<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT03008837</url>
  </required_header>
  <id_info>
    <org_study_id>F2113-M</org_study_id>
    <secondary_id>1IK1RX002113-01A2</secondary_id>
    <nct_id>NCT03008837</nct_id>
  </id_info>
  <brief_title>Feasibility Study: fMRI Evaluation of Auricular PENFS for Fibromyalgia</brief_title>
  <acronym>fMRI</acronym>
  <official_title>Feasibility Study: fMRI Evaluation of Auricular PENFS for Fibromyalgia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</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>
      Given recent increasing opioid-related deaths and evidence showing against the use of opioids&#xD;
      for non-malignant chronic pain, there is growing need for non-narcotic pain management.&#xD;
      Fibromyalgia is a difficult to treat chronic pain condition that is often treated with&#xD;
      opioids despite existing evidence. The prevalence of fibromyalgia is increased among Veterans&#xD;
      returning from the gulf war and is already a significant burden in senior Veterans who may&#xD;
      have suffered with chronic pain for decades already. Many treatment options for fibromyalgia&#xD;
      carry intolerable side effects. PENFS (percutaneous electrical neural field stimulation) is a&#xD;
      FDA-approved, non-pharmacologic therapy that is currently utilized within the military and VA&#xD;
      system, but sufficient evidence regarding its outcomes and neural mechanisms have not been&#xD;
      adequately investigated. An understanding of its neural underpinnings and analgesic effects&#xD;
      could lead to 1) improvements in pain management and quality of life, 2) cost-savings and 3)&#xD;
      development of new techniques to address pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND: Fibromyalgia is a chronic pain syndrome that consists of chronic widespread pain,&#xD;
      decreased physical function, fatigue, psychoemotional/sleep disturbances, and various somatic&#xD;
      complaints, affecting anywhere from 5-10 million Americans, with ~1,500 Veterans carrying a&#xD;
      diagnosis of fibromyalgia seen per year at the Atlanta VAMC alone. It is estimated that&#xD;
      fibromyalgia costs the American population over $20 billion/year in lost wages and&#xD;
      disability. Initial therapies often include complementary and alternative medicine (CAM)&#xD;
      therapies, which are generally considered safe, although their efficacy has not been&#xD;
      thoroughly evaluated for fibromyalgia. Thus, non-pharmacologic alternatives require more&#xD;
      rigorous scientific investigation for the treatment of fibromyalgia. There is evidence to&#xD;
      support the use of percutaneous electrical neural stimulation (PENS) in the treatment of pain&#xD;
      conditions, which may have increased effects relative to acupuncture based on systematic&#xD;
      reviews. While fMRI data for acupuncture and fibromyalgia exists, no such data exists for&#xD;
      PENS treatment. An evolved form of PENS, percutaneous electrical neural field stimulation&#xD;
      (PENFS) of the auricle is already used in the military and VA systems for the treatment of&#xD;
      chronic pain, but evidence regarding its mechanisms and effects is lacking. Stimulation of&#xD;
      the vagus nerve, which has auricular branches, has been previously studied for pain relief in&#xD;
      fibromyalgia. However, application of PENS-type stimulation to the auricle has not been&#xD;
      previously studied with fMRI, and this type of therapy may lead to neural changes worthy of&#xD;
      further exploration. OBJECTIVE: To evaluate the feasibility of using fMRI as a biomarker for&#xD;
      the neural substrates of pain and functional changes following PENFS treatments. HYPOTHESIS:&#xD;
      PENFS will result in decreased functional connectivity between the insula and default mode&#xD;
      network as evaluated by fMRI, which will correlate to more significant improvements in pain&#xD;
      and function relative to standard therapy for fibromyalgia. METHODS: Subjects who meet study&#xD;
      criteria will receive baseline assessments including resting state fMRI, collection of&#xD;
      biobehavioural information such as cognitive and psychological assessments on standardized&#xD;
      forms, eating, sleeping and drinking habits, Defense and Veterans Pain Rating Scale (DVPRS),&#xD;
      arm curl, 30-s chair stand, and pain interference scores. Subjects will be stratified based&#xD;
      on age and gender and then divided into standard therapy control (medication management and&#xD;
      physical therapy) or PENFS (series of 4, weekly) treatments and assessed for fMRI changes 2&#xD;
      weeks after the final treatment. Pain and function will also be assessed at the 2 weeks, 6&#xD;
      weeks and 12 weeks following the final treatment. CLINICAL RELEVANCE: Auricular PENFS has not&#xD;
      been studied with fMRI. Stimulation of the auricle may produce neural changes that differ&#xD;
      from traditional therapies. Understanding the underlying neural mechanisms of auricular PENFS&#xD;
      could assist in developing targeted treatments for fibromyalgia and chronic pain. Further, if&#xD;
      PENFS can significantly improve pain relief and function over standard therapies, it could&#xD;
      decrease the need for opioid analgesics and their associated risks, which is a primary&#xD;
      objective of the VA Opioid Safety Initiative. The present investigation will not only serve&#xD;
      to elucidate neural changes with PENFS, but could be directly applicable to our Veterans&#xD;
      suffering from fibromyalgia by providing evidence regarding the relative effectiveness of&#xD;
      this already clinically-employed non-pharmacologic treatment (or lack thereof), and result in&#xD;
      evidence-based implementation and potential cost savings to the VA system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">May 31, 2019</completion_date>
  <primary_completion_date type="Actual">May 31, 2019</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>
    <intervention_model_description>Percutaneous electrical neural field stimulator (PENFS) using the military field stimulator, a device that uses small needles inserted in the ear (like auricular acupuncture), which are connected by electrodes to a battery pack that is attached externally using adhesive to the back of the ear. The stimulator is meant to stimulate branches of the cranial nerves via the ear.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>fcMRI as a Biomarker to Investigate Functionally Correlated Neural Substrates of Pain in Patients Undergoing PENFS</measure>
    <time_frame>baseline and 2 weeks post-treatment</time_frame>
    <description>2 weeks following the final treatment, subjects in the PENFS group were be evaluated for changes in functional connectivity between the right posterior insula seed and other areas of the DMN as evaluated by fcMRI relative to standard treatment controls, using whole brain analysis. The measurement is increase/decrease of signal in a given region, thresholded at p &lt;0.05, summarized into a value representing 'size of region of increase' or 'size of region of decrease' after subjects scans were combined/mapped onto a standard MNI brain. Only clusters of over 40 voxels were included, and the size of the region is reported in voxel size. The averaged brains for baseline fcMRI was subtracted from post-treatment for each group, and then these averaged differences were subtracted from each other. While other areas of the brain met threshold criteria in the analysis, only areas belonging to the DMN are reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Defense Veterans Pain Rating Scale (DVPRS) From Baseline</measure>
