<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/NCT02195674</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00054004</org_study_id>
    <secondary_id>3R01AT004623-06S2</secondary_id>
    <nct_id>NCT02195674</nct_id>
  </id_info>
  <brief_title>EMBARK Follow-up Project</brief_title>
  <acronym>EFP</acronym>
  <official_title>Exploring Massage Benefits for Arthritis of the Knee (EMBARK): Post-study Massage Questionnaire</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the EMBARK Follow-up Project (EFP) is to determine if there is a significant&#xD;
      correlation between post-study massage-seeking and changes in pain reported by participants&#xD;
      during the Exploring Massage Benefits for Osteoarthritis of the Knee (EMBARK) parent study&#xD;
      (NCT00970008). The EFP hypothesizes that a positive correlation exists between pain relief&#xD;
      during the parent study and post-study massage-seeking behavior.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</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>EMBARK Follow-up Project Questionnaire (EFPQ)</measure>
    <time_frame>Eight weeks</time_frame>
    <description>The EFPQ is an original set of questions, designed and validated by Dr. Jerger under the supervision of NCCAM and Dr. Ruth Wolever to be administered by email or phone to address the specific aims of this project.</description>
  </primary_outcome>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Osteoarthritis of the Knee</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Participants in the EMBARK parent study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Completed in the EMBARK parent study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Did not complete the EMBARK parent study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adam I Perlman, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>November 12, 2015</last_update_submitted>
  <last_update_submitted_qc>November 12, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 16, 2015</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>Osteoarthritis, Knee</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/NCT02195674
org study id: Pro00054004
secondary id: 3R01AT004623-06S2
nct id: NCT02195674
lead sponsor: 
collaborator: 
has dmc: No
The purpose of the EMBARK Follow-up Project (EFP) is to determine if there is a significant
      correlation between post-study massage-seeking and changes in pain reported by participants
      during the Exploring Massage Benefits for Osteoarthritis of the Knee (EMBARK) parent study
      (NCT00970008). The EFP hypothesizes that a positive correlation exists between pain relief
      during the parent study and post-study massage-seeking behavior.
observational model: Cohort
time perspective: Prospective
measure: EMBARK Follow-up Project Questionnaire (EFPQ)
time frame: Eight weeks
description: The EFPQ is an original set of questions, designed and validated by Dr. Jerger under the supervision of NCCAM and Dr. Ruth Wolever to be administered by email or phone to address the specific aims of this project.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: N/A
healthy volunteers: No
last name: Adam I Perlman, MD, MPH
role: Principal Investigator
affiliation: Duke University
responsible party type: Sponsor
mesh term: Osteoarthritis, Knee