<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/NCT02986035</url>
  </required_header>
  <id_info>
    <org_study_id>46/16</org_study_id>
    <nct_id>NCT02986035</nct_id>
  </id_info>
  <brief_title>Effectiveness of ECA Cream on Calcifying Shoulder Tendinitis</brief_title>
  <acronym>ECA</acronym>
  <official_title>Effectiveness of ECA Cream on Calcifying Shoulder Tendinitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Consorci Sanitari del Maresme</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>PRODUCTOS SANITARIOS ECA-RVB SLI</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Consorci Sanitari del Maresme</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot trail aims to assess the effectiveness of ECA cream in the treatment of calcifying&#xD;
      shoulder tendinitis in terms of:&#xD;
&#xD;
        1. Reduction or removal of shoulder calcifications&#xD;
&#xD;
        2. Functional improvements&#xD;
&#xD;
        3. Pain improvements 10 subjects will be assessed prior and 1 and 2 months post&#xD;
           intervention onset. The intervention will consist in the application of the ECA cream in&#xD;
           the affected shoulder twice a day during 1 month.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of shoulder calcifications</measure>
    <time_frame>2 months</time_frame>
    <description>X-ray</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Size of shoulder calcifications</measure>
    <time_frame>2 months</time_frame>
    <description>Ultrasonography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Shoulder functionality</measure>
    <time_frame>1 and 2 months</time_frame>
    <description>Constant Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shoulder pain</measure>
    <time_frame>1 and 2 months</time_frame>
    <description>Pain VAS (Visual Analogue Scale )</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Calcifying Shoulder Tendinitis</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ECA cream</intervention_name>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients &gt;=18 years&#xD;
&#xD;
          -  diagnosed of calcifying shoulder tendinitis diagnosed by a medical specialist&#xD;
             (rehabilitation, orthopedic surgeon or rheumatologist) by x-ray&#xD;
&#xD;
          -  with disease evolution of more than 3 months and less than 12 months&#xD;
&#xD;
          -  that give their informed consent by writing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous shoulder surgery patients&#xD;
&#xD;
          -  Patients with shoulder affections treated with shockwaves or corticosteroid&#xD;
             injections.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Consorci Sanitari del Maresme</name>
      <address>
        <city>Mataró</city>
        <state>Barcelona</state>
        <zip>08304</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>January 30, 2017</last_update_submitted>
  <last_update_submitted_qc>January 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Consorci Sanitari del Maresme</investigator_affiliation>
    <investigator_full_name>Lluís Guirao</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tendinopathy</mesh_term>
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02986035
org study id: 46/16
nct id: NCT02986035
lead sponsor: 
collaborator: 
has dmc: Yes
This pilot trail aims to assess the effectiveness of ECA cream in the treatment of calcifying
      shoulder tendinitis in terms of:

        1. Reduction or removal of shoulder calcifications

        2. Functional improvements

        3. Pain improvements 10 subjects will be assessed prior and 1 and 2 months post
           intervention onset. The intervention will consist in the application of the ECA cream in
           the affected shoulder twice a day during 1 month.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Presence of shoulder calcifications
time frame: 2 months
description: X-ray
measure: Size of shoulder calcifications
time frame: 2 months
description: Ultrasonography
measure: Shoulder functionality
time frame: 1 and 2 months
description: Constant Scale
measure: Shoulder pain
time frame: 1 and 2 months
description: Pain VAS (Visual Analogue Scale )
arm group label: Intervention
arm group type: Experimental
intervention type: Other
intervention name: ECA cream
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Consorci Sanitari del Maresme
investigator full name: Lluís Guirao
investigator title: PhD
mesh term: Tendinopathy
mesh term: Rotator Cuff Injuries
sharing ipd: No