<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/NCT03009071</url>
  </required_header>
  <id_info>
    <org_study_id>JS-CT-2016-18</org_study_id>
    <nct_id>NCT03009071</nct_id>
  </id_info>
  <brief_title>Effectiveness and Cost-effectiveness of Doin (Conduction Exercise) for Chronic Neck Pain</brief_title>
  <official_title>The Effectiveness and Cost-effectiveness of Doin (Conduction Exercise) for Chronic Neck Pain: a Pilot Multicenter Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jaseng Medical Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jaseng Medical Foundation</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>
      A pilot multicenter randomized controlled trial will be conducted to evaluate the clinical&#xD;
      effectiveness, cost-effectiveness, and safety of Doin (conduction exercise) with acupuncture&#xD;
      for chronic neck pain patients compared to acupuncture alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A pilot multicenter randomized controlled, parallel, assessor-blinded trial will be conducted&#xD;
      to evaluate the comparative clinical effectiveness and cost-effectiveness of Doin (conduction&#xD;
      exercise) with acupuncture for chronic neck pain patients with acupuncture alone as assessed&#xD;
      by pain and functional disability scales, monitor its safety, and assess the feasibility of&#xD;
      and serve as the basis for a full-scale, multicenter trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 27, 2017</start_date>
  <completion_date type="Actual">August 22, 2018</completion_date>
  <primary_completion_date type="Actual">August 23, 2017</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Northwick Park Neck Pain Questionnaire (NPQ)</measure>
    <time_frame>6 weeks from baseline</time_frame>
    <description>Change in pain and functional disability questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Northwick Park Neck Pain Questionnaire (NPQ)</measure>
    <time_frame>Baseline (Week 1), Week 4, 6, 9, 17, 29, 53</time_frame>
    <description>Pain and functional disability questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numeric rating scale (NRS) of neck and arm pain</measure>
    <time_frame>Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53</time_frame>
    <description>Pain scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analogue scale (VAS) of neck and arm pain</measure>
    <time_frame>Baseline (Week 1), Week 2, 3, 4, 5, 6</time_frame>
    <description>Pain scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neck Disability Index (NDI)</measure>
    <time_frame>Baseline (Week 1), Week 4, 6, 9, 17, 29, 53</time_frame>
    <description>Functional disability questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol-5 Dimension (EQ-5D)</measure>
    <time_frame>Baseline (Week 1), Week 4, 6, 9, 17, 29, 53</time_frame>
    <description>Health-related quality of life questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change (PGIC)</measure>
    <time_frame>Week 4, 6, 9, 17, 29, 53</time_frame>
    <description>Global, patient-reported outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form Health Survey 12 (SF-12)</measure>
    <time_frame>Baseline (Week 1), Week 4, 6, 9, 17, 29, 53</time_frame>
    <description>Health-related quality of life questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost per QALY (quality-adjusted life year)</measure>
    <time_frame>Baseline (Week 1), Week 4, 6, 9, 17, 29, 53</time_frame>
    <description>Economic evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost per NRS</measure>
    <time_frame>Baseline (Week 1), Week 4, 6, 9, 17, 29, 53</time_frame>
    <description>Economic evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug Consumption</measure>
    <time_frame>Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit)</time_frame>
    <description>Drug type and dose of prescribe for medicine or rescue medicine, and type and frequency of other treatments (e.g. physical therapy, injection therapy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit)</time_frame>
    <description>Safety outcome</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Chronic Neck Pain</condition>
  <arm_group>
    <arm_group_label>Doin with Acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An acupuncture physician will administer acupuncture at 6-12 acupoints in the upper and middle trapezius area (mandatory points: both SI15, TE15, and LI16; and selective points: GB20, BL10, GV14, SI14, and Hyeopcheok (Huatuo Jiaji, EX B2) points at C3-5 levels). Cervical Doin (conduction exercise) will be performed with the needles in situ by increasing the cervical range of motion (rotation) with physician guidance and isometric resistance exercise (rotation) as needed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acupuncture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>An acupuncture physician will administer acupuncture at 6-12 acupoints in the upper and middle trapezius area (mandatory points: both SI15, TE15, and LI16; and selective points: GB20, BL10, GV14, SI14, and Hyeopcheok (Huatuo Jiaji, EX B2) points at C3-5 levels).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Doin (conduction exercise)</intervention_name>