    <time_frame>2, 6 and 12 weeks follow-up</time_frame>
    <description>For fibromyalgia patients, pain will be assessed in the PENFS group relative to standard treatment controls, as indicated by analgesic Defense and Veterans Pain Rating Scale (DVPRS) at 2, 6 and 12 weeks follow-up. This is a validated pain measure that includes a 0-10 scale where 0 means no pain and 10 means greatest pain imaginable. Higher scores indicate worse reported pain outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pain Interference With &quot;Activity,&quot; &quot;Sleep,&quot; &quot;Mood&quot;, and &quot;Stress&quot; From Baseline</measure>
    <time_frame>2, 6 and 12 weeks follow-up</time_frame>
    <description>Pain interference scores were measured using supplemental questions on the Defense and Veterans Pain Rating Scale (DVPRS). Participants were asked to evaluate on a scale of 0-10 the level to which pain interfered with their &quot;activity,&quot; &quot;sleep,&quot; &quot;mood&quot;, and &quot;stress,&quot; with 10 being the worst interference, and 0 being no interference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Number of Bicep Curls From Baseline (Left Arm)</measure>
    <time_frame>2, 6 and 12 weeks follow-up</time_frame>
    <description>Objective tests for functional improvement will be performed at 2, 6, and 12 weeks follow-up and include 30 sec chair stand tests. The total number of full bicep curls (left arm) participants could perform using were measured over a 30-second period at each visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Number of Bicep Curls From Baseline (Right Arm)</measure>
    <time_frame>2, 6 and 12 weeks follow-up</time_frame>
    <description>Objective tests for functional improvement will be performed at 2, 6, and 12 weeks follow-up and include 30 sec chair stand tests. The total number of full bicep curls (right arm) participants could perform using were measured over a 30-second period at each visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sit-to Stand Test From Baseline</measure>
    <time_frame>2, 6 and 12 weeks follow-up</time_frame>
    <description>Objective tests for functional improvement will be performed at 2, 6, and 12 weeks follow-up and include 30 sec chair stand tests. The total number of full sit-to-stands participants could perform were measured over a 30-second period at each visit.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>PENFS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Veterans with fibromyalgia who meet study criteria and are randomized to the experimental group will receive standard therapy in addition to percutaneous electrical neural field stimulation (PENFS), which involves placement of small electrodes through a similar process to ear acupuncture to the ear. These electrodes are attached to a battery pack that is taped behind the ear and worn for 5-day intervals. The intention of this FDA-approved device is to relieve pain, though data on its effectiveness is still limited. Device placement (series of 4, weekly) will be performed by an Anesthesiology Pain Clinic provider. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Veterans with fibromyalgia who meet study criteria and are randomized to standard therapy will receive physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Military Field Stimulator</intervention_name>
    <description>The Military Field Stimulator (MFS/Neuro-Stim System), a percutaneous electrical neural field stimulation (PENFS) device evolved from PENS, is currently employed by the United States (US) military and used in the VA (contract number V797D-50453). There is some evidence based on a small trial of 20 postoperative patients that suggests PENS may have greater benefit than acupuncture for acute pain.</description>
    <arm_group_label>PENFS</arm_group_label>
    <other_name>MFS, Neuro-Stim System, PENFS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Therapy</intervention_name>
    <description>Standard therapy for fibromyalgia will include physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist.</description>
    <arm_group_label>Standard Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must be male and female Veterans age 20-60 with a diagnosis of fibromyalgia&#xD;
             as diagnosed by a clinician, by chart review, and by the most recent American College&#xD;
             of Rheumatology 2010 criteria for the diagnosis of fibromyalgia. 70,71&#xD;
&#xD;
          -  Subjects must self-report consistent, daily pain (greater than 5 on the VAS) &gt;90 days.&#xD;
&#xD;
          -  Subjects must have intact skin free of infection at the site of implantation.&#xD;
&#xD;
          -  Subjects must be willing to participate and understand the consent.&#xD;
&#xD;
          -  Subjects must be right-handed in order to provide consistency in brain structure and&#xD;
             function.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects must not be currently pregnant, since effects of fMRI and electrical current&#xD;
             on the developing fetus are not well-known.&#xD;
&#xD;
          -  Subjects must not have an implanted electrical device such as a vagal stimulator,&#xD;
             pacemaker, or spinal pain pump, which are not compatible with MRI.&#xD;
&#xD;
          -  Subjects must not have a history of seizures or neurologic condition that may alter&#xD;
             the structure of the brain.&#xD;
&#xD;
          -  Subjects must not have a history of drug abuse or severe, uncontrolled psychiatric&#xD;
             illness such as schizophrenia or major depressive disorder with suicidal ideation.&#xD;
&#xD;
          -  Subjects must not have psoriasis vulgaris or other skin conditions that may increase&#xD;
             the risk of infection at the implantation site.&#xD;
&#xD;
          -  Subjects must not have severe anxiety, claustrophobia, or other conditions that may&#xD;
             prevent their ability to lie at rest in an MRI scanner. This will be determined after&#xD;
             discussion with the patient regarding their own perceived ability to lie at rest in an&#xD;
             MRI scanner without the use of additional sedating medications.&#xD;
&#xD;
          -  Subjects must not introduce new medications or treatments for fibromyalgia symptoms&#xD;
             during the course of the study to prevent confounding results.&#xD;
&#xD;
          -  Subjects must not have a concurrent autoimmune or inflammatory disease that causes&#xD;
             pain such as systemic lupus erythematosus, inflammatory bowel disease or rheumatoid&#xD;
             arthritis, since this could decrease the effect of treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anna Woodbury, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Atlanta VA Medical and Rehab Center, Decatur, GA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Atlanta VA Medical and Rehab Center, Decatur, GA</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://article.sapub.org/10.5923.j.cmd.20150504.03.html</url>
    <description>Peri-Auricular PENFS for Chronic Pain</description>
  </link>
  <reference>
    <citation>Gebre M, Woodbury A, Napadow V, Krishnamurthy V, Krishnamurthy LC, Sniecinski R, Crosson B. Functional Magnetic Resonance Imaging Evaluation of Auricular Percutaneous Electrical Neural Field Stimulation for Fibromyalgia: Protocol for a Feasibility Study. JMIR Res Protoc. 2018 Feb 6;7(2):e39. doi: 10.2196/resprot.8692.</citation>
