<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/NCT02219555</url>
  </required_header>
  <id_info>
    <org_study_id>14-003444</org_study_id>
    <nct_id>NCT02219555</nct_id>
  </id_info>
  <brief_title>DUCATS Trial: Dynamic Ultrasound to Enhance Understanding of Carpal Tunnel Syndrome</brief_title>
  <acronym>DUCATS</acronym>
  <official_title>DUCATS Trial: Dynamic Ultrasound to Enhance Understanding of Carpal Tunnel Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
      The purpose of this study is to learn if researchers can identify through ultrasound images&#xD;
      and clinical assessment which subjects with carpel tunnel syndrome will do better following&#xD;
      standard of care non-surgical or surgical treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">August 15, 2020</completion_date>
  <primary_completion_date type="Actual">August 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in CTSAQ symptom score</measure>
    <time_frame>Baseline - 12 months</time_frame>
    <description>A change from baseline scores will be used to assess outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Hand/wrist pain by VAS</measure>
    <time_frame>Baseline - 12 month</time_frame>
    <description>A change from baseline will be used to assess outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in CTSAQ function score</measure>
    <time_frame>Baseline - 12 month</time_frame>
    <description>A change from baseline will be used to assess outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Center for Epidemiological Studies Depression (CES-D) questionnaire scoring</measure>
    <time_frame>Baseline - 12 month</time_frame>
    <description>CES-D questionnaire scoring will be used to assess outcomes</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">204</enrollment>
  <condition>Carpal Tunnel</condition>
  <arm_group>
    <arm_group_label>Non-surgical treatment</arm_group_label>
    <description>When clinically indicated, subjects will receive a standard of care carpal tunnel injection whose volume and specific steroid drug will be based on the recommendation of the treating clinician</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Surgical treatment</arm_group_label>
    <description>When clinically indicated, subjects will receive standard of care carpel tunnel release surgery as recommended by treating clinician</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Steroid Injection</intervention_name>
    <description>volume and specific steroid drug will be based on the recommendation of the treating clinician</description>
    <arm_group_label>Non-surgical treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Carpel Tunnel surgery</intervention_name>
    <description>Standard of care carpel tunnel surgery</description>
    <arm_group_label>Surgical treatment</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be identified among those presenting to the Hand Clinic with a referral&#xD;
        diagnosis of CTS, and from those referred for EDS with a referral diagnosis of CTS, who are&#xD;
        clinically indicated for either a steroid injection or surgery. Those who meet these and&#xD;
        the inclusion criteria, do not meet the exclusion criteria, and who consent to participate&#xD;
        will be entered in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        The following criteria must be answered yes to be enrolled:&#xD;
&#xD;
          1. Does the patient have a clinical symptoms of Carpal Tunnel Syndrome (CTS)?&#xD;
&#xD;
          2. Is the patient an adult between the ages of 21 and 80?&#xD;
&#xD;
          3. Has the patient had symptoms of numbness or tingling for at least 4 weeks in at least&#xD;
             two digits on one hand that include thumb, index, long or radial border of ring&#xD;
             finger?&#xD;
&#xD;
          4. Does the patient have a clinical diagnosis of carpal tunnel syndrome?&#xD;
&#xD;
          5. Has the patient had and electrodiagnostic study (EDS) or EMG? (Does not need to be&#xD;
             positive&gt;)&#xD;
&#xD;
          6. Is the patient able to understand and complete the study questionnaires and medical&#xD;
             assessments in English?&#xD;
&#xD;
          7. Is the patient clinically indicated for treatment with either a steroid injection or&#xD;
             surgery as treatment for their CTS?&#xD;
&#xD;
        EXCLUSION CRITERIA The following questions if answered yes will exclude the patient from&#xD;
        participation in the study.&#xD;
&#xD;
          1. Has the patient had previous carpal tunnel release (CTR) or other volar wrist surgery&#xD;
             on the hand?&#xD;
&#xD;
          2. Does the patient have a known tumor, mass or deformity of the study hand or wrist?&#xD;
&#xD;
          3. Does the patient have a previous history of steroid injection into the carpal tunnel&#xD;
             (injection group only)?&#xD;
&#xD;
          4. Does the patient have any of the following diagnoses or conditions:&#xD;
&#xD;
               1. cervical radiculopathy&#xD;
&#xD;
               2. rheumatoid arthritis or other inflammatory arthritis, including gout&#xD;
&#xD;
               3. osteoarthritis in the wrist&#xD;
&#xD;
               4. renal failure&#xD;
&#xD;
               5. morbid obesity (body mass index &gt;40)&#xD;
&#xD;
               6. sarcoidosis&#xD;
&#xD;
               7. peripheral nerve disease&#xD;
&#xD;
               8. Diabetes&#xD;
&#xD;
               9. thyroid disease or other metabolic disorder&#xD;
&#xD;
              10. pregnancy&#xD;
&#xD;
              11. amyloidosis&#xD;
&#xD;
              12. major trauma (fractures or complete ligamentous tears) to the study hand or&#xD;
                  wrist?&#xD;
&#xD;
          5. Is the patient a prisoner, institutionalized individual or someone who could be&#xD;
             considered a vulnerable person, such as an individual with dementia?&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Amadio, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>August 16, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>May 13, 2021</last_update_submitted>
  <last_update_submitted_qc>May 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Peter C. Amadio, M.D.</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <keyword>Carpal tunnel</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carpal Tunnel 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/NCT02219555
org study id: 14-003444
nct id: NCT02219555
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to learn if researchers can identify through ultrasound images
      and clinical assessment which subjects with carpel tunnel syndrome will do better following
      standard of care non-surgical or surgical treatment.
observational model: Cohort
time perspective: Prospective
measure: Changes in CTSAQ symptom score
time frame: Baseline - 12 months
description: A change from baseline scores will be used to assess outcome
measure: Changes in Hand/wrist pain by VAS
time frame: Baseline - 12 month
description: A change from baseline will be used to assess outcome
measure: Change in CTSAQ function score
time frame: Baseline - 12 month
description: A change from baseline will be used to assess outcome
measure: Change in Center for Epidemiological Studies Depression (CES-D) questionnaire scoring
time frame: Baseline - 12 month
description: CES-D questionnaire scoring will be used to assess outcomes
arm group label: Non-surgical treatment
description: When clinically indicated, subjects will receive a standard of care carpal tunnel injection whose volume and specific steroid drug will be based on the recommendation of the treating clinician
arm group label: Surgical treatment
description: When clinically indicated, subjects will receive standard of care carpel tunnel release surgery as recommended by treating clinician
intervention type: Drug
intervention name: Steroid Injection
description: volume and specific steroid drug will be based on the recommendation of the treating clinician
arm group label: Non-surgical treatment
intervention type: Procedure
intervention name: Carpel Tunnel surgery
description: Standard of care carpel tunnel surgery
arm group label: Surgical treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: No
last name: Peter Amadio, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Peter C. Amadio, M.D.
investigator title: PI
mesh term: Carpal Tunnel Syndrome