<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/NCT02263001</url>
  </required_header>
  <id_info>
    <org_study_id>NMCSD.2011.0119</org_study_id>
    <nct_id>NCT02263001</nct_id>
  </id_info>
  <brief_title>Acupuncture Therapy for Treatment of Musculoskeletal Pain</brief_title>
  <official_title>Auricular Acupuncture Therapy for Treatment of Musculoskeletal Pain in the Setting of Military Personnel: A Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Scripps Center for Integrative Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>United States Naval Medical Center, San Diego</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Diego</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Musculoskeletal injuries resulting in pain are one of the most common reasons for disability&#xD;
      and missed duty among military personnel. Additionally, these injuries may create impairment&#xD;
      in the area of optimal function, sleep and mood that may not be completely resolved with&#xD;
      currently available therapies. This scenario creates the setting for testing and&#xD;
      incorporation of additional treatment options to potentially improve care outcomes. Recent&#xD;
      investigations have examined the adjunctive use of auricular therapy, which utilizes various&#xD;
      interventions, typically needle-based, to stimulate the ear. This intervention appears to&#xD;
      modulate the autonomic nervous system to produce more rapid onset of pain relief and&#xD;
      reduction in pain related co-morbidities. For this trial of adjunctive auricular therapy,&#xD;
      active duty personnel presenting with an acute or sub-acute musculoskeletal injury triaged to&#xD;
      outpatient care for treatment will be studied. Subjects randomized to auricular treatment&#xD;
      will receive, in addition to standard care, up to 12 treatments over a maximum of 3 months&#xD;
      from a clinician trained in auricular therapy. This trial will specifically examine whether&#xD;
      the addition of a specific auricular therapy protocol to standard care will have a beneficial&#xD;
      impact on the pain and functionality of military personnel who sustain an acute or sub-acute&#xD;
      musculoskeletal injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Musculoskeletal injuries resulting in pain are one of the most common reasons for disability&#xD;
      and missed duty among military personnel. Additionally, these injuries may create impairment&#xD;
      in the area of optimal function, sleep and mood that may not be completely resolved with&#xD;
      currently available therapies. This scenario creates the setting for testing and&#xD;
      incorporation of additional treatment options to potentially improve care outcomes. Recent&#xD;
      investigations have examined the adjunctive use of auricular therapy, which utilizes various&#xD;
      interventions, typically needle-based, to stimulate the ear. This intervention appears to&#xD;
      modulate the autonomic nervous system to produce more rapid onset of pain relief and&#xD;
      reduction in pain related co-morbidities. For this trial of adjunctive auricular therapy, 150&#xD;
      subjects will be enrolled at the Naval Medical Center San Diego. Subjects will be active duty&#xD;
      personnel aged 18-60 years old presenting with an acute or sub-acute musculoskeletal injury&#xD;
      triaged to outpatient care for treatment. Subjects randomized to auricular treatment will&#xD;
      receive, in addition to standard care, up to 12 treatments over a maximum of 3 months from a&#xD;
      clinician trained in auricular therapy. This trial will specifically examine whether the&#xD;
      addition of a specific auricular therapy protocol to standard care will have a beneficial&#xD;
      impact on the pain and functionality of military personnel who sustain an acute or sub-acute&#xD;
      musculoskeletal injury.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">December 2016</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary musculoskeletal pain</measure>
    <time_frame>12 weeks</time_frame>
    <description>Standardized scales and clinical assessments to determine if the addition of AT will significantly decrease pain at noted time endpoints after initiation of treatment compared to UC.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Musculoskeletal pain related to co-morbities</measure>
    <time_frame>12 weeks</time_frame>
    <description>Standardized scales and clinical assessments to determine if the addition of AT will significantly improve pain related co-morbidities (based on the 0-10 BPI Pain interference scale and SF-8) at noted endpoints after initiation of treatment than UC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return of functional ability</measure>
    <time_frame>12 weeks</time_frame>
    <description>Standardized scales and clinical assessments to determine if the addition of AT will significantly improve functionality at noted endpoints after initiation of treatment vs. UC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction of pain medication use</measure>
    <time_frame>12 weeks</time_frame>
    <description>Assessment of pharmacy records and self report to determine if AT will provide significant reduction in need for pain medication as compared to UC.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Musculoskeletal Pain</condition>
  <arm_group>
    <arm_group_label>Auricular Acupuncture Plus Usual Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Auricular acupuncture therapy for treatment of musculoskeletal pain, plus usual care therapy consisting of over-the-counter and prescribed pharmacotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual care therapy for treatment of musculoskeletal pain. Usual care therapy consists of over-the-counter and prescribed pharmacotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Auricular acupuncture</intervention_name>
    <description>Auricular therapy for treatment of musculoskeletal pain</description>
    <arm_group_label>Auricular Acupuncture Plus Usual Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Usual care therapy consists of over-the-counter and prescribed pharmacotherapy</description>
    <arm_group_label>Usual Care Only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Active duty personnel with a musculoskeletal injury&#xD;
&#xD;
          -  Injuries eligible for inclusion include all acute or subacute (&lt;3 months in duration)&#xD;
             non-fracture related musculoskeletal injuries of the axial or peripheral skeleton&#xD;
&#xD;
          -  Examples of injuries meeting inclusion include acute or sub-acute injuries of the&#xD;
             neck, low back as well as the upper and lower extremities&#xD;
&#xD;
          -  Individuals with the pre-existing chronic pain pain greater than 3 months in duration&#xD;
