<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/NCT01692275</url>
  </required_header>
  <id_info>
    <org_study_id>2010-0782</org_study_id>
    <nct_id>NCT01692275</nct_id>
  </id_info>
  <brief_title>Assessment of Chiropractic Treatment for Low Back Pain and Smoking Cessation in Military Active Duty Personnel.</brief_title>
  <official_title>Assessment of Chiropractic Treatment for Low Back Pain and Smoking Cessation in Military Active Duty Personnel</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RAND</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Palmer College of Chiropractic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Samueli Institute for Information Biology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>RAND</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effectiveness of chiropractic manipulative&#xD;
      therapy for pain management and improved function in active duty service members with low&#xD;
      back pain that do not require surgery. The study will also measure the impact of a tobacco&#xD;
      cessation program delivered to participants allocated to the chiropractic arm.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Low back pain (LBP) is the most common cause of disability worldwide, but it is even more&#xD;
      prevalent in active duty military personnel; more than 50% of all diagnoses resulting in&#xD;
      disability discharges from the military across all branches are due to musculoskeletal&#xD;
      conditions. LBP has been characterized as &quot;The Silent Military Threat&quot; because of its&#xD;
      negative impact on mission readiness and the degree to which it compromises a fit fighting&#xD;
      force. For these reasons, military personnel with LBP need a practical and effective&#xD;
      treatment that relieves their pain and allows them to return to duty quickly, but also one&#xD;
      that preserves function and military readiness, addresses the underlying causes of the&#xD;
      episode and protects against re-injury. Currently a clear &quot;gold standard&quot; medical treatment&#xD;
      for low back pain does not exist and studies show that evidence-based guidelines are rarely&#xD;
      used in general practice. Thus, there is a need to consider innovative treatment options for&#xD;
      chronic diseases such as LBP. Therefore the primary purpose of this study is to assess the&#xD;
      effectiveness of chiropractic manipulative therapy (CMT) for pain management and improved&#xD;
      function in active duty service members with orthopedic injuries or disorders of the low back&#xD;
      that do not require surgery. This multi-site Phase II Clinical Comparative Effectiveness&#xD;
      Trial is designed to rigorously compare the outcomes of CMT and conventional medical care&#xD;
      (CMC) to CMC alone. Chiropractic treatment will include CMT plus ancillary physiotherapeutic&#xD;
      interventions. CMC will be delivered following current standards of medical practice at each&#xD;
      site. At each of the four participating sites, active military personnel, ages 18-50, who&#xD;
      present with acute, sub-acute or chronic low back pain that does not require surgery will be&#xD;
      randomized to one of the two treatment groups. Outcome measures include the Numerical Rating&#xD;
      Scale for pain, the Roland-Morris Low Back Pain and Disability questionnaire, the Back Pain&#xD;
      Functional Scale for assessing function, and the Global Improvement questionnaire for patient&#xD;
      perception regarding improvement in function. Patient Expectation and Patient Satisfaction&#xD;
      questionnaires will be used to examine volunteer expectations toward care and perceptions of&#xD;
      that care. Pharmaceutical use and duty status data will also be collected. The PROMIS-29 will&#xD;
      be utilized to compare the general health component and quality of life of the sample at&#xD;
      baseline. In addition, doctors of chiropractic are well positioned to provide information to&#xD;
      support tobacco cessation. Thus this clinical trial will include a nested study designed to&#xD;
      measure the impact of a tobacco cessation program delivered by a doctor of chiropractic. The&#xD;
      results from this randomized clinical trial, with a nested tobacco cessation intervention,&#xD;
      will provide critical information regarding the health and mission-support benefits of&#xD;
      chiropractic health care delivery for active duty service members in the military&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">November 28, 2016</completion_date>
  <primary_completion_date type="Actual">November 28, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Numerical Rating Scale (NRS) for Prior Week</measure>
    <time_frame>Baseline, week 6, week 12</time_frame>
    <description>Volunteers will be asked to rate their average level of low back pain (LBP) during the prior week on an ordinal 11-box scale (0=no LBP; 10=worst LBP possible) at baseline and at all of the follow-up assessments. The NRS has excellent metric properties, is easy to administer and score, and has received much use in LBP research. Pain data will be collected at baseline and at all endpoint visits.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Roland Morris Disability Questionnaire (RMDQ)</measure>
    <time_frame>Baseline, week 6, week 12</time_frame>
    <description>We will use a volunteer self-report modified 24-item version of the RMDQ to assess LBP-related disability. The RMDQ may be the most common and respected LBP assessment instrument in LBP outcomes research. It is a one page questionnaire related to LBP disability with documented reliability and validity. It can discriminate between different forms of treatment for back pain, and it is sensitive to clinical change. The RMDQ has been chosen for a number of clinical trials of LBP treatments for its excellent metric properties, ease of use, patient acceptance, and high face validity. This questionnaire will be administered at baseline and at all endpoints. Higher score indicates higher disability. Scale: 0 (no disability) to 24 (maximum disability).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bothersomeness of Symptoms</measure>
    <time_frame>Baseline, week 6, week 12</time_frame>
    <description>The bothersomeness of symptoms commonly associated with LBP will be measured using an existing measure from the LBP literature. Bothersomeness questions are practical and have demonstrated good internal consistency, construct validity, and responsiveness to change with time in patients with LBP and sciatica.&#xD;
Possible score ranges from 1 (not at all bothersome) to 5 (extremely bothersome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numerical Pain Rating Scale (NRS) for Past 24 Hours</measure>
    <time_frame>Baseline, week 6, week 12</time_frame>
    <description>Volunteers will be asked to rate their level of pain on that day on an ordinal 11-box scale (0=no LBP; 10=worst LBP possible) at baseline and at all of the follow-up assessments. The NRS has excellent metric properties, is easy to administer and score, and has received much use in LBP research. Pain data will be collected at baseline and at all endpoint visits. The question will capture information pertaining to pain over the last 24 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare Utilization &amp; Medication Use</measure>
    <time_frame>week 6, week 12</time_frame>
    <description>Based on the pilot study, volunteers will most likely have been seen by other healthcare providers and prescribed pain medication by a primary care provider prior to being enrolled in the study, this questionnaire will ensure that we collect all healthcare and medication use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Improvement Scale</measure>
    <time_frame>Week 6</time_frame>
    <description>This is a modification of the visual analog scale (VAS) developed to assess degree of improvement over a specified period of time. Global low back pain (LBP) improvement was assessed by asking participants to rate their perceived LBP improvement since baseline on a 7-point scale: 0 = completely gone, 1 = much better, 2 = moderately better, 3 = a little better, 4 = about the same, 5 = a little worse, 6 = much worse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>Week 6</time_frame>
    <description>A one item patient satisfaction questionnaire. Satisfaction is measured as means on a numerical rating scale, 0 [not at all satisfied] to 10 [extremely satisfied].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Expectation</measure>
    <time_frame>Baseline only</time_frame>
    <description>Previous work has shown that patient expectation regarding benefit of care can be a significant non-specific effect.&#xD;
The score indicates participant's expectation of helpfulness of treatment for LBP, measured on a scale of 0 (not helpful at all) to 10 (extremely helpful).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Back Pain Functional Scale (BPFS)</measure>
    <time_frame>Baseline and all endpoint visits (week 2, week 4, week 6, week 12)</time_frame>
    <description>The BPFS is a 12-question functional status survey designed for use as an individual patient decision-making tool. Each of the 12 questions is answered using a 5-point Likert-type scale and therefore scores for this scale will range from 0-60 (higher scores indicate better function). In recent studies, the BPFS is improved sensitivity to change than the RMDQ. This scale will be administered at baseline and all endpoint visits.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">750</enrollment>
  <condition>Lower Back Pain</condition>
  <arm_group>
    <arm_group_label>Medical Care + Chiropractic Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Medical care plus chiropractic manipulative therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Medical Care Only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional medical care only</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medical Care + Chiropractic Care</intervention_name>
    <description>Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
