted_qc>May 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2021</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/NCT03289078
org study id: 9846
nct id: NCT03289078
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evaluation of functional improvement after spa therapy in Fontcaude center, for knee
      osteoarthritis Background. Knee osteoarthritis is the first indication of spa therapy in
      rheumatology. This therapeutic represents a non pharmacological treatment and is recommended
      by OARSI.

      In order to obtain agreement for spa therapy, the center Fontcaude, needs to show clinical
      improvement for patients, as demonstrated in the Thermarthrose study. This center is near
      Montpellier and could improve patients localised in this area.
Methods: randomised prospective clinical trial of patients with knee osteoarthritis.

      The spa therapy group received 18 days of therapy over 3 weeks. Patients in the control group
      received 18 days of therapy over 3 weeks after the 6-month follow-up visit.

      Follow-up was at 3 and 6 months, by a visit to the examination.

      The hypothesis of our study is to demonstrate clinical improvement at six months. The main
      endpoint is the number of patients achieving minimal clinically important improvement (MCII)
      at 6 months, defi ned as ≥19.9 mm on the visual analogue pain scale and/or ≥9.1 points in a
      normalised Western Ontario and McMaster Universities osteoarthritis index function score.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Achievement of minimal clinically important improvement (MCII) at 6 months
time frame: 30 months
description: The main endpoint is the number of patients achieving minimal clinically important improvement (MCII) at 6 months, defined as ≥19.9 mm on the visual analogue pain scale and/or ≥9.1 points in a normalised Western Ontario and McMaster Universities osteoart
measure: Achievement of minimal clinically important improvement (MCII) at 3 months
time frame: 30 months
description: The second outcome measure is the number of patients achieving minimal clinically important improvement (MCII) at 3 months, defi ned as ≥19.9 mm on the visual analogue pain scale and/or ≥9.1 points in a normalised Western Ontario and McMaster Universities osteoarthritis index function score, and also the safety.
arm group label: Thermal care
arm group type: Experimental
description: Spa Treatment realised daily 6 days a week during 18 days
arm group label: Standard Care
arm group type: No Intervention
description: Usual care
intervention type: Other
intervention name: Spa Treatment
description: The spa treatments will be realised daily 6 days a week and during 18 days. The care will be provided is : Swimming pool of mobilization by physical therapist (20 minutes daily, Cataplasms (10 minutes daily), Shower in the jet (10 minutes daily), Shower under affusion (10 minutes daily)
arm group label: Thermal care
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Isabel TAVARES, PH
role: Principal Investigator
affiliation: CHU de Montpellier
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No