<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03254719</url>
  </required_header>
  <id_info>
    <org_study_id>COCOV-Aim #3</org_study_id>
    <secondary_id>R34AT008427</secondary_id>
    <nct_id>NCT03254719</nct_id>
  </id_info>
  <brief_title>Care Outcomes for Chiropractic Outpatient Veterans</brief_title>
  <acronym>COCOV</acronym>
  <official_title>Care Outcomes for Chiropractic Outpatient Veterans Aim 3-pilot Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Palmer College of Chiropractic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Iowa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Palmer College of Chiropractic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objectives of this pilot trial are to evaluate the feasibility, safety and&#xD;
      acceptability of an integrative care pathway that includes chiropractic care, for the&#xD;
      coordinated care for Veterans Administration (VA) patients with chronic low back pain (cLBP),&#xD;
      with an emphasis on those with mental health comorbidity, in preparation for the conduct of&#xD;
      an appropriately powered multi-site randomized controlled trial (RCT). The secondary&#xD;
      objectives are to collect study outcomes at the baseline visit (BV) and at weeks 3, 5, 7, and&#xD;
      10 to: 1) assess the success of collecting outcomes; 2) determine the outcome measures to use&#xD;
      in a future RCT; and 3) determine preliminary intervention effect sizes and variability to&#xD;
      aid in sample size determination for a future RCT. The investigators hypothesize that&#xD;
      chiropractic care offers relief for pain and mental health symptoms through the direct&#xD;
      effects of treatment-focused CMT, as well as through the indirect, non-specific effects of&#xD;
      the team-based relationship with the clinician.&#xD;
&#xD;
      This pilot study is a single-arm trial. All participants will be asked to complete study&#xD;
      outcomes which include the Roland Morris Disability Questionnaire (RMDQ), LBP intensity and&#xD;
      interference as measured by the Defense and Veterans Pain Rating Scale (DVPRS), as well as&#xD;
      the Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder 7-item Scale&#xD;
      (GAD-7), Alcohol Use Disorders Identification Test (AUDIT), Post-traumatic Stress Disorder&#xD;
      Checklist-Civilian Version (PLC-C), self-care behaviors, Keele Start Back Screening Tool&#xD;
      (STarT Back), Healing Encounters and Attitudes Lists (HEAL), Expectations for Complementary&#xD;
      and Integrative Treatments Questionnaire (EXPECT), and Pain Intensity, Enjoyment of Life,&#xD;
      General Activity Assessment Tool (PEG) questionnaires, and the Pain Assessment Screening Tool&#xD;
      and Outcomes Registry (PASTOR) assessment, which includes measures of pain, disability,&#xD;
      mental health, quality of life enjoyment and satisfaction. All participants will receive up&#xD;
      to 10 weeks of chiropractic care and will complete outcome assessments at weeks 3, 5, 7, and&#xD;
      10 of the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The coinciding problems of chronic pain and mental illness are of great concern for patients&#xD;
      seeking care within the Department of Veterans Affairs (VA) healthcare facilities. Of the 5.7&#xD;
      million veterans treated in VA facilities in 2012, more than half reported chronic pain&#xD;
      syndromes, including chronic low back pain (cLBP). Veterans also experience many mental&#xD;
      health comorbidities, such as depression, anxiety, post-traumatic stress disorder (PTSD), and&#xD;
      substance abuse. Veterans in pain are often managed using prescription drugs, including&#xD;
      opioids, psychotropic medications, and sleep agents. Non-pharmacological treatments for&#xD;
      chronic pain, which also may provide relief of mental health symptoms, may be welcomed&#xD;
      complementary therapies for veterans suffering from these conditions.&#xD;
&#xD;
      Patients with musculoskeletal (MSK) pain and pain at multiple locations often report&#xD;
      depression, anxiety and other mental health symptoms. Chronic pain may perpetuate mental&#xD;
      health comorbidity as these conditions share common pathophysiological pathways. Research has&#xD;
      shown that the non-specific effects of empathetic doctor communication and therapeutic&#xD;
      alliance improves clinical outcomes. The investigators hypothesize that chiropractic care&#xD;
      offers relief for pain and mental health symptoms through the direct effects of&#xD;
      treatment-focused chiropractic manipulative therapy (CMT), as well as through the indirect,&#xD;
      non-specific effects of the team-based relationship with the clinician.&#xD;
&#xD;
      However, chiropractic care is not delivered in isolation from other treatments within the VA.&#xD;
      Thus, the investigators will test a feasible, effective, patient-centered, guideline-based,&#xD;
      integrative care model that integrates chiropractic into VA Patient Aligned Care Teams&#xD;
      (PACTs). This integrative care pathway will involve primary care providers, mental health&#xD;
      professionals, and doctors of chiropractic (DCs) engaged in the treatment of veterans with&#xD;
      cLBP, with or without mental health comorbidity. While DCs are providing services within VA&#xD;
      in increasing numbers over the past 13 years, as with any new service, adoption and&#xD;
      appropriate placement faces challenges. Many VA providers may know little about the clinical&#xD;
      approaches used by DCs. Similarly, DCs may not be fully aware of the processes involved in&#xD;
      the delivery of primary care services within VA or the healthcare needs of veterans with&#xD;
      mental illness. The purpose of this pilot clinical trial is to evaluate the feasibility,&#xD;
      safety and patient perceptions of an integrative care pathway, developed through a&#xD;
      consensus-based process, for the coordinated care for VA patients with cLBP and mental health&#xD;
      comorbidity.&#xD;
&#xD;
      As this is a pragmatic trial, chiropractic care will consist of usual chiropractic procedures&#xD;
      for the management chronic low back pain (cLBP). Treatment approaches will be based on&#xD;
      clinical evaluation, which may include diagnostic testing, to determine a working diagnosis,&#xD;
      rule out pathology, and/or to screen for conditions requiring referral or other&#xD;
      co-management. The investigators anticipate that chiropractic care often will include some&#xD;
      form of chiropractic manipulative therapy (CMT). DCs will likely also recommend&#xD;
      rehabilitative exercise, stretching, or nutritional and lifestyle advice based upon clinical&#xD;
      findings and patient goals/preferences. The investigators will evaluate treatments through&#xD;
      electronic health records (EHR) data abstraction following completion of chiropractic care at&#xD;
      Week 10. As per typical VA care, DCs will monitor the participant's health status throughout&#xD;
      the trial and initiate referrals as clinically indicated. Referrals to primary care and&#xD;
      mental health providers will be consistent with the chiropractic integrated care pathway&#xD;
      developed during a prior phase of the study. The investigators anticipate the most common&#xD;
      communication and referral methods will occur through note-review and countersign procedures,&#xD;
      which are already established among VA providers using the VA electronic health record, but&#xD;
      may also occur in person or via phone conversations. Chiropractic care will be administered&#xD;
      by licensed DCs who are current employees of the Iowa City VA Health Care System (ICVAHCS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 19, 2018</start_date>
  <completion_date type="Actual">November 5, 2018</completion_date>
  <primary_completion_date type="Actual">November 5, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Chiropractic care will be administered by licensed DCs who are current employees of the Iowa City VA Health Care System (ICVAHCS). Participants will receive chiropractic care at a frequency of 1-2 visits per week for a duration up to 10 weeks, with the frequency and duration of care individualized within established VA parameters. For this trial, the minimum treatment dose is 1 visit to the DC, while the maximum treatment dose is 12 visits.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of Study Recruitment</measure>
    <time_frame>From date of first participant enrolled to date last participant is enrolled, up to 8 months.</time_frame>
    <description>As part of the feasibility assessment, the investigators will monitor the amount of time it takes to complete study recruitment and enrollment, and data collection. The investigators will monitor this through a data capture program.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diversity of Patient Demographics</measure>
    <time_frame>Screening through baseline</time_frame>
    <description>As part of the recruitment plan, investigators are trying to target female and minority veterans. Historically these groups have been underrepresented in veteran research. The investigators will review EHR data for participant demographics.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Engaged in Use of MyHealthEVet</measure>
    <time_frame>10 weeks from Baseline</time_frame>