    <arm_group_label>Medical Care + Chiropractic Care</arm_group_label>
    <other_name>spinal manipulative therapy</other_name>
    <other_name>education self management medication heat and ice</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional Medical Care Only</intervention_name>
    <description>Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
    <arm_group_label>Conventional Medical Care Only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-50 (Inclusive)&#xD;
&#xD;
          -  Diagnosis of acute, subacute or chronic low back pain&#xD;
&#xD;
          -  Ability to provide voluntary written informed consent&#xD;
&#xD;
          -  Active duty at one of the three participating military sites&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  LBP from other than somatic tissues as determined by history, examination and course&#xD;
             (i.e., pain referred from visceral conditions)&#xD;
&#xD;
          -  Co-morbid pathology or poor health conditions that may directly impact spinal pain&#xD;
&#xD;
          -  Volunteers who have case histories and physical examination findings indicating other&#xD;
             than average good health&#xD;
&#xD;
          -  Bone and joint pathology contraindicating CMT (Chiropractic Manipulative Therapy)&#xD;
&#xD;
          -  Volunteers with recent spinal fracture (within the last 8 weeks), recent spinal&#xD;
             surgery (within the last 12 weeks), concurrent spinal or paraspinal tumor(s), spinal&#xD;
             or paraspinal infection(s), inflammatory arthropathies and significant/severe&#xD;
             osteoporosis will be referred for appropriate care&#xD;
&#xD;
          -  Other contraindications for CMT of the lumbar spine and pelvis (i.e., unstable spinal&#xD;
             segments, cauda equine syndrome)&#xD;
&#xD;
          -  Pregnant or planning to become pregnant within 3 months&#xD;
&#xD;
          -  Altered mental capacity as determined by the clinician&#xD;
&#xD;
          -  Unable to speak English&#xD;
&#xD;
          -  Use of manipulative care for any reason within the past month&#xD;
&#xD;
          -  Unwilling to provide phone and electronic contact information&#xD;
&#xD;
          -  Unable to confirm that they will not be transferred during the active phase of the&#xD;
             study, i.e., deployment, receive orders for a distant duty assignment or training site&#xD;
             or otherwise be absent from the current military site over the next 8 weeks (active&#xD;
             study participation period).&#xD;
&#xD;
          -  Does not agree to be enrolled regardless of group assignment&#xD;
&#xD;
          -  PTSD Classification&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ian D. Coulter, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>RAND</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Naval Medical Center San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92134-5000</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Naval Hospital Pensacola</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32508-5141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Walter Reed National Military Medical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20889-5600</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Goertz CM, Long CR, Vining RD, Pohlman KA, Kane B, Corber L, Walter J, Coulter I. Assessment of chiropractic treatment for active duty, U.S. military personnel with low back pain: study protocol for a randomized controlled trial. Trials. 2016 Feb 9;17:70. doi: 10.1186/s13063-016-1193-8.</citation>
    <PMID>26857706</PMID>
  </reference>
  <reference>
    <citation>Goertz CM, Long CR, Vining RD, Pohlman KA, Walter J, Coulter I. Effect of Usual Medical Care Plus Chiropractic Care vs Usual Medical Care Alone on Pain and Disability Among US Service Members With Low Back Pain: A Comparative Effectiveness Clinical Trial. JAMA Netw Open. 2018 May 18;1(1):e180105. doi: 10.1001/jamanetworkopen.2018.0105.</citation>
    <PMID>30646047</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>September 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <results_first_submitted>May 29, 2018</results_first_submitted>
  <results_first_submitted_qc>December 17, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">December 19, 2018</results_first_posted>
  <last_update_submitted>December 17, 2018</last_update_submitted>
  <last_update_submitted_qc>December 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Medical Care + Chiropractic Care</title>
          <description>Medical care plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
        </group>
        <group group_id="P2">
          <title>Conventional Medical Care Only</title>
          <description>Conventional medical care only&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="375"/>
                <participants group_id="P2" count="375"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="309"/>
                <participants group_id="P2" count="316"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="59"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="48"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Site: WRNMMC - UMC</title>
          <description>Site: Walter Reed National Military Medical Center (WRNMMC) Conventional medical care only/Usual Medical Care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
        </group>
        <group group_id="B2">
          <title>Site: WRNMMC - UMC + Chiropractic Care</title>
          <description>Site: Walter Reed National Military Medical Center (WR)&#xD;
Medical care (UMC) plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
        </group>
        <group group_id="B3">
          <title>Site: NHP - UMC</title>
          <description>Site: Naval Hospital Pensacola&#xD;
Conventional medical care only/Usual Medical Care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
        </group>
        <group group_id="B4">
          <title>Site: NHP - UMC + Chiropractic Care</title>
          <description>Site: Naval Hospital Pensacola&#xD;
Medical care (UMC) plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
        </group>
        <group group_id="B5">
          <title>Site: NMCSD - UMC</title>
          <description>Site: Naval Medical Center San Diego&#xD;
Conventional medical care only/Usual Medical Care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
        </group>
        <group group_id="B6">
          <title>Site: NMCSD - UMC + Chiropractic Care</title>
          <description>Site: Naval Medical Center San Diego&#xD;
Medical care (UMC) plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
        </group>
        <group group_id="B7">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="125"/>
            <count group_id="B2" value="125"/>
            <count group_id="B3" value="125"/>
            <count group_id="B4" value="125"/>
            <count group_id="B5" value="125"/>
            <count group_id="B6" value="125"/>
            <count group_id="B7" value="750"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="34.4" spread="8.4"/>
                    <measurement group_id="B2" value="34.7" spread="8.6"/>
                    <measurement group_id="B3" value="25.5" spread="7.9"/>
                    <measurement group_id="B4" value="25.7" spread="7.5"/>
                    <measurement group_id="B5" value="32.4" spread="7.4"/>
                    <measurement group_id="B6" value="32.4" spread="7.5"/>
                    <measurement group_id="B7" value="30.9" spread="8.7"/>
                  </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="39"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="30"/>
                    <measurement group_id="B6" value="29"/>
                    <measurement group_id="B7" value="175"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                    <measurement group_id="B2" value="85"/>
                    <measurement group_id="B3" value="106"/>
                    <measurement group_id="B4" value="107"/>
                    <measurement group_id="B5" value="95"/>
                    <measurement group_id="B6" value="96"/>
                    <measurement group_id="B7" value="575"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="29"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="21"/>
                    <measurement group_id="B6" value="31"/>
                    <measurement group_id="B7" value="118"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="109"/>
                    <measurement group_id="B2" value="116"/>
                    <measurement group_id="B3" value="96"/>
                    <measurement group_id="B4" value="113"/>
                    <measurement group_id="B5" value="104"/>
                    <measurement group_id="B6" value="94"/>
                    <measurement group_id="B7" value="632"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </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>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="14"/>
                    <measurement group_id="B6" value="20"/>
                    <measurement group_id="B7" value="149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="102"/>
                    <measurement group_id="B4" value="106"/>
                    <measurement group_id="B5" value="88"/>
                    <measurement group_id="B6" value="87"/>
                    <measurement group_id="B7" value="507"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other or unspecified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="17"/>
                    <measurement group_id="B7" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Numerical Rating Scale (NRS) for Prior Week</title>
        <description>Volunteers will be asked to rate their average level of low back pain (LBP) during the prior week on an ordinal 11-box scale (0=no LBP; 10=worst LBP possible) at baseline and at all of the follow-up assessments. The NRS has excellent metric properties, is easy to administer and score, and has received much use in LBP research. Pain data will be collected at baseline and at all endpoint visits.</description>
        <time_frame>Baseline, week 6, week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Site: WRNMMC - UMC</title>
