<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/NCT03008668</url>
  </required_header>
  <id_info>
    <org_study_id>201681590955</org_study_id>
    <nct_id>NCT03008668</nct_id>
  </id_info>
  <brief_title>A Pilot Trial of Acupuncture for Knee Osteoarthritis With Differential Functional Status of Acupoints</brief_title>
  <official_title>Acupuncture for Knee Osteoarthritis With Sensitized Acupoints: a Pilot Randomized Controlled Trial</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 undertake a rigorous multicentre randomised controlled trial,&#xD;
      comparing acupuncture on sensitized acupoints with low/non-sensitive points or no acupuncture&#xD;
      (waiting-list), to test if acupuncture on sensitized acupoints may result in improved&#xD;
      treatment outcomes in patients with Knee osteoarthritis (KOA).The current pilot study aimed&#xD;
      to assess the feasibility of performing the definitive randomised controlled trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients in the intervention group received acupuncture treatment on the 5 most sensitized&#xD;
      points/ acupoints.Patients in the control group received acupuncture treatment on the 5 least&#xD;
      /non-sensitized points. All other treatment settings were the same as in the intervention&#xD;
      group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</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,&#xD;
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>
  <other_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>Assessments will be conducted at 4 weeks after the acupuncture treatment and followed at 8, 12 and 16 weeks</time_frame>
    <description>Expected adverse events (AEs) of the acupuncture interventions include bleeding, nausea/vomiting, fainting, bruising at needle sites, feeling hot/burning, and transient pain at needle sites. We defined serious adverse events (SAEs) as: death, hospitalization, significant disability or incapacity, any life-threatening situations or any other medically significant events that were potentially related to the trial procedures or acupuncture treatments. The AEs or SAEs were identified by the certified treating acupuncturists.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Acupuncture</condition>
  <condition>Knee Osteoarthritis</condition>
  <condition>Randomized Controlled Trial</condition>
  <arm_group>
    <arm_group_label>experimental group: Acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>acupuncture on 5 most sensitized points/ acupoints</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group: Acupuncture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>acupuncture on 5 least low/non-sensitized points</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>Control group: Acupuncture</arm_group_label>
    <arm_group_label>experimental group: Acupuncture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible patients are those aged 40 years or older who are diagnosed with KOA and have&#xD;
             signed the informed consent.&#xD;
&#xD;
          -  The diagnosis of KOA will follow the diagnostic criteria according to the Chinese&#xD;
             Guidelines for the Medical Management of Osteoarthritis:&#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 indicated by&#xD;
             X-ray);&#xD;
&#xD;
          -  laboratory examinations of arthritis: clear and viscous synovial fluid (≥2 times) and&#xD;
             white blood cell count &lt; 2000/mm3;&#xD;
&#xD;
          -  age 40 years or older;&#xD;
&#xD;
          -  morning stiffness continues less than 30 minutes;&#xD;
&#xD;
          -  bone sound exists when joints was taking flexion and/or extension. A person is&#xD;
             confirmed to be diagnosed with KOA if meeting the either of the three criteria set: (1&#xD;
             and 2), or (1,3 and 5), or (1,4,5 and 6).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will be excluded if they:&#xD;
&#xD;
          -  Can not adhere to the study protocol in the future 6 months;&#xD;
&#xD;
          -  Are diagnosed with conditions leading to skeletal disorders, such as tuberculosis,&#xD;
             tumors or rheumatism of knee/bone joint, rheumatoid arthritis;&#xD;
&#xD;
          -  Have sprain or other trauma;&#xD;
&#xD;
          -  Are unable to walk properly due to foot deformity or pain;&#xD;
&#xD;
          -  Are present with mental disorders;&#xD;
&#xD;
          -  Have comorbidities including severe cardiovascular disease, liver or kidney&#xD;
             impairment, immunodeficiency, diabetes mellitus or blood disorder;&#xD;
&#xD;
          -  Females who are pregnant or lactating;&#xD;
&#xD;
          -  Were using physiotherapy treatments for osteoarthritis knee pain;&#xD;
&#xD;
          -  Had used intra-articular injection of glucocorticoid or viscosupplementation in the&#xD;
             past 6 months;&#xD;
&#xD;
          -  Received knee-replacement surgery;&#xD;
&#xD;
          -  Were participating or had 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>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>December 26, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>July 17, 2018</last_update_submitted>
  <last_update_submitted_qc>July 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2018</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>
  </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/NCT03008668
org study id: 201681590955
nct id: NCT03008668
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The investigators plan to undertake a rigorous multicentre randomised controlled trial,
      comparing acupuncture on sensitized acupoints with low/non-sensitive points or no acupuncture
      (waiting-list), to test if acupuncture on sensitized acupoints may result in improved
      treatment outcomes in patients with Knee osteoarthritis (KOA).The current pilot study aimed
      to assess the feasibility of performing the definitive randomised controlled trial.
Patients in the intervention group received acupuncture treatment on the 5 most sensitized
      points/ acupoints.Patients in the control group received acupuncture treatment on the 5 least
      /non-sensitized points. All other treatment settings were the same as in the intervention
      group.
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: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
time frame: Assessments will be conducted at 4 weeks after the acupuncture treatment and followed at 8, 12 and 16 weeks
description: Expected adverse events (AEs) of the acupuncture interventions include bleeding, nausea/vomiting, fainting, bruising at needle sites, feeling hot/burning, and transient pain at needle sites. We defined serious adverse events (SAEs) as: death, hospitalization, significant disability or incapacity, any life-threatening situations or any other medically significant events that were potentially related to the trial procedures or acupuncture treatments. The AEs or SAEs were identified by the certified treating acupuncturists.
arm group label: experimental group: Acupuncture
arm group type: Experimental
description: acupuncture on 5 most sensitized points/ acupoints
arm group label: Control group: Acupuncture
arm group type: Active Comparator
description: acupuncture on 5 least low/non-sensitized points
intervention type: Other
intervention name: acupuncture
description: a stimulation of the body or auricular points
arm group label: Control group: Acupuncture
arm group label: experimental group: Acupuncture
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
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