<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/NCT02224183</url>
  </required_header>
  <id_info>
    <org_study_id>H-32948</org_study_id>
    <secondary_id>3R01AT005956-05S1</secondary_id>
    <nct_id>NCT02224183</nct_id>
  </id_info>
  <brief_title>Yoga vs. Education for Veterans With Chronic Low Back Pain</brief_title>
  <official_title>Veterans Back to Health: A Study Comparing Yoga and Education for Veterans With Chronic Low Back Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic low back pain (cLBP) is the most common pain condition in the military, causing&#xD;
      substantial physical and psychological suffering, reduction in force readiness, and high&#xD;
      economic cost. Yoga has been studied in 10 RCTs in civilian populations with cLBP suggesting&#xD;
      it may be effective in reducing pain intensity, improving back-related function, and lowering&#xD;
      pain medication use. Multiple differences exist between civilian and military populations&#xD;
      with cLBP, making it necessary to adapt and test yoga for cLBP in military populations. This&#xD;
      study's primary aim is to evaluate the effectiveness of yoga for reducing pain in military&#xD;
      personnel and Veterans with cLBP through a structured, reproducible 12-week series of hatha&#xD;
      yoga classes, supplemented with home practice, compared to an education group. Additionally,&#xD;
      the enormous mental health burden often shouldered by returning military personnel presents&#xD;
      another important distinguishing factor. Thus, the study's secondary aim is to assess yoga's&#xD;
      capacity to reduce post-traumatic stress symptoms (PTSS). The third aim is to evaluate the&#xD;
      cost-effectiveness of yoga for cLBP at 3 months and 6 months from the perspective of the&#xD;
      provider, the Veteran, and the Veterans Health Administration. The fourth and final aim is to&#xD;
      evaluate the effect of back pain and yoga on marital and family functioning. The proposed RCT&#xD;
      will (1) establish a structured reproducible yoga protocol uniquely suited to Veterans&#xD;
      populations with cLBP; (2) develop web-based delivery systems to assist Veterans in yoga home&#xD;
      practice; (3) increase our knowledge of the feasibility and impact of yoga for Veterans' cLBP&#xD;
      and psychological comorbidities. These results will help determine whether yoga is an&#xD;
      effective modality for addressing cLBP in a Veteran population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">April 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>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in low back pain</measure>
    <time_frame>Baseline, 6 weeks, 12 weeks, 24 weeks</time_frame>
    <description>Measured using the Defense and Veterans Pain Rating Scale (DVPRS) which rates pain on a 0-10 scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in back-related function</measure>
    <time_frame>Baseline, 6 weeks, 12 weeks, 24 weeks</time_frame>
    <description>Back-related function will be measured using the 23-point modified Roland Morris Disability Questionnaire (RMDQ).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in pain medication use</measure>
    <time_frame>Baseline, 6 weeks, 12 weeks, 24 weeks</time_frame>
    <description>Pain medication use in the previous 7 days will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in health-related quality of life</measure>
    <time_frame>Baseline, 6 weeks, 12 weeks, 24 weeks</time_frame>
    <description>Measured using the VR-12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-rated global improvement</measure>
    <time_frame>6 weeks, 12 weeks, 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>Baseline, 6 weeks, 12 weeks, 24 weeks</time_frame>
    <description>Measured using a single question that asks patients' overall satisfaction with their treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in post-traumatic stress symptoms</measure>
    <time_frame>Baseline, 6 weeks, 12 weeks, 24 weeks</time_frame>
    <description>Measured using PTSD Checklist - Civilian version (PCL-C)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from baseline in post-concussive symptoms</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks</time_frame>
    <description>Measured using the Neurobehavioral Symptom Inventory (NSI)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in sleep quality</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks</time_frame>
    <description>Measured using the Pittsburgh Sleep Quality Index (PSQI)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in depressive symptoms</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks</time_frame>
    <description>Measured using 9-item Patient Health Questionnaire (PHQ-9)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in anxiety symptoms (GAD-7)</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks</time_frame>
    <description>Measured using the 7-item General Anxiety Disorder (GAD-7) questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in coping skills</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks</time_frame>
    <description>Measured using the Coping Strategies Questionnaire (CSQ)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in self-efficacy</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks</time_frame>
    <description>Measured using the Patient Self-Efficacy Questionnaire (PSEQ)</description>
  </other_outcome>
  <other_outcome>
    <measure>Marital/family functioning</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks</time_frame>
    <description>Measured using the Dyadic Adjustment Scale (DAS)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in work status</measure>
    <time_frame>Baseline, 12 weeks, 24 weeks</time_frame>
    <description>Measured using the Work Productivity and Activity Impairment questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>6 weeks, 12 weeks, 24 weeks</time_frame>
    <description>Medical record review and self-reported utilization data (medications, doctor visits, etc) will inform the cost effectiveness analysis of the interventions</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Recurrent Low Back Pain</condition>
  <arm_group>