            <description>Site: Walter Reed National Military Medical Center (WRNMMC) Conventional medical care only/Usual Medical Care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O2">
            <title>Site: WRNMMC - UMC + Chiropractic Care</title>
            <description>Site: Walter Reed National Military Medical Center (WR)&#xD;
Medical care (UMC) plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O3">
            <title>Site: NHP - UMC</title>
            <description>Site: Naval Hospital Pensacola&#xD;
Conventional medical care only/Usual Medical Care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O4">
            <title>Site: NHP - UMC + Chiropractic Care</title>
            <description>Site: Naval Hospital Pensacola&#xD;
Medical care (UMC) plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O5">
            <title>Site: NMCSD - UMC</title>
            <description>Site: Naval Medical Center San Diego&#xD;
Conventional medical care only/Usual Medical Care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O6">
            <title>Site: NMCSD - UMC + Chiropractic Care</title>
            <description>Site: Naval Medical Center San Diego&#xD;
Medical care (UMC) plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
        </group_list>
        <measure>
          <title>Numerical Rating Scale (NRS) for Prior Week</title>
          <description>Volunteers will be asked to rate their average level of low back pain (LBP) during the prior week on an ordinal 11-box scale (0=no LBP; 10=worst LBP possible) at baseline and at all of the follow-up assessments. The NRS has excellent metric properties, is easy to administer and score, and has received much use in LBP research. Pain data will be collected at baseline and at all endpoint visits.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="125"/>
                <count group_id="O2" value="125"/>
                <count group_id="O3" value="125"/>
                <count group_id="O4" value="125"/>
                <count group_id="O5" value="125"/>
                <count group_id="O6" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.27" lower_limit="3.88" upper_limit="4.66"/>
                    <measurement group_id="O2" value="4.36" lower_limit="3.98" upper_limit="4.75"/>
                    <measurement group_id="O3" value="4.73" lower_limit="4.33" upper_limit="5.14"/>
                    <measurement group_id="O4" value="4.45" lower_limit="4.04" upper_limit="4.85"/>
                    <measurement group_id="O5" value="4.68" lower_limit="4.28" upper_limit="5.08"/>
                    <measurement group_id="O6" value="4.87" lower_limit="4.48" upper_limit="5.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.90" lower_limit="3.47" upper_limit="4.33"/>
                    <measurement group_id="O2" value="3.18" lower_limit="2.75" upper_limit="3.61"/>
                    <measurement group_id="O3" value="3.39" lower_limit="2.92" upper_limit="3.85"/>
                    <measurement group_id="O4" value="2.17" lower_limit="1.71" upper_limit="2.63"/>
                    <measurement group_id="O5" value="4.63" lower_limit="4.19" upper_limit="5.07"/>
                    <measurement group_id="O6" value="3.3" lower_limit="2.86" upper_limit="3.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.63" lower_limit="3.18" upper_limit="4.07"/>
                    <measurement group_id="O2" value="3.21" lower_limit="2.76" upper_limit="3.66"/>
                    <measurement group_id="O3" value="2.82" lower_limit="2.33" upper_limit="3.3"/>
                    <measurement group_id="O4" value="1.69" lower_limit="1.2" upper_limit="2.17"/>
                    <measurement group_id="O5" value="4.0" lower_limit="3.54" upper_limit="4.45"/>
                    <measurement group_id="O6" value="2.91" lower_limit="2.45" upper_limit="3.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>All sites combined (week 6) - Between-group differences of mean in LBP</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.4</ci_lower_limit>
            <ci_upper_limit>-0.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>All sites combined (week 12) - Between-group differences of mean in LBP</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.2</ci_lower_limit>
            <ci_upper_limit>-0.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Walter Reed site (week 6) - Between-group differences of mean in LBP</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.3</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Walter Reed site (week 12) - Between-group differences of mean in LBP</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.0</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Naval Hospital Pensacola site (week 6) - Between-group differences of mean in LBP</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.8</ci_lower_limit>
            <ci_upper_limit>-0.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Naval Hospital Pensacola site (week 12) - Between-group differences of mean in LBP</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.8</ci_lower_limit>
            <ci_upper_limit>-0.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Naval Medical Center San Diego site (week 6) - Between-group differences of mean in LBP</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.9</ci_lower_limit>
            <ci_upper_limit>-0.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Naval Medical Center San Diego (week 12) - Between-group differences of mean in LBP</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.7</ci_lower_limit>
            <ci_upper_limit>-0.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Roland Morris Disability Questionnaire (RMDQ)</title>
        <description>We will use a volunteer self-report modified 24-item version of the RMDQ to assess LBP-related disability. The RMDQ may be the most common and respected LBP assessment instrument in LBP outcomes research. It is a one page questionnaire related to LBP disability with documented reliability and validity. It can discriminate between different forms of treatment for back pain, and it is sensitive to clinical change. The RMDQ has been chosen for a number of clinical trials of LBP treatments for its excellent metric properties, ease of use, patient acceptance, and high face validity. This questionnaire will be administered at baseline and at all endpoints. Higher score indicates higher disability. Scale: 0 (no disability) to 24 (maximum disability).</description>
        <time_frame>Baseline, week 6, week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Site: WRNMMC - UMC</title>
            <description>Site: Walter Reed National Military Medical Center (WRNMMC) Conventional medical care only/Usual Medical Care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O2">
            <title>Site: WRNMMC - UMC + Chiropractic Care</title>
            <description>Site: Walter Reed National Military Medical Center (WR)&#xD;
Medical care (UMC) plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O3">
            <title>Site: NHP - UMC</title>
            <description>Site: Naval Hospital Pensacola&#xD;
Conventional medical care only/Usual Medical Care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O4">
            <title>Site: NHP - UMC + Chiropractic Care</title>
            <description>Site: Naval Hospital Pensacola&#xD;
Medical care (UMC) plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O5">
            <title>Site: NMCSD - UMC</title>
            <description>Site: Naval Medical Center San Diego&#xD;
Conventional medical care only/Usual Medical Care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O6">
            <title>Site: NMCSD - UMC + Chiropractic Care</title>
            <description>Site: Naval Medical Center San Diego&#xD;
Medical care (UMC) plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
        </group_list>
        <measure>
          <title>Roland Morris Disability Questionnaire (RMDQ)</title>
          <description>We will use a volunteer self-report modified 24-item version of the RMDQ to assess LBP-related disability. The RMDQ may be the most common and respected LBP assessment instrument in LBP outcomes research. It is a one page questionnaire related to LBP disability with documented reliability and validity. It can discriminate between different forms of treatment for back pain, and it is sensitive to clinical change. The RMDQ has been chosen for a number of clinical trials of LBP treatments for its excellent metric properties, ease of use, patient acceptance, and high face validity. This questionnaire will be administered at baseline and at all endpoints. Higher score indicates higher disability. Scale: 0 (no disability) to 24 (maximum disability).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="125"/>
                <count group_id="O2" value="125"/>
                <count group_id="O3" value="125"/>
                <count group_id="O4" value="125"/>
                <count group_id="O5" value="125"/>
                <count group_id="O6" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.94" lower_limit="8.88" upper_limit="11.01"/>
                    <measurement group_id="O2" value="9.36" lower_limit="8.29" upper_limit="10.42"/>
                    <measurement group_id="O3" value="10.65" lower_limit="9.52" upper_limit="11.78"/>
                    <measurement group_id="O4" value="10.21" lower_limit="9.08" upper_limit="11.34"/>
                    <measurement group_id="O5" value="8.81" lower_limit="7.7" upper_limit="9.92"/>
                    <measurement group_id="O6" value="9.2" lower_limit="8.08" upper_limit="10.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" lower_limit="6.8" upper_limit="9.19"/>
                    <measurement group_id="O2" value="6.22" lower_limit="5.02" upper_limit="7.43"/>
                    <measurement group_id="O3" value="5.22" lower_limit="3.9" upper_limit="6.53"/>
                    <measurement group_id="O4" value="3.13" lower_limit="1.83" upper_limit="4.43"/>
                    <measurement group_id="O5" value="8.8" lower_limit="7.56" upper_limit="10.05"/>
