<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/NCT03299439</url>
  </required_header>
  <id_info>
    <org_study_id>20178159950025</org_study_id>
    <nct_id>NCT03299439</nct_id>
  </id_info>
  <brief_title>Acupuncture Treatment for Knee Osteoarthritis With Sensitive Acupoints and Tender Points</brief_title>
  <official_title>A Multi-center Randomized Controlled Trial of Acupuncture Treatment for Knee Osteoarthritis With Sensitive Acupoints and Tender Points</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West China Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators plan to investigate the effectiveness of acupuncture at highly sensitive&#xD;
      points, compared with lowly/non-sensitive points or no acupuncture (waiting-list), in&#xD;
      improving pain, joint function and quality of life, among patients with KOA. The safety of&#xD;
      acupuncture will also be assessed during the study period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants in the high sensitization group receive acupuncture treatment at the five highly&#xD;
      sensitive points; Participants in the low/non-sensitization group receive acupuncture&#xD;
      treatment at the five low/non-sensitive points and all other treatment settings will be the&#xD;
      same as in the high sensitization group. Patients in the waiting-list group will receive&#xD;
      standard acupuncture treatment after the study is completed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 25, 2017</start_date>
  <completion_date type="Actual">November 20, 2020</completion_date>
  <primary_completion_date type="Actual">November 20, 2020</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>The change of Western Ontario and McMaster Universities Osteoarthritis index total score from baseline to 16 weeks</measure>
    <time_frame>Assessments will be conducted at baseline and 16 weeks after randomization</time_frame>
    <description>It consists of 24 items assessing the knee osteoarthritis patients pain, stiffness, and physical function. Each of the 24 items will be graded on a visual analog scale ranging from 0 to 10, with higher scores reflecting more pain, stiffness and poorer physical function.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change of Short Form (SF)-12 health survey score from baseline to 16 weeks</measure>
    <time_frame>Assessments will be conducted at baseline and 16 weeks after randomization</time_frame>
    <description>It includes 12 items: 2 items on physical functioning, 2 items on role limitations because of physical health problems, 1 item on bodily pain, 1 item on general health perceptions, 1 item on vitality (energy/fatigue), 1 item on social functioning, 2 items on role limitations because of emotional problems, and 2 items on general mental health (psychological distress and psychological well-being).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The changes of knee ranges of motion (ROMs) from baseline to 16 weeks</measure>
    <time_frame>Assessments will be conducted at baseline and 16 weeks after randomization</time_frame>
    <description>The knee ROMs will be assessed both actively and passively by using a standard goniometer. It will include flexion, extension, internal rotation and external rotation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The changes of pressure-pain threshold of the five selected acupuncture points from baseline to 16 weeks</measure>
    <time_frame>Assessments will be conducted at baseline and 16 weeks after randomization</time_frame>
    <description>The pressure-pain threshold of the five selected acupuncture points will be measured using the electronic von Frey detector.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">666</enrollment>
  <condition>Acupuncture</condition>
  <condition>Knee Osteoarthritis</condition>
  <condition>Sensitive Acupoints</condition>
  <condition>Tender Points</condition>
  <arm_group>
    <arm_group_label>acupuncture at highly sensitive points</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sterile, single-use filiform acupuncture needles (Hwato Needles, Sino-foreign Joint Venture Suzhou Hwato Medical Instruments Co., China) with a length of 40 mm and a diameter of 0.30 mm will be inserted to a depth of 15-30mm in five highly sensitive points.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>acupuncture at lowly/non-sensitive points</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sterile, single-use filiform acupuncture needles (Hwato Needles, Sino-foreign Joint Venture Suzhou Hwato Medical Instruments Co., China) with a length of 40 mm and a diameter of 0.30 mm will be inserted to a depth of 15-30mm in five low/non-sensitive points.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no acupuncture (waiting-list)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in the waiting-list group will not receive any acupuncture intervention during the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>acupuncture</intervention_name>
    <description>a stimulation of the body or auricular points</description>
    <arm_group_label>acupuncture at highly sensitive points</arm_group_label>
    <arm_group_label>acupuncture at lowly/non-sensitive points</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants aged 40 years or older and diagnosed with mild or moderate knee&#xD;
             osteoarthritis(KOA) are eligible to participate in the study&#xD;
&#xD;
          -  The following criteria are used for diagnosis of KOA:&#xD;
&#xD;
               -  refractory knee pain for most days in the last month;&#xD;
&#xD;
               -  joint space narrowing, sclerosis or cystic change in subchondral bone (as&#xD;
                  demonstrated in X-ray);&#xD;
&#xD;
               -  laboratory examinations of arthritis: clear and viscous synovial fluid (≥2 times)&#xD;
                  and white blood cell count &lt; 2000/mm3;&#xD;
&#xD;
               -  morning stiffness continues less than 30 minutes;&#xD;
&#xD;
               -  bone sound exists when joints was taking flexion and/or extension. If a patient&#xD;
                  meets criteria 1 and 2, or criteria 1, 3, 4, and 5, a diagnosis of KOA is&#xD;
                  confirmed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will be excluded if they meet any of the following:&#xD;
&#xD;