    <PMID>29410385</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <results_first_submitted>May 11, 2020</results_first_submitted>
  <results_first_submitted_qc>July 9, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 27, 2020</results_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</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>June 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT03008837/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>27 veterans were initially consented. However, 6 of these veterans either could not begin the study within the study period, moved out of state, or received implanted MRI-incompatible devices that excluded them from the study following the initial consent, but prior to randomization.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>PENFS</title>
          <description>Veterans with fibromyalgia who meet study criteria and are randomized to the experimental group will receive standard therapy in addition to percutaneous electrical neural field stimulation (PENFS), which involves placement of small electrodes through a similar process to ear acupuncture to the ear. These electrodes are attached to a battery pack that is taped behind the ear and worn for 5-day intervals. The intention of this FDA-approved device is to relieve pain, though data on its effectiveness is still limited. Device placement (series of 4, weekly) will be performed by an Anesthesiology Pain Clinic provider. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.&#xD;
Military Field Stimulator: The Military Field Stimulator (MFS/Neuro-Stim System), a percutaneous electrical neural field stimulation (PENFS) device evolved from PENS, is currently employed by the United States (US) military</description>
        </group>
        <group group_id="P2">
          <title>Standard Therapy</title>
          <description>Veterans with fibromyalgia who meet study criteria and are randomized to standard therapy will receive physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.&#xD;
Standard Therapy: Standard therapy for fibromyalgia will include physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>PENFS</title>
          <description>Veterans with fibromyalgia who meet study criteria and are randomized to the experimental group will receive standard therapy in addition to percutaneous electrical neural field stimulation (PENFS), which involves placement of small electrodes through a similar process to ear acupuncture to the ear. These electrodes are attached to a battery pack that is taped behind the ear and worn for 5-day intervals. The intention of this FDA-approved device is to relieve pain, though data on its effectiveness is still limited. Device placement (series of 4, weekly) will be performed by an Anesthesiology Pain Clinic provider. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.</description>
        </group>
        <group group_id="B2">
          <title>Standard Therapy</title>
          <description>Veterans with fibromyalgia who meet study criteria and are randomized to standard therapy will receive physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.&#xD;
Standard Therapy: Standard therapy for fibromyalgia will include physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="21"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50" lower_limit="33" upper_limit="60"/>
                    <measurement group_id="B2" value="48.56" lower_limit="32" upper_limit="60"/>
                    <measurement group_id="B3" value="49.35" lower_limit="32" upper_limit="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>DVPRS (Pain)</title>
          <description>pain measure that includes a 0-10 scale where 0 means no pain and 10 means greatest pain imaginable</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.42" spread="0.84"/>
                    <measurement group_id="B2" value="8" spread="0.77"/>
                    <measurement group_id="B3" value="7.41" spread="1.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>fcMRI as a Biomarker to Investigate Functionally Correlated Neural Substrates of Pain in Patients Undergoing PENFS</title>
        <description>2 weeks following the final treatment, subjects in the PENFS group were be evaluated for changes in functional connectivity between the right posterior insula seed and other areas of the DMN as evaluated by fcMRI relative to standard treatment controls, using whole brain analysis. The measurement is increase/decrease of signal in a given region, thresholded at p &lt;0.05, summarized into a value representing 'size of region of increase' or 'size of region of decrease' after subjects scans were combined/mapped onto a standard MNI brain. Only clusters of over 40 voxels were included, and the size of the region is reported in voxel size. The averaged brains for baseline fcMRI was subtracted from post-treatment for each group, and then these averaged differences were subtracted from each other. While other areas of the brain met threshold criteria in the analysis, only areas belonging to the DMN are reported.</description>
        <time_frame>baseline and 2 weeks post-treatment</time_frame>
        <population>Using a right posterior insula seed for seed-based whole-brain analysis in AFNI, a difference of the differences was measured. Clusters greater than 40 voxels in size with p&lt;0.05 (set in AFNI) found in the default mode network (DMN) are included in the outcome table.</population>
        <group_list>
          <group group_id="O1">
            <title>PENFS (Post-pre)</title>
            <description>Veterans with fibromyalgia who meet study criteria and are randomized to the experimental group will receive standard therapy in addition to percutaneous electrical neural field stimulation (PENFS). This column shows the number of voxels in clusters that showed increased or decreased connectivity following treatment, &gt;40 voxel clusters, thresholded at p&lt;0.05 in AFNI.</description>
          </group>
          <group group_id="O2">
            <title>Standard Therapy Control (Post-pre)</title>
            <description>Veterans with fibromyalgia who meet study criteria and are randomized to the control group will receive standard therapy including medications and physical therapy. This column shows the number of voxels in clusters that showed increased or decreased connectivity following standard therapy, &gt;40 voxel clusters, thresholded at p&lt;0.05 in AFNI.</description>
          </group>
        </group_list>
        <measure>
          <title>fcMRI as a Biomarker to Investigate Functionally Correlated Neural Substrates of Pain in Patients Undergoing PENFS</title>
          <description>2 weeks following the final treatment, subjects in the PENFS group were be evaluated for changes in functional connectivity between the right posterior insula seed and other areas of the DMN as evaluated by fcMRI relative to standard treatment controls, using whole brain analysis. The measurement is increase/decrease of signal in a given region, thresholded at p &lt;0.05, summarized into a value representing 'size of region of increase' or 'size of region of decrease' after subjects scans were combined/mapped onto a standard MNI brain. Only clusters of over 40 voxels were included, and the size of the region is reported in voxel size. The averaged brains for baseline fcMRI was subtracted from post-treatment for each group, and then these averaged differences were subtracted from each other. While other areas of the brain met threshold criteria in the analysis, only areas belonging to the DMN are reported.</description>
