<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/NCT03299192</url>
  </required_header>
  <id_info>
    <org_study_id>R34AT009052</org_study_id>
    <nct_id>NCT03299192</nct_id>
  </id_info>
  <brief_title>Tai Chi for Chronic Low Back Pain in Older Adults</brief_title>
  <official_title>Tai Chi for Chronic Low Back Pain in Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaiser Permanente</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is a major gap in knowledge about safe and effective treatment options for older adults&#xD;
      with chronic low back pain. This project will determine the feasibility of conducting a&#xD;
      full-scale trial evaluating Tai Chi, a promising &quot;mind-body&quot; intervention that seems&#xD;
      particularly well-suited for older adults with chronic low back pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ultimate goal of this project is to help fill the substantial gap in knowledge about safe&#xD;
      and effective treatments for older adults with chronic low back pain. This deficiency is a&#xD;
      particular problem because treatments that have been found safe and effective for younger&#xD;
      adults may not be appropriate for an older population that is at higher risk of adverse&#xD;
      effects and that may have different needs and treatment preferences. Tai Chi, which has been&#xD;
      found effective for chronic back pain in younger adults, seems particularly well-suited for&#xD;
      older adults with chronic low back pain because it includes multiple therapeutic elements, is&#xD;
      gentle and has been found beneficial for a variety of health conditions more common to older&#xD;
      adults. The goal of this project is to prepare the foundation for successfully conducting a&#xD;
      full-scale trial evaluating the effectiveness of two doses of Tai Chi (Standard and Enhanced,&#xD;
      which includes Standard + Maintenance Tai Chi) for improving chronic low back pain in older&#xD;
      adults over the course of a year.&#xD;
&#xD;
      In the first phase of this study (Aim 1), the the Investigators will focus on finalization of&#xD;
      a Standard Tai Chi protocol, development of the maintenance Tai Chi protocol and development&#xD;
      of a credible attention control group. In the course of finalizing the feasibility trial&#xD;
      documents, members of the research study team will work with patient partners (older adults&#xD;
      with chronic low back pain) to adapt strategies for recruitment, adherence to Tai Chi,&#xD;
      safety, and optimizing follow-up rates for this population and the Investigators will&#xD;
      finalize the inclusion/exclusion criteria to maximize safety and generalizability.&#xD;
&#xD;
      After finalizing the key study components, the Investigators will conduct a randomized&#xD;
      feasibility trial comparing Enhanced Tai Chi with Health Education and Usual Medical Care.&#xD;
      Sixty-four older adults with cLBP - 65+ years of age will be randomized to the Enhanced&#xD;
      (standard + maintenance) Tai Chi, to Health Education or to Usual Medical Care. Outcomes will&#xD;
      be collected at 12, 26, and 52 weeks. The Investigators will evaluate the adequacy of key&#xD;
      elements of the study developed in Aim 1 for inclusion in a full-scale trial. Finally, the&#xD;
      research study team will conduct debriefing discussion groups with 30 trial participants to&#xD;
      elicit their ideas for improving the procedures and protocols. This evaluation will address&#xD;
      the overall feasibility of conducting a large trial and the value of including the Enhanced&#xD;
      dose Tai Chi treatment arm.&#xD;
&#xD;
      If successful, this feasibility study will pave the way for conducting an adequately-powered&#xD;
      randomized\ controlled trial evaluating the ability of Tai Chi to reduce the impact of&#xD;
      chronic low back pain on older adults. In view of the absence of knowledge about clearly safe&#xD;
      and effective treatments for this population, this line of research has the potential for&#xD;
      substantially reducing the suffering of many Americans with back pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 1, 2016</start_date>
  <completion_date type="Anticipated">April 30, 2020</completion_date>
  <primary_completion_date type="Actual">March 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Comparison of Tai Chi to Health Education and to Usual Medical Care</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Research Specialists will be unaware of study group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Roland Morris Disability Questionnaire Score</measure>
    <time_frame>Baseline, 12, 26, 52 weeks</time_frame>
    <description>standard measure of back-related disability</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Back Pain Lower Back Chronic</condition>
  <arm_group>
    <arm_group_label>Tai Chi</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>twice weekly classes for 12 weeks and then weekly for 6 weeks, every other week for 6 weeks and monthly for 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Health Education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>twice weekly classes for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Medical Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the usual care to which participants are entitled by their health insurance</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tai Chi</intervention_name>
    <description>Yang Style Tai Chi</description>
    <arm_group_label>Tai Chi</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health Education</intervention_name>
    <description>Comprehensive Health Education relevant for Healthy Aging in Patients with Chronic Back Pain</description>
    <arm_group_label>Health Education</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Medical Care</intervention_name>
    <description>Medications, PT, Complementary and Integrative Health and other miscellaneous treatments as appropriate.</description>
    <arm_group_label>Health Education</arm_group_label>
    <arm_group_label>Tai Chi</arm_group_label>
    <arm_group_label>Usual Medical Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Be men or women at least 65 years of age&#xD;
&#xD;
               -  Have low back pain that has persisted for at least three months&#xD;
&#xD;
               -  Have had back pain on at least half the days in the last 6 months&#xD;
&#xD;
               -  Have at least moderate intensity low back pain&#xD;
&#xD;
               -  Have some activity limitations due to back pain&#xD;
&#xD;
               -  Be members of Kaiser Permanente Washington integrative health care system or have&#xD;
                  a regular source of health care and health insurance&#xD;
&#xD;
               -  Have normal cognition or only mild cognitive impairment&#xD;
&#xD;
               -  Be capable of understanding the study procedures and complying with them for the&#xD;
                  entire study period.&#xD;
&#xD;
               -  Live close enough to the class site for attendance to be practical&#xD;
&#xD;
               -  Give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Have certain specific conditions of LBP&#xD;
&#xD;
               -  Prior lumbar spine surgery&#xD;
&#xD;
               -  Have sciatica, or scheduled visits to a neurosurgeon or orthopedic surgeon.&#xD;
&#xD;
               -  Receiving or seeking compensation for back pain&#xD;
&#xD;
               -  Red flags of serious underlying illness&#xD;
&#xD;
               -  Have practiced Tai Chi or yoga recently. Have other disabling conditions that&#xD;
                  might confound treatment effects&#xD;
&#xD;
               -  Conditions making consent or treatment difficult&#xD;
&#xD;
               -  Conditions making treatment unsafe or inappropriate&#xD;
&#xD;
               -  Unwillingness to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kaiser Permanente Washington Health Research Institute</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>May 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>October 3, 2019</last_update_submitted>
  <last_update_submitted_qc>October 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2019</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>
  <pending_results>
    <submitted>December 24, 2019</submitted>
    <returned>January 9, 2020</returned>
  </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/NCT03299192
org study id: R34AT009052
nct id: NCT03299192
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
There is a major gap in knowledge about safe and effective treatment options for older adults
      with chronic low back pain. This project will determine the feasibility of conducting a
      full-scale trial evaluating Tai Chi, a promising "mind-body" intervention that seems
      particularly well-suited for older adults with chronic low back pain.
The ultimate goal of this project is to help fill the substantial gap in knowledge about safe
      and effective treatments for older adults with chronic low back pain. This deficiency is a
      particular problem because treatments that have been found safe and effective for younger
      adults may not be appropriate for an older population that is at higher risk of adverse
      effects and that may have different needs and treatment preferences. Tai Chi, which has been
      found effective for chronic back pain in younger adults, seems particularly well-suited for
      older adults with chronic low back pain because it includes multiple therapeutic elements, is
      gentle and has been found beneficial for a variety of health conditions more common to older
      adults. The goal of this project is to prepare the foundation for successfully conducting a
      full-scale trial evaluating the effectiveness of two doses of Tai Chi (Standard and Enhanced,
      which includes Standard + Maintenance Tai Chi) for improving chronic low back pain in older
      adults over the course of a year.