                    <measurement group_id="O6" value="6.1" lower_limit="4.85" upper_limit="7.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.25" lower_limit="6.02" upper_limit="8.49"/>
                    <measurement group_id="O2" value="5.77" lower_limit="4.52" upper_limit="7.02"/>
                    <measurement group_id="O3" value="4.4" lower_limit="3.04" upper_limit="5.75"/>
                    <measurement group_id="O4" value="2.47" lower_limit="1.12" upper_limit="3.81"/>
                    <measurement group_id="O5" value="7.56" lower_limit="6.29" upper_limit="8.84"/>
                    <measurement group_id="O6" value="4.83" lower_limit="3.55" upper_limit="6.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>All sites combined (week 6) - RMDQ Between-Group Differences in Disability</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.1</ci_lower_limit>
            <ci_upper_limit>-1.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>All sites combined (week 12) - RMDQ Between-Group Differences in Disability</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.0</ci_lower_limit>
            <ci_upper_limit>-1.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Walter Reed site (week 6) - RMDQ Between-Group Differences in Disability</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.4</ci_lower_limit>
            <ci_upper_limit>-0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Walter Reed site (week 12) - RMDQ Between-Group Differences in Disability</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.2</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Pensacola site (week 6) - RMDQ Between-Group Differences in Disability</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.8</ci_lower_limit>
            <ci_upper_limit>-0.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Pensacola site (week 12) - RMDQ Between-Group Differences in Disability</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.7</ci_lower_limit>
            <ci_upper_limit>-0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>San Diego site (week 6) - RMDQ Between-Group Differences in Disability</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.3</ci_lower_limit>
            <ci_upper_limit>-1.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>San Diego site (week 12) - RMDQ Between-Group Differences in Disability</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.4</ci_lower_limit>
            <ci_upper_limit>-1.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bothersomeness of Symptoms</title>
        <description>The bothersomeness of symptoms commonly associated with LBP will be measured using an existing measure from the LBP literature. Bothersomeness questions are practical and have demonstrated good internal consistency, construct validity, and responsiveness to change with time in patients with LBP and sciatica.&#xD;
Possible score ranges from 1 (not at all bothersome) to 5 (extremely bothersome).</description>
        <time_frame>Baseline, week 6, week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Site: WRNMMC - UMC</title>
            <description>Site: Walter Reed National Military Medical Center (WRNMMC) Conventional medical care only/Usual Medical Care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O2">
            <title>Site: WRNMMC - UMC + Chiropractic Care</title>
            <description>Site: Walter Reed National Military Medical Center (WR)&#xD;
Medical care (UMC) plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O3">
            <title>Site: NHP - UMC</title>
            <description>Site: Naval Hospital Pensacola&#xD;
Conventional medical care only/Usual Medical Care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O4">
            <title>Site: NHP - UMC + Chiropractic Care</title>
            <description>Site: Naval Hospital Pensacola&#xD;
Medical care (UMC) plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O5">
            <title>Site: NMCSD - UMC</title>
            <description>Site: Naval Medical Center San Diego&#xD;
Conventional medical care only/Usual Medical Care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O6">
            <title>Site: NMCSD - UMC + Chiropractic Care</title>
            <description>Site: Naval Medical Center San Diego&#xD;
Medical care (UMC) plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
        </group_list>
        <measure>
          <title>Bothersomeness of Symptoms</title>
          <description>The bothersomeness of symptoms commonly associated with LBP will be measured using an existing measure from the LBP literature. Bothersomeness questions are practical and have demonstrated good internal consistency, construct validity, and responsiveness to change with time in patients with LBP and sciatica.&#xD;
Possible score ranges from 1 (not at all bothersome) to 5 (extremely bothersome).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="125"/>
                <count group_id="O2" value="125"/>
                <count group_id="O3" value="125"/>
                <count group_id="O4" value="125"/>
                <count group_id="O5" value="125"/>
                <count group_id="O6" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" lower_limit="3.5" upper_limit="3.8"/>
                    <measurement group_id="O2" value="3.5" lower_limit="3.3" upper_limit="3.6"/>
                    <measurement group_id="O3" value="3.7" lower_limit="3.6" upper_limit="3.9"/>
                    <measurement group_id="O4" value="3.6" lower_limit="3.4" upper_limit="3.8"/>
                    <measurement group_id="O5" value="3.5" lower_limit="3.3" upper_limit="3.6"/>
                    <measurement group_id="O6" value="3.4" lower_limit="3.3" upper_limit="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="2.8" upper_limit="3.2"/>
                    <measurement group_id="O2" value="2.8" lower_limit="2.6" upper_limit="3.0"/>
                    <measurement group_id="O3" value="2.7" lower_limit="2.4" upper_limit="2.9"/>
                    <measurement group_id="O4" value="2.1" lower_limit="1.9" upper_limit="2.3"/>
                    <measurement group_id="O5" value="3.2" lower_limit="3.0" upper_limit="3.4"/>
                    <measurement group_id="O6" value="2.8" lower_limit="2.6" upper_limit="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" lower_limit="2.7" upper_limit="3.1"/>
                    <measurement group_id="O2" value="2.8" lower_limit="2.6" upper_limit="3.0"/>
                    <measurement group_id="O3" value="2.4" lower_limit="2.1" upper_limit="2.6"/>
                    <measurement group_id="O4" value="1.8" lower_limit="1.6" upper_limit="2.1"/>
                    <measurement group_id="O5" value="2.9" lower_limit="2.6" upper_limit="3.1"/>
                    <measurement group_id="O6" value="2.4" lower_limit="2.2" upper_limit="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>All sites combined (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>-0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>All sites combined (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>-0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Walter Reed site (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Walter Reed site (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Pensacola site (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.8</ci_lower_limit>
            <ci_upper_limit>-0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Pensacola site (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.8</ci_lower_limit>
            <ci_upper_limit>-0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>San Diego site (week 6) - Between-Group Differences of Means in score of bothersomeness of LBP</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>-0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>San Diego site (week 12) - Between-Group Differences of Means in score of bothersomeness of LBP</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Numerical Pain Rating Scale (NRS) for Past 24 Hours</title>
        <description>Volunteers will be asked to rate their level of pain on that day on an ordinal 11-box scale (0=no LBP; 10=worst LBP possible) at baseline and at all of the follow-up assessments. The NRS has excellent metric properties, is easy to administer and score, and has received much use in LBP research. Pain data will be collected at baseline and at all endpoint visits. The question will capture information pertaining to pain over the last 24 hours.</description>
        <time_frame>Baseline, week 6, week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Site: WRNMMC - UMC</title>
            <description>Site: Walter Reed National Military Medical Center (WRNMMC) Conventional medical care only/Usual Medical Care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O2">
            <title>Site: WRNMMC - UMC + Chiropractic Care</title>
            <description>Site: Walter Reed National Military Medical Center (WR)&#xD;
Medical care (UMC) plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O3">
            <title>Site: NHP - UMC</title>
            <description>Site: Naval Hospital Pensacola&#xD;
Conventional medical care only/Usual Medical Care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O4">
            <title>Site: NHP - UMC + Chiropractic Care</title>
            <description>Site: Naval Hospital Pensacola&#xD;
Medical care (UMC) plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O5">
            <title>Site: NMCSD - UMC</title>
            <description>Site: Naval Medical Center San Diego&#xD;
Conventional medical care only/Usual Medical Care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O6">
            <title>Site: NMCSD - UMC + Chiropractic Care</title>
            <description>Site: Naval Medical Center San Diego&#xD;
Medical care (UMC) plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
        </group_list>
        <measure>
          <title>Numerical Pain Rating Scale (NRS) for Past 24 Hours</title>