          <population>Using a right posterior insula seed for seed-based whole-brain analysis in AFNI, a difference of the differences was measured. Clusters greater than 40 voxels in size with p&lt;0.05 (set in AFNI) found in the default mode network (DMN) are included in the outcome table.</population>
          <units>Cluster size (voxels)</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anterior cingulate (L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inferior parietal lobule (R)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Posterior cingulate cortex (L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>PENFS (post-pre) - Standard Therapy (post-pre)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Using seed-based analysis with a right posterior insula seed, cluster size was set at 40 voxels, and p-value was thresholded at p&lt;0.05 to compare the differences between the two groups in terms of connectivity between the right posterior insula and areas of the DMN identified based on a priori hypotheses.</non_inferiority_desc>
            <p_value>&lt;0.05</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>40</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Standard therapy control (post-pre) was subtracted from PENFS (post-pre).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Defense Veterans Pain Rating Scale (DVPRS) From Baseline</title>
        <description>For fibromyalgia patients, pain will be assessed in the PENFS group relative to standard treatment controls, as indicated by analgesic Defense and Veterans Pain Rating Scale (DVPRS) at 2, 6 and 12 weeks follow-up. This is a validated pain measure that includes a 0-10 scale where 0 means no pain and 10 means greatest pain imaginable. Higher scores indicate worse reported pain outcomes.</description>
        <time_frame>2, 6 and 12 weeks follow-up</time_frame>
        <population>Not all individuals presented for all follow-up visits, but all participants included in the analysis were present for baseline assessments, pre- and post- imaging studies, and at least one follow-up visit. Missing data was not imputed and not used for analysis in order to avoid distortions related to imputation in the small sample size.</population>
        <group_list>
          <group group_id="O1">
            <title>PENFS</title>
            <description>Veterans with fibromyalgia who meet study criteria and are randomized to the experimental group will receive standard therapy in addition to percutaneous electrical neural field stimulation (PENFS), which involves placement of small electrodes through a similar process to ear acupuncture to the ear. These electrodes are attached to a battery pack that is taped behind the ear and worn for 5-day intervals. The intention of this FDA-approved device is to relieve pain, though data on its effectiveness is still limited. Device placement (series of 4, weekly) will be performed by an Anesthesiology Pain Clinic provider. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.&#xD;
Military Field Stimulator: The Military Field Stimulator (MFS/Neuro-Stim System), a percutaneous electrical neural field stimulation (PENFS) device evolved from PENS, is currently employed by the United States (US) military</description>
          </group>
          <group group_id="O2">
            <title>Standard Therapy</title>
            <description>Veterans with fibromyalgia who meet study criteria and are randomized to standard therapy will receive physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.&#xD;
Standard Therapy: Standard therapy for fibromyalgia will include physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Defense Veterans Pain Rating Scale (DVPRS) From Baseline</title>
          <description>For fibromyalgia patients, pain will be assessed in the PENFS group relative to standard treatment controls, as indicated by analgesic Defense and Veterans Pain Rating Scale (DVPRS) at 2, 6 and 12 weeks follow-up. This is a validated pain measure that includes a 0-10 scale where 0 means no pain and 10 means greatest pain imaginable. Higher scores indicate worse reported pain outcomes.</description>
          <population>Not all individuals presented for all follow-up visits, but all participants included in the analysis were present for baseline assessments, pre- and post- imaging studies, and at least one follow-up visit. Missing data was not imputed and not used for analysis in order to avoid distortions related to imputation in the small sample size.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>2 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" lower_limit="-4.4" upper_limit="2.6"/>
                    <measurement group_id="O2" value="-1.4" lower_limit="-8.8" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" lower_limit="-5.1" upper_limit="2.9"/>
                    <measurement group_id="O2" value="-0.5" lower_limit="-2.6" upper_limit="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" lower_limit="-5.3" upper_limit="2.7"/>
                    <measurement group_id="O2" value="-0.1" lower_limit="-3.4" upper_limit="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pain Interference With &quot;Activity,&quot; &quot;Sleep,&quot; &quot;Mood&quot;, and &quot;Stress&quot; From Baseline</title>
        <description>Pain interference scores were measured using supplemental questions on the Defense and Veterans Pain Rating Scale (DVPRS). Participants were asked to evaluate on a scale of 0-10 the level to which pain interfered with their &quot;activity,&quot; &quot;sleep,&quot; &quot;mood&quot;, and &quot;stress,&quot; with 10 being the worst interference, and 0 being no interference.</description>
        <time_frame>2, 6 and 12 weeks follow-up</time_frame>
        <population>Not all individuals presented for all follow-up visits, but all participants included in the analysis were present for baseline assessments, pre- and post- imaging studies, and at least one follow-up visit. Missing data was not imputed and not used for analysis in order to avoid distortions related to imputation in the small sample size.</population>
        <group_list>
          <group group_id="O1">
            <title>PENFS</title>
            <description>Veterans with fibromyalgia who meet study criteria and are randomized to the experimental group will receive standard therapy in addition to percutaneous electrical neural field stimulation (PENFS), which involves placement of small electrodes through a similar process to ear acupuncture to the ear. These electrodes are attached to a battery pack that is taped behind the ear and worn for 5-day intervals. The intention of this FDA-approved device is to relieve pain, though data on its effectiveness is still limited. Device placement (series of 4, weekly) will be performed by an Anesthesiology Pain Clinic provider. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.&#xD;
Military Field Stimulator: The Military Field Stimulator (MFS/Neuro-Stim System), a percutaneous electrical neural field stimulation (PENFS) device evolved from PENS, is currently employed by the United States (US) military</description>
          </group>
          <group group_id="O2">
            <title>Standard Therapy</title>
            <description>Veterans with fibromyalgia who meet study criteria and are randomized to standard therapy will receive physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.&#xD;