    <description>As part of the feasibility assessment, investigators will monitor the number of study participants who enroll in and have at least one communication with MyHealthEVet. MyHealthEVet is an online communication tool designed to partner veterans and the veteran's health care team. It provides information on the veteran's health record and health topics as well as allows messaging communication between veterans and health care providers. Usage reports generated by MyHealthEVet will be analyzed to determine number of study participants engaged.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability</measure>
    <time_frame>At Week 10 of the study</time_frame>
    <description>Acceptability will be assessed by conducting structured, qualitative exit interviews with participants and providers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Reported Adverse Events</measure>
    <time_frame>10 weeks from Baseline</time_frame>
    <description>Safety for this study will be assessed by the number of adverse events counted and recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Did Not Attend the Initial Chiropractic Visit, Withdrew, or Are Lost to Follow-up</measure>
    <time_frame>10 weeks from Baseline</time_frame>
    <description>As part of the feasibility assessment and ability to calculate a sample size for a full scale trial with subgroup analysis, investigators will monitor the percentage of missing data. This will include the percentage of participants who did not attend the initial chiropractic visit and withdraw or are lost to follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Roland Morris Low Back Pain Disability Questionnaire (RMDQ)</measure>
    <time_frame>Baseline visit and weeks 5 and 10</time_frame>
    <description>The RMDQ is a widely used health status measure for low back pain. Scoring of the RMDQ ranges from 0-24, with a higher score indicating an increase in low back pain disability. (0-24, 0=No Disability, 24=Severe Disability)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Assessment Screening Tool and Outcomes Registry (PASTOR)</measure>
    <time_frame>Baseline visit and weeks 5 and 10</time_frame>
    <description>PASTOR is an on-line data collection tool based on the NIH Patient Reported Outcomes Measurement Information System (PROMIS) and adopted by the DoD/VA Pain Management Task Force. Specific measures include the Defense &amp; Veterans Pain Rating Scale (DVPRS), an enhanced 11-item (total range 0-10, 0=no pain, 10=worst pain) numeric rating scale (NRS) that improves on standard pain NRS by including a Faces Rating Scale component; 'traffic light' color-coding system to delineate mild, moderate and severe pain; and word descriptors, paired with 4, 0-10 NRS items to quantify the impact of pain on general activity, sleep, mood, and stress. PASTOR incorporates PROMIS measures for mental health conditions (PTSD, depression, anxiety, anger, and alcohol use), physical and social function, fatigue, and pain interference with daily activities to provide graphical representation of improvements or declines in patient status that are compared to matched US samples on age, race/ethnicity and sex.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>STarT Back Screening Tool</measure>
    <time_frame>Baseline visit and week 10</time_frame>
    <description>This is a 9-item, validated tool developed by Keele University to be used as a screening tool for patients with low back pain. It stratifies patients based on their prognosis of persistent disabling symptoms and allows practitioners to group patients into 3 categories (low, medium, or high risk of poor outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy for Managing Symptoms (SF8a)</measure>
    <time_frame>Baseline visit and week 10</time_frame>
    <description>Developed by the Patient-Reported Outcomes Measurement Information System (PROMIS), this 8-item, self-reported tool will assess a person's level of confidence to manage/control symptoms, to manage their symptoms in different settings and to keep symptoms from interfering with work, sleep, relationships or recreational activities. Each question usually has five response options ranging in value from 1 to 5. The total raw score for a measure is converted to into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. A higher PROMIS T-score represents more of the concept being measured. For example, a T-score of 55 on the PROMIS Self-Efficacy for Managing Symptoms indicates that the respondent has greater self-efficacy for managing their symptoms than the general chronic condition population (half a standard deviation higher).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>Baseline visit and week 10</time_frame>
    <description>This instrument is self-reported with nine items and will be used to assess depressive disorder. Total scores range from 0 to 27 with a score of 10-14 considered to be in the moderate range (0-27, 0=No Depression, 27=Severe Depression). It has been tested in primary care settings and has a test-retest reliability of 0.81 to 0.96.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generalized Anxiety Disorder-7 (GAD-7)</measure>
    <time_frame>Baseline visit and week 10</time_frame>
    <description>This instrument is self-reported with seven items and will be used to assess generalized anxiety disorder. At a cut off score of 10 (0-21, 0=No Anxiety Disorder, 21=Severe Anxiety Disorder), it has a sensitivity of 0.89 and specificity of 0.82 for identifying patients with GAD in primary care settings.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Use Disorders Identification Test (AUDIT)</measure>
    <time_frame>Baseline visit and week 10</time_frame>
    <description>Developed by the World Health Organization (WHO), this 10-item screening questionnaire determines harmful or hazardous consumption of alcohol, correctly classifying 95% of people as having a clinical diagnosis of an alcohol abuse disorder (0-12, 0=No Alcohol Use).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PTSD Checklist-Civilian (PCL-C)</measure>
    <time_frame>Baseline visit and week 10</time_frame>
    <description>This 17-item, self-reported instrument will assess PTSD. A total severity score is determined by summing scores from each of 17 items. A change of 5-10 points represents the minimum threshold for determining treatment response; a 10-20 point change represents a clinically significant change in PTSD symptom severity (17-85, 17=Not at all Severe PTSD Symptoms, 85=Extremely Severe PTSD Symptoms).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healing Encounters and Attitudes Lists (HEAL)</measure>
    <time_frame>After the initial chiropractic visit</time_frame>
    <description>HEAL is a validated item-bank comprised of 6 domains developed through the Patient Reported Outcomes Measurement Information System (PROMIS) methodology. Investigators will use HEAL to assess nonspecific factors known to influence patient outcomes, including perceptions of the patient-provider connection, healthcare environment, treatment expectancy, spirituality, positive or negative outlook, and attitudes toward complementary and alternative medicine (CAM). A higher T-score represents more of the concept being measured. A T-score of 50 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of more positive perception. For example, a T-score of 55 on Patient-Provider Connection indicates that the respondent has a more positive perception toward the patient-provider connection than the general chronic condition population (half a standard deviation higher).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain, Enjoyment, and General Activity (PEG)</measure>
    <time_frame>Week 3 and Week 7</time_frame>
    <description>The PEG is a 3-item tool to improve assessment and monitoring of chronic pain. The overall PEG-3 score ranges from 0-10 with 10 indicating more pain, more interference with enjoyment of life, and more interference with general activity. Questions assess average pain intensity (P) (AVERAGE pain in past week: 0-10, 0= No Pain, 10=Pain as bad as you can imagine), interference with enjoyment of life (E), and interference with general activity (G) (In past week, how pain interfered with...(0-10, 0=Does not interfere, 10=Completely interferes).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Low Back Pain</condition>
  <condition>PTSD</condition>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Treatment Arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All participants enrolled in the study will receive chiropractic care consistent with the usual chiropractic procedures for the management of chronic low back pain at the Iowa City VA Health Care System. Participants will also complete study assessments as described in outcomes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Study assessments</intervention_name>
    <description>All participants will be asked to complete study assessments at baseline visit, and weeks 3, 5, 7, and 10. Study participants will receive spinal manipulation and appropriate adjunctive therapies provided by doctors of chiropractic.</description>
    <arm_group_label>Treatment Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Veterans age 18 years or older&#xD;
&#xD;
          -  Self-reported chronic LBP&#xD;
&#xD;
          -  Ability to sign informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of chiropractic care within the past 90 days&#xD;
&#xD;
          -  Impaired cognitive ability&#xD;
&#xD;
          -  Not a candidate for chiropractic care&#xD;
&#xD;
          -  Not able to attend chiropractic appointments&#xD;
&#xD;
