<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/NCT02265029</url>
  </required_header>
  <id_info>
    <org_study_id>DCIC/13/68</org_study_id>
    <nct_id>NCT02265029</nct_id>
  </id_info>
  <brief_title>Evaluation of Spa Therapy in the Treatment of Fibromyalgia</brief_title>
  <acronym>THERMALGI</acronym>
  <official_title>Evaluation of Spa Therapy in the Treatment of Fibromyalgia : a Randomized, Controlled, Open Multicenter Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Association Francaise pour la Recherche Thermale</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Floralis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Association Francaise pour la Recherche Thermale</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fibromyalgia is a common health problem that causes widespread pain and tenderness (sensitive&#xD;
      to touch). The pain and tenderness tend to come and go, and move about the body. There is no&#xD;
      cure for fibromyalgia. Complementary and alternative therapy such as acupuncture,&#xD;
      chiropractic and massage therapy, can be useful to manage fibromyalgia symptoms. Many of&#xD;
      these treatments have not been well tested in patients with fibromyalgia. Fibromyalgia affect&#xD;
      3 to 4% of the general population and 14 % of patients with rheumatologic disease.&#xD;
      Fibromyalgia is most common in women 90 % in many studies. It most often starts in middle&#xD;
      adulthood. A chronic evolution occured for Fibromyalgic patients with a major alteration of&#xD;
      quality of life.&#xD;
&#xD;
      Thermalgi is a randomized, multicentre, open label trial wich aims to evaluate the effects of&#xD;
      spa therapy in rheumatologia on evolution of disability in daily life of patients with&#xD;
      fibromyalgia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      THERMALGI is a controlled, randomized, multicentre, open label trial wich aims to evaluate&#xD;
      the effects of spa therapy in rheumatologia on evolution of disability in daily life of&#xD;
      patients with fibromyalgia.&#xD;
&#xD;
      Patients with fibromyalgia (American College of Rheumatology Criteria) and a FIQ score&#xD;
      (Fibromyalgia Impact Questionnaire) &gt; 39 will be randomized.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">October 2018</completion_date>
  <primary_completion_date type="Actual">March 30, 2018</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>Handicap in everyday life</measure>
    <time_frame>6 months</time_frame>
    <description>Decrease of 14% (success rate) of FIQ questionnaire at 6 months compare to baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>at baseline, 3, 6, 9 and 12 months</time_frame>
    <description>Comparison of the FIQ questionnaire mean between baseline, 3 and 6 months. Quantitative evaluation of the primary outcome.&#xD;
EUROQUOL (EQ5D) score evolution between baseline, 6 and 12 months.&#xD;
Evolution of PGA (autoevaluation) (Patient Global Assessment) and IGA (hetero evaluation) (Investigator's Global Assessment) scores between baseline, 3, 6, 9 and 12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain evolution</measure>
    <time_frame>at baseline, 3, 6, 9 and 12 months</time_frame>
    <description>Monthly evolution of VAS (Visual Analogic Scale) pain and PCS questionnaire (Pain Catastrophizing Scale) between baseline, 3, 6, 9 and 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality</measure>
    <time_frame>at baseline, 3, 6, 9 and 12 months</time_frame>
    <description>Evolution of PSQI questionnaire (Pittsburg Sleep Quality Index) and Epworth Scale (ESS) (Epworth Sleepiness Scale) between baseline, 3, 6, 9 and 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>at baseline, 3, 6, 9 and 12 months</time_frame>
    <description>Evolution of Pichot questionnaire between baseline, 3, 6, 9 and 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>at baseline, 3, 6, 9 and 12 months</time_frame>
    <description>Evolution of HADS (Hospital Anxiety Depression Scale) and Coping-Etat questionnaires between baseline, 3, 6, 9 and 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability to cope</measure>
    <time_frame>at baseline, 6 and 12 months</time_frame>
    <description>Evolution of Coping-Etat questionnaire between baseline, 6 and 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>at baseline, 3, 6, 9 and 12 months</time_frame>
    <description>Evolution of Baecke score between baseline, 3, 6, 9 and 12 months&#xD;
evolution of BMI (Bone Mass Index) between baseline, 3, 6, 9 and 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medico economic impact</measure>
    <time_frame>at baseline, 3, 6, 9 and 12 months</time_frame>
    <description>Drugs consumption, medical and paramedical consultations, hospitalisations, professional absenteeism, complementary medicines resort.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective physical activity</measure>
    <time_frame>at baseline, 3, and 6 months</time_frame>
    <description>Record of day activity during one week with actigraphy at baseline, 3 and 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective sleep quality</measure>
    <time_frame>at baseline, 3, and 6 months</time_frame>
    <description>Record of night activity and cardiac variability at baseline, 3 and 6 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">220</enrollment>