          <description>Volunteers will be asked to rate their level of pain on that day on an ordinal 11-box scale (0=no LBP; 10=worst LBP possible) at baseline and at all of the follow-up assessments. The NRS has excellent metric properties, is easy to administer and score, and has received much use in LBP research. Pain data will be collected at baseline and at all endpoint visits. The question will capture information pertaining to pain over the last 24 hours.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="125"/>
                <count group_id="O2" value="125"/>
                <count group_id="O3" value="125"/>
                <count group_id="O4" value="125"/>
                <count group_id="O5" value="125"/>
                <count group_id="O6" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" lower_limit="5.2" upper_limit="5.7"/>
                    <measurement group_id="O2" value="5.6" lower_limit="5.4" upper_limit="5.8"/>
                    <measurement group_id="O3" value="6.1" lower_limit="5.9" upper_limit="6.4"/>
                    <measurement group_id="O4" value="5.9" lower_limit="5.6" upper_limit="6.1"/>
                    <measurement group_id="O5" value="5.4" lower_limit="5.2" upper_limit="5.6"/>
                    <measurement group_id="O6" value="5.4" lower_limit="5.2" upper_limit="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" lower_limit="4.1" upper_limit="5.0"/>
                    <measurement group_id="O2" value="3.9" lower_limit="3.4" upper_limit="4.3"/>
                    <measurement group_id="O3" value="3.4" lower_limit="2.9" upper_limit="3.9"/>
                    <measurement group_id="O4" value="2.1" lower_limit="1.6" upper_limit="2.6"/>
                    <measurement group_id="O5" value="5.3" lower_limit="4.8" upper_limit="5.7"/>
                    <measurement group_id="O6" value="3.6" lower_limit="3.2" upper_limit="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" lower_limit="3.9" upper_limit="4.9"/>
                    <measurement group_id="O2" value="3.7" lower_limit="3.2" upper_limit="4.2"/>
                    <measurement group_id="O3" value="3.0" lower_limit="2.4" upper_limit="3.5"/>
                    <measurement group_id="O4" value="1.4" lower_limit="0.9" upper_limit="2.0"/>
                    <measurement group_id="O5" value="4.3" lower_limit="3.8" upper_limit="4.8"/>
                    <measurement group_id="O6" value="3.2" lower_limit="2.7" upper_limit="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>All sites combined (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.6</ci_lower_limit>
            <ci_upper_limit>-0.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>All sites combined (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.6</ci_lower_limit>
            <ci_upper_limit>-0.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Walter Reed site (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.3</ci_lower_limit>
            <ci_upper_limit>-0.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Walter Reed site (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.5</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Pensacola site (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.0</ci_lower_limit>
            <ci_upper_limit>-0.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Pensacola site (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.3</ci_lower_limit>
            <ci_upper_limit>-0.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>San Diego site (week 6) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.3</ci_lower_limit>
            <ci_upper_limit>-1.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>San Diego site (week 12) - NRS score for worst LBP in past 24 hours - Between-Group Differences of Mean</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.9</ci_lower_limit>
            <ci_upper_limit>-0.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Healthcare Utilization &amp; Medication Use</title>
        <description>Based on the pilot study, volunteers will most likely have been seen by other healthcare providers and prescribed pain medication by a primary care provider prior to being enrolled in the study, this questionnaire will ensure that we collect all healthcare and medication use.</description>
        <time_frame>week 6, week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Site: WRNMMC - UMC</title>
            <description>Site: Walter Reed National Military Medical Center (WRNMMC) Conventional medical care only/Usual Medical Care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O2">
            <title>Site: WRNMMC - UMC + Chiropractic Care</title>
            <description>Site: Walter Reed National Military Medical Center (WR)&#xD;
Medical care (UMC) plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O3">
            <title>Site: NHP - UMC</title>
            <description>Site: Naval Hospital Pensacola&#xD;
Conventional medical care only/Usual Medical Care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O4">
            <title>Site: NHP - UMC + Chiropractic Care</title>
            <description>Site: Naval Hospital Pensacola&#xD;
Medical care (UMC) plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O5">
            <title>Site: NMCSD - UMC</title>
            <description>Site: Naval Medical Center San Diego&#xD;
Conventional medical care only/Usual Medical Care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O6">
            <title>Site: NMCSD - UMC + Chiropractic Care</title>
            <description>Site: Naval Medical Center San Diego&#xD;
Medical care (UMC) plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
        </group_list>
        <measure>
          <title>Healthcare Utilization &amp; Medication Use</title>
          <description>Based on the pilot study, volunteers will most likely have been seen by other healthcare providers and prescribed pain medication by a primary care provider prior to being enrolled in the study, this questionnaire will ensure that we collect all healthcare and medication use.</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="125"/>
                <count group_id="O2" value="125"/>
                <count group_id="O3" value="125"/>
                <count group_id="O4" value="125"/>
                <count group_id="O5" value="125"/>
                <count group_id="O6" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 6 Med Frequency</title>
              <category_list>
                <category>
                  <title>0 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="36"/>
                    <measurement group_id="O3" value="28"/>
                    <measurement group_id="O4" value="34"/>
                    <measurement group_id="O5" value="39"/>
                    <measurement group_id="O6" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1-2 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="17"/>
                    <measurement group_id="O5" value="22"/>
                    <measurement group_id="O6" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3-4 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="12"/>
                    <measurement group_id="O6" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5-6 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="10"/>
                    <measurement group_id="O6" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>7 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="8"/>
                    <measurement group_id="O5" value="9"/>
                    <measurement group_id="O6" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="42"/>
                    <measurement group_id="O3" value="63"/>
                    <measurement group_id="O4" value="62"/>
                    <measurement group_id="O5" value="33"/>
                    <measurement group_id="O6" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 Med Frequency</title>
              <category_list>
                <category>
                  <title>0 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="38"/>
                    <measurement group_id="O3" value="38"/>
                    <measurement group_id="O4" value="48"/>
                    <measurement group_id="O5" value="49"/>
                    <measurement group_id="O6" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1-2 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="21"/>
                    <measurement group_id="O6" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3-4 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="10"/>
                    <measurement group_id="O6" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5-6 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>7 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="8"/>
                    <measurement group_id="O6" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="42"/>
                    <measurement group_id="O3" value="63"/>
                    <measurement group_id="O4" value="62"/>
                    <measurement group_id="O5" value="33"/>
                    <measurement group_id="O6" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Week 6: All 3 sites combined</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.73</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.54</ci_lower_limit>
            <ci_upper_limit>0.97</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Week 12: All 3 sites combined</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.58</ci_lower_limit>
            <ci_upper_limit>1.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Global Improvement Scale</title>
        <description>This is a modification of the visual analog scale (VAS) developed to assess degree of improvement over a specified period of time. Global low back pain (LBP) improvement was assessed by asking participants to rate their perceived LBP improvement since baseline on a 7-point scale: 0 = completely gone, 1 = much better, 2 = moderately better, 3 = a little better, 4 = about the same, 5 = a little worse, 6 = much worse.</description>
        <time_frame>Week 6</time_frame>
        <group_list>
          <group group_id="O1">
            <title>WR - UMC</title>
            <description>Walter Reed National Military Medical Center (WR) - Usual Medical Care</description>
          </group>
          <group group_id="O2">
            <title>WR - UMC + CC</title>