    <description>Doin (conduction exercise) will be combined with acupuncture as active and passive movement to the aim of effective treatment of pain and functional disability. Doin (conduction exercise) sessions will be conducted 2 times a week for 5 weeks.</description>
    <arm_group_label>Doin with Acupuncture</arm_group_label>
    <other_name>Doin Exercise</other_name>
    <other_name>Do-in Exercise</other_name>
    <other_name>Conduction Exercise</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Acupuncture</intervention_name>
    <description>Acupuncture will be performed with manual stimulation (needle twirling) to evoke de-qi sensation. Acupuncture sessions will be conducted 2 times a week for 5 weeks.</description>
    <arm_group_label>Acupuncture</arm_group_label>
    <arm_group_label>Doin with Acupuncture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Onset of at least 6 months previous for neck area pain&#xD;
&#xD;
          -  Current neck area pain of Numeric Rating Scale (NRS) 5 or higher&#xD;
&#xD;
          -  Patients who have agreed to voluntarily participate in the clinical trial and given&#xD;
             written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pathologies of non-spinal or soft tissue origin or high severity which may cause neck&#xD;
             or radiating arm pain (e.g. malignant tumor, spinal infection, inflammatory&#xD;
             spondylitis, fibromyalgia, rheumatic arthritis, gout)&#xD;
&#xD;
          -  Progressive neurologic deficit or severe neurologic symptoms (e.g. cauda equina&#xD;
             syndrome, progressive muscle weakness)&#xD;
&#xD;
          -  Other chronic diseases which may interfere with treatment effect or interpretation of&#xD;
             results (e.g. cardiovascular disorder, renal disease, diabetic neuropathy, dementia,&#xD;
             epilepsy)&#xD;
&#xD;
          -  Current intake of steroids, immunosuppressant medicine, psychiatric medicine or other&#xD;
             medication which may interfere with treatment results&#xD;
&#xD;
          -  Patients considered unsuitable or unsafe to receive acupuncture (e.g. patients with&#xD;
             hemorrhagic diseases, blood clotting disorders, history of anti-coagulation medicine&#xD;
             intake, severe diabetes with high risk of infection, severe cardiovascular diseases)&#xD;
&#xD;
          -  Patients who were treated with invasive interventions such as acupuncture or&#xD;
             injections, or with medicine that may potentially influence pain such as NSAIDs&#xD;
             (nonsteroidal antiinflammatory drugs) within the past week&#xD;
&#xD;
          -  History of cervical surgery within the past 3 months&#xD;
&#xD;
          -  Pregnancy or plans of pregnancy&#xD;
&#xD;
          -  Severe psychopathy&#xD;
&#xD;
          -  Participation in other clinical studies&#xD;
&#xD;
          -  Inability to give written informed consent&#xD;
&#xD;
          -  Other reasons rendering trial participation inappropriate as judged by the researchers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>In-Hyuk Ha, KMD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jaseng Medical Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jaseng Medical Foundation</name>
      <address>
        <city>Seoul</city>
        <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>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>November 6, 2018</last_update_submitted>
  <last_update_submitted_qc>November 6, 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 Medical Foundation</investigator_affiliation>
    <investigator_full_name>In-Hyuk Ha, KMD</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>Neck Pain</keyword>
  <keyword>Disability Evaluation</keyword>
  <keyword>Costs and Cost Analysis</keyword>
  <keyword>Doin Exercise Therapy</keyword>
  <keyword>Acupuncture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neck Pain</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/NCT03009071
org study id: JS-CT-2016-18
nct id: NCT03009071
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A pilot multicenter randomized controlled trial will be conducted to evaluate the clinical
      effectiveness, cost-effectiveness, and safety of Doin (conduction exercise) with acupuncture
      for chronic neck pain patients compared to acupuncture alone.
