<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/NCT01727960</url>
  </required_header>
  <id_info>
    <org_study_id>EduNSP</org_study_id>
    <nct_id>NCT01727960</nct_id>
  </id_info>
  <brief_title>The Effect of Education on Decreasing the Prevalence and Severity of Neck and Shoulder Pain</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Soonchunhyang University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Soonchunhyang University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Neck and shoulder pain (NSP) is fairly common among high school students in Korea.&#xD;
      Presumably, the high prevalence of NSP in Korean adolescents is a consequence of an&#xD;
      inappropriate static position for a prolonged period of time. We suspect that proper&#xD;
      education and posture correction for Korean adolescents may decrease the prevalence or&#xD;
      severity of NSP. Although several studies have focused on the etiology of NSP during&#xD;
      adolescence, few studies have addressed the management or prevention of NSP in adolescents,&#xD;
      despite its high prevalence in this age group. The aims of this prospective study was to&#xD;
      identify the effects of education, in terms of recognition of this issue and posture&#xD;
      correction, on prevalence and severity of NSP in Korean adolescents&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2012</start_date>
  <completion_date type="Anticipated">December 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</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>NRS score of neck and shoulder pain</measure>
    <time_frame>3 months later</time_frame>
    <description>numeric rating scale (NRS; range, 0-100)of neck and shoulder pain during the 1-week period preceding follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neck Disability Index (NDI)</measure>
    <time_frame>3 months later</time_frame>
    <description>Total NDI scores were interpreted as follows: 0-4, no disability; 5-14, mild disability; 15-24, moderate disability; 25-34, severe disability; &gt;34, complete disability</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1302</enrollment>
  <condition>Korean</condition>
  <condition>Male</condition>
  <condition>Adolescents</condition>
  <arm_group>
    <arm_group_label>Korean Male Adolescents</arm_group_label>
    <description>students from two academic high schools</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education and posture correction</intervention_name>
    <description>a lecture concerning the fine posture for health and exercises</description>
    <arm_group_label>Korean Male Adolescents</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        students from two academic high schools in the city of Seoul 912 students ranging in age&#xD;
        from participated.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  high school students&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  deny to participate&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Soonchunhyang Univsrsity Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>140-743</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Park Sun Young, Dr</last_name>
      <phone>8227099291</phone>
    </contact>
    <investigator>
      <last_name>Koh Min Jung, student</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>November 12, 2012</last_update_submitted>
  <last_update_submitted_qc>November 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 16, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Soonchunhyang University Hospital</investigator_affiliation>
    <investigator_full_name>Sun Young Park</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>Education</keyword>
  <keyword>Neck pain</keyword>
  <keyword>Shoulder pain</keyword>
  <keyword>Prevalence</keyword>
  <keyword>Associated factors</keyword>
  <keyword>Students</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</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/NCT01727960
org study id: EduNSP
nct id: NCT01727960
lead sponsor: 
has dmc: Yes
Neck and shoulder pain (NSP) is fairly common among high school students in Korea.
      Presumably, the high prevalence of NSP in Korean adolescents is a consequence of an
      inappropriate static position for a prolonged period of time. We suspect that proper
      education and posture correction for Korean adolescents may decrease the prevalence or
      severity of NSP. Although several studies have focused on the etiology of NSP during
      adolescence, few studies have addressed the management or prevention of NSP in adolescents,
      despite its high prevalence in this age group. The aims of this prospective study was to
      identify the effects of education, in terms of recognition of this issue and posture
      correction, on prevalence and severity of NSP in Korean adolescents
observational model: Cohort
time perspective: Prospective
measure: NRS score of neck and shoulder pain
time frame: 3 months later
description: numeric rating scale (NRS; range, 0-100)of neck and shoulder pain during the 1-week period preceding follow-up
measure: Neck Disability Index (NDI)
time frame: 3 months later
description: Total NDI scores were interpreted as follows: 0-4, no disability; 5-14, mild disability; 15-24, moderate disability; 25-34, severe disability; >34, complete disability
arm group label: Korean Male Adolescents
description: students from two academic high schools
intervention type: Behavioral
intervention name: Education and posture correction
description: a lecture concerning the fine posture for health and exercises
arm group label: Korean Male Adolescents
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 16 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Soonchunhyang University Hospital
investigator full name: Sun Young Park
investigator title: Doctor
mesh term: Shoulder Pain