Standard Therapy: Standard therapy for fibromyalgia will include physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pain Interference With &quot;Activity,&quot; &quot;Sleep,&quot; &quot;Mood&quot;, and &quot;Stress&quot; From Baseline</title>
          <description>Pain interference scores were measured using supplemental questions on the Defense and Veterans Pain Rating Scale (DVPRS). Participants were asked to evaluate on a scale of 0-10 the level to which pain interfered with their &quot;activity,&quot; &quot;sleep,&quot; &quot;mood&quot;, and &quot;stress,&quot; with 10 being the worst interference, and 0 being no interference.</description>
          <population>Not all individuals presented for all follow-up visits, but all participants included in the analysis were present for baseline assessments, pre- and post- imaging studies, and at least one follow-up visit. Missing data was not imputed and not used for analysis in order to avoid distortions related to imputation in the small sample size.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>2 weeks - Activity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" lower_limit="-4.7" upper_limit="2.3"/>
                    <measurement group_id="O2" value="0.9" lower_limit="-8" upper_limit="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 weeks - Sleep</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" lower_limit="-7.4" upper_limit="4.2"/>
                    <measurement group_id="O2" value="-0.4" lower_limit="-11.7" upper_limit="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 weeks - Mood</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1" lower_limit="-6.1" upper_limit="4.1"/>
                    <measurement group_id="O2" value="-0.6" lower_limit="-11.1" upper_limit="9.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 weeks - Stress</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" lower_limit="-5" upper_limit="2.2"/>
                    <measurement group_id="O2" value="0" lower_limit="-9.7" upper_limit="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 weeks - Activity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" lower_limit="-5.7" upper_limit="3.3"/>
                    <measurement group_id="O2" value="1.2" lower_limit="-1.9" upper_limit="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 weeks - Sleep</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" lower_limit="-7.1" upper_limit="3.9"/>
                    <measurement group_id="O2" value="1.8" lower_limit="-2.4" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 weeks - Mood</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" lower_limit="-6.7" upper_limit="3.9"/>
                    <measurement group_id="O2" value="1.8" lower_limit="-2.7" upper_limit="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 weeks - Stress</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" lower_limit="-6.2" upper_limit="2.6"/>
                    <measurement group_id="O2" value="1.7" lower_limit="-1.9" upper_limit="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 weeks - Activity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" lower_limit="-6.3" upper_limit="3.1"/>
                    <measurement group_id="O2" value="1" lower_limit="-6.2" upper_limit="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 weeks - Sleep</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.7" lower_limit="-6.3" upper_limit="2.9"/>
                    <measurement group_id="O2" value="2.2" lower_limit="-3.7" upper_limit="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 weeks - Mood</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.1" lower_limit="-6.4" upper_limit="2.2"/>
                    <measurement group_id="O2" value="1.8" lower_limit="-5.5" upper_limit="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 weeks - Stress</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.9" lower_limit="-5.2" upper_limit="1.4"/>
                    <measurement group_id="O2" value="1.8" lower_limit="-4.6" upper_limit="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Number of Bicep Curls From Baseline (Left Arm)</title>
        <description>Objective tests for functional improvement will be performed at 2, 6, and 12 weeks follow-up and include 30 sec chair stand tests. The total number of full bicep curls (left arm) participants could perform using were measured over a 30-second period at each visit.</description>
        <time_frame>2, 6 and 12 weeks follow-up</time_frame>
        <population>Not all individuals presented for all follow-up visits, but all participants included in the analysis were present for baseline assessments, pre- and post- imaging studies, and at least one follow-up visit. Missing data was not imputed and not used for analysis in order to avoid distortions related to imputation in the small sample size.</population>
        <group_list>
          <group group_id="O1">
            <title>PENFS</title>
            <description>Veterans with fibromyalgia who meet study criteria and are randomized to the experimental group will receive standard therapy in addition to percutaneous electrical neural field stimulation (PENFS), which involves placement of small electrodes through a similar process to ear acupuncture to the ear. These electrodes are attached to a battery pack that is taped behind the ear and worn for 5-day intervals. The intention of this FDA-approved device is to relieve pain, though data on its effectiveness is still limited. Device placement (series of 4, weekly) will be performed by an Anesthesiology Pain Clinic provider. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.</description>
          </group>
          <group group_id="O2">
            <title>Standard Therapy</title>
            <description>Veterans with fibromyalgia who meet study criteria and are randomized to standard therapy will receive physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.&#xD;
Standard Therapy: Standard therapy for fibromyalgia will include physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Number of Bicep Curls From Baseline (Left Arm)</title>
          <description>Objective tests for functional improvement will be performed at 2, 6, and 12 weeks follow-up and include 30 sec chair stand tests. The total number of full bicep curls (left arm) participants could perform using were measured over a 30-second period at each visit.</description>
          <population>Not all individuals presented for all follow-up visits, but all participants included in the analysis were present for baseline assessments, pre- and post- imaging studies, and at least one follow-up visit. Missing data was not imputed and not used for analysis in order to avoid distortions related to imputation in the small sample size.</population>
          <units>bicep curls</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>2 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" lower_limit="-8.1" upper_limit="17.3"/>
                    <measurement group_id="O2" value="1.7" lower_limit="-12" upper_limit="15.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1" lower_limit="-7" upper_limit="19.2"/>
                    <measurement group_id="O2" value="-1.8" lower_limit="-14.2" upper_limit="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8" lower_limit="-7.4" upper_limit="19"/>
                    <measurement group_id="O2" value="0" lower_limit="-15.5" upper_limit="15.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Number of Bicep Curls From Baseline (Right Arm)</title>