            <description>Walter Reed National Military Medical Center - Usual Medical Care + Chiropractic Care group</description>
          </group>
          <group group_id="O3">
            <title>Pensacola - UMC</title>
            <description>Naval Hospital Pensacola - Usual Medical Care group</description>
          </group>
          <group group_id="O4">
            <title>Pensacola - UMC + CC</title>
            <description>Naval Hospital Pensacola - Usual Medical Care + Chiropractic Care group</description>
          </group>
          <group group_id="O5">
            <title>San Diego - UMC</title>
            <description>Naval Medical Center San Diego - Usual Medical Care group</description>
          </group>
          <group group_id="O6">
            <title>San Diego - UMC + CC</title>
            <description>Naval Medical Center San Diego - Usual Medical Care + Chiropractic Care group</description>
          </group>
        </group_list>
        <measure>
          <title>Global Improvement Scale</title>
          <description>This is a modification of the visual analog scale (VAS) developed to assess degree of improvement over a specified period of time. Global low back pain (LBP) improvement was assessed by asking participants to rate their perceived LBP improvement since baseline on a 7-point scale: 0 = completely gone, 1 = much better, 2 = moderately better, 3 = a little better, 4 = about the same, 5 = a little worse, 6 = much worse.</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="125"/>
                <count group_id="O2" value="125"/>
                <count group_id="O3" value="125"/>
                <count group_id="O4" value="125"/>
                <count group_id="O5" value="125"/>
                <count group_id="O6" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Completely gone</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="16"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Much better</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="20"/>
                    <measurement group_id="O4" value="32"/>
                    <measurement group_id="O5" value="10"/>
                    <measurement group_id="O6" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderately better</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="11"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>A little better</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="8"/>
                    <measurement group_id="O6" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>About the same</title>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="47"/>
                    <measurement group_id="O6" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>A little worse</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="23"/>
                    <measurement group_id="O6" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Much worse</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="54"/>
                    <measurement group_id="O4" value="52"/>
                    <measurement group_id="O5" value="27"/>
                    <measurement group_id="O6" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>All sites combined: 6 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.13</ci_lower_limit>
            <ci_upper_limit>0.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Walter Reed site: 6 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.16</ci_lower_limit>
            <ci_upper_limit>0.42</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Naval Hospital Pensacola site: 6 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.10</ci_lower_limit>
            <ci_upper_limit>0.33</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Naval Medical Center San Diego site: 6 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.08</ci_lower_limit>
            <ci_upper_limit>0.21</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction</title>
        <description>A one item patient satisfaction questionnaire. Satisfaction is measured as means on a numerical rating scale, 0 [not at all satisfied] to 10 [extremely satisfied].</description>
        <time_frame>Week 6</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Site: WRNMMC - UMC</title>
            <description>Site: Walter Reed National Military Medical Center (WRNMMC) Conventional medical care only/Usual Medical Care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O2">
            <title>Site: WRNMMC - UMC + Chiropractic Care</title>
            <description>Site: Walter Reed National Military Medical Center (WR)&#xD;
Medical care (UMC) plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O3">
            <title>Site: NHP - UMC</title>
            <description>Site: Naval Hospital Pensacola&#xD;
Conventional medical care only/Usual Medical Care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O4">
            <title>Site: NHP - UMC + Chiropractic Care</title>
            <description>Site: Naval Hospital Pensacola&#xD;
Medical care (UMC) plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O5">
            <title>Site: NMCSD - UMC</title>
            <description>Site: Naval Medical Center San Diego&#xD;
Conventional medical care only/Usual Medical Care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O6">
            <title>Site: NMCSD - UMC + Chiropractic Care</title>
            <description>Site: Naval Medical Center San Diego&#xD;
Medical care (UMC) plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction</title>
          <description>A one item patient satisfaction questionnaire. Satisfaction is measured as means on a numerical rating scale, 0 [not at all satisfied] to 10 [extremely satisfied].</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="125"/>
                <count group_id="O2" value="125"/>
                <count group_id="O3" value="125"/>
                <count group_id="O4" value="125"/>
                <count group_id="O5" value="125"/>
                <count group_id="O6" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.65" lower_limit="5.19" upper_limit="6.11"/>
                    <measurement group_id="O2" value="7.64" lower_limit="7.17" upper_limit="8.11"/>
                    <measurement group_id="O3" value="6.04" lower_limit="5.51" upper_limit="6.56"/>
                    <measurement group_id="O4" value="8.34" lower_limit="7.82" upper_limit="8.85"/>
                    <measurement group_id="O5" value="4.34" lower_limit="3.86" upper_limit="4.83"/>
                    <measurement group_id="O6" value="7.45" lower_limit="6.97" upper_limit="7.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>All sites combined: 6 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.1</ci_lower_limit>
            <ci_upper_limit>2.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Walter Reed site: 6 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.4</ci_lower_limit>
            <ci_upper_limit>2.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Naval Hospital Pensacola site: 6 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.6</ci_lower_limit>
            <ci_upper_limit>3.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Naval Medical Center San Diego site: 6 weeks</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>3.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.5</ci_lower_limit>
            <ci_upper_limit>3.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Expectation</title>
        <description>Previous work has shown that patient expectation regarding benefit of care can be a significant non-specific effect.&#xD;
The score indicates participant's expectation of helpfulness of treatment for LBP, measured on a scale of 0 (not helpful at all) to 10 (extremely helpful).</description>
        <time_frame>Baseline only</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Site: WRNMMC - UMC</title>
            <description>Site: Walter Reed National Military Medical Center (WRNMMC) Conventional medical care only/Usual Medical Care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O2">
            <title>Site: WRNMMC - UMC + Chiropractic Care</title>
            <description>Site: Walter Reed National Military Medical Center (WR)&#xD;
Medical care (UMC) plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O3">
            <title>Site: NHP - UMC</title>
            <description>Site: Naval Hospital Pensacola&#xD;
Conventional medical care only/Usual Medical Care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O4">
            <title>Site: NHP - UMC + Chiropractic Care</title>
            <description>Site: Naval Hospital Pensacola&#xD;
Medical care (UMC) plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O5">
            <title>Site: NMCSD - UMC</title>
            <description>Site: Naval Medical Center San Diego&#xD;
Conventional medical care only/Usual Medical Care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O6">
            <title>Site: NMCSD - UMC + Chiropractic Care</title>
            <description>Site: Naval Medical Center San Diego&#xD;
Medical care (UMC) plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O7">
            <title>All Sites - UMC</title>
            <description>All 3 sites combined (WRNMMC, NHP, NMCSD)&#xD;
Conventional medical care only/Usual Medical Care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O8">
            <title>All Sites Combined - UMC + Chiropractic Care</title>
            <description>All 3 sites combined (WRNMMC, NHP, NMCSD)&#xD;
Medical care (UMC) plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Expectation</title>
          <description>Previous work has shown that patient expectation regarding benefit of care can be a significant non-specific effect.&#xD;
The score indicates participant's expectation of helpfulness of treatment for LBP, measured on a scale of 0 (not helpful at all) to 10 (extremely helpful).</description>
          <units>units 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="125"/>
                <count group_id="O2" value="125"/>
                <count group_id="O3" value="125"/>
                <count group_id="O4" value="125"/>
                <count group_id="O5" value="125"/>
                <count group_id="O6" value="125"/>