          -  Identified as at risk for suicide&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christine M Goertz, DC, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Spine Institute for Quality</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cynthia Long, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Palmer Center for Chiropractic Research (PCCR)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Community Based Outpatient Clinic</name>
      <address>
        <city>Coralville</city>
        <state>Iowa</state>
        <zip>52241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palmer Center for Chiropractic Research</name>
      <address>
        <city>Davenport</city>
        <state>Iowa</state>
        <zip>52803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iowa City Veterans Affairs Health Care System</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Spine Institute for Quality</name>
      <address>
        <city>Oskaloosa</city>
        <state>Iowa</state>
        <zip>52577</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Lisi AJ, Salsbury SA, Hawk C, Vining RD, Wallace RB, Branson R, Long CR, Burgo-Black AL, Goertz CM. Chiropractic Integrated Care Pathway for Low Back Pain in Veterans: Results of a Delphi Consensus Process. J Manipulative Physiol Ther. 2018 Feb;41(2):137-148. doi: 10.1016/j.jmpt.2017.10.001.</citation>
    <PMID>29482827</PMID>
  </results_reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <results_first_submitted>February 11, 2020</results_first_submitted>
  <results_first_submitted_qc>May 4, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">May 18, 2020</results_first_posted>
  <last_update_submitted>May 4, 2020</last_update_submitted>
  <last_update_submitted_qc>May 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Low Back Pain</keyword>
  <keyword>Chiropractic</keyword>
  <keyword>Veterans</keyword>
  <keyword>PTSD</keyword>
  <keyword>Depression</keyword>
  <keyword>Anxiety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Feasibility/pilot study</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT03254719/ICF_000.pdf</document_url>
    </provided_document>
    <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>August 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT03254719/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Treatment Arm</title>
          <description>All participants enrolled in the study will receive chiropractic care consistent with the usual chiropractic procedures for the management of chronic low back pain at the Iowa City VA Health Care System. Participants will also complete study assessments as described in outcomes.&#xD;
Study assessments: All participants will be asked to complete study assessments at baseline visit, and weeks 3, 5, 7, and 10. Study participants will receive spinal manipulation and appropriate adjunctive therapies provided by doctors of chiropractic.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Treatment Arm</title>
          <description>All participants enrolled in the study will receive chiropractic care consistent with the usual chiropractic procedures for the management of chronic low back pain at the Iowa City VA Health Care System. Participants will also complete study assessments as described in outcomes.&#xD;
Study assessments: All participants will be asked to complete study assessments at baseline visit, and weeks 3, 5, 7, and 10. Study participants will receive spinal manipulation and appropriate adjunctive therapies provided by doctors of chiropractic.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.3" spread="15.1"/>
                  </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="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race</title>
              <category_list>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Multi-racial</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Declined to Answer</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Ethnicity</title>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Duration of Study Recruitment</title>
        <description>As part of the feasibility assessment, the investigators will monitor the amount of time it takes to complete study recruitment and enrollment, and data collection. The investigators will monitor this through a data capture program.</description>
        <time_frame>From date of first participant enrolled to date last participant is enrolled, up to 8 months.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>All participants enrolled in the study will receive chiropractic care consistent with the usual chiropractic procedures for the management of chronic low back pain at the Iowa City VA Health Care System. Participants will also complete study assessments as described in outcomes.&#xD;
Study assessments: All participants will be asked to complete study assessments at baseline visit, and weeks 3, 5, 7, and 10. Study participants will receive spinal manipulation and appropriate adjunctive therapies provided by doctors of chiropractic.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Study Recruitment</title>
          <description>As part of the feasibility assessment, the investigators will monitor the amount of time it takes to complete study recruitment and enrollment, and data collection. The investigators will monitor this through a data capture program.</description>
          <units>months</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Diversity of Patient Demographics</title>
        <description>As part of the recruitment plan, investigators are trying to target female and minority veterans. Historically these groups have been underrepresented in veteran research. The investigators will review EHR data for participant demographics.</description>
        <time_frame>Screening through baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>All participants enrolled in the study will receive chiropractic care consistent with the usual chiropractic procedures for the management of chronic low back pain at the Iowa City VA Health Care System. Participants will also complete study assessments as described in outcomes.&#xD;
Study assessments: All participants will be asked to complete study assessments at baseline visit, and weeks 3, 5, 7, and 10. Study participants will receive spinal manipulation and appropriate adjunctive therapies provided by doctors of chiropractic.</description>
          </group>
        </group_list>
        <measure>
          <title>Diversity of Patient Demographics</title>
          <description>As part of the recruitment plan, investigators are trying to target female and minority veterans. Historically these groups have been underrepresented in veteran research. The investigators will review EHR data for participant demographics.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Multi-racial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other or unspecified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18-35 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36-54 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>55+ years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Engaged in Use of MyHealthEVet</title>
        <description>As part of the feasibility assessment, investigators will monitor the number of study participants who enroll in and have at least one communication with MyHealthEVet. MyHealthEVet is an online communication tool designed to partner veterans and the veteran's health care team. It provides information on the veteran's health record and health topics as well as allows messaging communication between veterans and health care providers. Usage reports generated by MyHealthEVet will be analyzed to determine number of study participants engaged.</description>
        <time_frame>10 weeks from Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>All participants enrolled in the study will receive chiropractic care consistent with the usual chiropractic procedures for the management of chronic low back pain at the Iowa City VA Health Care System. Participants will also complete study assessments as described in outcomes.&#xD;
Study assessments: All participants will be asked to complete study assessments at baseline visit, and weeks 3, 5, 7, and 10. Study participants will receive spinal manipulation and appropriate adjunctive therapies provided by doctors of chiropractic.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Engaged in Use of MyHealthEVet</title>
          <description>As part of the feasibility assessment, investigators will monitor the number of study participants who enroll in and have at least one communication with MyHealthEVet. MyHealthEVet is an online communication tool designed to partner veterans and the veteran's health care team. It provides information on the veteran's health record and health topics as well as allows messaging communication between veterans and health care providers. Usage reports generated by MyHealthEVet will be analyzed to determine number of study participants engaged.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Acceptability</title>
        <description>Acceptability will be assessed by conducting structured, qualitative exit interviews with participants and providers.</description>
        <time_frame>At Week 10 of the study</time_frame>
        <population>Acceptability of chiropractic service delivery as viewed by those veterans who were interviewed.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>All participants enrolled in the study will receive chiropractic care consistent with the usual chiropractic procedures for the management of chronic low back pain at the Iowa City VA Health Care System. Participants will also complete study assessments as described in outcomes.&#xD;