          -  diagnosed with conditions leading to skeletal disorders, such as tuberculosis, tumors&#xD;
             or rheumatism of the knee joint and rheumatoid arthritis;&#xD;
&#xD;
          -  present sprain or trauma in the lower limb;&#xD;
&#xD;
          -  unable to walk properly due to foot deformity or pain;&#xD;
&#xD;
          -  present with mental disorders;&#xD;
&#xD;
          -  present with comorbidities including severe cardiovascular disease, liver or kidney&#xD;
             impairment, immunodeficiency, diabetes mellitus, blood disorder or skin disease;&#xD;
&#xD;
          -  females who are pregnant or lactating;&#xD;
&#xD;
          -  using physiotherapy treatments for osteoarthritis knee pain;&#xD;
&#xD;
          -  have used intra-articular injection of glucocorticoid or viscosupplementation in the&#xD;
             past six months;&#xD;
&#xD;
          -  received knee-replacement surgery;&#xD;
&#xD;
          -  diagnosed with severe (stage 4, according to Kellgren and Lawrence radiographic&#xD;
             classification) or late clinical stage of KOA;&#xD;
&#xD;
          -  have a swollen knee or positive result of floating patella test; or'&#xD;
&#xD;
          -  are participating or have participated in the other clinical trials.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xin Sun, Phd</last_name>
    <role>Study Chair</role>
    <affiliation>West China Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>the Third Affiliated Hospital of Henan University of Traditional Chinese Medicine</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wuhan Integrated Traditional Chinese Medicine and Western Medicine Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610075</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>December 21, 2021</last_update_submitted>
  <last_update_submitted_qc>December 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West China Hospital</investigator_affiliation>
    <investigator_full_name>Sun Xin</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT03299439/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT03299439/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03299439
org study id: 20178159950025
nct id: NCT03299439
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The investigators plan to investigate the effectiveness of acupuncture at highly sensitive
      points, compared with lowly/non-sensitive points or no acupuncture (waiting-list), in
      improving pain, joint function and quality of life, among patients with KOA. The safety of
      acupuncture will also be assessed during the study period.
Participants in the high sensitization group receive acupuncture treatment at the five highly
      sensitive points; Participants in the low/non-sensitization group receive acupuncture
      treatment at the five low/non-sensitive points and all other treatment settings will be the
      same as in the high sensitization group. Patients in the waiting-list group will receive
      standard acupuncture treatment after the study is completed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: The change of Western Ontario and McMaster Universities Osteoarthritis index total score from baseline to 16 weeks
time frame: Assessments will be conducted at baseline and 16 weeks after randomization
description: It consists of 24 items assessing the knee osteoarthritis patients pain, stiffness, and physical function. Each of the 24 items will be graded on a visual analog scale ranging from 0 to 10, with higher scores reflecting more pain, stiffness and poorer physical function.
measure: The change of Short Form (SF)-12 health survey score from baseline to 16 weeks
time frame: Assessments will be conducted at baseline and 16 weeks after randomization
description: It includes 12 items: 2 items on physical functioning, 2 items on role limitations because of physical health problems, 1 item on bodily pain, 1 item on general health perceptions, 1 item on vitality (energy/fatigue), 1 item on social functioning, 2 items on role limitations because of emotional problems, and 2 items on general mental health (psychological distress and psychological well-being).
measure: The changes of knee ranges of motion (ROMs) from baseline to 16 weeks
time frame: Assessments will be conducted at baseline and 16 weeks after randomization
description: The knee ROMs will be assessed both actively and passively by using a standard goniometer. It will include flexion, extension, internal rotation and external rotation.
measure: The changes of pressure-pain threshold of the five selected acupuncture points from baseline to 16 weeks
time frame: Assessments will be conducted at baseline and 16 weeks after randomization
description: The pressure-pain threshold of the five selected acupuncture points will be measured using the electronic von Frey detector.
arm group label: acupuncture at highly sensitive points
arm group type: Experimental
description: Sterile, single-use filiform acupuncture needles (Hwato Needles, Sino-foreign Joint Venture Suzhou Hwato Medical Instruments Co., China) with a length of 40 mm and a diameter of 0.30 mm will be inserted to a depth of 15-30mm in five highly sensitive points.
arm group label: acupuncture at lowly/non-sensitive points
arm group type: Active Comparator
description: Sterile, single-use filiform acupuncture needles (Hwato Needles, Sino-foreign Joint Venture Suzhou Hwato Medical Instruments Co., China) with a length of 40 mm and a diameter of 0.30 mm will be inserted to a depth of 15-30mm in five low/non-sensitive points.
arm group label: no acupuncture (waiting-list)
arm group type: No Intervention
description: Patients in the waiting-list group will not receive any acupuncture intervention during the study.
intervention type: Other
intervention name: acupuncture
description: a stimulation of the body or auricular points
arm group label: acupuncture at highly sensitive points
arm group label: acupuncture at lowly/non-sensitive points
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Xin Sun, Phd
role: Study Chair
affiliation: West China Hospital
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: West China Hospital
investigator full name: Sun Xin
investigator title: Director
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Hypersensitivity
sharing ipd: No
provided document: 
provided document: 