<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/NCT01674387</url>
  </required_header>
  <id_info>
    <org_study_id>64385700</org_study_id>
    <secondary_id>ZYSNXD-CCHPGC-JD-007</secondary_id>
    <nct_id>NCT01674387</nct_id>
  </id_info>
  <brief_title>Clinical Study on Electroacupuncture Therapy for Chronic Neck Pain</brief_title>
  <official_title>Lu's Acupuncture Protocol for Chronic Neck Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Longhua Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanghai University of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose of this test is to observe and objectively evaluate electroacupuncture (EA) therapy&#xD;
      on the clinical efficacy in patients with chronic neck pain, and provide a reliable clinical&#xD;
      basis for the chronic neck pain treatment and evaluation of efficacy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to statistics, the incidence of chronic neck pain has significantly increased year&#xD;
      by year, particularly tending to younger people, as social competition increase fiercely and&#xD;
      the pace of people's daily work and life accelerate. Studying the effective treatment and&#xD;
      prevention of chronic neck pain has obvious medical, social and economic significance.&#xD;
      Purpose of this trial is to observe and objectively evaluate electroacupuncture (EA) therapy&#xD;
      on the clinical efficacy in patients with chronic neck pain, and provide a reliable clinical&#xD;
      basis for the chronic neck pain treatment and evaluation of efficacy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">August 2013</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>chronic neck pain-the Neck Pain Scale (NPQ)</measure>
    <time_frame>20 days(One course)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>the short-form McGill Pain Questionnaire</measure>
    <time_frame>20 days(One course)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>the SF-36 Health Questionnaire combined with Neck Disability Index (NDI).</measure>
    <time_frame>20 days(one course)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>chronic neck pain-the Neck Pain Scale (NPQ)</measure>
    <time_frame>one month after a course.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the short-form McGill Pain Questionnaire</measure>
    <time_frame>one month after a course</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the SF-36 Health Questionnaire combined with Neck Disability Index (NDI).</measure>
    <time_frame>one months after a course</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Neck Pains</condition>
  <arm_group>
    <arm_group_label>acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>56 patients (the EA group) receive the acupuncture treatment at nine acupuncture points: Dazhui (GV14), bilateral Jianzhongshu (SI15), bilateral Jingbailao (EX HN15), bilateral cervical Jiaji (EX-B2),and two trigger points.Bilateral Jianzhongshu (SI15) and Jiaji (EX-B2) receive the electro acupuncture treatment, with dilatational wave. All the needles retained for 20 minutes, one treatment every other day, 10 times a course, and the treatment assessed after a course.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>comprehensive treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Other 56 patients (the matched group) receive the comprehensive treatment, including traction and TENS(Transcutaneous Electrical Nerve Stimulation) therapy. Each treatment 20 minutes, one treatment every other day, 10 times a course, and the treatment assessed after a course.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>acupuncture</intervention_name>
    <description>56 patients (the EA group) receive the acupuncture treatment at nine acupuncture points: Dazhui (GV14), bilateral Jianzhongshu (SI15), bilateral Jingbailao (EX HN15), bilateral Jiaji (EX-B2) of cervical positive reaction plane (taking two pairs). Besides, bilateral Jianzhongshu (SI15) and bilateral Jiaji (EX-B2) receive the electro acupuncture treatment, with dilatational wave. All the needles retained for 20 minutes, one treatment every other day, 10 times a course, and the treatment assessed after a course.</description>
    <arm_group_label>acupuncture</arm_group_label>
    <other_name>electroacupuncture</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>comprehensive treatment</intervention_name>
    <description>Other 56 patients (the matched group) receive the comprehensive treatment, including traction and TENS therapy. Each treatment 20 minutes, one treatment every other day, 10 times a course, and the treatment assessed after a course.</description>
    <arm_group_label>comprehensive treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age of a subject is older than 18 and is younger than 65.&#xD;
&#xD;
          2. With more than 3 months history of neck pain.&#xD;
&#xD;
          3. Informed consent is signed by a subject or his lineal relation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. With serious protopathy or disease ofcardiovascular,liver,renal,gastrointestinal,&#xD;
             hematological systems and so on.&#xD;
&#xD;
          2. Psychotic，patients with allergic constitution or easily getting infected or bleeding.&#xD;
&#xD;
          3. Patients have used drugs for preventing neck pain in the last four weeks.&#xD;
&#xD;
          4. Pregnant women or women in lactation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jian Pei, MD</last_name>
    <role>Study Director</role>
    <affiliation>Longhua Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Qinhui Fu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Longhua Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jia Yan, MM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Univercity of TCM</affiliation>
  </overall_official>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>August 10, 2021</last_update_submitted>
  <last_update_submitted_qc>August 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai University of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Jian Pei,MD</investigator_full_name>
    <investigator_title>MD,professor</investigator_title>
  </responsible_party>
  <keyword>electroacupuncture therapy</keyword>
  <keyword>neck pain</keyword>
  <keyword>McGill Pain Questionnaire</keyword>
  <keyword>Acupuncture Therapy</keyword>
  <keyword>Electroacupuncture</keyword>
  <keyword>Meridians</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT01674387
org study id: 64385700
secondary id: ZYSNXD-CCHPGC-JD-007
nct id: NCT01674387
lead sponsor: 
collaborator: 
has dmc: Yes
Purpose of this test is to observe and objectively evaluate electroacupuncture (EA) therapy
      on the clinical efficacy in patients with chronic neck pain, and provide a reliable clinical
      basis for the chronic neck pain treatment and evaluation of efficacy.
