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/NCT05989373</url>
    </required_header>
    <id_info>
      <org_study_id>2022-A01972-41</org_study_id>
      <nct_id>NCT05989373</nct_id>
    </id_info>
    <brief_title>Objective Evaluation of the Scratch Collapse Test With Dynamometer, a Prospective Multicenter Trial.</brief_title>
    <official_title>Scratch Collapse Test: Prospective, Objective, Multi Multicenter</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Clinique Saint Jean, France</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Clinique Saint Jean, 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>
        Carpal tunnel syndrome and compression of the ulnar nerve at the elbow are common&#xD;
        pathologies, which are treated surgically.&#xD;
  &#xD;
        Diagnosis is usually based on an electromyogram (EMG), as well as symptomatology, etiology of&#xD;
        typical symptoms and an evocative clinical examination. Provocative tests performed in&#xD;
        consultation include the Tinel and Phalen sign for the carpal tunnel, and the Tinel and&#xD;
        prolonged flexion sign for the ulnar nerve at the elbow.&#xD;
  &#xD;
        The Scratch Collapse Test (SCT) has recently emerged as a new provocation test to help&#xD;
        diagnose nerve compression in the upper limb.&#xD;
  &#xD;
        This non-invasive, pain-free test looks for a reduction in the force of external rotation of&#xD;
        the shoulder by applying resistance (the doctor's arm), before and then after a sensory&#xD;
        stimulus by &quot;scratching&quot; the area of compression. Nevertheless, this test remains&#xD;
        controversial and not based on objective measurements.&#xD;
  &#xD;
        Our aim is therefore to assess shoulder external rotation force, and thus TBS, objectively&#xD;
        with a dynamometer, before and after stimulation in cases of median nerve compression&#xD;
        syndrome at the carpal tunnel and ulnar nerve compression syndrome at the elbow, when these&#xD;
        are clinically and electromyographically proven.&#xD;
  &#xD;
        This test has already been studied in the literature, but the results in terms of sensitivity&#xD;
        and specificity are highly disparate. One study has already published negative results on the&#xD;
        subject, with the limitation that the trial was monocentric.&#xD;
  &#xD;
        Through this multicenter study, principal investigator wish to highlight the very probable&#xD;
        subjectivity of the SCT when it is performed. As the resistance is applied by the physician's&#xD;
        arm, the investigator cannot determine the force applied against the patient, unlike with a&#xD;
        measurement object. The principal investigator expects this study to refute the notion that&#xD;
        external shoulder rotation force decreases after trigger zone stimulation in cases of proven&#xD;
        nerve compression syndrome.&#xD;
  &#xD;
        The results of this study will thus make it possible to discontinue the use of this technique&#xD;
        if it does not help in the diagnosis of compression.&#xD;
  &#xD;
        The literature shows a lack of prospective, objective studies involving a large number of&#xD;
        patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Variation in the force of external rotation of the elbow</measure>
      <time_frame>Inclusion day</time_frame>
      <description>measurement taken before the test and the measurement taken immediately after nerve stimulation according to the SCT. The force is measured with a dynamometer.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">250</enrollment>
    <condition>Carpal Tunnel Syndrome</condition>
    <condition>Ulnar Nerve Compression</condition>
    <arm_group>
      <arm_group_label>nerve stimulation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The test in currently used to search for a nerv compression</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Scratch collapse test</intervention_name>
      <description>Scratch test performed by the surgeon but with a dynamometer</description>
      <arm_group_label>nerve stimulation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient affiliated or entitled to a social security plan&#xD;
  &#xD;
            -  Patient who has received informed information about the study&#xD;
  &#xD;
            -  Patient of legal age&#xD;
  &#xD;
            -  Patient with ulnar nerve or carpal tunnel compression confirmed by EMG during&#xD;
               preoperative consultation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Recurrence of nerve compression&#xD;
  &#xD;
            -  Any history that may affect arm sensitivity&#xD;
  &#xD;
            -  Infra-electromyographic nerve compression syndrome (pure ulnar nerve instability)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>110 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Clinique St Jean sud de france</name>
        <address>
          <city>Saint-Jean-de-Védas</city>
          <zip>34730</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Cecile Spirito</last_name>
        <phone>0033688644120</phone>
        <email>cecile.spirito@capsante.fr</email>
      </contact>
      <investigator>
        <last_name>Benjamin Degeorge</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Clinique Saint Jean, France</investigator_affiliation>
      <investigator_full_name>Benjamin DEGEORGE</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carpal Tunnel Syndrome</mesh_term>
      <mesh_term>Ulnar Nerve Compression Syndromes</mesh_term>
    </condition_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/NCT05989373
  org study id: 2022-A01972-41
  nct id: NCT05989373
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Carpal tunnel syndrome and compression of the ulnar nerve at the elbow are common
        pathologies, which are treated surgically.
  
        Diagnosis is usually based on an electromyogram (EMG), as well as symptomatology, etiology of
        typical symptoms and an evocative clinical examination. Provocative tests performed in
        consultation include the Tinel and Phalen sign for the carpal tunnel, and the Tinel and
        prolonged flexion sign for the ulnar nerve at the elbow.
  
        The Scratch Collapse Test (SCT) has recently emerged as a new provocation test to help
        diagnose nerve compression in the upper limb.
  
        This non-invasive, pain-free test looks for a reduction in the force of external rotation of
        the shoulder by applying resistance (the doctor's arm), before and then after a sensory
        stimulus by "scratching" the area of compression. Nevertheless, this test remains
        controversial and not based on objective measurements.
  
        Our aim is therefore to assess shoulder external rotation force, and thus TBS, objectively
        with a dynamometer, before and after stimulation in cases of median nerve compression
        syndrome at the carpal tunnel and ulnar nerve compression syndrome at the elbow, when these
        are clinically and electromyographically proven.
  
        This test has already been studied in the literature, but the results in terms of sensitivity
        and specificity are highly disparate. One study has already published negative results on the
        subject, with the limitation that the trial was monocentric.
  
        Through this multicenter study, principal investigator wish to highlight the very probable
        subjectivity of the SCT when it is performed. As the resistance is applied by the physician's
        arm, the investigator cannot determine the force applied against the patient, unlike with a
        measurement object. The principal investigator expects this study to refute the notion that
        external shoulder rotation force decreases after trigger zone stimulation in cases of proven
        nerve compression syndrome.
  
        The results of this study will thus make it possible to discontinue the use of this technique
        if it does not help in the diagnosis of compression.
  
        The literature shows a lack of prospective, objective studies involving a large number of
        patients.
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Variation in the force of external rotation of the elbow
  time frame: Inclusion day
  description: measurement taken before the test and the measurement taken immediately after nerve stimulation according to the SCT. The force is measured with a dynamometer.
  arm group label: nerve stimulation
  arm group type: Experimental
  description: The test in currently used to search for a nerv compression
  intervention type: Diagnostic Test
  intervention name: Scratch collapse test
  description: Scratch test performed by the surgeon but with a dynamometer
  arm group label: nerve stimulation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 110 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: France
  responsible party type: Principal Investigator
  investigator affiliation: Clinique Saint Jean, France
  investigator full name: Benjamin DEGEORGE
  investigator title: Principal investigator
  mesh term: Carpal Tunnel Syndrome
  mesh term: Ulnar Nerve Compression Syndromes
  sharing ipd: No