<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/NCT04464954</url>
  </required_header>
  <id_info>
    <org_study_id>FWH20200117H</org_study_id>
    <nct_id>NCT04464954</nct_id>
  </id_info>
  <brief_title>BFA Treatment of Pain</brief_title>
  <official_title>Pilot Study: Effect of Battlefield Acupuncture Needle Selection on Symptom Relief and Patient Tolerance in the Treatment of Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Paul Crawford</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mike O'Callaghan Military Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this pilot study is to conduct an unblinded pilot randomized clinical study on the&#xD;
      effectiveness and tolerability of auricular semi-permanent (ASP) vs intradermal (long), and&#xD;
      pyonex needles in Battlefield Acupuncture (BFA) for the treatment of pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Begin to identify which of 3 needles is most efficacious for BFA treatment of pain;&#xD;
&#xD;
        2. Identify patient experiences and tolerance of three commonly used acupuncture needles at&#xD;
           Mike O'Callaghan Military Medical Center at Nellis Air Force Base. This study will&#xD;
           compare 30 patients (10 per needling group) and will serve as a pilot study for a&#xD;
           potential larger randomized control trial (RCT) across multiple MTFs in the Defense&#xD;
           Health Agency (DHA) to establish better BFA care practices. We will be recruiting a&#xD;
           total of 39 subjects, which is inclusive of a 30% drop out rate to accommodate those&#xD;
           that may be lost to the study or have missing data to achieve a final total of 30&#xD;
           subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2020</start_date>
  <completion_date type="Actual">April 20, 2021</completion_date>
  <primary_completion_date type="Actual">April 20, 2021</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effectiveness: scale</measure>
    <time_frame>Four repeated measurements of change in the DVRPS: preacupuncture (Day 0), post-acupuncture (10-15 minutes post needle insertion), 24 hours and one week post-therapy.</time_frame>
    <description>Defense and Veterans Pain Rating Scale (DVPRS).DVPRS is an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS demonstrates linear scale qualities allowing parametric methods to be used.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Needle Tolerance: questionnaire</measure>
    <time_frame>Three repeated measurements of change in needle tolerance: post-acupuncture (10-15 minutes post needle insertion), 24 hours and 1 week posttherapy.</time_frame>
    <description>Will be measured using an in-house developed questionnaire. It employs 5-point ordinal scales to evaluate 12 post-therapy experiences or perception encompassing adverse outcomes, inconveniences, and satisfaction</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Musculoskeletal Pain</condition>
  <condition>Acute Pain</condition>
  <arm_group>
    <arm_group_label>Auricular semi-permanent (ASP gold) needles</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Intradermal (long) needles using J-type No. 2 (.18)x 15mm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Pyonex needles (Seirin Yellow 0.2 x 0.6mm)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Auricular semi-permanent (ASP gold) needles</intervention_name>
    <description>ASP semi-permanent Battlefield Acupuncture needles are semi-permanent needles that will remain in subject ears for 2-8 days and will be allowed to fall out on their own</description>
    <arm_group_label>Auricular semi-permanent (ASP gold) needles</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intradermal (long) needles using J-type No. 2 (.18)x 15mm</intervention_name>
    <description>Intradermal (long) needles will remain in subject ears for 15-30 minutes and will be removed by a member of the study staff.</description>
    <arm_group_label>Intradermal (long) needles using J-type No. 2 (.18)x 15mm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pyonex needles (Seirin Yellow 0.2 x 0.6mm)</intervention_name>
    <description>Pyonex needles will remain in subject ears for 2-21 days and allowed to fall out on their own.</description>
    <arm_group_label>Pyonex needles (Seirin Yellow 0.2 x 0.6mm)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        **Patients must be able to get care at Nellis Air Force Base (a military installation) in&#xD;
        order to participate in this study**&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Active duty and DoD Beneficiaries aged 18 years or older&#xD;
&#xD;
          -  Acute (0-4 days) musculoskeletal injury&#xD;
&#xD;
          -  Injuries eligible for inclusion include all acute non-fracture related musculoskeletal&#xD;
