<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/NCT02262234</url>
  </required_header>
  <id_info>
    <org_study_id>R-815-14</org_study_id>
    <nct_id>NCT02262234</nct_id>
  </id_info>
  <brief_title>Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study</brief_title>
  <official_title>Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kessler Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Craig H. Neilsen Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kessler Institute for Rehabilitation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Kessler Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic pain (pain that is that is present for a long period of time) is very common among&#xD;
      people with spinal cord injury (SCI). Unfortunately, chronic pain is very difficult to treat.&#xD;
      Many treatments reduce chronic pain only partially. As a result, many people with SCI must&#xD;
      find ways of accomplishing daily activities even though they have pain.&#xD;
&#xD;
      The purpose of this research study is to determine how well two different kinds of education&#xD;
      programs reduce the extent to which chronic pain interferes with daily life and well-being.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pain is a highly prevalent and disabling condition among persons with spinal cord injury&#xD;
      (SCI). Unfortunately, current pain treatments offer incomplete relief, produce side effects,&#xD;
      and/or involve significant cost. Low-risk, low-cost treatments capable of addressing residual&#xD;
      pain and pain-related disability are greatly needed. A number of research studies have&#xD;
      associated educational interventions with improvements in pain-related outcomes.&#xD;
&#xD;
      The overall goal of the proposed pilot study is to evaluate the feasibility, acceptability,&#xD;
      and potential benefits of two types of educational programs for people with chronic pain and&#xD;
      spinal cord injury. This study aims to identify a low-cost, low-risk treatment option that&#xD;
      empowers people with pain and SCI to improve their functioning and quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>Phase 1/Phase 2</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain interference with activities</measure>
    <time_frame>Week 10 versus baseline</time_frame>
    <description>The extent to which pain interferes with daily activities will be measured with the Life Interference Subscale of the Multidimensional Pain Inventory (MPI-LIS). The MPI-LIS is a 10-item self-report of extent of interference of pain with life activities and the enjoyment of life. The subscale will be modified to remove two items related to work, as recommended based on a factor analysis of the subscale in persons with SCI.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>Week 10 versus baseline</time_frame>
    <description>Pain intensity will be rated on a 0-10 numerical rating scale (0=&quot;no pain&quot; and 10=&quot;pain as bad as you can imagine&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental health and well-being</measure>
    <time_frame>Week 10 versus baseline</time_frame>
    <description>The Brief Patient Health Questionnaire and Perceived Stress Scale will be used to assess changes in mental health that occur between baseline and the end of the education program.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain attitudes</measure>
    <time_frame>Week 10 versus baseline</time_frame>
    <description>The Survey of Pain Attitudes will be used to assess changes in thoughts and beliefs about pain.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Spinal Cord Injury</condition>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Education Program Type 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Education Program Type 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Education Program Type 1</intervention_name>
    <description>The first part of the education program involves four weeks of in-person classes (2 hours per class) given once per week with homework assignments of approximately 30 minutes per day for at least 5 days per week. The second part of the education program involves home-based activities only, performed approximately 30 minutes per day for at least 5 days per week.</description>
    <arm_group_label>Education Program Type 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Education Program Type 2</intervention_name>
    <description>The first part of the education program involves four weeks of in-person classes (2 hours per class) given once per week with homework assignments of approximately 30 minutes per day for at least 5 days per week. The second part of the education program involves home-based activities only, performed approximately 30 minutes per day for at least 5 days per week.</description>
    <arm_group_label>Education Program Type 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Spinal cord injury for at least one year&#xD;
&#xD;
          -  Chronic pain for at least three months that is moderate to severe (rated at or above&#xD;
             4/10 on a scale of 0 to 10 where 0 = &quot;no pain&quot; and 10 = &quot;pain as bad as you can&#xD;
             imagine&quot;)&#xD;
&#xD;
          -  Fluent in English&#xD;
&#xD;
          -  Not currently starting a new pain treatment or changing a previous pain treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cancer or conditions that may worsen over time (such as multiple sclerosis, Parkinson&#xD;
             Disease, Alzheimer's disease) and may affect my physical or mental functioning&#xD;
&#xD;
          -  Significant difficulties with learning or memory&#xD;
&#xD;
          -  Previous participation in a health and function education program specifically&#xD;
             designed for people with chronic pain and SCI&#xD;
&#xD;
          -  Inability to understand English&#xD;
&#xD;
          -  Presence of other conditions not related to SCI that cause pain (such as fibromyalgia)&#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>Jeanne M Zanca, PhD, MPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kessler Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kessler Foundation</name>
      <address>
        <city>West Orange</city>
        <state>New Jersey</state>
        <zip>07052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://KesslerFoundation.org</url>
    <description>Kessler Foundation Home Page</description>
  </link>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>October 7, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>May 8, 2020</last_update_submitted>
  <last_update_submitted_qc>May 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Spinal cord injury</keyword>
  <keyword>Chronic pain</keyword>
  <keyword>Education</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Chronic 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/NCT02262234
org study id: R-815-14
nct id: NCT02262234
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Chronic pain (pain that is that is present for a long period of time) is very common among
      people with spinal cord injury (SCI). Unfortunately, chronic pain is very difficult to treat.
