<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/NCT02240849</url>
  </required_header>
  <id_info>
    <org_study_id>JS-CT-2014-03</org_study_id>
    <nct_id>NCT02240849</nct_id>
  </id_info>
  <brief_title>Effectiveness of Functional Pillow on Neck Pain, Disability, Quality of Sleep and Life</brief_title>
  <acronym>EPNS</acronym>
  <official_title>Effectiveness of Functionally Customized Pillow on Neck Pain, Disability, Quality of Sleep and Life: Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jaseng Hospital of Korean Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jaseng Hospital of Korean Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effects of functional cervical pillow on&#xD;
      inpatients with neck discomfort.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      50 inpatients with neck discomfort(NRS&gt;4) will be randomly allocated to 2 groups. The&#xD;
      experimental group was treated with functional cervical pillow and the control group was&#xD;
      treated with general pillow. All applications of pillow were limited to 3-4 weeks. Primary&#xD;
      outcomes were measured using the VAS scale. Post-treatment follow-up will be performed to&#xD;
      measure primary outcomes at baseline, 3 day, per weeks until the duration of admission.&#xD;
      Satisfaction levels of the patient's current status, Neck disability Index(NDI) PSQI, EQ-5D&#xD;
      will also be collected. The applicants will also get thru the diagnosis of range of motion by&#xD;
      X-ray(flexion, neutral, extension of their neck position)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in Neck discomfort on Visual Analogue Scale(VAS)</measure>
    <time_frame>At baseline, 3 day, week 1, 2, 3, 4 following intervention</time_frame>
    <description>The patient is asked to mark on the visual analogue scale the intensity of the neck discomfort they are experiencing during night and morning</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Satisfaction levels on present status of him/her</measure>
    <time_frame>At baseline, 3 day, week 1, 2, 3, 4 following intervention</time_frame>
    <description>5-point Likert scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in functional impairment on Neck Disability Index(NDI)</measure>
    <time_frame>At baseline, week 2, 4 following intervention</time_frame>
    <description>The NDI is a modification of the Oswestry Low Back Pain Disability Index . It is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in quality of sleep on Pittsburgh Sleep Quality Index(PSQI)</measure>
    <time_frame>At baseline, week 2, 4 following intervention</time_frame>
    <description>The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep. It differentiates &quot;poor&quot; from &quot;good&quot; sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration,habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in quality of life on EuroQol Group-5 dimension(EQ-5D)</measure>
    <time_frame>At baseline, week 4 following intervention</time_frame>
    <description>This is for checking the patients' changes on Quality of Life after using the cervical pillow</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in radiological angle on Range of motion(ROM)</measure>
    <time_frame>At baseline, week 4</time_frame>
    <description>ROM of applicants will be assessed by X-ray diagnosis. (neutral, flexion, extension view)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Neck Pain</condition>
  <condition>Posterior Cervical Pain</condition>
  <condition>Sleep Disorders</condition>
  <arm_group>
    <arm_group_label>Functional pillow</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cervical pillow, designed functionally to decrease neck pain and help to ensure the right support of the cervical curve, was applied to patients' posterior neck area.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>General pillow</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Applicants Randomly allocated to this group were issued by placebo-general pillow. There is not any specific intervention for their neck discomfort except for that.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Functional pillow</intervention_name>
    <description>streamlined shape for cervical lordosis memory foam pillow functional design considered several sleep position</description>
    <arm_group_label>Functional pillow</arm_group_label>
    <other_name>Functional pillow (Jaseng-chuna pillow™)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo general pillow</intervention_name>
    <arm_group_label>General pillow</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted to a Korean Medicine hospital&#xD;
&#xD;
          -  Age between 18 and 69&#xD;
&#xD;
          -  NRS score of &gt;4 on the day of the intervention&#xD;
&#xD;
          -  Voluntary participation with written consent given to study consent form, including&#xD;
             cervical x-ray&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of serious disease(s) which are possible causes of neck pain such as&#xD;
             malignancy, vertebral fracture, spinal infection, inflammatory spondylitis,&#xD;
             cauda-equina compression, etc.&#xD;
&#xD;
          -  Prior diagnosis of other chronic disease(s) which could affect effectiveness or&#xD;
             interpretation of treatment results such as cardiovascular disease, diabetic&#xD;
             neuropathy, fibromyalgia, rheumatoid arthritis, Alzheimer's disease, epilepsy, etc.&#xD;
&#xD;
          -  Progressive neurologic deficit(s) or concurrent severe neurological symptoms&#xD;
&#xD;
          -  Previously using any kind of functional pillow&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joonshik Shin</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jaseng Hospital of Korean Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jaseng Hospital of Korean Medicine</name>
      <address>
        <city>Seoul</city>
        <state>Gangnam-Gu</state>
        <zip>135-896</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>November 5, 2018</last_update_submitted>
  <last_update_submitted_qc>November 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jaseng Hospital of Korean Medicine</investigator_affiliation>
    <investigator_full_name>In-Hyuk Ha</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>Neck pain</keyword>
  <keyword>functional pillow</keyword>
  <keyword>sleep</keyword>
  <keyword>cervical lordosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Wake Disorders</mesh_term>
    <mesh_term>Neck 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/NCT02240849
org study id: JS-CT-2014-03
nct id: NCT02240849
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the effects of functional cervical pillow on
      inpatients with neck discomfort.