             injuries of the axial or peripheral skeleton.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Taking any opioid medications daily&#xD;
&#xD;
          -  Rheumatologic and autoimmune conditions which may be creating pain, such as rheumatoid&#xD;
             arthritis, advanced osteoarthritis, or spinal stenosis&#xD;
&#xD;
          -  Contra-indication to needle use including known bleeding disorder and psychogenic&#xD;
             issues related to needle use (e.g., needle-phobia)&#xD;
&#xD;
          -  Evidence or history of clinically significant immune deficiency, hematological,&#xD;
             oncological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic,&#xD;
             psychiatric, neurologic, or severe allergic disease (including to metals and adhesive&#xD;
             tapes) which could interfere with this study&#xD;
&#xD;
          -  Individuals with progressive radiating pain with motor-sensory changes (including&#xD;
             weakness or numbness) related to their presenting pain complaint&#xD;
&#xD;
          -  Women who are pregnant, may be pregnant, or attempting to become pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mike O'Callaghan Military Medical Center</name>
      <address>
        <city>Nellis Air Force Base</city>
        <state>Nevada</state>
        <zip>89191</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Chen YM. Clinical application of lower He-Sea points for abdominal pain [presentation] 28th Annual International Symposium on Acupuncture, Electro-Therapeutics Researches, Columbia University Faculty House, New York, NY, October 27, 2012.</citation>
  </reference>
  <reference>
    <citation>Melzack, Ronald. Pain Forum. Volume 5 (2). Summer 1996. Pages 128-138.</citation>
  </reference>
  <reference>
    <citation>Madsen MV, Gotzsche PC, Hrobjartsson A. Acupuncture treatment for pain: systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups. BMJ. 2009 Jan 27;338:a3115. doi: 10.1136/bmj.a3115.</citation>
    <PMID>19174438</PMID>
  </reference>
  <reference>
    <citation>Vickers AJ, Vertosick EA, Lewith G, MacPherson H, Foster NE, Sherman KJ, Irnich D, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for Chronic Pain: Update of an Individual Patient Data Meta-Analysis. J Pain. 2018 May;19(5):455-474. doi: 10.1016/j.jpain.2017.11.005. Epub 2017 Dec 2.</citation>
    <PMID>29198932</PMID>
  </reference>
  <reference>
    <citation>Yuan QL, Wang P, Liu L, Sun F, Cai YS, Wu WT, Ye ML, Ma JT, Xu BB, Zhang YG. Acupuncture for musculoskeletal pain: A meta-analysis and meta-regression of sham-controlled randomized clinical trials. Sci Rep. 2016 Jul 29;6:30675. doi: 10.1038/srep30675.</citation>
    <PMID>27471137</PMID>
  </reference>
  <reference>
    <citation>Devitt M. Research Finds Acupuncture Effective for Chronic Pain [Internet]. AAFP Home | American Academy of Family Physicians. 2018 [cited 2020Apr1]. Available from: https://www.aafp.org/home. html</citation>
  </reference>
  <reference>
    <citation>Center for Medicare and Medicaid Services. Decision Summary: Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N). Center for Medicare and Medicaid Services. July 15, 2019. https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decisionmemo. aspx?NCAId=295</citation>
  </reference>
  <reference>
    <citation>Pain management task force final report77. (2010). Office of the Army Surgeon General. Retrieved from http://www.armymedicine.army.mil/reports/Pain_Management_Task_Force.pdf.</citation>
  </reference>
  <reference>
    <citation>Walker PH, Pock A, Ling CG, Kwon KN, Vaughan M. Battlefield acupuncture: Opening the door for acupuncture in Department of Defense/Veteran's Administration health care. Nurs Outlook. 2016 Sep-Oct;64(5):491-8. doi: 10.1016/j.outlook.2016.07.008. Epub 2016 Jul 20.</citation>
    <PMID>27601311</PMID>
  </reference>
  <reference>
    <citation>Defense and Veterans Center for Integrative Pain Management.(2016). Retrieved from http://www. dvcipm.org/.</citation>
  </reference>
  <reference>
    <citation>Spotswood, S. (2014). Auricular acupuncture: Convenient technique for battlefield pain. U.S. Medicine, Retrieved from http://www.usmedicine.com/agencies/department-ofdefense-dod/auricular-acupunctureconvenient- techniquefor-battlefield-pain/.</citation>
  </reference>
  <reference>
    <citation>Koffman, R., &amp; Helms, M. (2013). Acupuncture and PTSD: 'come for the needles, stay for the therapy'. Psychiatric Annals, 43(5),236e239.</citation>
  </reference>
  <reference>
    <citation>Crawford P, Penzien DB, Coeytaux R. Reduction in Pain Medication Prescriptions and Self-Reported Outcomes Associated with Acupuncture in a Military Patient Population. Med Acupunct. 2017 Aug 1;29(4):229-231. doi: 10.1089/acu.2017.1234.</citation>
    <PMID>28874924</PMID>
