<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/NCT03005301</url>
  </required_header>
  <id_info>
    <org_study_id>2016XL007</org_study_id>
    <nct_id>NCT03005301</nct_id>
  </id_info>
  <brief_title>The CX-DZ-Ⅱ Intelligent Electroacupuncture Instrument for Neck Pain</brief_title>
  <official_title>The CX-DZ-Ⅱ Intelligent Electroacupuncture Instrument for Neck Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chengdu University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chengdu University of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study is a prospective, two-center, randomized, controlled, open-label,&#xD;
      non-inferiority trial evaluating the efficacy and safety of a new intelligent&#xD;
      electroacupuncture instrument in treating neck pain caused by cervical spondylosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 160 eligible patients will be included in this trial and randomly assigned to&#xD;
      experimental group and control group in a 1:1 ratio. In experimental group, selected&#xD;
      acupoints will be stimulated by the new intelligent electro-acupuncture instrument; while for&#xD;
      control group, electroacupuncture treatment will be accomplished by a pre-existing&#xD;
      electro-acupuncture instrument. The duration of treatment will be 2 weeks. The primary&#xD;
      outcome is the change of visual analog scale score after one course of treatment. The&#xD;
      secondary outcomes are visual analog scale score after each treatment, the responder rate,&#xD;
      drug-usage rate of non-steroidal antipyretic analgesics, the occurrence rate of adverse&#xD;
      events, defect rate of instrument, and excellent rate of instrument.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change of VAS scores from baseline to the completion of treatment</measure>
    <time_frame>0-2 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>VAS score after each treatment</measure>
    <time_frame>0-2weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Responder rate</measure>
    <time_frame>0-2weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of non-steroidal antipyretic analgesics</measure>
    <time_frame>0-2weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>0-2weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Acupuncture</condition>
  <condition>Neck Pain</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Selected acupoints will be stimulated by the new intelligent electro-acupuncture instrument.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Selected acupoints will be stimulated by the Hwato electroacupuncture instrument.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>intelligent electroacupuncture instrument</intervention_name>
    <description>Choice of major points: GB20, GB21, EX-B2, GV14. Choice of adjunct points based on syndrome differentiation.&#xD;
Trial instrument of this study is the CX-DZ-Ⅱ type intelligent electroacupuncture therapeutic instrument.Choice of acupuncture needle: one-off stainless acupuncture needle, which is 25~40mm in length and 0.30~0,38mm in diameter.Waveform: continuous-wave with frequency of 120~250 times per minute and current intensity within patients' tolerance.Treatment time: each treatment time is 30 minutes.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hwato electroacupuncture instrument</intervention_name>
    <description>Choice of major points: GB20, GB21, EX-B2, GV14. Choice of adjunct points based on syndrome differentiation.&#xD;
The Hwato electroacupuncture treatment instrument. Waveform: continuous-wave with frequency of 120~250 times per minute and current intensity within patients' tolerance.&#xD;
Treatment time: each treatment time is 30 minutes.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female between 18 and 75 years old.&#xD;
&#xD;
          -  Subject is diagnosed with CS of neck type or nerve-root type by clinical and medical&#xD;
             imaging examination.&#xD;
&#xD;
          -  A history of recurrent episodes of neck pain (one or more neck pain per month lasting&#xD;
             for more than 3 months).&#xD;
&#xD;
          -  Pain intensity is more than 3 points on a VAS upon recruitment.&#xD;
&#xD;
          -  Subject or his guardian comprehend the aims of this trial, promise not to accept other&#xD;
             relative treatments during the trial, and sign the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has acute neck trauma.&#xD;
&#xD;
          -  Previous medical history of neck trauma treated by surgery, or neurological deficit,&#xD;
             or congenital and developmental spinal disorders, or systemic bone diseases, or&#xD;
             systemic joint diseases (e.g. joint slippage).&#xD;
&#xD;
          -  Subject is diagnosed with carotid artery dissection.&#xD;
&#xD;
          -  Subject is unable to express clearly self-feelings (e.g. subject with severe&#xD;
             cerebrovascular accident sequelae).&#xD;
&#xD;
          -  Subject has infection in acupuncture region.&#xD;
&#xD;
          -  A history of acupuncture treatment for neck pain in the previous 1 week.&#xD;
&#xD;
