Pain Management Groups in Occupational Health Settings

November 25, 2019 updated by: Helena Miranda, Finnish Institute of Occupational Health

Study on Pain Management Groups in Occupational Health Settings

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pain management group
6 + 1 meetings 2 hours each
Chronic pain patients participate in a peer group. They are provided information about chronic pain self-management based on biopsychosocial framework.
No Intervention: Treatment as usual
Waiting list - will receive treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: Change in pain intensity from before intervention to immediately after intervention and at 6 months
self-reported questionnaire, 1-item question, scale 0-10, n=60
Change in pain intensity from before intervention to immediately after intervention and at 6 months
Pain self-efficacy
Time Frame: Change in pain self-efficacy from before intervention to immediately after intervention and at 6 months
self-reported questionnaire, set of 10 questions, item response scale 0 - 6, n=60
Change in pain self-efficacy from before intervention to immediately after intervention and at 6 months
Chronic pain acceptance
Time Frame: Change in chronic pain acceptance from before intervention to immediately after intervention and at 6 months
self-reported questionnaire, set of 8 questions, item response scale 0 - 6, n=60
Change in chronic pain acceptance from before intervention to immediately after intervention and at 6 months
Fear-avoidance beliefs
Time Frame: Change in fear-avoidance beliefs from before intervention to immediately after intervention and at 6 months
self-reported questionnaire, set of 3 questions, item response scale 0 - 6, n=18
Change in fear-avoidance beliefs from before intervention to immediately after intervention and at 6 months
Depressive symptoms
Time Frame: Change in depressive symptoms from before intervention to immediately after intervention and at 6 months
self-reported questionnaire, 1-item question, response scale 0-10, n=60
Change in depressive symptoms from before intervention to immediately after intervention and at 6 months
Sleep problems
Time Frame: Change in sleep problems from before intervention to immediately after intervention and at 6 months
self-reported questionnaire, 1-item question, response scale 0-10, n=60
Change in sleep problems from before intervention to immediately after intervention and at 6 months
Work ability
Time Frame: Change in work ability from before intervention to immediately after intervention and at 6 months
self-reported questionnaire, 1-item question, response scale 0-10, n=60
Change in work ability from before intervention to immediately after intervention and at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sickness absence
Time Frame: 6 months before and 6 months after intervention
register based, number of sick leave days
6 months before and 6 months after intervention
health care contacts
Time Frame: 6 months before and 6 months after intervention
register based, number of contacts to OHS
6 months before and 6 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Helena Miranda, Dr.Med.Sc., Helsinki City OHS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2016

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

October 20, 2016

First Submitted That Met QC Criteria

November 16, 2016

First Posted (Estimate)

November 18, 2016

Study Record Updates

Last Update Posted (Actual)

November 26, 2019

Last Update Submitted That Met QC Criteria

November 25, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 115395

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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