<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/NCT02260310</url>
  </required_header>
  <id_info>
    <org_study_id>BL40GB30</org_study_id>
    <nct_id>NCT02260310</nct_id>
  </id_info>
  <brief_title>The Effect of Acupuncture Protocol Involving in Weizhong (BL4) and Huantiao (GB30) Points in Treating Ankylosing Spondylitis</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chengdu PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chengdu PLA General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of acupuncture protocol involving in&#xD;
      Weizhong (BL4) and Huantiao (GB30) points in treating ankylosing spondylitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">January 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in McGill Pain Questionnaire (MPQ) at 12 weeks</measure>
    <time_frame>At 0 week, 6 weeks, 12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Visual Analog Scale at 12 weeks</measure>
    <time_frame>At 0 week, 6 weeks, 12 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Ankylosing Spondylitis</condition>
  <arm_group>
    <arm_group_label>Weizhong and Huantiao</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with Ankylosing Spondylitis use the Acupuncture Protocol Involving in Weizhong (BL4) and Huantiao (GB30) Points</description>
  </arm_group>
  <arm_group>
    <arm_group_label>A-shi point</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with Ankylosing Spondylitis use the Acupuncture Protocol Involving in A-shi points, without including Weizhong (BL4) and Huantiao (GB30) Points</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Weizhong and Huantiao</intervention_name>
    <arm_group_label>Weizhong and Huantiao</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>A-shi point</intervention_name>
    <arm_group_label>A-shi point</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible adult (≥18 years of age) patients&#xD;
&#xD;
          -  had a diagnosis of AS for at least 3 months defined as definite by the 1984 modified&#xD;
             New York criteria&#xD;
&#xD;
          -  Eligible patients also had a Bath Ankylosing Spondylitis Disease Activity Index&#xD;
             (BASDAI) of ≥4 (0-10 cm scale)&#xD;
&#xD;
          -  A visual analogue scale (VAS) score for total back pain of ≥4 (0-10 cm scale)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Had received prior Acupuncture therapy&#xD;
&#xD;
          -  With complete ankylosis of the spine, defined as the presence of bridging&#xD;
             syndesmophytes at all intervertebral levels of the cervical and lumbar spine on&#xD;
             lateral view spinal radiographs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>270 Rongdu street, Jin-niu district,Rheumatology Center of Integrated Medicine, General Hospital of Chengdu Military Area Command PLA，</name>
      <address>
        <city>Chengdu city</city>
        <state>Sichuan</state>
        <zip>610083</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>March 31, 2017</last_update_submitted>
  <last_update_submitted_qc>March 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chengdu PLA General Hospital</investigator_affiliation>
    <investigator_full_name>Yang Min</investigator_full_name>
    <investigator_title>Ph.D</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
    <mesh_term>Spondylitis, Ankylosing</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/NCT02260310
org study id: BL40GB30
nct id: NCT02260310
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the effect of acupuncture protocol involving in
      Weizhong (BL4) and Huantiao (GB30) points in treating ankylosing spondylitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change from Baseline in McGill Pain Questionnaire (MPQ) at 12 weeks
time frame: At 0 week, 6 weeks, 12 weeks
measure: Change from Baseline in Visual Analog Scale at 12 weeks
time frame: At 0 week, 6 weeks, 12 weeks
arm group label: Weizhong and Huantiao
arm group type: Experimental
description: Patients with Ankylosing Spondylitis use the Acupuncture Protocol Involving in Weizhong (BL4) and Huantiao (GB30) Points
arm group label: A-shi point
arm group type: Active Comparator
description: Patients with Ankylosing Spondylitis use the Acupuncture Protocol Involving in A-shi points, without including Weizhong (BL4) and Huantiao (GB30) Points
intervention type: Other
intervention name: Weizhong and Huantiao
arm group label: Weizhong and Huantiao
intervention type: Other
intervention name: A-shi point
arm group label: A-shi point
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chengdu PLA General Hospital
investigator full name: Yang Min
investigator title: Ph.D
mesh term: Spondylitis
mesh term: Spondylarthritis
mesh term: Spondylitis, Ankylosing