A pilot multicenter randomized controlled, parallel, assessor-blinded trial will be conducted
      to evaluate the comparative clinical effectiveness and cost-effectiveness of Doin (conduction
      exercise) with acupuncture for chronic neck pain patients with acupuncture alone as assessed
      by pain and functional disability scales, monitor its safety, and assess the feasibility of
      and serve as the basis for a full-scale, multicenter trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Northwick Park Neck Pain Questionnaire (NPQ)
time frame: 6 weeks from baseline
description: Change in pain and functional disability questionnaire
measure: Northwick Park Neck Pain Questionnaire (NPQ)
time frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
description: Pain and functional disability questionnaire
measure: Numeric rating scale (NRS) of neck and arm pain
time frame: Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53
description: Pain scale
measure: Visual analogue scale (VAS) of neck and arm pain
time frame: Baseline (Week 1), Week 2, 3, 4, 5, 6
description: Pain scale
measure: Neck Disability Index (NDI)
time frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
description: Functional disability questionnaire
measure: EuroQol-5 Dimension (EQ-5D)
time frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
description: Health-related quality of life questionnaire
measure: Patient Global Impression of Change (PGIC)
time frame: Week 4, 6, 9, 17, 29, 53
description: Global, patient-reported outcome
measure: Short Form Health Survey 12 (SF-12)
time frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
description: Health-related quality of life questionnaire
measure: Cost per QALY (quality-adjusted life year)
time frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
description: Economic evaluation
measure: Cost per NRS
time frame: Baseline (Week 1), Week 4, 6, 9, 17, 29, 53
description: Economic evaluation
measure: Drug Consumption
time frame: Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit)
description: Drug type and dose of prescribe for medicine or rescue medicine, and type and frequency of other treatments (e.g. physical therapy, injection therapy)
measure: Adverse events
time frame: Baseline (Week 1), Week 2, 3, 4, 5, 6, 9, 17, 29, 53 (every visit)
description: Safety outcome
arm group label: Doin with Acupuncture
arm group type: Experimental
description: An acupuncture physician will administer acupuncture at 6-12 acupoints in the upper and middle trapezius area (mandatory points: both SI15, TE15, and LI16; and selective points: GB20, BL10, GV14, SI14, and Hyeopcheok (Huatuo Jiaji, EX B2) points at C3-5 levels). Cervical Doin (conduction exercise) will be performed with the needles in situ by increasing the cervical range of motion (rotation) with physician guidance and isometric resistance exercise (rotation) as needed.
arm group label: Acupuncture
arm group type: Active Comparator
description: An acupuncture physician will administer acupuncture at 6-12 acupoints in the upper and middle trapezius area (mandatory points: both SI15, TE15, and LI16; and selective points: GB20, BL10, GV14, SI14, and Hyeopcheok (Huatuo Jiaji, EX B2) points at C3-5 levels).
intervention type: Procedure
intervention name: Doin (conduction exercise)
description: Doin (conduction exercise) will be combined with acupuncture as active and passive movement to the aim of effective treatment of pain and functional disability. Doin (conduction exercise) sessions will be conducted 2 times a week for 5 weeks.
arm group label: Doin with Acupuncture
other name: Doin Exercise
other name: Do-in Exercise
other name: Conduction Exercise
intervention type: Device
intervention name: Acupuncture
description: Acupuncture will be performed with manual stimulation (needle twirling) to evoke de-qi sensation. Acupuncture sessions will be conducted 2 times a week for 5 weeks.
arm group label: Acupuncture
arm group label: Doin with Acupuncture
criteria: 
gender: All
minimum age: 19 Years
maximum age: 70 Years
healthy volunteers: No
last name: In-Hyuk Ha, KMD, MPH
role: Principal Investigator
affiliation: Jaseng Medical Foundation
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Jaseng Medical Foundation
investigator full name: In-Hyuk Ha, KMD
investigator title: Director
mesh term: Neck Pain
sharing ipd: No