  </reference>
  <reference>
    <citation>Niemtzow, R. (2007). Battlefield acupuncture. Medical Acupuncture,19, 225e228.</citation>
  </reference>
  <reference>
    <citation>DHA-PI 6025.33, Acupuncture Practice in Military Medical Treatment Facilities February 20, 2020. Retrieved from pdf.</citation>
  </reference>
  <reference>
    <citation>Bonakdar RA, Mills PJ. Auricular Acupuncture Therapy for Treatment of Musculoskeletal Pain in the Setting of Military Personnel: A Randomized Trial. United States Naval Medical Center San Diego in collaboration with Scripps Integrative Medical Center at La Jolla, CA. NIH Clinical Trail NCT02263001. Last Updated May 4, 2017.</citation>
  </reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>January 13, 2022</last_update_submitted>
  <last_update_submitted_qc>January 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Mike O'Callaghan Military Hospital</investigator_affiliation>
    <investigator_full_name>Paul Crawford</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>acupuncture</keyword>
  <keyword>battlefield acupuncture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Pain</mesh_term>
    <mesh_term>Acute Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We do not plan on sharing data.</ipd_description>
  </patient_data>
  <provided_document_section>
    <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>November 13, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/54/NCT04464954/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>August 11, 2023</submitted>
    <returned>September 5, 2023</returned>
  </pending_results>
  <!-- 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/NCT04464954
org study id: FWH20200117H
nct id: NCT04464954
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The aim of this pilot study is to conduct an unblinded pilot randomized clinical study on the
      effectiveness and tolerability of auricular semi-permanent (ASP) vs intradermal (long), and
      pyonex needles in Battlefield Acupuncture (BFA) for the treatment of pain.
1. Begin to identify which of 3 needles is most efficacious for BFA treatment of pain;

        2. Identify patient experiences and tolerance of three commonly used acupuncture needles at
           Mike O'Callaghan Military Medical Center at Nellis Air Force Base. This study will
           compare 30 patients (10 per needling group) and will serve as a pilot study for a
           potential larger randomized control trial (RCT) across multiple MTFs in the Defense
           Health Agency (DHA) to establish better BFA care practices. We will be recruiting a
           total of 39 subjects, which is inclusive of a 30% drop out rate to accommodate those
           that may be lost to the study or have missing data to achieve a final total of 30
           subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Effectiveness: scale
time frame: Four repeated measurements of change in the DVRPS: preacupuncture (Day 0), post-acupuncture (10-15 minutes post needle insertion), 24 hours and one week post-therapy.
description: Defense and Veterans Pain Rating Scale (DVPRS).DVPRS is an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS demonstrates linear scale qualities allowing parametric methods to be used.
measure: Needle Tolerance: questionnaire
time frame: Three repeated measurements of change in needle tolerance: post-acupuncture (10-15 minutes post needle insertion), 24 hours and 1 week posttherapy.
description: Will be measured using an in-house developed questionnaire. It employs 5-point ordinal scales to evaluate 12 post-therapy experiences or perception encompassing adverse outcomes, inconveniences, and satisfaction
arm group label: Auricular semi-permanent (ASP gold) needles
arm group type: Experimental
arm group label: Intradermal (long) needles using J-type No. 2 (.18)x 15mm
arm group type: Experimental
arm group label: Pyonex needles (Seirin Yellow 0.2 x 0.6mm)
arm group type: Experimental
intervention type: Device
intervention name: Auricular semi-permanent (ASP gold) needles
description: ASP semi-permanent Battlefield Acupuncture needles are semi-permanent needles that will remain in subject ears for 2-8 days and will be allowed to fall out on their own
arm group label: Auricular semi-permanent (ASP gold) needles
intervention type: Device
intervention name: Intradermal (long) needles using J-type No. 2 (.18)x 15mm
description: Intradermal (long) needles will remain in subject ears for 15-30 minutes and will be removed by a member of the study staff.
arm group label: Intradermal (long) needles using J-type No. 2 (.18)x 15mm
intervention type: Device
intervention name: Pyonex needles (Seirin Yellow 0.2 x 0.6mm)
description: Pyonex needles will remain in subject ears for 2-21 days and allowed to fall out on their own.
