<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/NCT01733914</url>
  </required_header>
  <id_info>
    <org_study_id>2007CB512501</org_study_id>
    <nct_id>NCT01733914</nct_id>
  </id_info>
  <brief_title>Contralateral Acupuncture in the Treatment of Chronic Shoulder Pain</brief_title>
  <official_title>Phase II Study of Contralateral Acupuncture in the Treatment of Chronic Shoulder Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Maryland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      According to traditional Chinese medical theories, a variety of acupuncture formulas can&#xD;
      treat diseases such as pain. For example, stimulating acupoints either local or distal to the&#xD;
      pain site has been proposed under some conditions. We hypothesize that stimulating acupoints&#xD;
      contralateral to the pain site can successfully treat chronic shoulder pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual analogue scale (VAS)</measure>
    <time_frame>before and 2, 4, 8 and 16 weeks after treatment start</time_frame>
    <description>Pain assessment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The MOS item short from health survey (SF-36)</measure>
    <time_frame>before and 8 and 16 weeks after treatment start</time_frame>
    <description>Quality of life assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Constant-Murley score</measure>
    <time_frame>before and 2, 4, 8 and 16 weeks after treatment start</time_frame>
    <description>shoulder motion score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DASH score</measure>
    <time_frame>before and 2, 4, 8 and 16 weeks after treatment start</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Shoulder Pain</condition>
  <arm_group>
    <arm_group_label>Acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting list</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Acupuncture</intervention_name>
    <description>Acupuncture in the following acupoints on the contralateral side of pain site: Jiantong, Zhongzhu, Houxi, and Quchi. The patient will receive 5 treatments (each lasts 30 min) per week for four weeks.</description>
    <arm_group_label>Acupuncture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Patients in the waiting list group received conventional orthopaedic therapy including physical exercise, heat or cold therapy. 50 mg diclofenac daily could be taken when the patient suffered from the pain. Injections or cortisone applications of any kind were not allowed.</description>
    <arm_group_label>Waiting list</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Uni-lateral shoulder pain for 6 weeks to 2 years&#xD;
&#xD;
          -  VAS score ≤ 50&#xD;
&#xD;
          -  25-65 years of age&#xD;
&#xD;
          -  Positive Neer's or Hawkins' signs&#xD;
&#xD;
          -  Accept the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Shoulder pain of neurological origins&#xD;
&#xD;
          -  Shoulder pain of neck origins&#xD;
&#xD;
          -  Systematic arthritis&#xD;
&#xD;
          -  Wrist problems&#xD;
&#xD;
          -  Previous shoulder, arm, neck or chest fractures or surgeries&#xD;
&#xD;
          -  Mental diseases&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Inability to work for more than 3 months before treatment&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Coagulative dysfunction&#xD;
&#xD;
          -  Corticosterone or physicotherapy experience on the affected shoulder in the last 6&#xD;
             months&#xD;
&#xD;
          -  Failure to accept the informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ming Yi, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Province Hospital of Integrative Chinese and Western Medicine, Sichuan</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>April 12, 2015</last_update_submitted>
  <last_update_submitted_qc>April 12, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 14, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>Ming Yi, PhD, principle investigator</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>shoulder pain</keyword>
  <keyword>acupuncture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder 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/NCT01733914
org study id: 2007CB512501
nct id: NCT01733914
lead sponsor: 
collaborator: 
has dmc: No
According to traditional Chinese medical theories, a variety of acupuncture formulas can
      treat diseases such as pain. For example, stimulating acupoints either local or distal to the
      pain site has been proposed under some conditions. We hypothesize that stimulating acupoints
      contralateral to the pain site can successfully treat chronic shoulder pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Visual analogue scale (VAS)
time frame: before and 2, 4, 8 and 16 weeks after treatment start
description: Pain assessment
measure: The MOS item short from health survey (SF-36)
time frame: before and 8 and 16 weeks after treatment start
description: Quality of life assessment
measure: Constant-Murley score
time frame: before and 2, 4, 8 and 16 weeks after treatment start
description: shoulder motion score
measure: DASH score
time frame: before and 2, 4, 8 and 16 weeks after treatment start
arm group label: Acupuncture
arm group type: Experimental
description: Experimental group
arm group label: Waiting list
arm group type: Sham Comparator
description: Control group
intervention type: Procedure
intervention name: Acupuncture
description: Acupuncture in the following acupoints on the contralateral side of pain site: Jiantong, Zhongzhu, Houxi, and Quchi. The patient will receive 5 treatments (each lasts 30 min) per week for four weeks.
arm group label: Acupuncture
intervention type: Other
intervention name: Control
description: Patients in the waiting list group received conventional orthopaedic therapy including physical exercise, heat or cold therapy. 50 mg diclofenac daily could be taken when the patient suffered from the pain. Injections or cortisone applications of any kind were not allowed.
arm group label: Waiting list
criteria: 
gender: All
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ming Yi, PhD
role: Principal Investigator
affiliation: Peking University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University
investigator full name: Ming Yi, PhD, principle investigator
investigator title: Dr
mesh term: Shoulder Pain