                <count group_id="O7" value="750"/>
                <count group_id="O8" value="750"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Expectation UMC + Chiropractic Care</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2" spread="1.8"/>
                    <measurement group_id="O2" value="8.4" spread="1.6"/>
                    <measurement group_id="O3" value="8.1" spread="1.9"/>
                    <measurement group_id="O4" value="8.3" spread="1.9"/>
                    <measurement group_id="O5" value="8.6" spread="1.8"/>
                    <measurement group_id="O6" value="8.5" spread="1.9"/>
                    <measurement group_id="O7" value="8.3" spread="1.9"/>
                    <measurement group_id="O8" value="8.4" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Expectation UMC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" spread="2.4"/>
                    <measurement group_id="O2" value="4.9" spread="2.5"/>
                    <measurement group_id="O3" value="5.3" spread="2.3"/>
                    <measurement group_id="O4" value="5.4" spread="2.5"/>
                    <measurement group_id="O5" value="4.5" spread="2.8"/>
                    <measurement group_id="O6" value="5.2" spread="3.0"/>
                    <measurement group_id="O7" value="5.0" spread="2.5"/>
                    <measurement group_id="O8" value="5.2" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Back Pain Functional Scale (BPFS)</title>
        <description>The BPFS is a 12-question functional status survey designed for use as an individual patient decision-making tool. Each of the 12 questions is answered using a 5-point Likert-type scale and therefore scores for this scale will range from 0-60 (higher scores indicate better function). In recent studies, the BPFS is improved sensitivity to change than the RMDQ. This scale will be administered at baseline and all endpoint visits.</description>
        <time_frame>Baseline and all endpoint visits (week 2, week 4, week 6, week 12)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Site: WRNMMC - UMC</title>
            <description>Site: Walter Reed National Military Medical Center (WRNMMC) Conventional medical care only/Usual Medical Care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O2">
            <title>Site: WRNMMC - UMC + Chiropractic Care</title>
            <description>Site: Walter Reed National Military Medical Center (WR)&#xD;
Medical care (UMC) plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O3">
            <title>Site: NHP - UMC</title>
            <description>Site: Naval Hospital Pensacola&#xD;
Conventional medical care only/Usual Medical Care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O4">
            <title>Site: NHP - UMC + Chiropractic Care</title>
            <description>Site: Naval Hospital Pensacola&#xD;
Medical care (UMC) plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O5">
            <title>Site: NMCSD - UMC</title>
            <description>Site: Naval Medical Center San Diego&#xD;
Conventional medical care only/Usual Medical Care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
          <group group_id="O6">
            <title>Site: NMCSD - UMC + Chiropractic Care</title>
            <description>Site: Naval Medical Center San Diego&#xD;
Medical care (UMC) plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
          </group>
        </group_list>
        <measure>
          <title>Back Pain Functional Scale (BPFS)</title>
          <description>The BPFS is a 12-question functional status survey designed for use as an individual patient decision-making tool. Each of the 12 questions is answered using a 5-point Likert-type scale and therefore scores for this scale will range from 0-60 (higher scores indicate better function). In recent studies, the BPFS is improved sensitivity to change than the RMDQ. This scale will be administered at baseline and all endpoint visits.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="125"/>
                <count group_id="O2" value="125"/>
                <count group_id="O3" value="125"/>
                <count group_id="O4" value="125"/>
                <count group_id="O5" value="125"/>
                <count group_id="O6" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.48" lower_limit="37.5" upper_limit="41.47"/>
                    <measurement group_id="O2" value="39.18" lower_limit="37.2" upper_limit="41.16"/>
                    <measurement group_id="O3" value="37.68" lower_limit="35.57" upper_limit="39.78"/>
                    <measurement group_id="O4" value="38" lower_limit="35.9" upper_limit="40.1"/>
                    <measurement group_id="O5" value="39.97" lower_limit="37.9" upper_limit="42.03"/>
                    <measurement group_id="O6" value="39.98" lower_limit="37.9" upper_limit="42.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.08" lower_limit="39.92" upper_limit="44.23"/>
                    <measurement group_id="O2" value="42.65" lower_limit="40.52" upper_limit="44.7"/>
                    <measurement group_id="O3" value="44.21" lower_limit="41.81" upper_limit="46.59"/>
                    <measurement group_id="O4" value="46.76" lower_limit="44.46" upper_limit="49.06"/>
                    <measurement group_id="O5" value="39.07" lower_limit="36.87" upper_limit="41.28"/>
                    <measurement group_id="O6" value="42.45" lower_limit="40.24" upper_limit="44.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.03" lower_limit="39.76" upper_limit="44.3"/>
                    <measurement group_id="O2" value="44.77" lower_limit="42.49" upper_limit="47.04"/>
                    <measurement group_id="O3" value="46.45" lower_limit="43.93" upper_limit="48.97"/>
                    <measurement group_id="O4" value="50.31" lower_limit="47.87" upper_limit="52.76"/>
                    <measurement group_id="O5" value="39.36" lower_limit="37.03" upper_limit="41.68"/>
                    <measurement group_id="O6" value="45.02" lower_limit="42.69" upper_limit="47.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.72" lower_limit="40.47" upper_limit="44.96"/>
                    <measurement group_id="O2" value="45.74" lower_limit="43.5" upper_limit="47.98"/>
                    <measurement group_id="O3" value="48.55" lower_limit="46.06" upper_limit="51.04"/>
                    <measurement group_id="O4" value="52.64" lower_limit="50.21" upper_limit="55.08"/>
                    <measurement group_id="O5" value="40.52" lower_limit="38.2" upper_limit="42.83"/>
                    <measurement group_id="O6" value="46.02" lower_limit="43.72" upper_limit="48.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.73" lower_limit="41.43" upper_limit="46.03"/>
                    <measurement group_id="O2" value="45.51" lower_limit="43.2" upper_limit="47.82"/>
                    <measurement group_id="O3" value="49.7" lower_limit="47.15" upper_limit="52.25"/>
                    <measurement group_id="O4" value="54.56" lower_limit="52.04" upper_limit="57.07"/>
                    <measurement group_id="O5" value="43.57" lower_limit="41.23" upper_limit="45.91"/>
                    <measurement group_id="O6" value="47.8" lower_limit="45.46" upper_limit="50.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks</time_frame>
      <desc>Any untoward medical occurence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures.&#xD;
*The total number of Adverse Events (AEs) may exceed the total # of people affected because some people experienced multiple AEs.&#xD;
AEs were monitored via self-report AE collected at Week 2, Week 4, and Week 6 assessments or via self-report to the study physician or site project manager directly during the 12 week period.</desc>
      <group_list>
        <group group_id="E1">
          <title>Usual Medical Care</title>
          <description>Conventional medical care only/usual medical care (UMC)&#xD;
Conventional Medical Care Only: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</description>
        </group>
        <group group_id="E2">
          <title>UMC + Chiropractic Care</title>
          <description>Medical care plus chiropractic manipulative therapy&#xD;
Medical Care + Chiropractic Care: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.</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="375"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="375"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>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="13" subjects_at_risk="375"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="375"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Spine-related pain</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="375"/>
                <counts group_id="E2" events="30" subjects_affected="24" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Spine-related pain with radiation</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="375"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Extremity pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>General stiffness/tightness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Muscle spasm/cramp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="375"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="375"/>
              </event>
              <event>
                <sub_title>Muscle pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="375"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="375"/>
              </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. Cyndy Long</name_or_title>
      <organization>Palmer Center for Chiropractic Research</organization>
      <phone>563-884-5157</phone>
      <email>LONG_C@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/NCT01692275
org study id: 2010-0782
nct id: NCT01692275
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to evaluate the effectiveness of chiropractic manipulative
      therapy for pain management and improved function in active duty service members with low
      back pain that do not require surgery. The study will also measure the impact of a tobacco
      cessation program delivered to participants allocated to the chiropractic arm.