Study assessments: All participants will be asked to complete study assessments at baseline visit, and weeks 3, 5, 7, and 10. Study participants will receive spinal manipulation and appropriate adjunctive therapies provided by doctors of chiropractic.</description>
          </group>
        </group_list>
        <measure>
          <title>Acceptability</title>
          <description>Acceptability will be assessed by conducting structured, qualitative exit interviews with participants and providers.</description>
          <population>Acceptability of chiropractic service delivery as viewed by those veterans who were interviewed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Viewed as Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Viewed as Mixed Positive/Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Viewed as Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Reported Adverse Events</title>
        <description>Safety for this study will be assessed by the number of adverse events counted and recorded.</description>
        <time_frame>10 weeks from Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>All participants enrolled in the study will receive chiropractic care consistent with the usual chiropractic procedures for the management of chronic low back pain at the Iowa City VA Health Care System. Participants will also complete study assessments as described in outcomes.&#xD;
Study assessments: All participants will be asked to complete study assessments at baseline visit, and weeks 3, 5, 7, and 10. Study participants will receive spinal manipulation and appropriate adjunctive therapies provided by doctors of chiropractic.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Reported Adverse Events</title>
          <description>Safety for this study will be assessed by the number of adverse events counted and recorded.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Did Not Attend the Initial Chiropractic Visit, Withdrew, or Are Lost to Follow-up</title>
        <description>As part of the feasibility assessment and ability to calculate a sample size for a full scale trial with subgroup analysis, investigators will monitor the percentage of missing data. This will include the percentage of participants who did not attend the initial chiropractic visit and withdraw or are lost to follow-up.</description>
        <time_frame>10 weeks from Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>All participants enrolled in the study will receive chiropractic care consistent with the usual chiropractic procedures for the management of chronic low back pain at the Iowa City VA Health Care System. Participants will also complete study assessments as described in outcomes.&#xD;
Study assessments: All participants will be asked to complete study assessments at baseline visit, and weeks 3, 5, 7, and 10. Study participants will receive spinal manipulation and appropriate adjunctive therapies provided by doctors of chiropractic.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Did Not Attend the Initial Chiropractic Visit, Withdrew, or Are Lost to Follow-up</title>
          <description>As part of the feasibility assessment and ability to calculate a sample size for a full scale trial with subgroup analysis, investigators will monitor the percentage of missing data. This will include the percentage of participants who did not attend the initial chiropractic visit and withdraw or are lost to follow-up.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Roland Morris Low Back Pain Disability Questionnaire (RMDQ)</title>
        <description>The RMDQ is a widely used health status measure for low back pain. Scoring of the RMDQ ranges from 0-24, with a higher score indicating an increase in low back pain disability. (0-24, 0=No Disability, 24=Severe Disability)</description>
        <time_frame>Baseline visit and weeks 5 and 10</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>All participants enrolled in the study will receive chiropractic care consistent with the usual chiropractic procedures for the management of chronic low back pain at the Iowa City VA Health Care System. Participants will also complete study assessments as described in outcomes.&#xD;
Study assessments: All participants will be asked to complete study assessments at baseline visit, and weeks 3, 5, 7, and 10. Study participants will receive spinal manipulation and appropriate adjunctive therapies provided by doctors of chiropractic.</description>
          </group>
        </group_list>
        <measure>
          <title>Roland Morris Low Back Pain Disability Questionnaire (RMDQ)</title>
          <description>The RMDQ is a widely used health status measure for low back pain. Scoring of the RMDQ ranges from 0-24, with a higher score indicating an increase in low back pain disability. (0-24, 0=No Disability, 24=Severe Disability)</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.9" spread="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.2" spread="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.6" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Assessment Screening Tool and Outcomes Registry (PASTOR)</title>
        <description>PASTOR is an on-line data collection tool based on the NIH Patient Reported Outcomes Measurement Information System (PROMIS) and adopted by the DoD/VA Pain Management Task Force. Specific measures include the Defense &amp; Veterans Pain Rating Scale (DVPRS), an enhanced 11-item (total range 0-10, 0=no pain, 10=worst pain) numeric rating scale (NRS) that improves on standard pain NRS by including a Faces Rating Scale component; 'traffic light' color-coding system to delineate mild, moderate and severe pain; and word descriptors, paired with 4, 0-10 NRS items to quantify the impact of pain on general activity, sleep, mood, and stress. PASTOR incorporates PROMIS measures for mental health conditions (PTSD, depression, anxiety, anger, and alcohol use), physical and social function, fatigue, and pain interference with daily activities to provide graphical representation of improvements or declines in patient status that are compared to matched US samples on age, race/ethnicity and sex.</description>
        <time_frame>Baseline visit and weeks 5 and 10</time_frame>
        <population>There are missing data when a participant was lost to follow-up or chose not to complete an item.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>All participants enrolled in the study will receive chiropractic care consistent with the usual chiropractic procedures for the management of chronic low back pain at the Iowa City VA Health Care System. Participants will also complete study assessments as described in outcomes.&#xD;
Study assessments: All participants will be asked to complete study assessments at baseline visit, and weeks 3, 5, 7, and 10. Study participants will receive spinal manipulation and appropriate adjunctive therapies provided by doctors of chiropractic.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Assessment Screening Tool and Outcomes Registry (PASTOR)</title>
          <description>PASTOR is an on-line data collection tool based on the NIH Patient Reported Outcomes Measurement Information System (PROMIS) and adopted by the DoD/VA Pain Management Task Force. Specific measures include the Defense &amp; Veterans Pain Rating Scale (DVPRS), an enhanced 11-item (total range 0-10, 0=no pain, 10=worst pain) numeric rating scale (NRS) that improves on standard pain NRS by including a Faces Rating Scale component; 'traffic light' color-coding system to delineate mild, moderate and severe pain; and word descriptors, paired with 4, 0-10 NRS items to quantify the impact of pain on general activity, sleep, mood, and stress. PASTOR incorporates PROMIS measures for mental health conditions (PTSD, depression, anxiety, anger, and alcohol use), physical and social function, fatigue, and pain interference with daily activities to provide graphical representation of improvements or declines in patient status that are compared to matched US samples on age, race/ethnicity and sex.</description>
          <population>There are missing data when a participant was lost to follow-up or chose not to complete an item.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Worst Pain, Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Worst Pain, Week 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Worst Pain, Week 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average Pain, Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average Pain, Week 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average Pain, Week 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>STarT Back Screening Tool</title>
        <description>This is a 9-item, validated tool developed by Keele University to be used as a screening tool for patients with low back pain. It stratifies patients based on their prognosis of persistent disabling symptoms and allows practitioners to group patients into 3 categories (low, medium, or high risk of poor outcome).</description>
        <time_frame>Baseline visit and week 10</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>All participants enrolled in the study will receive chiropractic care consistent with the usual chiropractic procedures for the management of chronic low back pain at the Iowa City VA Health Care System. Participants will also complete study assessments as described in outcomes.&#xD;