        <description>Objective tests for functional improvement will be performed at 2, 6, and 12 weeks follow-up and include 30 sec chair stand tests. The total number of full bicep curls (right arm) participants could perform using were measured over a 30-second period at each visit.</description>
        <time_frame>2, 6 and 12 weeks follow-up</time_frame>
        <population>Not all individuals presented for all follow-up visits, but all participants included in the analysis were present for baseline assessments, pre- and post- imaging studies, and at least one follow-up visit. Missing data was not imputed and not used for analysis in order to avoid distortions related to imputation in the small sample size.</population>
        <group_list>
          <group group_id="O1">
            <title>PENFS</title>
            <description>Veterans with fibromyalgia who meet study criteria and are randomized to the experimental group will receive standard therapy in addition to percutaneous electrical neural field stimulation (PENFS), which involves placement of small electrodes through a similar process to ear acupuncture to the ear. These electrodes are attached to a battery pack that is taped behind the ear and worn for 5-day intervals. The intention of this FDA-approved device is to relieve pain, though data on its effectiveness is still limited. Device placement (series of 4, weekly) will be performed by an Anesthesiology Pain Clinic provider. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.&#xD;
Military Field Stimulator: The Military Field Stimulator (MFS/Neuro-Stim System), a percutaneous electrical neural field stimulation (PENFS) device evolved from PENS, is currently employed by the United States (US) military</description>
          </group>
          <group group_id="O2">
            <title>Standard Therapy</title>
            <description>Veterans with fibromyalgia who meet study criteria and are randomized to standard therapy will receive physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.&#xD;
Standard Therapy: Standard therapy for fibromyalgia will include physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Number of Bicep Curls From Baseline (Right Arm)</title>
          <description>Objective tests for functional improvement will be performed at 2, 6, and 12 weeks follow-up and include 30 sec chair stand tests. The total number of full bicep curls (right arm) participants could perform using were measured over a 30-second period at each visit.</description>
          <population>Not all individuals presented for all follow-up visits, but all participants included in the analysis were present for baseline assessments, pre- and post- imaging studies, and at least one follow-up visit. Missing data was not imputed and not used for analysis in order to avoid distortions related to imputation in the small sample size.</population>
          <units>bicep curls</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>2 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" lower_limit="-5.8" upper_limit="14.2"/>
                    <measurement group_id="O2" value="0.7" lower_limit="-14.4" upper_limit="15.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" lower_limit="-8.4" upper_limit="20.4"/>
                    <measurement group_id="O2" value="0.8" lower_limit="-12.4" upper_limit="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" lower_limit="-8.7" upper_limit="17.9"/>
                    <measurement group_id="O2" value="0.2" lower_limit="-11.2" upper_limit="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Sit-to Stand Test From Baseline</title>
        <description>Objective tests for functional improvement will be performed at 2, 6, and 12 weeks follow-up and include 30 sec chair stand tests. The total number of full sit-to-stands participants could perform were measured over a 30-second period at each visit.</description>
        <time_frame>2, 6 and 12 weeks follow-up</time_frame>
        <population>Not all individuals presented for all follow-up visits, but all participants included in the analysis were present for baseline assessments, pre- and post- imaging studies, and at least one follow-up visit. Missing data was not imputed and not used for analysis in order to avoid distortions related to imputation in the small sample size.</population>
        <group_list>
          <group group_id="O1">
            <title>PENFS</title>
            <description>Veterans with fibromyalgia who meet study criteria and are randomized to the experimental group will receive standard therapy in addition to percutaneous electrical neural field stimulation (PENFS), which involves placement of small electrodes through a similar process to ear acupuncture to the ear. These electrodes are attached to a battery pack that is taped behind the ear and worn for 5-day intervals. The intention of this FDA-approved device is to relieve pain, though data on its effectiveness is still limited. Device placement (series of 4, weekly) will be performed by an Anesthesiology Pain Clinic provider. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.</description>
          </group>
          <group group_id="O2">
            <title>Standard Therapy</title>
            <description>Veterans with fibromyalgia who meet study criteria and are randomized to standard therapy will receive physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.&#xD;
Standard Therapy: Standard therapy for fibromyalgia will include physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Sit-to Stand Test From Baseline</title>
          <description>Objective tests for functional improvement will be performed at 2, 6, and 12 weeks follow-up and include 30 sec chair stand tests. The total number of full sit-to-stands participants could perform were measured over a 30-second period at each visit.</description>
          <population>Not all individuals presented for all follow-up visits, but all participants included in the analysis were present for baseline assessments, pre- and post- imaging studies, and at least one follow-up visit. Missing data was not imputed and not used for analysis in order to avoid distortions related to imputation in the small sample size.</population>
          <units>sit-to-stands</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>2 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" lower_limit="-3.9" upper_limit="9.3"/>
                    <measurement group_id="O2" value="0.3" lower_limit="-7.8" upper_limit="8.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" lower_limit="-6.6" upper_limit="12.8"/>
                    <measurement group_id="O2" value="0.3" lower_limit="-7.8" upper_limit="8.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 weeks</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" lower_limit="-7" upper_limit="10.4"/>
                    <measurement group_id="O2" value="1.4" lower_limit="-6.3" upper_limit="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>PENFS</title>
          <description>Veterans with fibromyalgia who meet study criteria and are randomized to the experimental group will receive standard therapy in addition to percutaneous electrical neural field stimulation (PENFS), which involves placement of small electrodes through a similar process to ear acupuncture to the ear. These electrodes are attached to a battery pack that is taped behind the ear and worn for 5-day intervals. The intention of this FDA-approved device is to relieve pain, though data on its effectiveness is still limited. Device placement (series of 4, weekly) will be performed by an Anesthesiology Pain Clinic provider. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.</description>