Low back pain (LBP) is the most common cause of disability worldwide, but it is even more
      prevalent in active duty military personnel; more than 50% of all diagnoses resulting in
      disability discharges from the military across all branches are due to musculoskeletal
      conditions. LBP has been characterized as "The Silent Military Threat" because of its
      negative impact on mission readiness and the degree to which it compromises a fit fighting
      force. For these reasons, military personnel with LBP need a practical and effective
      treatment that relieves their pain and allows them to return to duty quickly, but also one
      that preserves function and military readiness, addresses the underlying causes of the
      episode and protects against re-injury. Currently a clear "gold standard" medical treatment
      for low back pain does not exist and studies show that evidence-based guidelines are rarely
      used in general practice. Thus, there is a need to consider innovative treatment options for
      chronic diseases such as LBP. Therefore the primary purpose of this study is to assess the
      effectiveness of chiropractic manipulative therapy (CMT) for pain management and improved
      function in active duty service members with orthopedic injuries or disorders of the low back
      that do not require surgery. This multi-site Phase II Clinical Comparative Effectiveness
      Trial is designed to rigorously compare the outcomes of CMT and conventional medical care
      (CMC) to CMC alone. Chiropractic treatment will include CMT plus ancillary physiotherapeutic
      interventions. CMC will be delivered following current standards of medical practice at each
      site. At each of the four participating sites, active military personnel, ages 18-50, who
      present with acute, sub-acute or chronic low back pain that does not require surgery will be
      randomized to one of the two treatment groups. Outcome measures include the Numerical Rating
      Scale for pain, the Roland-Morris Low Back Pain and Disability questionnaire, the Back Pain
      Functional Scale for assessing function, and the Global Improvement questionnaire for patient
      perception regarding improvement in function. Patient Expectation and Patient Satisfaction
      questionnaires will be used to examine volunteer expectations toward care and perceptions of
      that care. Pharmaceutical use and duty status data will also be collected. The PROMIS-29 will
      be utilized to compare the general health component and quality of life of the sample at
      baseline. In addition, doctors of chiropractic are well positioned to provide information to
      support tobacco cessation. Thus this clinical trial will include a nested study designed to
      measure the impact of a tobacco cessation program delivered by a doctor of chiropractic. The
      results from this randomized clinical trial, with a nested tobacco cessation intervention,
      will provide critical information regarding the health and mission-support benefits of
      chiropractic health care delivery for active duty service members in the military
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Investigator)
measure: Numerical Rating Scale (NRS) for Prior Week
time frame: Baseline, week 6, week 12
description: Volunteers will be asked to rate their average level of low back pain (LBP) during the prior week on an ordinal 11-box scale (0=no LBP; 10=worst LBP possible) at baseline and at all of the follow-up assessments. The NRS has excellent metric properties, is easy to administer and score, and has received much use in LBP research. Pain data will be collected at baseline and at all endpoint visits.
measure: Roland Morris Disability Questionnaire (RMDQ)
time frame: Baseline, week 6, week 12
description: We will use a volunteer self-report modified 24-item version of the RMDQ to assess LBP-related disability. The RMDQ may be the most common and respected LBP assessment instrument in LBP outcomes research. It is a one page questionnaire related to LBP disability with documented reliability and validity. It can discriminate between different forms of treatment for back pain, and it is sensitive to clinical change. The RMDQ has been chosen for a number of clinical trials of LBP treatments for its excellent metric properties, ease of use, patient acceptance, and high face validity. This questionnaire will be administered at baseline and at all endpoints. Higher score indicates higher disability. Scale: 0 (no disability) to 24 (maximum disability).
measure: Bothersomeness of Symptoms
time frame: Baseline, week 6, week 12
description: The bothersomeness of symptoms commonly associated with LBP will be measured using an existing measure from the LBP literature. Bothersomeness questions are practical and have demonstrated good internal consistency, construct validity, and responsiveness to change with time in patients with LBP and sciatica.
Possible score ranges from 1 (not at all bothersome) to 5 (extremely bothersome).
measure: Numerical Pain Rating Scale (NRS) for Past 24 Hours
time frame: Baseline, week 6, week 12
description: Volunteers will be asked to rate their level of pain on that day on an ordinal 11-box scale (0=no LBP; 10=worst LBP possible) at baseline and at all of the follow-up assessments. The NRS has excellent metric properties, is easy to administer and score, and has received much use in LBP research. Pain data will be collected at baseline and at all endpoint visits. The question will capture information pertaining to pain over the last 24 hours.
measure: Healthcare Utilization & Medication Use
time frame: week 6, week 12
description: Based on the pilot study, volunteers will most likely have been seen by other healthcare providers and prescribed pain medication by a primary care provider prior to being enrolled in the study, this questionnaire will ensure that we collect all healthcare and medication use.
measure: Global Improvement Scale
time frame: Week 6
description: This is a modification of the visual analog scale (VAS) developed to assess degree of improvement over a specified period of time. Global low back pain (LBP) improvement was assessed by asking participants to rate their perceived LBP improvement since baseline on a 7-point scale: 0 = completely gone, 1 = much better, 2 = moderately better, 3 = a little better, 4 = about the same, 5 = a little worse, 6 = much worse.
measure: Patient Satisfaction
time frame: Week 6
description: A one item patient satisfaction questionnaire. Satisfaction is measured as means on a numerical rating scale, 0 [not at all satisfied] to 10 [extremely satisfied].
measure: Patient Expectation
time frame: Baseline only
description: Previous work has shown that patient expectation regarding benefit of care can be a significant non-specific effect.
The score indicates participant's expectation of helpfulness of treatment for LBP, measured on a scale of 0 (not helpful at all) to 10 (extremely helpful).
measure: Back Pain Functional Scale (BPFS)
time frame: Baseline and all endpoint visits (week 2, week 4, week 6, week 12)
description: The BPFS is a 12-question functional status survey designed for use as an individual patient decision-making tool. Each of the 12 questions is answered using a 5-point Likert-type scale and therefore scores for this scale will range from 0-60 (higher scores indicate better function). In recent studies, the BPFS is improved sensitivity to change than the RMDQ. This scale will be administered at baseline and all endpoint visits.
arm group label: Medical Care + Chiropractic Care
arm group type: Active Comparator
description: Medical care plus chiropractic manipulative therapy
arm group label: Conventional Medical Care Only
arm group type: Active Comparator
description: Conventional medical care only
intervention type: Other
intervention name: Medical Care + Chiropractic Care
description: Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.
arm group label: Medical Care + Chiropractic Care
other name: spinal manipulative therapy
other name: education self management medication heat and ice
intervention type: Other
intervention name: Conventional Medical Care Only
description: Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.
arm group label: Conventional Medical Care Only
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Ian D. Coulter, Ph.D.
role: Principal Investigator
affiliation: RAND
facility: 
facility: 
facility: 
country: United States
citation: Goertz CM, Long CR, Vining RD, Pohlman KA, Kane B, Corber L, Walter J, Coulter I. Assessment of chiropractic treatment for active duty, U.S. military personnel with low back pain: study protocol for a randomized controlled trial. Trials. 2016 Feb 9;17:70. doi: 10.1186/s13063-016-1193-8.
PMID: 26857706
citation: Goertz CM, Long CR, Vining RD, Pohlman KA, Walter J, Coulter I. Effect of Usual Medical Care Plus Chiropractic Care vs Usual Medical Care Alone on Pain and Disability Among US Service Members With Low Back Pain: A Comparative Effectiveness Clinical Trial. JAMA Netw Open. 2018 May 18;1(1):e180105. doi: 10.1001/jamanetworkopen.2018.0105.
PMID: 30646047
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 