             will be eligible if they have a presenting acute or sub-acute pain condition as&#xD;
             described above&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Injuries involving hospitalization or surgery for treatment in the presenting area of&#xD;
             pain&#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 (needle-phobia)&quot;&#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;
          -  Any contra-indication to the use of electrical stimulation, including history of&#xD;
             epilepsy, cardiac arrhythmias, pacemaker or any other implantable programmable device&#xD;
&#xD;
          -  Treatment with acupuncture or auricular therapy within the last 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Bonakdar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Scripps Integrative Medical Center, La Jolla, CA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Naval Medical Center San DIego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>May 2, 2017</last_update_submitted>
  <last_update_submitted_qc>May 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Paul J. Mills</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Auricular therapy</keyword>
  <keyword>Acupuncture</keyword>
  <keyword>Acute, sub-acute pain</keyword>
  <keyword>Auricular Acupuncture Needles</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal 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/NCT02263001
org study id: NMCSD.2011.0119
nct id: NCT02263001
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Musculoskeletal injuries resulting in pain are one of the most common reasons for disability
      and missed duty among military personnel. Additionally, these injuries may create impairment
      in the area of optimal function, sleep and mood that may not be completely resolved with
      currently available therapies. This scenario creates the setting for testing and
      incorporation of additional treatment options to potentially improve care outcomes. Recent
      investigations have examined the adjunctive use of auricular therapy, which utilizes various
      interventions, typically needle-based, to stimulate the ear. This intervention appears to
      modulate the autonomic nervous system to produce more rapid onset of pain relief and
      reduction in pain related co-morbidities. For this trial of adjunctive auricular therapy,
      active duty personnel presenting with an acute or sub-acute musculoskeletal injury triaged to
      outpatient care for treatment will be studied. Subjects randomized to auricular treatment
      will receive, in addition to standard care, up to 12 treatments over a maximum of 3 months
      from a clinician trained in auricular therapy. This trial will specifically examine whether
      the addition of a specific auricular therapy protocol to standard care will have a beneficial
      impact on the pain and functionality of military personnel who sustain an acute or sub-acute
      musculoskeletal injury.
Musculoskeletal injuries resulting in pain are one of the most common reasons for disability
      and missed duty among military personnel. Additionally, these injuries may create impairment
      in the area of optimal function, sleep and mood that may not be completely resolved with
      currently available therapies. This scenario creates the setting for testing and
      incorporation of additional treatment options to potentially improve care outcomes. Recent
      investigations have examined the adjunctive use of auricular therapy, which utilizes various
      interventions, typically needle-based, to stimulate the ear. This intervention appears to
      modulate the autonomic nervous system to produce more rapid onset of pain relief and
      reduction in pain related co-morbidities. For this trial of adjunctive auricular therapy, 150
      subjects will be enrolled at the Naval Medical Center San Diego. Subjects will be active duty
      personnel aged 18-60 years old presenting with an acute or sub-acute musculoskeletal injury
      triaged to outpatient care for treatment. Subjects randomized to auricular treatment will
      receive, in addition to standard care, up to 12 treatments over a maximum of 3 months from a
      clinician trained in auricular therapy. This trial will specifically examine whether the
      addition of a specific auricular therapy protocol to standard care will have a beneficial
      impact on the pain and functionality of military personnel who sustain an acute or sub-acute
      musculoskeletal injury.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Primary musculoskeletal pain
time frame: 12 weeks
description: Standardized scales and clinical assessments to determine if the addition of AT will significantly decrease pain at noted time endpoints after initiation of treatment compared to UC.
measure: Musculoskeletal pain related to co-morbities
time frame: 12 weeks
description: Standardized scales and clinical assessments to determine if the addition of AT will significantly improve pain related co-morbidities (based on the 0-10 BPI Pain interference scale and SF-8) at noted endpoints after initiation of treatment than UC.
measure: Return of functional ability
time frame: 12 weeks
description: Standardized scales and clinical assessments to determine if the addition of AT will significantly improve functionality at noted endpoints after initiation of treatment vs. UC.
measure: Reduction of pain medication use
time frame: 12 weeks
description: Assessment of pharmacy records and self report to determine if AT will provide significant reduction in need for pain medication as compared to UC.
arm group label: Auricular Acupuncture Plus Usual Care
arm group type: Experimental
description: Auricular acupuncture therapy for treatment of musculoskeletal pain, plus usual care therapy consisting of over-the-counter and prescribed pharmacotherapy.
arm group label: Usual Care Only
arm group type: Active Comparator
description: Usual care therapy for treatment of musculoskeletal pain. Usual care therapy consists of over-the-counter and prescribed pharmacotherapy.
intervention type: Other
intervention name: Auricular acupuncture
description: Auricular therapy for treatment of musculoskeletal pain
arm group label: Auricular Acupuncture Plus Usual Care
intervention type: Other
intervention name: Usual Care
description: Usual care therapy consists of over-the-counter and prescribed pharmacotherapy
arm group label: Usual Care Only
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Robert Bonakdar, MD
role: Principal Investigator
affiliation: Scripps Integrative Medical Center, La Jolla, CA
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Paul J. Mills
investigator title: Professor
mesh term: Musculoskeletal Pain