  <condition>Fibromyalgia</condition>
  <condition>Rheumatism, Muscular</condition>
  <arm_group>
    <arm_group_label>Immediate spa treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Spa treatment during 18 days soon after randomization : the most adapted to the concerned pathology and common to all of spa resorts (whirpool bath with automatic air and water massage cycles, massaging shower,...)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Late SPA treatment</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Spa treatment during 18 days soon after 6 months visit : the most adapted to the concerned pathology and common to all of spa resorts (whirpool bath with automatic air and water massage cycles, massaging shower,...)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Immediate spa treatment</intervention_name>
    <description>spa treatment in rheumatology with sedative and antalgique techniques and mobilizing techniques (rehabilitation in pool)</description>
    <arm_group_label>Immediate spa treatment</arm_group_label>
    <other_name>Spa treatment soon after randomisation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Late spa treatment</intervention_name>
    <description>spa treatment in rheumatology with sedative and antalgique techniques and mobilizing techniques (rehabilitation in pool)</description>
    <arm_group_label>Late SPA treatment</arm_group_label>
    <other_name>Spa treatment after 6 months visit in the study</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  both sexes, more than 18 years old patients&#xD;
&#xD;
          -  available for a spa treatment in rheumatology during 18 days (immediate or late spa)&#xD;
             and a follow-up period of 12 months&#xD;
&#xD;
          -  with fibromyalgia ( ACR criteria 2010) for at least 1 year and with a stable treatment&#xD;
             for at least 3 months&#xD;
&#xD;
          -  with a FIQ score &gt; or = 39 (fibromyalgia moderate to severe)&#xD;
&#xD;
          -  voluntary to participate to the study, informed consent form signed after appropriate&#xD;
             information&#xD;
&#xD;
          -  affiliation to the social security system or equivalent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contra-indication of spa treatment (cancer in progress, psychiatrics disorders,&#xD;
             immunodeficiency)&#xD;
&#xD;
          -  no previous spa treatment in rheumatology within 1 year prior to inclusion&#xD;
&#xD;
          -  substantial variation of the therapeutic coverage in the previous 3 months the&#xD;
             inclusion (change of medicinal class, starting up of a réentrainement in the effort or&#xD;
             a cognitivio-behavioral technique)&#xD;
&#xD;
          -  subject with an other chronic severe disease (severe asthma, severe cardiac&#xD;
             insuffisiancy, respiratory, renal or liver failures, evolutive rheumatic disease,&#xD;
             inflammatory colitis...)&#xD;
&#xD;
          -  subject participating to an other clinical study inerventionnal&#xD;
&#xD;
          -  pregnancy, parturient or breast feeding&#xD;
&#xD;
          -  no psychiatric illness or social situation that would preclude study compliance&#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>Caroline MAINDET DOMINICI, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital University Grenoble</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>station thermale AIX LES BAINS</name>
      <address>
        <city>Aix les Bains</city>
        <zip>73100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>station thermale ALLEVARD LES BAINS</name>
      <address>
        <city>Allevard</city>
        <zip>38580</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>station thermale BOURBON LANCY</name>
      <address>
        <city>Bourbon-Lancy</city>
        <zip>71140</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>station thermale LAMALOU LES BAINS</name>
      <address>
        <city>Lamalou les Bains</city>
        <zip>34240</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Station thermale URIAGE LES BAINS</name>
      <address>
        <city>Uriage les bains</city>
        <zip>38410</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
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  <verification_date>January 2019</verification_date>
  <study_first_submitted>October 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>fibromyalgia</keyword>
  <keyword>rheumatism</keyword>
  <keyword>fatigue syndrom</keyword>
  <keyword>pain</keyword>
  <keyword>spa treatment in rheumatology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
    <mesh_term>Rheumatic Diseases</mesh_term>
    <mesh_term>Collagen Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT02265029
org study id: DCIC/13/68
nct id: NCT02265029
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Fibromyalgia is a common health problem that causes widespread pain and tenderness (sensitive
      to touch). The pain and tenderness tend to come and go, and move about the body. There is no
      cure for fibromyalgia. Complementary and alternative therapy such as acupuncture,
      chiropractic and massage therapy, can be useful to manage fibromyalgia symptoms. Many of
      these treatments have not been well tested in patients with fibromyalgia. Fibromyalgia affect
      3 to 4% of the general population and 14 % of patients with rheumatologic disease.