Study assessments: All participants will be asked to complete study assessments at baseline visit, and weeks 3, 5, 7, and 10. Study participants will receive spinal manipulation and appropriate adjunctive therapies provided by doctors of chiropractic.</description>
          </group>
        </group_list>
        <measure>
          <title>STarT Back Screening Tool</title>
          <description>This is a 9-item, validated tool developed by Keele University to be used as a screening tool for patients with low back pain. It stratifies patients based on their prognosis of persistent disabling symptoms and allows practitioners to group patients into 3 categories (low, medium, or high risk of poor outcome).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <title>Low Risk</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Medium Risk</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>High Risk</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <category_list>
                <category>
                  <title>Low Risk</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Medium Risk</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>High Risk</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Self-Efficacy for Managing Symptoms (SF8a)</title>
        <description>Developed by the Patient-Reported Outcomes Measurement Information System (PROMIS), this 8-item, self-reported tool will assess a person's level of confidence to manage/control symptoms, to manage their symptoms in different settings and to keep symptoms from interfering with work, sleep, relationships or recreational activities. Each question usually has five response options ranging in value from 1 to 5. The total raw score for a measure is converted to into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. A higher PROMIS T-score represents more of the concept being measured. For example, a T-score of 55 on the PROMIS Self-Efficacy for Managing Symptoms indicates that the respondent has greater self-efficacy for managing their symptoms than the general chronic condition population (half a standard deviation higher).</description>
        <time_frame>Baseline visit and week 10</time_frame>
        <population>PROMIS - Self-Efficacy for Managing Symptoms - T score at Baseline and Week 10 follow-up.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>All participants enrolled in the study will receive chiropractic care consistent with the usual chiropractic procedures for the management of chronic low back pain at the Iowa City VA Health Care System. Participants will also complete study assessments as described in outcomes.&#xD;
Study assessments: All participants will be asked to complete study assessments at baseline visit, and weeks 3, 5, 7, and 10. Study participants will receive spinal manipulation and appropriate adjunctive therapies provided by doctors of chiropractic.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-Efficacy for Managing Symptoms (SF8a)</title>
          <description>Developed by the Patient-Reported Outcomes Measurement Information System (PROMIS), this 8-item, self-reported tool will assess a person's level of confidence to manage/control symptoms, to manage their symptoms in different settings and to keep symptoms from interfering with work, sleep, relationships or recreational activities. Each question usually has five response options ranging in value from 1 to 5. The total raw score for a measure is converted to into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. A higher PROMIS T-score represents more of the concept being measured. For example, a T-score of 55 on the PROMIS Self-Efficacy for Managing Symptoms indicates that the respondent has greater self-efficacy for managing their symptoms than the general chronic condition population (half a standard deviation higher).</description>
          <population>PROMIS - Self-Efficacy for Managing Symptoms - T score at Baseline and Week 10 follow-up.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.6" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.5" spread="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Health Questionnaire (PHQ-9)</title>
        <description>This instrument is self-reported with nine items and will be used to assess depressive disorder. Total scores range from 0 to 27 with a score of 10-14 considered to be in the moderate range (0-27, 0=No Depression, 27=Severe Depression). It has been tested in primary care settings and has a test-retest reliability of 0.81 to 0.96.</description>
        <time_frame>Baseline visit and week 10</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>All participants enrolled in the study will receive chiropractic care consistent with the usual chiropractic procedures for the management of chronic low back pain at the Iowa City VA Health Care System. Participants will also complete study assessments as described in outcomes.&#xD;
Study assessments: All participants will be asked to complete study assessments at baseline visit, and weeks 3, 5, 7, and 10. Study participants will receive spinal manipulation and appropriate adjunctive therapies provided by doctors of chiropractic.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Health Questionnaire (PHQ-9)</title>
          <description>This instrument is self-reported with nine items and will be used to assess depressive disorder. Total scores range from 0 to 27 with a score of 10-14 considered to be in the moderate range (0-27, 0=No Depression, 27=Severe Depression). It has been tested in primary care settings and has a test-retest reliability of 0.81 to 0.96.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.7" spread="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Generalized Anxiety Disorder-7 (GAD-7)</title>
        <description>This instrument is self-reported with seven items and will be used to assess generalized anxiety disorder. At a cut off score of 10 (0-21, 0=No Anxiety Disorder, 21=Severe Anxiety Disorder), it has a sensitivity of 0.89 and specificity of 0.82 for identifying patients with GAD in primary care settings.</description>
        <time_frame>Baseline visit and week 10</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>All participants enrolled in the study will receive chiropractic care consistent with the usual chiropractic procedures for the management of chronic low back pain at the Iowa City VA Health Care System. Participants will also complete study assessments as described in outcomes.&#xD;
Study assessments: All participants will be asked to complete study assessments at baseline visit, and weeks 3, 5, 7, and 10. Study participants will receive spinal manipulation and appropriate adjunctive therapies provided by doctors of chiropractic.</description>
          </group>
        </group_list>
        <measure>
          <title>Generalized Anxiety Disorder-7 (GAD-7)</title>
          <description>This instrument is self-reported with seven items and will be used to assess generalized anxiety disorder. At a cut off score of 10 (0-21, 0=No Anxiety Disorder, 21=Severe Anxiety Disorder), it has a sensitivity of 0.89 and specificity of 0.82 for identifying patients with GAD in primary care settings.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" spread="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8" spread="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alcohol Use Disorders Identification Test (AUDIT)</title>
        <description>Developed by the World Health Organization (WHO), this 10-item screening questionnaire determines harmful or hazardous consumption of alcohol, correctly classifying 95% of people as having a clinical diagnosis of an alcohol abuse disorder (0-12, 0=No Alcohol Use).</description>
        <time_frame>Baseline visit and week 10</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>All participants enrolled in the study will receive chiropractic care consistent with the usual chiropractic procedures for the management of chronic low back pain at the Iowa City VA Health Care System. Participants will also complete study assessments as described in outcomes.&#xD;
Study assessments: All participants will be asked to complete study assessments at baseline visit, and weeks 3, 5, 7, and 10. Study participants will receive spinal manipulation and appropriate adjunctive therapies provided by doctors of chiropractic.</description>
          </group>
        </group_list>
        <measure>
          <title>Alcohol Use Disorders Identification Test (AUDIT)</title>
          <description>Developed by the World Health Organization (WHO), this 10-item screening questionnaire determines harmful or hazardous consumption of alcohol, correctly classifying 95% of people as having a clinical diagnosis of an alcohol abuse disorder (0-12, 0=No Alcohol Use).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PTSD Checklist-Civilian (PCL-C)</title>
        <description>This 17-item, self-reported instrument will assess PTSD. A total severity score is determined by summing scores from each of 17 items. A change of 5-10 points represents the minimum threshold for determining treatment response; a 10-20 point change represents a clinically significant change in PTSD symptom severity (17-85, 17=Not at all Severe PTSD Symptoms, 85=Extremely Severe PTSD Symptoms).</description>
        <time_frame>Baseline visit and week 10</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>All participants enrolled in the study will receive chiropractic care consistent with the usual chiropractic procedures for the management of chronic low back pain at the Iowa City VA Health Care System. Participants will also complete study assessments as described in outcomes.&#xD;