        </group>
        <group group_id="E2">
          <title>Standard Therapy</title>
          <description>Veterans with fibromyalgia who meet study criteria and are randomized to standard therapy will receive physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.&#xD;
Standard Therapy: Standard therapy for fibromyalgia will include physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin Irritation</sub_title>
                <description>Minor skin irritation reported at implantation site</description>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Anna Woodbury</name_or_title>
      <organization>VAORD</organization>
      <phone>404-321-6111</phone>
      <email>anna.woodbury@va.gov</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03008837
org study id: F2113-M
secondary id: 1IK1RX002113-01A2
nct id: NCT03008837
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Given recent increasing opioid-related deaths and evidence showing against the use of opioids
      for non-malignant chronic pain, there is growing need for non-narcotic pain management.
      Fibromyalgia is a difficult to treat chronic pain condition that is often treated with
      opioids despite existing evidence. The prevalence of fibromyalgia is increased among Veterans
      returning from the gulf war and is already a significant burden in senior Veterans who may
      have suffered with chronic pain for decades already. Many treatment options for fibromyalgia
      carry intolerable side effects. PENFS (percutaneous electrical neural field stimulation) is a
      FDA-approved, non-pharmacologic therapy that is currently utilized within the military and VA
      system, but sufficient evidence regarding its outcomes and neural mechanisms have not been
      adequately investigated. An understanding of its neural underpinnings and analgesic effects
      could lead to 1) improvements in pain management and quality of life, 2) cost-savings and 3)
      development of new techniques to address pain.
BACKGROUND: Fibromyalgia is a chronic pain syndrome that consists of chronic widespread pain,
      decreased physical function, fatigue, psychoemotional/sleep disturbances, and various somatic
      complaints, affecting anywhere from 5-10 million Americans, with ~1,500 Veterans carrying a
      diagnosis of fibromyalgia seen per year at the Atlanta VAMC alone. It is estimated that
      fibromyalgia costs the American population over $20 billion/year in lost wages and
      disability. Initial therapies often include complementary and alternative medicine (CAM)
      therapies, which are generally considered safe, although their efficacy has not been
      thoroughly evaluated for fibromyalgia. Thus, non-pharmacologic alternatives require more
      rigorous scientific investigation for the treatment of fibromyalgia. There is evidence to
      support the use of percutaneous electrical neural stimulation (PENS) in the treatment of pain
      conditions, which may have increased effects relative to acupuncture based on systematic
      reviews. While fMRI data for acupuncture and fibromyalgia exists, no such data exists for
      PENS treatment. An evolved form of PENS, percutaneous electrical neural field stimulation
      (PENFS) of the auricle is already used in the military and VA systems for the treatment of
      chronic pain, but evidence regarding its mechanisms and effects is lacking. Stimulation of
      the vagus nerve, which has auricular branches, has been previously studied for pain relief in
      fibromyalgia. However, application of PENS-type stimulation to the auricle has not been
      previously studied with fMRI, and this type of therapy may lead to neural changes worthy of
      further exploration. OBJECTIVE: To evaluate the feasibility of using fMRI as a biomarker for
      the neural substrates of pain and functional changes following PENFS treatments. HYPOTHESIS:
      PENFS will result in decreased functional connectivity between the insula and default mode
      network as evaluated by fMRI, which will correlate to more significant improvements in pain
      and function relative to standard therapy for fibromyalgia. METHODS: Subjects who meet study
      criteria will receive baseline assessments including resting state fMRI, collection of
      biobehavioural information such as cognitive and psychological assessments on standardized
      forms, eating, sleeping and drinking habits, Defense and Veterans Pain Rating Scale (DVPRS),
      arm curl, 30-s chair stand, and pain interference scores. Subjects will be stratified based
      on age and gender and then divided into standard therapy control (medication management and
      physical therapy) or PENFS (series of 4, weekly) treatments and assessed for fMRI changes 2
      weeks after the final treatment. Pain and function will also be assessed at the 2 weeks, 6
      weeks and 12 weeks following the final treatment. CLINICAL RELEVANCE: Auricular PENFS has not
      been studied with fMRI. Stimulation of the auricle may produce neural changes that differ
      from traditional therapies. Understanding the underlying neural mechanisms of auricular PENFS
      could assist in developing targeted treatments for fibromyalgia and chronic pain. Further, if
      PENFS can significantly improve pain relief and function over standard therapies, it could
      decrease the need for opioid analgesics and their associated risks, which is a primary
      objective of the VA Opioid Safety Initiative. The present investigation will not only serve
      to elucidate neural changes with PENFS, but could be directly applicable to our Veterans
      suffering from fibromyalgia by providing evidence regarding the relative effectiveness of
      this already clinically-employed non-pharmacologic treatment (or lack thereof), and result in
      evidence-based implementation and potential cost savings to the VA system.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Percutaneous electrical neural field stimulator (PENFS) using the military field stimulator, a device that uses small needles inserted in the ear (like auricular acupuncture), which are connected by electrodes to a battery pack that is attached externally using adhesive to the back of the ear. The stimulator is meant to stimulate branches of the cranial nerves via the ear.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: fcMRI as a Biomarker to Investigate Functionally Correlated Neural Substrates of Pain in Patients Undergoing PENFS
time frame: baseline and 2 weeks post-treatment
description: 2 weeks following the final treatment, subjects in the PENFS group were be evaluated for changes in functional connectivity between the right posterior insula seed and other areas of the DMN as evaluated by fcMRI relative to standard treatment controls, using whole brain analysis. The measurement is increase/decrease of signal in a given region, thresholded at p <0.05, summarized into a value representing 'size of region of increase' or 'size of region of decrease' after subjects scans were combined/mapped onto a standard MNI brain. Only clusters of over 40 voxels were included, and the size of the region is reported in voxel size. The averaged brains for baseline fcMRI was subtracted from post-treatment for each group, and then these averaged differences were subtracted from each other. While other areas of the brain met threshold criteria in the analysis, only areas belonging to the DMN are reported.
