<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/NCT02967705</url>
  </required_header>
  <id_info>
    <org_study_id>115395</org_study_id>
    <nct_id>NCT02967705</nct_id>
  </id_info>
  <brief_title>Pain Management Groups in Occupational Health Settings</brief_title>
  <official_title>Study on Pain Management Groups in Occupational Health Settings</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Finnish Institute of Occupational Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Finnish Work Environment Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Työterveys Helsinki (Helsinki city occupational health service)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Finnish Institute of Occupational Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This cluster randomized waiting-list controlled study will evaluate the effectiveness of pain&#xD;
      management group activity organized by the OH on pain intensity and associated disability,&#xD;
      and co-occurrence of mental or sleep problem in patients with chronic pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pain is very prevalent among the working population causing a considerable amount of work&#xD;
      disability days. Pain management group therapy has shown to have a significant effect on&#xD;
      chronic pain. However, little is known of the effect of such therapy on work disability.&#xD;
      There are especially very few studies prescribing the effectiveness of pain management groups&#xD;
      provided by the occupational health service.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">February 20, 2016</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>Change in pain intensity from before intervention to immediately after intervention and at 6 months</time_frame>
    <description>self-reported questionnaire, 1-item question, scale 0-10, n=60</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain self-efficacy</measure>
    <time_frame>Change in pain self-efficacy from before intervention to immediately after intervention and at 6 months</time_frame>
    <description>self-reported questionnaire, set of 10 questions, item response scale 0 - 6, n=60</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chronic pain acceptance</measure>
    <time_frame>Change in chronic pain acceptance from before intervention to immediately after intervention and at 6 months</time_frame>
    <description>self-reported questionnaire, set of 8 questions, item response scale 0 - 6, n=60</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fear-avoidance beliefs</measure>
    <time_frame>Change in fear-avoidance beliefs from before intervention to immediately after intervention and at 6 months</time_frame>
    <description>self-reported questionnaire, set of 3 questions, item response scale 0 - 6, n=18</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>Change in depressive symptoms from before intervention to immediately after intervention and at 6 months</time_frame>
    <description>self-reported questionnaire, 1-item question, response scale 0-10, n=60</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep problems</measure>
    <time_frame>Change in sleep problems from before intervention to immediately after intervention and at 6 months</time_frame>
    <description>self-reported questionnaire, 1-item question, response scale 0-10, n=60</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Work ability</measure>
    <time_frame>Change in work ability from before intervention to immediately after intervention and at 6 months</time_frame>
    <description>self-reported questionnaire, 1-item question, response scale 0-10, n=60</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>sickness absence</measure>
    <time_frame>6 months before and 6 months after intervention</time_frame>
    <description>register based, number of sick leave days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>health care contacts</measure>
    <time_frame>6 months before and 6 months after intervention</time_frame>
    <description>register based, number of contacts to OHS</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Pain management group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 + 1 meetings 2 hours each</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Waiting list - will receive treatment as usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pain management group</intervention_name>
    <description>Chronic pain patients participate in a peer group. They are provided information about chronic pain self-management based on biopsychosocial framework.</description>
    <arm_group_label>Pain management group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - chronic pain + increased risk of work disability (based on a screening survey)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a malignant disease such as cancer, or severe mental illness such as depression&#xD;
             causing significant functional disability.&#xD;
&#xD;
          -  participating in another pain group elsewhere.&#xD;
&#xD;
          -  in the middle of a major life crises such as divorce.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helena Miranda, Dr.Med.Sc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Helsinki City OHS</affiliation>
  </overall_official>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>October 20, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 25, 2019</last_update_submitted>
  <last_update_submitted_qc>November 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Finnish Institute of Occupational Health</investigator_affiliation>
    <investigator_full_name>Helena Miranda</investigator_full_name>
    <investigator_title>Project coordinator</investigator_title>
  </responsible_party>
  <keyword>Pain Management</keyword>
  <keyword>Chronic Pain</keyword>
  <keyword>Health Services</keyword>
  <keyword>Occupational Health</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>
  <!-- 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/NCT02967705
org study id: 115395
nct id: NCT02967705
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This cluster randomized waiting-list controlled study will evaluate the effectiveness of pain
      management group activity organized by the OH on pain intensity and associated disability,
      and co-occurrence of mental or sleep problem in patients with chronic pain.
Pain is very prevalent among the working population causing a considerable amount of work
      disability days. Pain management group therapy has shown to have a significant effect on
      chronic pain. However, little is known of the effect of such therapy on work disability.
      There are especially very few studies prescribing the effectiveness of pain management groups
      provided by the occupational health service.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Pain intensity
time frame: Change in pain intensity from before intervention to immediately after intervention and at 6 months
description: self-reported questionnaire, 1-item question, scale 0-10, n=60
measure: Pain self-efficacy
time frame: Change in pain self-efficacy from before intervention to immediately after intervention and at 6 months
description: self-reported questionnaire, set of 10 questions, item response scale 0 - 6, n=60
measure: Chronic pain acceptance
time frame: Change in chronic pain acceptance from before intervention to immediately after intervention and at 6 months
description: self-reported questionnaire, set of 8 questions, item response scale 0 - 6, n=60
measure: Fear-avoidance beliefs
time frame: Change in fear-avoidance beliefs from before intervention to immediately after intervention and at 6 months
description: self-reported questionnaire, set of 3 questions, item response scale 0 - 6, n=18
measure: Depressive symptoms
time frame: Change in depressive symptoms from before intervention to immediately after intervention and at 6 months
description: self-reported questionnaire, 1-item question, response scale 0-10, n=60
measure: Sleep problems
time frame: Change in sleep problems from before intervention to immediately after intervention and at 6 months
description: self-reported questionnaire, 1-item question, response scale 0-10, n=60
measure: Work ability
time frame: Change in work ability from before intervention to immediately after intervention and at 6 months
description: self-reported questionnaire, 1-item question, response scale 0-10, n=60
measure: sickness absence
time frame: 6 months before and 6 months after intervention
description: register based, number of sick leave days
measure: health care contacts
time frame: 6 months before and 6 months after intervention
description: register based, number of contacts to OHS
arm group label: Pain management group
arm group type: Experimental
description: 6 + 1 meetings 2 hours each
arm group label: Treatment as usual
arm group type: No Intervention
description: Waiting list - will receive treatment as usual
intervention type: Behavioral
intervention name: Pain management group
description: Chronic pain patients participate in a peer group. They are provided information about chronic pain self-management based on biopsychosocial framework.
arm group label: Pain management group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Helena Miranda, Dr.Med.Sc.
role: Principal Investigator
affiliation: Helsinki City OHS
responsible party type: Principal Investigator
investigator affiliation: Finnish Institute of Occupational Health
investigator full name: Helena Miranda
investigator title: Project coordinator
mesh term: Chronic Pain
sharing ipd: No