Study assessments: All participants will be asked to complete study assessments at baseline visit, and weeks 3, 5, 7, and 10. Study participants will receive spinal manipulation and appropriate adjunctive therapies provided by doctors of chiropractic.</description>
          </group>
        </group_list>
        <measure>
          <title>PTSD Checklist-Civilian (PCL-C)</title>
          <description>This 17-item, self-reported instrument will assess PTSD. A total severity score is determined by summing scores from each of 17 items. A change of 5-10 points represents the minimum threshold for determining treatment response; a 10-20 point change represents a clinically significant change in PTSD symptom severity (17-85, 17=Not at all Severe PTSD Symptoms, 85=Extremely Severe PTSD Symptoms).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.3" spread="18.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.1" spread="19.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Healing Encounters and Attitudes Lists (HEAL)</title>
        <description>HEAL is a validated item-bank comprised of 6 domains developed through the Patient Reported Outcomes Measurement Information System (PROMIS) methodology. Investigators will use HEAL to assess nonspecific factors known to influence patient outcomes, including perceptions of the patient-provider connection, healthcare environment, treatment expectancy, spirituality, positive or negative outlook, and attitudes toward complementary and alternative medicine (CAM). A higher T-score represents more of the concept being measured. A T-score of 50 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of more positive perception. For example, a T-score of 55 on Patient-Provider Connection indicates that the respondent has a more positive perception toward the patient-provider connection than the general chronic condition population (half a standard deviation higher).</description>
        <time_frame>After the initial chiropractic visit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>All participants enrolled in the study will receive chiropractic care consistent with the usual chiropractic procedures for the management of chronic low back pain at the Iowa City VA Health Care System. Participants will also complete study assessments as described in outcomes.&#xD;
Study assessments: All participants will be asked to complete study assessments at baseline visit, and weeks 3, 5, 7, and 10. Study participants will receive spinal manipulation and appropriate adjunctive therapies provided by doctors of chiropractic.</description>
          </group>
        </group_list>
        <measure>
          <title>Healing Encounters and Attitudes Lists (HEAL)</title>
          <description>HEAL is a validated item-bank comprised of 6 domains developed through the Patient Reported Outcomes Measurement Information System (PROMIS) methodology. Investigators will use HEAL to assess nonspecific factors known to influence patient outcomes, including perceptions of the patient-provider connection, healthcare environment, treatment expectancy, spirituality, positive or negative outlook, and attitudes toward complementary and alternative medicine (CAM). A higher T-score represents more of the concept being measured. A T-score of 50 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of more positive perception. For example, a T-score of 55 on Patient-Provider Connection indicates that the respondent has a more positive perception toward the patient-provider connection than the general chronic condition population (half a standard deviation higher).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Patient-Provider Connection - T-Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.9" spread="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Healthcare Environment - T-Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.4" spread="8.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment Expectancy - T-Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.6" spread="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Positive Outlook - T-Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.0" spread="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spirituality - T-Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.9" spread="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Attitudes toward CAM - T-Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.0" spread="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain, Enjoyment, and General Activity (PEG)</title>
        <description>The PEG is a 3-item tool to improve assessment and monitoring of chronic pain. The overall PEG-3 score ranges from 0-10 with 10 indicating more pain, more interference with enjoyment of life, and more interference with general activity. Questions assess average pain intensity (P) (AVERAGE pain in past week: 0-10, 0= No Pain, 10=Pain as bad as you can imagine), interference with enjoyment of life (E), and interference with general activity (G) (In past week, how pain interfered with...(0-10, 0=Does not interfere, 10=Completely interferes).</description>
        <time_frame>Week 3 and Week 7</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>All participants enrolled in the study will receive chiropractic care consistent with the usual chiropractic procedures for the management of chronic low back pain at the Iowa City VA Health Care System. Participants will also complete study assessments as described in outcomes.&#xD;
Study assessments: All participants will be asked to complete study assessments at baseline visit, and weeks 3, 5, 7, and 10. Study participants will receive spinal manipulation and appropriate adjunctive therapies provided by doctors of chiropractic.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain, Enjoyment, and General Activity (PEG)</title>
          <description>The PEG is a 3-item tool to improve assessment and monitoring of chronic pain. The overall PEG-3 score ranges from 0-10 with 10 indicating more pain, more interference with enjoyment of life, and more interference with general activity. Questions assess average pain intensity (P) (AVERAGE pain in past week: 0-10, 0= No Pain, 10=Pain as bad as you can imagine), interference with enjoyment of life (E), and interference with general activity (G) (In past week, how pain interfered with...(0-10, 0=Does not interfere, 10=Completely interferes).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Average pain, Week 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average pain, Week 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Enjoyment of Life Pain Interference, Week 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Enjoyment of Life Pain Interference, Week 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General Activity Pain Interference, Week 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General Activity Pain Interference, Week 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall PEG-3 Score, Week 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall PEG-3 Score, Week 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline to 10 weeks.</time_frame>
      <desc>An AE is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.</desc>
      <group_list>
        <group group_id="E1">
          <title>Treatment Arm</title>
          <description>All participants enrolled in the study will receive chiropractic care consistent with the usual chiropractic procedures for the management of chronic low back pain at the Iowa City VA Health Care System. Participants will also complete study assessments as described in outcomes.&#xD;
Study assessments: All participants will be asked to complete study assessments at baseline visit, and weeks 3, 5, 7, and 10. Study participants will receive spinal manipulation and appropriate adjunctive therapies provided by doctors of chiropractic.</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="40"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (15.0)</default_vocab>
        <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="5" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="40"/>
              </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 Walden-Cobb</name_or_title>
      <organization>Palmer Center for Chiropractic Research</organization>
      <phone>563-949-0676</phone>
      <email>anna.waldencobb@palmer.edu</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/NCT03254719
org study id: COCOV-Aim #3
secondary id: R34AT008427
nct id: NCT03254719
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary objectives of this pilot trial are to evaluate the feasibility, safety and
      acceptability of an integrative care pathway that includes chiropractic care, for the
      coordinated care for Veterans Administration (VA) patients with chronic low back pain (cLBP),
      with an emphasis on those with mental health comorbidity, in preparation for the conduct of
      an appropriately powered multi-site randomized controlled trial (RCT). The secondary
      objectives are to collect study outcomes at the baseline visit (BV) and at weeks 3, 5, 7, and
      10 to: 1) assess the success of collecting outcomes; 2) determine the outcome measures to use
      in a future RCT; and 3) determine preliminary intervention effect sizes and variability to
      aid in sample size determination for a future RCT. The investigators hypothesize that
      chiropractic care offers relief for pain and mental health symptoms through the direct
      effects of treatment-focused CMT, as well as through the indirect, non-specific effects of
      the team-based relationship with the clinician.