50 inpatients with neck discomfort(NRS>4) will be randomly allocated to 2 groups. The
      experimental group was treated with functional cervical pillow and the control group was
      treated with general pillow. All applications of pillow were limited to 3-4 weeks. Primary
      outcomes were measured using the VAS scale. Post-treatment follow-up will be performed to
      measure primary outcomes at baseline, 3 day, per weeks until the duration of admission.
      Satisfaction levels of the patient's current status, Neck disability Index(NDI) PSQI, EQ-5D
      will also be collected. The applicants will also get thru the diagnosis of range of motion by
      X-ray(flexion, neutral, extension of their neck position)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Change from baseline in Neck discomfort on Visual Analogue Scale(VAS)
time frame: At baseline, 3 day, week 1, 2, 3, 4 following intervention
description: The patient is asked to mark on the visual analogue scale the intensity of the neck discomfort they are experiencing during night and morning
measure: Change from baseline in Satisfaction levels on present status of him/her
time frame: At baseline, 3 day, week 1, 2, 3, 4 following intervention
description: 5-point Likert scale
measure: Change from baseline in functional impairment on Neck Disability Index(NDI)
time frame: At baseline, week 2, 4 following intervention
description: The NDI is a modification of the Oswestry Low Back Pain Disability Index . It is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.
measure: Change from baseline in quality of sleep on Pittsburgh Sleep Quality Index(PSQI)
time frame: At baseline, week 2, 4 following intervention
description: The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep. It differentiates "poor" from "good" sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration,habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month.
measure: Change from baseline in quality of life on EuroQol Group-5 dimension(EQ-5D)
time frame: At baseline, week 4 following intervention
description: This is for checking the patients' changes on Quality of Life after using the cervical pillow
measure: Change from baseline in radiological angle on Range of motion(ROM)
time frame: At baseline, week 4
description: ROM of applicants will be assessed by X-ray diagnosis. (neutral, flexion, extension view)
arm group label: Functional pillow
arm group type: Experimental
description: cervical pillow, designed functionally to decrease neck pain and help to ensure the right support of the cervical curve, was applied to patients' posterior neck area.
arm group label: General pillow
arm group type: Placebo Comparator
description: Applicants Randomly allocated to this group were issued by placebo-general pillow. There is not any specific intervention for their neck discomfort except for that.
intervention type: Device
intervention name: Functional pillow
description: streamlined shape for cervical lordosis memory foam pillow functional design considered several sleep position
arm group label: Functional pillow
other name: Functional pillow (Jaseng-chuna pillow™)
intervention type: Device
intervention name: Placebo general pillow
arm group label: General pillow
criteria: 
gender: All
minimum age: 18 Years
maximum age: 69 Years
healthy volunteers: No
last name: Joonshik Shin
role: Principal Investigator
affiliation: Jaseng Hospital of Korean Medicine
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Jaseng Hospital of Korean Medicine
investigator full name: In-Hyuk Ha
investigator title: Dr
mesh term: Sleep Wake Disorders
mesh term: Neck Pain