- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02967705
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
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.
Collaborators
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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