    <arm_group_label>Education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Individuals randomized to the education group will receive The Back Pain Helpbook, an educational book with strategies for self-care including an exercise program, lifestyle modification, and tips for managing flare-ups. In addition, they will receive an assignment sheet outlining specific chapters to read over the course of the 12-weeks. In addition, participants receive at 3, 6, 9, and 12 weeks newsletters highlighting main points from the assigned chapters.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Yoga</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Weekly yoga classes will each be taught by two yoga instructors. Classes will be 75 minutes long. Mats and props will be provided. Yoga participants will be encouraged to practice for 30 minutes on days when they do not have class. They will be provided free of charge with a participant handbook, mat, block, and strap to aid home practice. Yoga home practice videos will be placed online for home practice and the website will track time spent using the videos for home practice. DVDs will be provided for those that do not have consistent access to the internet at home.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education</intervention_name>
    <description>Individuals randomized to the education group will receive The Back Pain Helpbook, an educational book with strategies for self-care including an exercise program, lifestyle modification, and tips for managing flare-ups. In addition, they will receive an assignment sheet outlining specific chapters to read over the course of the 12-weeks. In addition, participants receive at 3, 6, 9, and 12 weeks newsletters highlighting main points from the assigned chapters.</description>
    <arm_group_label>Education</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Yoga</intervention_name>
    <description>Weekly yoga classes will each be taught by two yoga instructors. Classes will be 75 minutes long. Mats and props will be provided. Yoga participants will be encouraged to practice for 30 minutes on days when they do not have class. They will be provided free of charge with a participant handbook, mat, block, and strap to aid home practice. Yoga home practice videos will be placed online for home practice and the website will track time spent using the videos for home practice. DVDs will be provided for those that do not have consistent access to the internet at home.</description>
    <arm_group_label>Yoga</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Veteran of any branch of military service&#xD;
&#xD;
          -  Current low-back pain present for at least half the days over the past 6 months mean&#xD;
             pain intensity for the previous week ≥4 on 0-10 rating scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant yoga practice in the previous 6 months&#xD;
&#xD;
          -  Have read The Back Pain Helpbook in the previous 6 months&#xD;
&#xD;
          -  New LBP treatments started within the previous month or anticipated to begin in the&#xD;
             next 3 months&#xD;
&#xD;
          -  Known pregnancy&#xD;
&#xD;
          -  Known inflammatory or systemic causes of LBP&#xD;
&#xD;
          -  Severe and/or progressive medical, neurological, or psychiatric comorbidities&#xD;
&#xD;
          -  Inability to understand/speak English&#xD;
&#xD;
          -  Plans to move out of the area in the next 6 months&#xD;
&#xD;
          -  Lack of informed consent&#xD;
&#xD;
          -  Unwillingness to be randomized&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert B Saper, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bedford VA Edith Nourse Rogers Memorial VA Hospital</name>
      <address>
        <city>Bedford</city>
        <state>Massachusetts</state>
        <zip>01730</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>July 18, 2016</last_update_submitted>
  <last_update_submitted_qc>July 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Medical Center</investigator_affiliation>
    <investigator_full_name>Robert B Saper</investigator_full_name>
    <investigator_title>BMC Attending Physician</investigator_title>
  </responsible_party>
  <keyword>low back pain</keyword>
  <keyword>yoga</keyword>
  <keyword>education</keyword>
  <keyword>Veterans</keyword>
  <keyword>cost-effectiveness</keyword>
  <keyword>military</keyword>
  <keyword>back pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02224183
org study id: H-32948
secondary id: 3R01AT005956-05S1
nct id: NCT02224183
lead sponsor: 
collaborator: 
has dmc: Yes
Chronic low back pain (cLBP) is the most common pain condition in the military, causing
      substantial physical and psychological suffering, reduction in force readiness, and high
      economic cost. Yoga has been studied in 10 RCTs in civilian populations with cLBP suggesting
      it may be effective in reducing pain intensity, improving back-related function, and lowering
      pain medication use. Multiple differences exist between civilian and military populations
      with cLBP, making it necessary to adapt and test yoga for cLBP in military populations. This
      study's primary aim is to evaluate the effectiveness of yoga for reducing pain in military
      personnel and Veterans with cLBP through a structured, reproducible 12-week series of hatha
      yoga classes, supplemented with home practice, compared to an education group. Additionally,
      the enormous mental health burden often shouldered by returning military personnel presents
      another important distinguishing factor. Thus, the study's secondary aim is to assess yoga's
      capacity to reduce post-traumatic stress symptoms (PTSS). The third aim is to evaluate the
      cost-effectiveness of yoga for cLBP at 3 months and 6 months from the perspective of the
      provider, the Veteran, and the Veterans Health Administration. The fourth and final aim is to
      evaluate the effect of back pain and yoga on marital and family functioning. The proposed RCT
      will (1) establish a structured reproducible yoga protocol uniquely suited to Veterans
      populations with cLBP; (2) develop web-based delivery systems to assist Veterans in yoga home
      practice; (3) increase our knowledge of the feasibility and impact of yoga for Veterans' cLBP
      and psychological comorbidities. These results will help determine whether yoga is an
      effective modality for addressing cLBP in a Veteran population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Change from baseline in low back pain
time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
description: Measured using the Defense and Veterans Pain Rating Scale (DVPRS) which rates pain on a 0-10 scale
measure: Change from baseline in back-related function
time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
description: Back-related function will be measured using the 23-point modified Roland Morris Disability Questionnaire (RMDQ).
