<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/NCT02260401</url>
  </required_header>
  <id_info>
    <org_study_id>39023</org_study_id>
    <nct_id>NCT02260401</nct_id>
  </id_info>
  <brief_title>Long Term Outcomes of Lumbar Epidural Steroid Injections for Spinal Stenosis</brief_title>
  <acronym>LESSER</acronym>
  <official_title>Long Term Outcomes of Lumbar Epidural Steroid Injections for Spinal Stenosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Spinal stenosis is one of the most common causes of low back pain among older adults and can&#xD;
      result in significant disability. Despite this, it still isn't known which treatments are&#xD;
      most effective or what outcomes are most important to these older adults. Through a Patient&#xD;
      Centered Outcomes Research Institute (PCORI) contract, the investigators are building on the&#xD;
      existing infrastructure of an AHRQ-funded (ARRA CHOICE award) comparative effectiveness&#xD;
      research (CER) trial of epidural steroid injections (ESI) for spinal stenosis (the LESS&#xD;
      trial) to address several critical research questions. The proposed study will answer the&#xD;
      following key questions. Do decision aids tailored to older adults with spinal stenosis&#xD;
      change patient decision-making regarding subsequent treatments? Do patients respond&#xD;
      differently at subsequent outcome assessments time-points after receiving tailored decision&#xD;
      aids that contain their own individual outcome data from prior treatments? The investigators&#xD;
      hypothesize that providing these individualized reports will allow patients to make more&#xD;
      informed choices regarding subsequent treatments, leading to reduced use of ineffective&#xD;
      treatments and improved outcomes overall.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      LESS trial participants will be randomized to receive the individualized outcome report&#xD;
      before the 18-month interview or after the 24-month follow up. Both groups will be asked to&#xD;
      rank outcome domains of most importance to them, to answer questions regarding their beliefs&#xD;
      about receiving future treatments for spinal stenosis and to complete the standard&#xD;
      self-reported outcomes questionnaire. In addition, we will ask the study participants whether&#xD;
      the information presented in the individualized report was helpful in deciding their future&#xD;
      epidural injection treatments as well as if the content of the reports was easy to&#xD;
      understand. At 24 months, we will repeat the interview and the outcomes assessment. We will&#xD;
      again compare the groups in terms of their responses to determine if there are lasting&#xD;
      differences in how patients who received the individualized reports make decisions regarding&#xD;
      future treatments and respond to the self-reported outcomes questions. In addition, we will&#xD;
      compare healthcare utilization between the two groups from 18 months to 24 months to&#xD;
      determine if providing the individualized outcomes reports changed treatment utilization&#xD;
      (i.e., do people who receive the report undergo fewer subsequent injections or other&#xD;
      treatments for pain?). We hypothesize that providing these individualized reports will allow&#xD;
      patients to make more informed choices regarding subsequent treatments, leading to reduced&#xD;
      use of ineffective treatments and improved outcomes overall.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Utilization of ESI</measure>
    <time_frame>24 months</time_frame>
    <description>We will measure whether or not providing these individualized reports to patients impacts patients decision-making regarding use of epidural steroid injections between 18 and 24 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Healthcare Utilization</measure>
    <time_frame>24 months</time_frame>
    <description>We will determine if providing individualized reports to the LESS trial participants at 198 months impacts healthcare utilization for spinal stenosis between 18 and 24 months (including doctors visits, physical therapy, surgery, opioid use)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">165</enrollment>
  <condition>Lumbar Spinal Stenosis</condition>
  <arm_group>
    <arm_group_label>Individualized report</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Individualized Reports after 24 months</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Individualized report</intervention_name>
    <description>Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)</description>
    <arm_group_label>Individualized report</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients already enrolled in the LESS trial will be eligible for participation in the&#xD;
        LESSER trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>October 5, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <results_first_submitted>March 31, 2017</results_first_submitted>
  <results_first_submitted_qc>March 31, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">June 16, 2017</results_first_posted>
  <last_update_submitted>March 31, 2017</last_update_submitted>
  <last_update_submitted_qc>March 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Janna Friedly</investigator_full_name>
    <investigator_title>Assistant Professor, Rehabilitation Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Stenosis</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Individualized Report</title>
          <description>Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months.&#xD;
Individualized report: Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)</description>
        </group>
        <group group_id="P2">
          <title>Individualized Reports After 24 Months</title>
          <description>Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="80"/>
                <participants group_id="P2" count="85"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
                <participants group_id="P2" count="73"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Individualized Report</title>
          <description>Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months.&#xD;
Individualized report: Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)</description>
        </group>
        <group group_id="B2">
          <title>Individualized Reports After 24 Months</title>
          <description>Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group.</description>
        </group>
        <group group_id="B3">
          <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="80"/>
            <count group_id="B2" value="85"/>
            <count group_id="B3" value="165"/>
          </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="66.4" spread="10"/>
                    <measurement group_id="B2" value="69.1" spread="9.4"/>
                    <measurement group_id="B3" value="67.8" spread="9.7"/>