      Many treatments reduce chronic pain only partially. As a result, many people with SCI must
      find ways of accomplishing daily activities even though they have pain.

      The purpose of this research study is to determine how well two different kinds of education
      programs reduce the extent to which chronic pain interferes with daily life and well-being.
Pain is a highly prevalent and disabling condition among persons with spinal cord injury
      (SCI). Unfortunately, current pain treatments offer incomplete relief, produce side effects,
      and/or involve significant cost. Low-risk, low-cost treatments capable of addressing residual
      pain and pain-related disability are greatly needed. A number of research studies have
      associated educational interventions with improvements in pain-related outcomes.

      The overall goal of the proposed pilot study is to evaluate the feasibility, acceptability,
      and potential benefits of two types of educational programs for people with chronic pain and
      spinal cord injury. This study aims to identify a low-cost, low-risk treatment option that
      empowers people with pain and SCI to improve their functioning and quality of life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain interference with activities
time frame: Week 10 versus baseline
description: The extent to which pain interferes with daily activities will be measured with the Life Interference Subscale of the Multidimensional Pain Inventory (MPI-LIS). The MPI-LIS is a 10-item self-report of extent of interference of pain with life activities and the enjoyment of life. The subscale will be modified to remove two items related to work, as recommended based on a factor analysis of the subscale in persons with SCI.
measure: Pain intensity
time frame: Week 10 versus baseline
description: Pain intensity will be rated on a 0-10 numerical rating scale (0="no pain" and 10="pain as bad as you can imagine").
measure: Mental health and well-being
time frame: Week 10 versus baseline
description: The Brief Patient Health Questionnaire and Perceived Stress Scale will be used to assess changes in mental health that occur between baseline and the end of the education program.
measure: Pain attitudes
time frame: Week 10 versus baseline
description: The Survey of Pain Attitudes will be used to assess changes in thoughts and beliefs about pain.
arm group label: Education Program Type 1
arm group type: Experimental
arm group label: Education Program Type 2
arm group type: Experimental
intervention type: Other
intervention name: Education Program Type 1
description: The first part of the education program involves four weeks of in-person classes (2 hours per class) given once per week with homework assignments of approximately 30 minutes per day for at least 5 days per week. The second part of the education program involves home-based activities only, performed approximately 30 minutes per day for at least 5 days per week.
arm group label: Education Program Type 1
intervention type: Other
intervention name: Education Program Type 2
description: The first part of the education program involves four weeks of in-person classes (2 hours per class) given once per week with homework assignments of approximately 30 minutes per day for at least 5 days per week. The second part of the education program involves home-based activities only, performed approximately 30 minutes per day for at least 5 days per week.
arm group label: Education Program Type 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeanne M Zanca, PhD, MPT
role: Principal Investigator
affiliation: Kessler Foundation
facility: 
country: United States
url: http://KesslerFoundation.org
description: Kessler Foundation Home Page
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
mesh term: Chronic Pain