      This pilot study is a single-arm trial. All participants will be asked to complete study
      outcomes which include the Roland Morris Disability Questionnaire (RMDQ), LBP intensity and
      interference as measured by the Defense and Veterans Pain Rating Scale (DVPRS), as well as
      the Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder 7-item Scale
      (GAD-7), Alcohol Use Disorders Identification Test (AUDIT), Post-traumatic Stress Disorder
      Checklist-Civilian Version (PLC-C), self-care behaviors, Keele Start Back Screening Tool
      (STarT Back), Healing Encounters and Attitudes Lists (HEAL), Expectations for Complementary
      and Integrative Treatments Questionnaire (EXPECT), and Pain Intensity, Enjoyment of Life,
      General Activity Assessment Tool (PEG) questionnaires, and the Pain Assessment Screening Tool
      and Outcomes Registry (PASTOR) assessment, which includes measures of pain, disability,
      mental health, quality of life enjoyment and satisfaction. All participants will receive up
      to 10 weeks of chiropractic care and will complete outcome assessments at weeks 3, 5, 7, and
      10 of the study.
The coinciding problems of chronic pain and mental illness are of great concern for patients
      seeking care within the Department of Veterans Affairs (VA) healthcare facilities. Of the 5.7
      million veterans treated in VA facilities in 2012, more than half reported chronic pain
      syndromes, including chronic low back pain (cLBP). Veterans also experience many mental
      health comorbidities, such as depression, anxiety, post-traumatic stress disorder (PTSD), and
      substance abuse. Veterans in pain are often managed using prescription drugs, including
      opioids, psychotropic medications, and sleep agents. Non-pharmacological treatments for
      chronic pain, which also may provide relief of mental health symptoms, may be welcomed
      complementary therapies for veterans suffering from these conditions.

      Patients with musculoskeletal (MSK) pain and pain at multiple locations often report
      depression, anxiety and other mental health symptoms. Chronic pain may perpetuate mental
      health comorbidity as these conditions share common pathophysiological pathways. Research has
      shown that the non-specific effects of empathetic doctor communication and therapeutic
      alliance improves clinical outcomes. The investigators hypothesize that chiropractic care
      offers relief for pain and mental health symptoms through the direct effects of
      treatment-focused chiropractic manipulative therapy (CMT), as well as through the indirect,
      non-specific effects of the team-based relationship with the clinician.

      However, chiropractic care is not delivered in isolation from other treatments within the VA.
      Thus, the investigators will test a feasible, effective, patient-centered, guideline-based,
      integrative care model that integrates chiropractic into VA Patient Aligned Care Teams
      (PACTs). This integrative care pathway will involve primary care providers, mental health
      professionals, and doctors of chiropractic (DCs) engaged in the treatment of veterans with
      cLBP, with or without mental health comorbidity. While DCs are providing services within VA
      in increasing numbers over the past 13 years, as with any new service, adoption and
      appropriate placement faces challenges. Many VA providers may know little about the clinical
      approaches used by DCs. Similarly, DCs may not be fully aware of the processes involved in
      the delivery of primary care services within VA or the healthcare needs of veterans with
      mental illness. The purpose of this pilot clinical trial is to evaluate the feasibility,
      safety and patient perceptions of an integrative care pathway, developed through a
      consensus-based process, for the coordinated care for VA patients with cLBP and mental health
      comorbidity.

      As this is a pragmatic trial, chiropractic care will consist of usual chiropractic procedures
      for the management chronic low back pain (cLBP). Treatment approaches will be based on
      clinical evaluation, which may include diagnostic testing, to determine a working diagnosis,
      rule out pathology, and/or to screen for conditions requiring referral or other
      co-management. The investigators anticipate that chiropractic care often will include some
      form of chiropractic manipulative therapy (CMT). DCs will likely also recommend
      rehabilitative exercise, stretching, or nutritional and lifestyle advice based upon clinical
      findings and patient goals/preferences. The investigators will evaluate treatments through
      electronic health records (EHR) data abstraction following completion of chiropractic care at
      Week 10. As per typical VA care, DCs will monitor the participant's health status throughout
      the trial and initiate referrals as clinically indicated. Referrals to primary care and
      mental health providers will be consistent with the chiropractic integrated care pathway
      developed during a prior phase of the study. The investigators anticipate the most common
      communication and referral methods will occur through note-review and countersign procedures,
      which are already established among VA providers using the VA electronic health record, but
      may also occur in person or via phone conversations. Chiropractic care will be administered
      by licensed DCs who are current employees of the Iowa City VA Health Care System (ICVAHCS).
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Chiropractic care will be administered by licensed DCs who are current employees of the Iowa City VA Health Care System (ICVAHCS). Participants will receive chiropractic care at a frequency of 1-2 visits per week for a duration up to 10 weeks, with the frequency and duration of care individualized within established VA parameters. For this trial, the minimum treatment dose is 1 visit to the DC, while the maximum treatment dose is 12 visits.
primary purpose: Other
masking: None (Open Label)
measure: Duration of Study Recruitment
time frame: From date of first participant enrolled to date last participant is enrolled, up to 8 months.
description: As part of the feasibility assessment, the investigators will monitor the amount of time it takes to complete study recruitment and enrollment, and data collection. The investigators will monitor this through a data capture program.
measure: Diversity of Patient Demographics
time frame: Screening through baseline
description: As part of the recruitment plan, investigators are trying to target female and minority veterans. Historically these groups have been underrepresented in veteran research. The investigators will review EHR data for participant demographics.
measure: Number of Participants Engaged in Use of MyHealthEVet
time frame: 10 weeks from Baseline
description: As part of the feasibility assessment, investigators will monitor the number of study participants who enroll in and have at least one communication with MyHealthEVet. MyHealthEVet is an online communication tool designed to partner veterans and the veteran's health care team. It provides information on the veteran's health record and health topics as well as allows messaging communication between veterans and health care providers. Usage reports generated by MyHealthEVet will be analyzed to determine number of study participants engaged.
measure: Acceptability
time frame: At Week 10 of the study
description: Acceptability will be assessed by conducting structured, qualitative exit interviews with participants and providers.
measure: Number of Participants With Reported Adverse Events
time frame: 10 weeks from Baseline
description: Safety for this study will be assessed by the number of adverse events counted and recorded.