                  </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="36"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="79"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="86"/>
                  </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="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="81"/>
                    <measurement group_id="B3" value="156"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Utilization of ESI</title>
        <description>We will measure whether or not providing these individualized reports to patients impacts patients decision-making regarding use of epidural steroid injections between 18 and 24 months</description>
        <time_frame>24 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Individualized Report</title>
            <description>Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months.&#xD;
Individualized report: Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)</description>
          </group>
          <group group_id="O2">
            <title>Individualized Reports After 24 Months</title>
            <description>Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group.</description>
          </group>
        </group_list>
        <measure>
          <title>Utilization of ESI</title>
          <description>We will measure whether or not providing these individualized reports to patients impacts patients decision-making regarding use of epidural steroid injections between 18 and 24 months</description>
          <units>number of ESI between 18-24 months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="85"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="2.0"/>
                    <measurement group_id="O2" value="3.3" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Healthcare Utilization</title>
        <description>We will determine if providing individualized reports to the LESS trial participants at 198 months impacts healthcare utilization for spinal stenosis between 18 and 24 months (including doctors visits, physical therapy, surgery, opioid use)</description>
        <time_frame>24 months</time_frame>
        <posting_date>04/2017</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Individualized Report</title>
          <description>Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months.&#xD;
Individualized report: Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)</description>
        </group>
        <group group_id="E2">
          <title>Individualized Reports After 24 Months</title>
          <description>Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="85"/>
              </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. Janna Friedly</name_or_title>
      <organization>University of Washington</organization>
      <phone>206-744-3000</phone>
      <email>friedlyj@uw.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/NCT02260401
org study id: 39023
nct id: NCT02260401
lead sponsor: 
collaborator: 
has dmc: No
Spinal stenosis is one of the most common causes of low back pain among older adults and can
      result in significant disability. Despite this, it still isn't known which treatments are
      most effective or what outcomes are most important to these older adults. Through a Patient
      Centered Outcomes Research Institute (PCORI) contract, the investigators are building on the
      existing infrastructure of an AHRQ-funded (ARRA CHOICE award) comparative effectiveness
      research (CER) trial of epidural steroid injections (ESI) for spinal stenosis (the LESS
      trial) to address several critical research questions. The proposed study will answer the
      following key questions. Do decision aids tailored to older adults with spinal stenosis
      change patient decision-making regarding subsequent treatments? Do patients respond
      differently at subsequent outcome assessments time-points after receiving tailored decision
      aids that contain their own individual outcome data from prior treatments? The investigators
      hypothesize that providing these individualized reports will allow patients to make more
      informed choices regarding subsequent treatments, leading to reduced use of ineffective
      treatments and improved outcomes overall.
LESS trial participants will be randomized to receive the individualized outcome report
      before the 18-month interview or after the 24-month follow up. Both groups will be asked to
      rank outcome domains of most importance to them, to answer questions regarding their beliefs
      about receiving future treatments for spinal stenosis and to complete the standard
      self-reported outcomes questionnaire. In addition, we will ask the study participants whether
      the information presented in the individualized report was helpful in deciding their future
      epidural injection treatments as well as if the content of the reports was easy to
      understand. At 24 months, we will repeat the interview and the outcomes assessment. We will
      again compare the groups in terms of their responses to determine if there are lasting
      differences in how patients who received the individualized reports make decisions regarding
      future treatments and respond to the self-reported outcomes questions. In addition, we will
      compare healthcare utilization between the two groups from 18 months to 24 months to
      determine if providing the individualized outcomes reports changed treatment utilization
      (i.e., do people who receive the report undergo fewer subsequent injections or other
      treatments for pain?). We hypothesize that providing these individualized reports will allow
      patients to make more informed choices regarding subsequent treatments, leading to reduced
      use of ineffective treatments and improved outcomes overall.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Utilization of ESI
time frame: 24 months
description: We will measure whether or not providing these individualized reports to patients impacts patients decision-making regarding use of epidural steroid injections between 18 and 24 months
measure: Healthcare Utilization
time frame: 24 months
description: We will determine if providing individualized reports to the LESS trial participants at 198 months impacts healthcare utilization for spinal stenosis between 18 and 24 months (including doctors visits, physical therapy, surgery, opioid use)
arm group label: Individualized report
arm group type: Experimental
description: Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months.
arm group label: Individualized Reports after 24 months
arm group type: No Intervention
description: Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group.
intervention type: Other
intervention name: Individualized report
description: Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)
arm group label: Individualized report
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Janna Friedly
investigator title: Assistant Professor, Rehabilitation Medicine
mesh term: Spinal Stenosis
mesh term: Constriction, Pathologic
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 