<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/NCT04491058</url>
  </required_header>
  <id_info>
    <org_study_id>S63134</org_study_id>
    <nct_id>NCT04491058</nct_id>
  </id_info>
  <brief_title>Assessment of Subsynovial Connective Tissue Thickness in Carpal Tunnel Syndrome</brief_title>
  <official_title>Assessment of Subsynovial Connective Tissue Thickness in Carpal Tunnel Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KU Leuven</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The general aim of this research is to gain insight in the role of SSCT in the etiology and&#xD;
      progression of CTS. We hypothesize that (degenerative) damage of the SSCT occurs early on in&#xD;
      the pathogenesis of CTS. Fibrotic damage to the SSCT will lead to altered morphology and&#xD;
      biomechanical characteristics. This eventually may lead to damage of the median nerve. To&#xD;
      examine the SSCT an ultrasound technique described by Van Doesburg et al. 2012 will be used&#xD;
      First, the reliability of the US technique to characterize morphology of the SSCT will be&#xD;
      investigated. Secondly, cross-sectional data will be collected in healthy subjects and CTS&#xD;
      patients to provide descriptive parameters and to describe differences between patients and&#xD;
      controls. In the final part a prospective study will be conducted to look at changes of SSCT&#xD;
      thickness over time and after treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 11, 2020</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Anticipated">August 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Inter- and intrarater reliability of subsynovial connective tissue thickness measurement with ultrasound</measure>
    <time_frame>baseline</time_frame>
    <description>To determine whether ultrasound is a reliable tool to measure SSCT thickness in patients with carpal tunnel syndrome and healthy subjects.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Baseline subsynovial connective tissue thickness</measure>
    <time_frame>Baseline</time_frame>
    <description>To determine correlations between SSCT thickness and participant characteristics (e.g., age, gender) in patients with carpal tunnel syndrome and healthy subjects. To obtain normative data for SSCT thickness in healthy subjects and patients with carpal tunnel syndrome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in subsynovial connective tissue thickness after 3, 6 and 12 months</measure>
    <time_frame>3, 6, 12 months</time_frame>
    <description>To evaluate the change in SSCT thickness over time in patients with carpal tunnel syndrome and healthy subjects (without intervention).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in subsynovial connective tissue thickness after treatment</measure>
    <time_frame>3, 6, 12 months</time_frame>
    <description>To evaluate the effect of treatment (i.e., surgery or infiltration) on SSCT thickness in patients with carpal tunnel syndrome. Orthopedic surgeon decides independently if and which treatment is necessary for the patient. If possible, to subgroup patients according to the correlation between their response to treatment, assessed with electrodiagnostic testing and clinical variables, and (change in) SSCT thickness.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Carpal Tunnel Syndrome</condition>
  <arm_group>
    <arm_group_label>Carpal tunnel syndrome patients</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>SSCT thickness measurement</intervention_name>
    <description>Thickness measurement with ultrasound</description>
    <arm_group_label>Carpal tunnel syndrome patients</arm_group_label>
    <arm_group_label>Healthy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with and without carpal tunnel syndrome&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For CTS patients&#xD;
&#xD;
          -  Human adults, 18 years and older&#xD;
&#xD;
          -  Complaints compatible with CTS (Katz Hand Diagram[31] rating of 'classic', 'probable'&#xD;
             or 'possible' or typical clinical signs)&#xD;
&#xD;
          -  Indication for electrodiagnostic testing&#xD;
&#xD;
          -  Informed consent to participate&#xD;
&#xD;
          -  For Healthy subjects&#xD;
&#xD;
          -  Human adults, 18 years and older&#xD;
&#xD;
          -  Negative electrodiagnostic testing and scoring 'unlikely' at Katz Hand diagram&#xD;
&#xD;
          -  Informed consent to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  History of renal disease, diabetes, chemotherapy, tumors, other neurological diseases&#xD;
             (e.g., polyneuropathy), thyroid disease&#xD;
&#xD;
          -  Problems of the upper limb, e.g., degenerative and inflammatory joint disease, gout,&#xD;
             tendinopathy at the wrist, acute trauma of the upper limb&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Elise Robben, MD</last_name>
    <phone>+3216338700</phone>
    <email>elise.robben@kuleuven.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elise Robben</last_name>
      <phone>+3216338700</phone>
      <email>elise.robben@kuleuven.be</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>September 29, 2021</last_update_submitted>
  <last_update_submitted_qc>September 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KU Leuven</investigator_affiliation>
    <investigator_full_name>Elise Robben</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Carpal Tunnel Syndrome</keyword>
  <keyword>Subsynovial Connective Tissue</keyword>
  <keyword>Ultrasound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carpal Tunnel Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT04491058
org study id: S63134
nct id: NCT04491058
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The general aim of this research is to gain insight in the role of SSCT in the etiology and
      progression of CTS. We hypothesize that (degenerative) damage of the SSCT occurs early on in
      the pathogenesis of CTS. Fibrotic damage to the SSCT will lead to altered morphology and
      biomechanical characteristics. This eventually may lead to damage of the median nerve. To
      examine the SSCT an ultrasound technique described by Van Doesburg et al. 2012 will be used
      First, the reliability of the US technique to characterize morphology of the SSCT will be
      investigated. Secondly, cross-sectional data will be collected in healthy subjects and CTS
      patients to provide descriptive parameters and to describe differences between patients and
      controls. In the final part a prospective study will be conducted to look at changes of SSCT
      thickness over time and after treatment.
observational model: Case-Control
time perspective: Prospective
measure: Inter- and intrarater reliability of subsynovial connective tissue thickness measurement with ultrasound
time frame: baseline
description: To determine whether ultrasound is a reliable tool to measure SSCT thickness in patients with carpal tunnel syndrome and healthy subjects.
measure: Baseline subsynovial connective tissue thickness
time frame: Baseline
description: To determine correlations between SSCT thickness and participant characteristics (e.g., age, gender) in patients with carpal tunnel syndrome and healthy subjects. To obtain normative data for SSCT thickness in healthy subjects and patients with carpal tunnel syndrome.
measure: Change in subsynovial connective tissue thickness after 3, 6 and 12 months
time frame: 3, 6, 12 months
description: To evaluate the change in SSCT thickness over time in patients with carpal tunnel syndrome and healthy subjects (without intervention).
measure: Change in subsynovial connective tissue thickness after treatment
time frame: 3, 6, 12 months
description: To evaluate the effect of treatment (i.e., surgery or infiltration) on SSCT thickness in patients with carpal tunnel syndrome. Orthopedic surgeon decides independently if and which treatment is necessary for the patient. If possible, to subgroup patients according to the correlation between their response to treatment, assessed with electrodiagnostic testing and clinical variables, and (change in) SSCT thickness.
arm group label: Carpal tunnel syndrome patients
arm group label: Healthy
intervention type: Diagnostic Test
intervention name: SSCT thickness measurement
description: Thickness measurement with ultrasound
arm group label: Carpal tunnel syndrome patients
arm group label: Healthy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Elise Robben, MD
phone: +3216338700
email: elise.robben@kuleuven.be
facility: 
status: Recruiting
contact: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: KU Leuven
investigator full name: Elise Robben
investigator title: Principal investigator
mesh term: Carpal Tunnel Syndrome
mesh term: Syndrome