      In the first phase of this study (Aim 1), the the Investigators will focus on finalization of
      a Standard Tai Chi protocol, development of the maintenance Tai Chi protocol and development
      of a credible attention control group. In the course of finalizing the feasibility trial
      documents, members of the research study team will work with patient partners (older adults
      with chronic low back pain) to adapt strategies for recruitment, adherence to Tai Chi,
      safety, and optimizing follow-up rates for this population and the Investigators will
      finalize the inclusion/exclusion criteria to maximize safety and generalizability.

      After finalizing the key study components, the Investigators will conduct a randomized
      feasibility trial comparing Enhanced Tai Chi with Health Education and Usual Medical Care.
      Sixty-four older adults with cLBP - 65+ years of age will be randomized to the Enhanced
      (standard + maintenance) Tai Chi, to Health Education or to Usual Medical Care. Outcomes will
      be collected at 12, 26, and 52 weeks. The Investigators will evaluate the adequacy of key
      elements of the study developed in Aim 1 for inclusion in a full-scale trial. Finally, the
      research study team will conduct debriefing discussion groups with 30 trial participants to
      elicit their ideas for improving the procedures and protocols. This evaluation will address
      the overall feasibility of conducting a large trial and the value of including the Enhanced
      dose Tai Chi treatment arm.

      If successful, this feasibility study will pave the way for conducting an adequately-powered
      randomized\ controlled trial evaluating the ability of Tai Chi to reduce the impact of
      chronic low back pain on older adults. In view of the absence of knowledge about clearly safe
      and effective treatments for this population, this line of research has the potential for
      substantially reducing the suffering of many Americans with back pain.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Comparison of Tai Chi to Health Education and to Usual Medical Care
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Research Specialists will be unaware of study group.
measure: Change in Roland Morris Disability Questionnaire Score
time frame: Baseline, 12, 26, 52 weeks
description: standard measure of back-related disability
arm group label: Tai Chi
arm group type: Experimental
description: twice weekly classes for 12 weeks and then weekly for 6 weeks, every other week for 6 weeks and monthly for 3 months
arm group label: Health Education
arm group type: Active Comparator
description: twice weekly classes for 12 weeks
arm group label: Usual Medical Care
arm group type: Active Comparator
description: the usual care to which participants are entitled by their health insurance
intervention type: Behavioral
intervention name: Tai Chi
description: Yang Style Tai Chi
arm group label: Tai Chi
intervention type: Behavioral
intervention name: Health Education
description: Comprehensive Health Education relevant for Healthy Aging in Patients with Chronic Back Pain
arm group label: Health Education
intervention type: Other
intervention name: Usual Medical Care
description: Medications, PT, Complementary and Integrative Health and other miscellaneous treatments as appropriate.
arm group label: Health Education
arm group label: Tai Chi
arm group label: Usual Medical Care
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
sharing ipd: No
submitted: December 24, 2019
returned: January 9, 2020