      Fibromyalgia is most common in women 90 % in many studies. It most often starts in middle
      adulthood. A chronic evolution occured for Fibromyalgic patients with a major alteration of
      quality of life.

      Thermalgi is a randomized, multicentre, open label trial wich aims to evaluate the effects of
      spa therapy in rheumatologia on evolution of disability in daily life of patients with
      fibromyalgia.
THERMALGI is a controlled, randomized, multicentre, open label trial wich aims to evaluate
      the effects of spa therapy in rheumatologia on evolution of disability in daily life of
      patients with fibromyalgia.

      Patients with fibromyalgia (American College of Rheumatology Criteria) and a FIQ score
      (Fibromyalgia Impact Questionnaire) > 39 will be randomized.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Handicap in everyday life
time frame: 6 months
description: Decrease of 14% (success rate) of FIQ questionnaire at 6 months compare to baseline
measure: Quality of life
time frame: at baseline, 3, 6, 9 and 12 months
description: Comparison of the FIQ questionnaire mean between baseline, 3 and 6 months. Quantitative evaluation of the primary outcome.
EUROQUOL (EQ5D) score evolution between baseline, 6 and 12 months.
Evolution of PGA (autoevaluation) (Patient Global Assessment) and IGA (hetero evaluation) (Investigator's Global Assessment) scores between baseline, 3, 6, 9 and 12 months.
measure: Pain evolution
time frame: at baseline, 3, 6, 9 and 12 months
description: Monthly evolution of VAS (Visual Analogic Scale) pain and PCS questionnaire (Pain Catastrophizing Scale) between baseline, 3, 6, 9 and 12 months
measure: Sleep quality
time frame: at baseline, 3, 6, 9 and 12 months
description: Evolution of PSQI questionnaire (Pittsburg Sleep Quality Index) and Epworth Scale (ESS) (Epworth Sleepiness Scale) between baseline, 3, 6, 9 and 12 months
measure: Fatigue
time frame: at baseline, 3, 6, 9 and 12 months
description: Evolution of Pichot questionnaire between baseline, 3, 6, 9 and 12 months
measure: Depression
time frame: at baseline, 3, 6, 9 and 12 months
description: Evolution of HADS (Hospital Anxiety Depression Scale) and Coping-Etat questionnaires between baseline, 3, 6, 9 and 12 months
measure: Ability to cope
time frame: at baseline, 6 and 12 months
description: Evolution of Coping-Etat questionnaire between baseline, 6 and 12 months
measure: Physical activity
time frame: at baseline, 3, 6, 9 and 12 months
description: Evolution of Baecke score between baseline, 3, 6, 9 and 12 months
evolution of BMI (Bone Mass Index) between baseline, 3, 6, 9 and 12 months
measure: Medico economic impact
time frame: at baseline, 3, 6, 9 and 12 months
description: Drugs consumption, medical and paramedical consultations, hospitalisations, professional absenteeism, complementary medicines resort.
measure: Objective physical activity
time frame: at baseline, 3, and 6 months
description: Record of day activity during one week with actigraphy at baseline, 3 and 6 months
measure: Objective sleep quality
time frame: at baseline, 3, and 6 months
description: Record of night activity and cardiac variability at baseline, 3 and 6 months
arm group label: Immediate spa treatment
arm group type: Active Comparator
description: Spa treatment during 18 days soon after randomization : the most adapted to the concerned pathology and common to all of spa resorts (whirpool bath with automatic air and water massage cycles, massaging shower,...)
arm group label: Late SPA treatment
arm group type: Sham Comparator
description: Spa treatment during 18 days soon after 6 months visit : the most adapted to the concerned pathology and common to all of spa resorts (whirpool bath with automatic air and water massage cycles, massaging shower,...)
intervention type: Other
intervention name: Immediate spa treatment
description: spa treatment in rheumatology with sedative and antalgique techniques and mobilizing techniques (rehabilitation in pool)
arm group label: Immediate spa treatment
other name: Spa treatment soon after randomisation
intervention type: Other
intervention name: Late spa treatment
description: spa treatment in rheumatology with sedative and antalgique techniques and mobilizing techniques (rehabilitation in pool)
arm group label: Late SPA treatment
other name: Spa treatment after 6 months visit in the study
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Caroline MAINDET DOMINICI, MD
role: Principal Investigator
affiliation: Hospital University Grenoble
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
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responsible party type: Sponsor
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
mesh term: Rheumatic Diseases
mesh term: Collagen Diseases