measure: Change in Defense Veterans Pain Rating Scale (DVPRS) From Baseline
time frame: 2, 6 and 12 weeks follow-up
description: For fibromyalgia patients, pain will be assessed in the PENFS group relative to standard treatment controls, as indicated by analgesic Defense and Veterans Pain Rating Scale (DVPRS) at 2, 6 and 12 weeks follow-up. This is a validated pain measure that includes a 0-10 scale where 0 means no pain and 10 means greatest pain imaginable. Higher scores indicate worse reported pain outcomes.
measure: Change in Pain Interference With "Activity," "Sleep," "Mood", and "Stress" From Baseline
time frame: 2, 6 and 12 weeks follow-up
description: Pain interference scores were measured using supplemental questions on the Defense and Veterans Pain Rating Scale (DVPRS). Participants were asked to evaluate on a scale of 0-10 the level to which pain interfered with their "activity," "sleep," "mood", and "stress," with 10 being the worst interference, and 0 being no interference.
measure: Change in Number of Bicep Curls From Baseline (Left Arm)
time frame: 2, 6 and 12 weeks follow-up
description: Objective tests for functional improvement will be performed at 2, 6, and 12 weeks follow-up and include 30 sec chair stand tests. The total number of full bicep curls (left arm) participants could perform using were measured over a 30-second period at each visit.
measure: Change in Number of Bicep Curls From Baseline (Right Arm)
time frame: 2, 6 and 12 weeks follow-up
description: Objective tests for functional improvement will be performed at 2, 6, and 12 weeks follow-up and include 30 sec chair stand tests. The total number of full bicep curls (right arm) participants could perform using were measured over a 30-second period at each visit.
measure: Change in Sit-to Stand Test From Baseline
time frame: 2, 6 and 12 weeks follow-up
description: Objective tests for functional improvement will be performed at 2, 6, and 12 weeks follow-up and include 30 sec chair stand tests. The total number of full sit-to-stands participants could perform were measured over a 30-second period at each visit.
arm group label: PENFS
arm group type: Experimental
description: Veterans with fibromyalgia who meet study criteria and are randomized to the experimental group will receive standard therapy in addition to percutaneous electrical neural field stimulation (PENFS), which involves placement of small electrodes through a similar process to ear acupuncture to the ear. These electrodes are attached to a battery pack that is taped behind the ear and worn for 5-day intervals. The intention of this FDA-approved device is to relieve pain, though data on its effectiveness is still limited. Device placement (series of 4, weekly) will be performed by an Anesthesiology Pain Clinic provider. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.
arm group label: Standard Therapy
arm group type: Active Comparator
description: Veterans with fibromyalgia who meet study criteria and are randomized to standard therapy will receive physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.
intervention type: Device
intervention name: Military Field Stimulator
description: The Military Field Stimulator (MFS/Neuro-Stim System), a percutaneous electrical neural field stimulation (PENFS) device evolved from PENS, is currently employed by the United States (US) military and used in the VA (contract number V797D-50453). There is some evidence based on a small trial of 20 postoperative patients that suggests PENS may have greater benefit than acupuncture for acute pain.
arm group label: PENFS
other name: MFS, Neuro-Stim System, PENFS
intervention type: Other
intervention name: Standard Therapy
description: Standard therapy for fibromyalgia will include physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist.
arm group label: Standard Therapy
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Anna Woodbury, MD
role: Principal Investigator
affiliation: Atlanta VA Medical and Rehab Center, Decatur, GA
facility: 
country: United States
url: http://article.sapub.org/10.5923.j.cmd.20150504.03.html
description: Peri-Auricular PENFS for Chronic Pain
citation: Gebre M, Woodbury A, Napadow V, Krishnamurthy V, Krishnamurthy LC, Sniecinski R, Crosson B. Functional Magnetic Resonance Imaging Evaluation of Auricular Percutaneous Electrical Neural Field Stimulation for Fibromyalgia: Protocol for a Feasibility Study. JMIR Res Protoc. 2018 Feb 6;7(2):e39. doi: 10.2196/resprot.8692.
PMID: 29410385
responsible party type: Sponsor
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 