          -  Use of non-steroidal antipyretic analgesics in the previous 3 days.&#xD;
&#xD;
          -  Subject has to use central analgesics or narcotic analgesics (e.g. Tramadol, Morphine,&#xD;
             Dolantin) during the period of clinic trial.&#xD;
&#xD;
          -  Use of various ointments or medicinal liquors with functions of promoting blood&#xD;
             circulation and/or easing pain.&#xD;
&#xD;
          -  Use of oral and intravenous medicines with functions of opening blood vessels and&#xD;
             providing nutrition to nerve.&#xD;
&#xD;
          -  Combinations of severe systematic diseases (e.g. a history of myocardial infarction,&#xD;
             or severe hepatic and renal dysfunction, or acute infectious diseases, or malignant&#xD;
             tumors, or severe mental disturbance diseases in previous 12 months).&#xD;
&#xD;
          -  Intolerance of acupuncture and electro-acupuncture.&#xD;
&#xD;
          -  Allergy to acupuncture.&#xD;
&#xD;
          -  Female in pregnancy or lactation.&#xD;
&#xD;
          -  Subject participate other clinic trials in previous 3 months.&#xD;
&#xD;
          -  Subject is considered to be unsuited to this trial by investigators.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yulan Ren, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chengdu University of Traditional Chinese Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Affliated Hospital of Chengdu University of Traditional Chinese Medicine</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610072</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital, Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610072</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>December 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>May 31, 2018</last_update_submitted>
  <last_update_submitted_qc>May 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>electroacupuncture instrument</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/NCT03005301
org study id: 2016XL007
nct id: NCT03005301
lead sponsor: 
collaborator: 
has dmc: No
The present study is a prospective, two-center, randomized, controlled, open-label,
      non-inferiority trial evaluating the efficacy and safety of a new intelligent
      electroacupuncture instrument in treating neck pain caused by cervical spondylosis.
A total of 160 eligible patients will be included in this trial and randomly assigned to
      experimental group and control group in a 1:1 ratio. In experimental group, selected
      acupoints will be stimulated by the new intelligent electro-acupuncture instrument; while for
      control group, electroacupuncture treatment will be accomplished by a pre-existing
      electro-acupuncture instrument. The duration of treatment will be 2 weeks. The primary
      outcome is the change of visual analog scale score after one course of treatment. The
      secondary outcomes are visual analog scale score after each treatment, the responder rate,
      drug-usage rate of non-steroidal antipyretic analgesics, the occurrence rate of adverse
      events, defect rate of instrument, and excellent rate of instrument.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The change of VAS scores from baseline to the completion of treatment
time frame: 0-2 weeks
measure: VAS score after each treatment
time frame: 0-2weeks
measure: Responder rate
time frame: 0-2weeks
measure: Use of non-steroidal antipyretic analgesics
time frame: 0-2weeks
measure: Adverse events
time frame: 0-2weeks
arm group label: Experimental group
arm group type: Experimental
description: Selected acupoints will be stimulated by the new intelligent electro-acupuncture instrument.
arm group label: Control group
arm group type: Active Comparator
description: Selected acupoints will be stimulated by the Hwato electroacupuncture instrument.
intervention type: Device
intervention name: intelligent electroacupuncture instrument
description: Choice of major points: GB20, GB21, EX-B2, GV14. Choice of adjunct points based on syndrome differentiation.
Trial instrument of this study is the CX-DZ-Ⅱ type intelligent electroacupuncture therapeutic instrument.Choice of acupuncture needle: one-off stainless acupuncture needle, which is 25~40mm in length and 0.30~0,38mm in diameter.Waveform: continuous-wave with frequency of 120~250 times per minute and current intensity within patients' tolerance.Treatment time: each treatment time is 30 minutes.
arm group label: Experimental group
intervention type: Device
intervention name: Hwato electroacupuncture instrument
description: Choice of major points: GB20, GB21, EX-B2, GV14. Choice of adjunct points based on syndrome differentiation.
The Hwato electroacupuncture treatment instrument. Waveform: continuous-wave with frequency of 120~250 times per minute and current intensity within patients' tolerance.
Treatment time: each treatment time is 30 minutes.
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yulan Ren, Professor
role: Principal Investigator
affiliation: Chengdu University of Traditional Chinese Medicine
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Neck Pain
sharing ipd: No