<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/NCT02979574</url>
  </required_header>
  <id_info>
    <org_study_id>16-1579</org_study_id>
    <nct_id>NCT02979574</nct_id>
  </id_info>
  <brief_title>PEACE: Comparing Chronic Pain Treatment Options</brief_title>
  <acronym>PEACE</acronym>
  <official_title>Personalize Electro-acupuncture vs. Auricular-acupuncture Comparative Effectiveness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare two types of acupuncture with usual care on treating&#xD;
      chronic pain. This study has three groups. Two groups will received acupuncture. One group&#xD;
      will receive usual standard of care for 12 weeks and then will receive acupuncture.&#xD;
      Acupuncture is an ancient Chinese technique of using very thin needles inserted in the skin&#xD;
      to treat different symptoms and illness, and to promote healing. Each group will undergo a&#xD;
      different method of needle administration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Anticipated">November 2023</completion_date>
  <primary_completion_date type="Anticipated">November 2023</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>Pain intensity and pain interference will be measured by using the Brief Pain Inventory (BPI) measure.</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">360</enrollment>
  <condition>Chronic Pain</condition>
  <condition>Musculoskeletal Pain</condition>
  <condition>Fibromyalgia</condition>
  <condition>Pain Management</condition>
  <arm_group>
    <arm_group_label>Electro-Acupuncture (EA) Procedure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive 10 treatment of EA acupuncture over the course of 10 weeks (with a maximum of 2 treatments per week).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Battle Field Acupuncture (BFA) Procedure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive 10 treatment of BFA acupuncture over the course of 10 weeks (with a maximum of 2 treatments per week).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait List Control (WLC) Usual Care Procedure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in the WLC group continue to receive their standard medical care and pain management as prescribed by their physicians or other health care providers, including analgesic medications. After the 12 week follow up period, patients in the WLC will receive up to ten treatments of either EA or BFA based on their personal preference.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Electro-Acupuncture (EA)</intervention_name>
    <description>Participants will receive 10 treatment of Electro-Acupuncture over the course of 10 weeks (with a maximum of 2 treatments per week). The acupuncturist will insert acupuncture needles in at least 4 local points around the body with the most pain and at least 4 distant points to address the patient's baseline constitution. The needles will be electrically stimulate at 2 Hz by connecting to a TENS unit. The needles will be in place for 30 minutes.</description>
    <arm_group_label>Electro-Acupuncture (EA) Procedure</arm_group_label>
    <arm_group_label>Wait List Control (WLC) Usual Care Procedure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Battle Field Acupuncture (BFA)</intervention_name>
    <description>Participants will receive 10 treatment of Battle Field Acupuncture over the course of 10 weeks (with a maximum of 2 treatments per week). Acupuncture needles will be placed in the participants' ears. The total duration of BFA delivery is about 10 to 20 minutes depending on how many needles are used in the procedure.</description>
    <arm_group_label>Battle Field Acupuncture (BFA) Procedure</arm_group_label>
    <arm_group_label>Wait List Control (WLC) Usual Care Procedure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Wait List Control (WLC)</intervention_name>
    <description>After the waiting period (12 weeks from randomization), participants in the WLC will receive up to ten treatments of either EA or BFA based on their personal preference.</description>
    <arm_group_label>Wait List Control (WLC) Usual Care Procedure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Age &gt;/= 18 years or older&#xD;
&#xD;
          -  Having musculoskeletal pain, defined as regional (joints, extremities, back, neck) or&#xD;
             more generalized (fibromyalgia or chronic widespread pain)&#xD;
&#xD;
          -  Having a pain rating of 4 or greater in worst pain on a 1-10 numerical rating scale in&#xD;
             the preceding week (Patients with a neuropathic component to their pain that involves&#xD;
             the extremities or back will be eligible)&#xD;
&#xD;
          -  Having had pain for at least 3 months and at least 15 days with pain in the preceding&#xD;
             30 days&#xD;
&#xD;
          -  A diagnosis of cancer with no restrictions placed on type of cancer, other than that&#xD;
             patients with metastatic disease will be excluded. Eligibility criteria are not&#xD;
             restricted to MSK confirmed biopsy/diagnosis. Participating institution's testing is&#xD;
             sufficient for other study sites.&#xD;
&#xD;
          -  Complete active treatment (surgery, chemotherapy, and/or radiotherapy) at least one&#xD;
             month prior to study initiation (patients on continued hormone treatment will not be&#xD;
             excluded).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have non-musculoskeletal pain syndromes (headache, facial pain, chest pain, visceral&#xD;
