<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/NCT03010878</url>
  </required_header>
  <id_info>
    <org_study_id>15.6017H</org_study_id>
    <nct_id>NCT03010878</nct_id>
  </id_info>
  <brief_title>Yoga and Occupational Therapy to Improve Pain</brief_title>
  <acronym>YoPain</acronym>
  <official_title>Yoga and Occupational Therapy to Improve Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Colorado State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Colorado State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was a randomized control trial of a yoga and self-management intervention for&#xD;
      individuals with chronic pain. Participants were assigned to either a wait-list control group&#xD;
      (self-management only), or a yoga intervention (self-management and yoga). Self-management&#xD;
      education session occurred monthly within the community. Group yoga intervention was&#xD;
      delivered two times a week with a specifically designed program that was progressively more&#xD;
      difficult. Assessments were then administered pre and post intervention, and a&#xD;
      semi-structured interview was completed following the intervention. Quantitative and&#xD;
      qualitative data were then compared between groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a randomized control trial completed with two specific aims.&#xD;
&#xD;
      Aim 1: To assess the feasibility of completing a group yoga intervention in conjunction with&#xD;
      an ongoing self-management education for people with chronic pain.&#xD;
&#xD;
      Aim 2: To explore the preliminary efficacy of a group yoga intervention in people with&#xD;
      chronic pain. The key variables of interest were pain interference, functional performance,&#xD;
      balance, strength, mobility, and quality of life (QoL)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2015</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>Phase 1</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>Brief Pain Inventory--Short Form</measure>
    <time_frame>8 weeks</time_frame>
    <description>The Brief Pain Inventory (Short Form) is a 9 item self-report questionnaire designed to assess general pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Berg Balance Scale</measure>
    <time_frame>8 weeks</time_frame>
    <description>14 items to assess balance</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">83</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Yoga Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Yoga administered twice a week for 8 weeks. Self-management education sessions administered once a month through the University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic (Pain Clinic). Yoga interventions were administered twice a week at the Pain Clinic.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list Control Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received only self-management intervention, which is provided once a month through the University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Yoga</intervention_name>
    <description>The yoga intervention group addressed pain as a primary variable and balance as a secondary variable and how to best manage these symptoms in the clinic and community.&#xD;
Yoga was delivered in sitting, standing, and floor postures</description>
    <arm_group_label>Yoga Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Self-management</intervention_name>
    <description>The self-management education group was provide once a month through University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic. The program consisted of lifestyle variations, accountability, modifications, and strategies to management pain in daily life.</description>
    <arm_group_label>Wait-list Control Arm</arm_group_label>
    <arm_group_label>Yoga Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  greater than 18 years of age&#xD;
&#xD;
          -  Individual with self-reported pain for over six months&#xD;
&#xD;
          -  attending outpatient pain clinic&#xD;
&#xD;
          -  ability to attend yoga classes&#xD;
&#xD;
          -  ability to complete assessments&#xD;
&#xD;
          -  ability to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  consistent yoga practice over the past year&#xD;
&#xD;
          -  self-reported exercise restrictions&#xD;
&#xD;
          -  serious and recent medical procedures or conditions without doctor's note&#xD;
&#xD;
          -  high risk pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arlene Schmid, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Colorado State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UC Health Fort Collins Family Medicine Residency Program Pain Management Clinic</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80524</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Colorado State University</investigator_affiliation>
    <investigator_full_name>Arlene Schmid</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>yoga</keyword>
  <keyword>chronic pain</keyword>
  <keyword>occupational therapy</keyword>
  <keyword>self-management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>June 21, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03010878
org study id: 15.6017H
nct id: NCT03010878
lead sponsor: 
has dmc: No
This was a randomized control trial of a yoga and self-management intervention for
      individuals with chronic pain. Participants were assigned to either a wait-list control group
      (self-management only), or a yoga intervention (self-management and yoga). Self-management
      education session occurred monthly within the community. Group yoga intervention was
      delivered two times a week with a specifically designed program that was progressively more
      difficult. Assessments were then administered pre and post intervention, and a
      semi-structured interview was completed following the intervention. Quantitative and
      qualitative data were then compared between groups.
This was a randomized control trial completed with two specific aims.

      Aim 1: To assess the feasibility of completing a group yoga intervention in conjunction with
      an ongoing self-management education for people with chronic pain.

      Aim 2: To explore the preliminary efficacy of a group yoga intervention in people with
      chronic pain. The key variables of interest were pain interference, functional performance,
      balance, strength, mobility, and quality of life (QoL)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Brief Pain Inventory--Short Form
time frame: 8 weeks
description: The Brief Pain Inventory (Short Form) is a 9 item self-report questionnaire designed to assess general pain.
measure: Berg Balance Scale
time frame: 8 weeks
description: 14 items to assess balance
arm group label: Yoga Arm
arm group type: Experimental
description: Yoga administered twice a week for 8 weeks. Self-management education sessions administered once a month through the University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic (Pain Clinic). Yoga interventions were administered twice a week at the Pain Clinic.
arm group label: Wait-list Control Arm
arm group type: Experimental
description: Participants received only self-management intervention, which is provided once a month through the University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic.
intervention type: Other
intervention name: Yoga
description: The yoga intervention group addressed pain as a primary variable and balance as a secondary variable and how to best manage these symptoms in the clinic and community.
Yoga was delivered in sitting, standing, and floor postures
arm group label: Yoga Arm
intervention type: Other
intervention name: Self-management
description: The self-management education group was provide once a month through University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic. The program consisted of lifestyle variations, accountability, modifications, and strategies to management pain in daily life.
arm group label: Wait-list Control Arm
arm group label: Yoga Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Arlene Schmid, PhD
role: Principal Investigator
affiliation: Colorado State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Colorado State University
investigator full name: Arlene Schmid
investigator title: Associate Professor
mesh term: Chronic Pain
sharing ipd: No
submitted: June 21, 2023