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/NCT06012097</url>
    </required_header>
    <id_info>
      <org_study_id>7452</org_study_id>
      <nct_id>NCT06012097</nct_id>
    </id_info>
    <brief_title>Impact of Gel Aromatherapy on Pain for Patients With De Quervain Disease</brief_title>
    <acronym>Helping Hand</acronym>
    <official_title>Impact of Gel Aromatherapy on Pain for Patients With De Quervain Disease : Monocentric Study, Controlled, Randomized, Partially Blinded, in Paralleled Groups</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Strasbourg, France</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Strasbourg, France</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>
        De Quervain disease is characterized by an adductor pollicis longus and extensor pollicis&#xD;
        brevis tendons inflammation as thys pass beneath the extensor retinaculum at the radial&#xD;
        styloid. This pathology is recognized as a musculoskeletal disorder of the upper limb&#xD;
        triggering functional deficits resulting to possible modifications in the professional&#xD;
        activity, sources of absenteeism, thus constituting an economic cost for society. At the&#xD;
        etiological level, this pathology also affects young mothers (it's called &quot;mother's wrist&quot; or&#xD;
        mommy thumb&quot;), mobile phone users (&quot;textonite&quot;, &quot;Blackberryte&quot;) or video game players&#xD;
        (&quot;Nintendoite&quot;).&#xD;
  &#xD;
        Currently, the treatment is mainly conservative by splint and anti-inflammatory gel and/or&#xD;
        corticosteroid infiltration. Howewer, these therapies have undesirable effects. The interest&#xD;
        of this study is therefore to propose another therapy based on aromatherapy gel.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">April 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2026</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Measure of pain during the WHAT test</measure>
      <time_frame>Day 0</time_frame>
      <description>Visual analogue pain scale (quotation between 0 and 10) during WHAT Test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Measure of pain during the WHAT test</measure>
      <time_frame>Day 42</time_frame>
      <description>Visual analogue pain scale (quotation between 0 and 10) during WHAT Test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Measure of pain during the WHAT test</measure>
      <time_frame>Day 84</time_frame>
      <description>Visual analogue pain scale (quotation between 0 and 10) during WHAT Test</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>De Quervain Disease</condition>
    <arm_group>
      <arm_group_label>active comparator</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Diclofenac gel Splint of the thumb and wrist</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Experimental Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Aromatherapy Gel Splint of the thumb and wrist</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Diclofenac gel</intervention_name>
      <description>using diclofenac as a comparator</description>
      <arm_group_label>active comparator</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Aromatherapy gel</intervention_name>
      <description>using Aromatherapy gel as an experimetnal treatment</description>
      <arm_group_label>Experimental Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female patient aged 18 to 75,&#xD;
  &#xD;
            -  Patient with unilateral De Quervain's tenosynovitis,&#xD;
  &#xD;
            -  Patient cared in the Hand Surgery Department, SOS Mains Emergency Department or&#xD;
               Rheumatology Department of Strasbourg University Hospitals,&#xD;
  &#xD;
            -  Patient informed of the results of the prior medical examination,&#xD;
  &#xD;
            -  Informed consent signed by the patient,&#xD;
  &#xD;
            -  Patient affiliated to a health insurance social protection scheme or beneficiary,&#xD;
  &#xD;
            -  For a woman of childbearing potential, negative urine pregnancy test at the inclusion&#xD;
               visit and maintenance of effective contraception throughout the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant or breastfeeding patient,&#xD;
  &#xD;
            -  Patient allergic to a component of the gel with essential oils, Dicloflenac®, NSAIDs,&#xD;
               or one of the excipients&#xD;
  &#xD;
            -  Patient treated with oral non-steroidal anti-inflammatory drugs&#xD;
  &#xD;
            -  Patient with ongoing treatment with another ointment at the treatment application site&#xD;
               (radial edge of the wrist)&#xD;
  &#xD;
            -  Patient with damaged skin, whatever the lesion: oozing dermatosis, eczema, infected&#xD;
               lesion, burn or wound,&#xD;
  &#xD;
            -  Patient with atopic skin disease,&#xD;
  &#xD;
            -  Patient with epilepsy or with a history of epilepsy,&#xD;
  &#xD;
            -  Patient with a history of homolateral De Quervain's tenosynovitis, or having already&#xD;
               had corticosteroid infiltrations in the 6 months before his inclusion on the&#xD;
               ipsilateral side of the pathology,&#xD;
  &#xD;
            -  Patient with associated tendinopathies in the elbow or forearm region,&#xD;
  &#xD;
            -  Impossibility of giving the patient information (patient in an emergency situation,&#xD;
               patient with difficulties of understandin, agitation of the patient),&#xD;
  &#xD;
            -  Patient under legal protection, under guardianship or curatorship.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Marie SCHWEBEL</last_name>
      <phone>03 68 76 53 40</phone>
      <email>marie.schwebel@chru-strasbourg.fr</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 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>De Quervain Disease</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diclofenac</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06012097
  org study id: 7452
  nct id: NCT06012097
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  De Quervain disease is characterized by an adductor pollicis longus and extensor pollicis
        brevis tendons inflammation as thys pass beneath the extensor retinaculum at the radial
        styloid. This pathology is recognized as a musculoskeletal disorder of the upper limb
        triggering functional deficits resulting to possible modifications in the professional
        activity, sources of absenteeism, thus constituting an economic cost for society. At the
        etiological level, this pathology also affects young mothers (it's called "mother's wrist" or
        mommy thumb"), mobile phone users ("textonite", "Blackberryte") or video game players
        ("Nintendoite").
  
        Currently, the treatment is mainly conservative by splint and anti-inflammatory gel and/or
        corticosteroid infiltration. Howewer, these therapies have undesirable effects. The interest
        of this study is therefore to propose another therapy based on aromatherapy gel.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Measure of pain during the WHAT test
  time frame: Day 0
  description: Visual analogue pain scale (quotation between 0 and 10) during WHAT Test
  measure: Measure of pain during the WHAT test
  time frame: Day 42
  description: Visual analogue pain scale (quotation between 0 and 10) during WHAT Test
  measure: Measure of pain during the WHAT test
  time frame: Day 84
  description: Visual analogue pain scale (quotation between 0 and 10) during WHAT Test
  arm group label: active comparator
  arm group type: Active Comparator
  description: Diclofenac gel Splint of the thumb and wrist
  arm group label: Experimental Group
  arm group type: Experimental
  description: Aromatherapy Gel Splint of the thumb and wrist
  intervention type: Drug
  intervention name: Diclofenac gel
  description: using diclofenac as a comparator
  arm group label: active comparator
  intervention type: Drug
  intervention name: Aromatherapy gel
  description: using Aromatherapy gel as an experimetnal treatment
  arm group label: Experimental Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Marie SCHWEBEL
  phone: 03 68 76 53 40
  email: marie.schwebel@chru-strasbourg.fr
  responsible party type: Sponsor
  mesh term: De Quervain Disease
  mesh term: Diclofenac
  sharing ipd: No