             abdominal pain) if these are the sole source of pain, but can be present as co-morbid&#xD;
             conditions as long as a patient has a primary musculoskeletal pain condition defined s&#xD;
             above.&#xD;
&#xD;
          -  Inflammatory arthritis that require disease modifying drugs (e.g. rheumatoid&#xD;
             arthritis)&#xD;
&#xD;
          -  Phantom limb pain&#xD;
&#xD;
          -  Patients with a history of metastatic cancer who are not currently NED&#xD;
&#xD;
          -  Have a pending pain-related VA or social security or worker's comp disability claim by&#xD;
             self-report&#xD;
&#xD;
          -  Have an implanted electronically charged medical device&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jun Mao, MD, MSCE</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Basking Ridge</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <zip>07920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Monmouth</name>
      <address>
        <city>Middletown</city>
        <state>New Jersey</state>
        <zip>07748</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Bergen</name>
      <address>
        <city>Montvale</city>
        <state>New Jersey</state>
        <zip>07645</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Commack</name>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Westchester</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Rockville Centre</name>
      <address>
        <city>Rockville Centre</city>
        <state>New York</state>
        <zip>11570</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mskcc.org/</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>December 1, 2022</last_update_submitted>
  <last_update_submitted_qc>December 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acupuncture</keyword>
  <keyword>pain</keyword>
  <keyword>chronic pain</keyword>
  <keyword>pain management</keyword>
  <keyword>16-1579</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Musculoskeletal Pain</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02979574
org study id: 16-1579
nct id: NCT02979574
lead sponsor: 
has dmc: No
The purpose of this study is to compare two types of acupuncture with usual care on treating
      chronic pain. This study has three groups. Two groups will received acupuncture. One group
      will receive usual standard of care for 12 weeks and then will receive acupuncture.
      Acupuncture is an ancient Chinese technique of using very thin needles inserted in the skin
      to treat different symptoms and illness, and to promote healing. Each group will undergo a
      different method of needle administration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Pain intensity and pain interference will be measured by using the Brief Pain Inventory (BPI) measure.
time frame: 12 weeks
arm group label: Electro-Acupuncture (EA) Procedure
arm group type: Active Comparator
description: Participants will receive 10 treatment of EA acupuncture over the course of 10 weeks (with a maximum of 2 treatments per week).
arm group label: Battle Field Acupuncture (BFA) Procedure
arm group type: Active Comparator
description: Participants will receive 10 treatment of BFA acupuncture over the course of 10 weeks (with a maximum of 2 treatments per week).
arm group label: Wait List Control (WLC) Usual Care Procedure
arm group type: Active Comparator
description: Subjects in the WLC group continue to receive their standard medical care and pain management as prescribed by their physicians or other health care providers, including analgesic medications. After the 12 week follow up period, patients in the WLC will receive up to ten treatments of either EA or BFA based on their personal preference.
intervention type: Procedure
intervention name: Electro-Acupuncture (EA)
description: Participants will receive 10 treatment of Electro-Acupuncture over the course of 10 weeks (with a maximum of 2 treatments per week). The acupuncturist will insert acupuncture needles in at least 4 local points around the body with the most pain and at least 4 distant points to address the patient's baseline constitution. The needles will be electrically stimulate at 2 Hz by connecting to a TENS unit. The needles will be in place for 30 minutes.
arm group label: Electro-Acupuncture (EA) Procedure
arm group label: Wait List Control (WLC) Usual Care Procedure
intervention type: Procedure
intervention name: Battle Field Acupuncture (BFA)
description: Participants will receive 10 treatment of Battle Field Acupuncture over the course of 10 weeks (with a maximum of 2 treatments per week). Acupuncture needles will be placed in the participants' ears. The total duration of BFA delivery is about 10 to 20 minutes depending on how many needles are used in the procedure.
arm group label: Battle Field Acupuncture (BFA) Procedure
arm group label: Wait List Control (WLC) Usual Care Procedure
intervention type: Device
intervention name: Wait List Control (WLC)
description: After the waiting period (12 weeks from randomization), participants in the WLC will receive up to ten treatments of either EA or BFA based on their personal preference.
arm group label: Wait List Control (WLC) Usual Care Procedure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jun Mao, MD, MSCE
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://www.mskcc.org/
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Fibromyalgia
mesh term: Musculoskeletal Pain
mesh term: Chronic Pain
sharing ipd: Undecided