measure: Percentage of Participants Who Did Not Attend the Initial Chiropractic Visit, Withdrew, or Are Lost to Follow-up
time frame: 10 weeks from Baseline
description: As part of the feasibility assessment and ability to calculate a sample size for a full scale trial with subgroup analysis, investigators will monitor the percentage of missing data. This will include the percentage of participants who did not attend the initial chiropractic visit and withdraw or are lost to follow-up.
measure: Roland Morris Low Back Pain Disability Questionnaire (RMDQ)
time frame: Baseline visit and weeks 5 and 10
description: The RMDQ is a widely used health status measure for low back pain. Scoring of the RMDQ ranges from 0-24, with a higher score indicating an increase in low back pain disability. (0-24, 0=No Disability, 24=Severe Disability)
measure: Pain Assessment Screening Tool and Outcomes Registry (PASTOR)
time frame: Baseline visit and weeks 5 and 10
description: PASTOR is an on-line data collection tool based on the NIH Patient Reported Outcomes Measurement Information System (PROMIS) and adopted by the DoD/VA Pain Management Task Force. Specific measures include the Defense & Veterans Pain Rating Scale (DVPRS), an enhanced 11-item (total range 0-10, 0=no pain, 10=worst pain) numeric rating scale (NRS) that improves on standard pain NRS by including a Faces Rating Scale component; 'traffic light' color-coding system to delineate mild, moderate and severe pain; and word descriptors, paired with 4, 0-10 NRS items to quantify the impact of pain on general activity, sleep, mood, and stress. PASTOR incorporates PROMIS measures for mental health conditions (PTSD, depression, anxiety, anger, and alcohol use), physical and social function, fatigue, and pain interference with daily activities to provide graphical representation of improvements or declines in patient status that are compared to matched US samples on age, race/ethnicity and sex.
measure: STarT Back Screening Tool
time frame: Baseline visit and week 10
description: This is a 9-item, validated tool developed by Keele University to be used as a screening tool for patients with low back pain. It stratifies patients based on their prognosis of persistent disabling symptoms and allows practitioners to group patients into 3 categories (low, medium, or high risk of poor outcome).
measure: Self-Efficacy for Managing Symptoms (SF8a)
time frame: Baseline visit and week 10
description: Developed by the Patient-Reported Outcomes Measurement Information System (PROMIS), this 8-item, self-reported tool will assess a person's level of confidence to manage/control symptoms, to manage their symptoms in different settings and to keep symptoms from interfering with work, sleep, relationships or recreational activities. Each question usually has five response options ranging in value from 1 to 5. The total raw score for a measure is converted to into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. A higher PROMIS T-score represents more of the concept being measured. For example, a T-score of 55 on the PROMIS Self-Efficacy for Managing Symptoms indicates that the respondent has greater self-efficacy for managing their symptoms than the general chronic condition population (half a standard deviation higher).
measure: Patient Health Questionnaire (PHQ-9)
time frame: Baseline visit and week 10
description: This instrument is self-reported with nine items and will be used to assess depressive disorder. Total scores range from 0 to 27 with a score of 10-14 considered to be in the moderate range (0-27, 0=No Depression, 27=Severe Depression). It has been tested in primary care settings and has a test-retest reliability of 0.81 to 0.96.
measure: Generalized Anxiety Disorder-7 (GAD-7)
time frame: Baseline visit and week 10
description: This instrument is self-reported with seven items and will be used to assess generalized anxiety disorder. At a cut off score of 10 (0-21, 0=No Anxiety Disorder, 21=Severe Anxiety Disorder), it has a sensitivity of 0.89 and specificity of 0.82 for identifying patients with GAD in primary care settings.
measure: Alcohol Use Disorders Identification Test (AUDIT)
time frame: Baseline visit and week 10
description: Developed by the World Health Organization (WHO), this 10-item screening questionnaire determines harmful or hazardous consumption of alcohol, correctly classifying 95% of people as having a clinical diagnosis of an alcohol abuse disorder (0-12, 0=No Alcohol Use).
measure: PTSD Checklist-Civilian (PCL-C)
time frame: Baseline visit and week 10
description: This 17-item, self-reported instrument will assess PTSD. A total severity score is determined by summing scores from each of 17 items. A change of 5-10 points represents the minimum threshold for determining treatment response; a 10-20 point change represents a clinically significant change in PTSD symptom severity (17-85, 17=Not at all Severe PTSD Symptoms, 85=Extremely Severe PTSD Symptoms).
measure: Healing Encounters and Attitudes Lists (HEAL)
time frame: After the initial chiropractic visit
description: HEAL is a validated item-bank comprised of 6 domains developed through the Patient Reported Outcomes Measurement Information System (PROMIS) methodology. Investigators will use HEAL to assess nonspecific factors known to influence patient outcomes, including perceptions of the patient-provider connection, healthcare environment, treatment expectancy, spirituality, positive or negative outlook, and attitudes toward complementary and alternative medicine (CAM). A higher T-score represents more of the concept being measured. A T-score of 50 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of more positive perception. For example, a T-score of 55 on Patient-Provider Connection indicates that the respondent has a more positive perception toward the patient-provider connection than the general chronic condition population (half a standard deviation higher).
measure: Pain, Enjoyment, and General Activity (PEG)
time frame: Week 3 and Week 7
description: The PEG is a 3-item tool to improve assessment and monitoring of chronic pain. The overall PEG-3 score ranges from 0-10 with 10 indicating more pain, more interference with enjoyment of life, and more interference with general activity. Questions assess average pain intensity (P) (AVERAGE pain in past week: 0-10, 0= No Pain, 10=Pain as bad as you can imagine), interference with enjoyment of life (E), and interference with general activity (G) (In past week, how pain interfered with...(0-10, 0=Does not interfere, 10=Completely interferes).
arm group label: Treatment Arm
arm group type: Other
description: All participants enrolled in the study will receive chiropractic care consistent with the usual chiropractic procedures for the management of chronic low back pain at the Iowa City VA Health Care System. Participants will also complete study assessments as described in outcomes.
intervention type: Other
intervention name: Study assessments
description: All participants will be asked to complete study assessments at baseline visit, and weeks 3, 5, 7, and 10. Study participants will receive spinal manipulation and appropriate adjunctive therapies provided by doctors of chiropractic.
arm group label: Treatment Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christine M Goertz, DC, PhD
role: Principal Investigator
affiliation: The Spine Institute for Quality
last name: Cynthia Long, PhD
role: Principal Investigator
affiliation: Palmer Center for Chiropractic Research (PCCR)
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Lisi AJ, Salsbury SA, Hawk C, Vining RD, Wallace RB, Branson R, Long CR, Burgo-Black AL, Goertz CM. Chiropractic Integrated Care Pathway for Low Back Pain in Veterans: Results of a Delphi Consensus Process. J Manipulative Physiol Ther. 2018 Feb;41(2):137-148. doi: 10.1016/j.jmpt.2017.10.001.
PMID: 29482827
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
mesh term: Depression
sharing ipd: No
ipd description: Feasibility/pilot study
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 