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Pain Management Groups in Occupational Health Settings

Primary Purpose

Chronic Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pain management group
Sponsored by
Finnish Institute of Occupational Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Pain focused on measuring Pain Management, Chronic Pain, Health Services, Occupational Health

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- chronic pain + increased risk of work disability (based on a screening survey)

Exclusion Criteria:

  • a malignant disease such as cancer, or severe mental illness such as depression causing significant functional disability.
  • participating in another pain group elsewhere.
  • in the middle of a major life crises such as divorce.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Pain management group

    Treatment as usual

    Arm Description

    6 + 1 meetings 2 hours each

    Waiting list - will receive treatment as usual

    Outcomes

    Primary Outcome Measures

    Pain intensity
    self-reported questionnaire, 1-item question, scale 0-10, n=60
    Pain self-efficacy
    self-reported questionnaire, set of 10 questions, item response scale 0 - 6, n=60
    Chronic pain acceptance
    self-reported questionnaire, set of 8 questions, item response scale 0 - 6, n=60
    Fear-avoidance beliefs
    self-reported questionnaire, set of 3 questions, item response scale 0 - 6, n=18
    Depressive symptoms
    self-reported questionnaire, 1-item question, response scale 0-10, n=60
    Sleep problems
    self-reported questionnaire, 1-item question, response scale 0-10, n=60
    Work ability
    self-reported questionnaire, 1-item question, response scale 0-10, n=60

    Secondary Outcome Measures

    sickness absence
    register based, number of sick leave days
    health care contacts
    register based, number of contacts to OHS

    Full Information

    First Posted
    October 20, 2016
    Last Updated
    November 25, 2019
    Sponsor
    Finnish Institute of Occupational Health
    Collaborators
    Finnish Work Environment Fund, Työterveys Helsinki (Helsinki city occupational health service)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02967705
    Brief Title
    Pain Management Groups in Occupational Health Settings
    Official Title
    Study on Pain Management Groups in Occupational Health Settings
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 20, 2016 (Actual)
    Primary Completion Date
    December 2020 (Anticipated)
    Study Completion Date
    December 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Finnish Institute of Occupational Health
    Collaborators
    Finnish Work Environment Fund, Työterveys Helsinki (Helsinki city occupational health service)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Pain
    Keywords
    Pain Management, Chronic Pain, Health Services, Occupational Health

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pain management group
    Arm Type
    Experimental
    Arm Description
    6 + 1 meetings 2 hours each
    Arm Title
    Treatment as usual
    Arm Type
    No Intervention
    Arm Description
    Waiting list - will receive treatment as usual
    Intervention Type
    Behavioral
    Intervention Name(s)
    Pain management group
    Intervention Description
    Chronic pain patients participate in a peer group. They are provided information about chronic pain self-management based on biopsychosocial framework.
    Primary Outcome Measure Information:
    Title
    Pain intensity
    Description
    self-reported questionnaire, 1-item question, scale 0-10, n=60
    Time Frame
    Change in pain intensity from before intervention to immediately after intervention and at 6 months
    Title
    Pain self-efficacy
    Description
    self-reported questionnaire, set of 10 questions, item response scale 0 - 6, n=60
    Time Frame
    Change in pain self-efficacy from before intervention to immediately after intervention and at 6 months
    Title
    Chronic pain acceptance
    Description
    self-reported questionnaire, set of 8 questions, item response scale 0 - 6, n=60
    Time Frame
    Change in chronic pain acceptance from before intervention to immediately after intervention and at 6 months
    Title
    Fear-avoidance beliefs
    Description
    self-reported questionnaire, set of 3 questions, item response scale 0 - 6, n=18
    Time Frame
    Change in fear-avoidance beliefs from before intervention to immediately after intervention and at 6 months
    Title
    Depressive symptoms
    Description
    self-reported questionnaire, 1-item question, response scale 0-10, n=60
    Time Frame
    Change in depressive symptoms from before intervention to immediately after intervention and at 6 months
    Title
    Sleep problems
    Description
    self-reported questionnaire, 1-item question, response scale 0-10, n=60
    Time Frame
    Change in sleep problems from before intervention to immediately after intervention and at 6 months
    Title
    Work ability
    Description
    self-reported questionnaire, 1-item question, response scale 0-10, n=60
    Time Frame
    Change in work ability from before intervention to immediately after intervention and at 6 months
    Secondary Outcome Measure Information:
    Title
    sickness absence
    Description
    register based, number of sick leave days
    Time Frame
    6 months before and 6 months after intervention
    Title
    health care contacts
    Description
    register based, number of contacts to OHS
    Time Frame
    6 months before and 6 months after intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - chronic pain + increased risk of work disability (based on a screening survey) Exclusion Criteria: a malignant disease such as cancer, or severe mental illness such as depression causing significant functional disability. participating in another pain group elsewhere. in the middle of a major life crises such as divorce.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Helena Miranda, Dr.Med.Sc.
    Organizational Affiliation
    Helsinki City OHS
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Pain Management Groups in Occupational Health Settings

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