According to statistics, the incidence of chronic neck pain has significantly increased year
      by year, particularly tending to younger people, as social competition increase fiercely and
      the pace of people's daily work and life accelerate. Studying the effective treatment and
      prevention of chronic neck pain has obvious medical, social and economic significance.
      Purpose of this trial is to observe and objectively evaluate electroacupuncture (EA) therapy
      on the clinical efficacy in patients with chronic neck pain, and provide a reliable clinical
      basis for the chronic neck pain treatment and evaluation of efficacy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: chronic neck pain-the Neck Pain Scale (NPQ)
time frame: 20 days(One course)
measure: the short-form McGill Pain Questionnaire
time frame: 20 days(One course)
measure: the SF-36 Health Questionnaire combined with Neck Disability Index (NDI).
time frame: 20 days(one course)
measure: chronic neck pain-the Neck Pain Scale (NPQ)
time frame: one month after a course.
measure: the short-form McGill Pain Questionnaire
time frame: one month after a course
measure: the SF-36 Health Questionnaire combined with Neck Disability Index (NDI).
time frame: one months after a course
arm group label: acupuncture
arm group type: Experimental
description: 56 patients (the EA group) receive the acupuncture treatment at nine acupuncture points: Dazhui (GV14), bilateral Jianzhongshu (SI15), bilateral Jingbailao (EX HN15), bilateral cervical Jiaji (EX-B2),and two trigger points.Bilateral Jianzhongshu (SI15) and Jiaji (EX-B2) receive the electro acupuncture treatment, with dilatational wave. All the needles retained for 20 minutes, one treatment every other day, 10 times a course, and the treatment assessed after a course.
arm group label: comprehensive treatment
arm group type: Other
description: Other 56 patients (the matched group) receive the comprehensive treatment, including traction and TENS(Transcutaneous Electrical Nerve Stimulation) therapy. Each treatment 20 minutes, one treatment every other day, 10 times a course, and the treatment assessed after a course.
intervention type: Device
intervention name: acupuncture
description: 56 patients (the EA group) receive the acupuncture treatment at nine acupuncture points: Dazhui (GV14), bilateral Jianzhongshu (SI15), bilateral Jingbailao (EX HN15), bilateral Jiaji (EX-B2) of cervical positive reaction plane (taking two pairs). Besides, bilateral Jianzhongshu (SI15) and bilateral Jiaji (EX-B2) receive the electro acupuncture treatment, with dilatational wave. All the needles retained for 20 minutes, one treatment every other day, 10 times a course, and the treatment assessed after a course.
arm group label: acupuncture
other name: electroacupuncture
intervention type: Other
intervention name: comprehensive treatment
description: Other 56 patients (the matched group) receive the comprehensive treatment, including traction and TENS therapy. Each treatment 20 minutes, one treatment every other day, 10 times a course, and the treatment assessed after a course.
arm group label: comprehensive treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jian Pei, MD
role: Study Director
affiliation: Longhua Hospital
last name: Qinhui Fu, MD
role: Principal Investigator
affiliation: Longhua Hospital
last name: Jia Yan, MM
role: Principal Investigator
affiliation: Shanghai Univercity of TCM
responsible party type: Principal Investigator
investigator affiliation: Shanghai University of Traditional Chinese Medicine
investigator full name: Jian Pei,MD
investigator title: MD,professor
mesh term: Neck Pain