arm group label: Pyonex needles (Seirin Yellow 0.2 x 0.6mm)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
citation: Chen YM. Clinical application of lower He-Sea points for abdominal pain [presentation] 28th Annual International Symposium on Acupuncture, Electro-Therapeutics Researches, Columbia University Faculty House, New York, NY, October 27, 2012.
citation: Melzack, Ronald. Pain Forum. Volume 5 (2). Summer 1996. Pages 128-138.
citation: Madsen MV, Gotzsche PC, Hrobjartsson A. Acupuncture treatment for pain: systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups. BMJ. 2009 Jan 27;338:a3115. doi: 10.1136/bmj.a3115.
PMID: 19174438
citation: Vickers AJ, Vertosick EA, Lewith G, MacPherson H, Foster NE, Sherman KJ, Irnich D, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for Chronic Pain: Update of an Individual Patient Data Meta-Analysis. J Pain. 2018 May;19(5):455-474. doi: 10.1016/j.jpain.2017.11.005. Epub 2017 Dec 2.
PMID: 29198932
citation: Yuan QL, Wang P, Liu L, Sun F, Cai YS, Wu WT, Ye ML, Ma JT, Xu BB, Zhang YG. Acupuncture for musculoskeletal pain: A meta-analysis and meta-regression of sham-controlled randomized clinical trials. Sci Rep. 2016 Jul 29;6:30675. doi: 10.1038/srep30675.
PMID: 27471137
citation: Devitt M. Research Finds Acupuncture Effective for Chronic Pain [Internet]. AAFP Home | American Academy of Family Physicians. 2018 [cited 2020Apr1]. Available from: https://www.aafp.org/home. html
citation: Center for Medicare and Medicaid Services. Decision Summary: Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N). Center for Medicare and Medicaid Services. July 15, 2019. https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decisionmemo. aspx?NCAId=295
citation: Pain management task force final report77. (2010). Office of the Army Surgeon General. Retrieved from http://www.armymedicine.army.mil/reports/Pain_Management_Task_Force.pdf.
citation: Walker PH, Pock A, Ling CG, Kwon KN, Vaughan M. Battlefield acupuncture: Opening the door for acupuncture in Department of Defense/Veteran's Administration health care. Nurs Outlook. 2016 Sep-Oct;64(5):491-8. doi: 10.1016/j.outlook.2016.07.008. Epub 2016 Jul 20.
PMID: 27601311
citation: Defense and Veterans Center for Integrative Pain Management.(2016). Retrieved from http://www. dvcipm.org/.
citation: Spotswood, S. (2014). Auricular acupuncture: Convenient technique for battlefield pain. U.S. Medicine, Retrieved from http://www.usmedicine.com/agencies/department-ofdefense-dod/auricular-acupunctureconvenient- techniquefor-battlefield-pain/.
citation: Koffman, R., & Helms, M. (2013). Acupuncture and PTSD: 'come for the needles, stay for the therapy'. Psychiatric Annals, 43(5),236e239.
citation: Crawford P, Penzien DB, Coeytaux R. Reduction in Pain Medication Prescriptions and Self-Reported Outcomes Associated with Acupuncture in a Military Patient Population. Med Acupunct. 2017 Aug 1;29(4):229-231. doi: 10.1089/acu.2017.1234.
PMID: 28874924
citation: Niemtzow, R. (2007). Battlefield acupuncture. Medical Acupuncture,19, 225e228.
citation: DHA-PI 6025.33, Acupuncture Practice in Military Medical Treatment Facilities February 20, 2020. Retrieved from pdf.
citation: Bonakdar RA, Mills PJ. Auricular Acupuncture Therapy for Treatment of Musculoskeletal Pain in the Setting of Military Personnel: A Randomized Trial. United States Naval Medical Center San Diego in collaboration with Scripps Integrative Medical Center at La Jolla, CA. NIH Clinical Trail NCT02263001. Last Updated May 4, 2017.
responsible party type: Sponsor-Investigator
investigator affiliation: Mike O'Callaghan Military Hospital
investigator full name: Paul Crawford
investigator title: Principal Investigator
mesh term: Musculoskeletal Pain
mesh term: Acute Pain
sharing ipd: No
ipd description: We do not plan on sharing data.
provided document: 
submitted: August 11, 2023
returned: September 5, 2023