measure: Change from baseline in pain medication use
time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
description: Pain medication use in the previous 7 days will be measured
measure: Change from baseline in health-related quality of life
time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
description: Measured using the VR-12
measure: Self-rated global improvement
time frame: 6 weeks, 12 weeks, 24 weeks
measure: Patient satisfaction
time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
description: Measured using a single question that asks patients' overall satisfaction with their treatment
measure: Change in post-traumatic stress symptoms
time frame: Baseline, 6 weeks, 12 weeks, 24 weeks
description: Measured using PTSD Checklist - Civilian version (PCL-C)
measure: Change from baseline in post-concussive symptoms
time frame: Baseline, 12 weeks, 24 weeks
description: Measured using the Neurobehavioral Symptom Inventory (NSI)
measure: Change from baseline in sleep quality
time frame: Baseline, 12 weeks, 24 weeks
description: Measured using the Pittsburgh Sleep Quality Index (PSQI)
measure: Change from baseline in depressive symptoms
time frame: Baseline, 12 weeks, 24 weeks
description: Measured using 9-item Patient Health Questionnaire (PHQ-9)
measure: Change from baseline in anxiety symptoms (GAD-7)
time frame: Baseline, 12 weeks, 24 weeks
description: Measured using the 7-item General Anxiety Disorder (GAD-7) questionnaire
measure: Change from baseline in coping skills
time frame: Baseline, 12 weeks, 24 weeks
description: Measured using the Coping Strategies Questionnaire (CSQ)
measure: Change from baseline in self-efficacy
time frame: Baseline, 12 weeks, 24 weeks
description: Measured using the Patient Self-Efficacy Questionnaire (PSEQ)
measure: Marital/family functioning
time frame: Baseline, 12 weeks, 24 weeks
description: Measured using the Dyadic Adjustment Scale (DAS)
measure: Change in work status
time frame: Baseline, 12 weeks, 24 weeks
description: Measured using the Work Productivity and Activity Impairment questionnaire
measure: Cost-effectiveness
time frame: 6 weeks, 12 weeks, 24 weeks
description: Medical record review and self-reported utilization data (medications, doctor visits, etc) will inform the cost effectiveness analysis of the interventions
arm group label: Education
arm group type: Active Comparator
description: Individuals randomized to the education group will receive The Back Pain Helpbook, an educational book with strategies for self-care including an exercise program, lifestyle modification, and tips for managing flare-ups. In addition, they will receive an assignment sheet outlining specific chapters to read over the course of the 12-weeks. In addition, participants receive at 3, 6, 9, and 12 weeks newsletters highlighting main points from the assigned chapters.
arm group label: Yoga
arm group type: Active Comparator
description: Weekly yoga classes will each be taught by two yoga instructors. Classes will be 75 minutes long. Mats and props will be provided. Yoga participants will be encouraged to practice for 30 minutes on days when they do not have class. They will be provided free of charge with a participant handbook, mat, block, and strap to aid home practice. Yoga home practice videos will be placed online for home practice and the website will track time spent using the videos for home practice. DVDs will be provided for those that do not have consistent access to the internet at home.
intervention type: Behavioral
intervention name: Education
description: Individuals randomized to the education group will receive The Back Pain Helpbook, an educational book with strategies for self-care including an exercise program, lifestyle modification, and tips for managing flare-ups. In addition, they will receive an assignment sheet outlining specific chapters to read over the course of the 12-weeks. In addition, participants receive at 3, 6, 9, and 12 weeks newsletters highlighting main points from the assigned chapters.
arm group label: Education
intervention type: Behavioral
intervention name: Yoga
description: Weekly yoga classes will each be taught by two yoga instructors. Classes will be 75 minutes long. Mats and props will be provided. Yoga participants will be encouraged to practice for 30 minutes on days when they do not have class. They will be provided free of charge with a participant handbook, mat, block, and strap to aid home practice. Yoga home practice videos will be placed online for home practice and the website will track time spent using the videos for home practice. DVDs will be provided for those that do not have consistent access to the internet at home.
arm group label: Yoga
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert B Saper, MD, MPH
role: Principal Investigator
affiliation: Boston Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Medical Center
investigator full name: Robert B Saper
investigator title: BMC Attending Physician
mesh term: Back Pain
mesh term: Low Back Pain