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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02967705
Other study ID # 115395
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 20, 2016
Est. completion date December 2020

Study information

Verified date November 2019
Source Finnish Institute of Occupational Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Pain management group
Chronic pain patients participate in a peer group. They are provided information about chronic pain self-management based on biopsychosocial framework.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Finnish Institute of Occupational Health Finnish Work Environment Fund, Työterveys Helsinki (Helsinki city occupational health service)

Outcome

Type Measure Description Time frame Safety issue
Primary Pain intensity 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
Primary Pain self-efficacy 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
Primary Chronic pain acceptance 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
Primary Fear-avoidance beliefs 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
Primary Depressive symptoms 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
Primary Sleep problems 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
Primary Work ability 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 sickness absence register based, number of sick leave days 6 months before and 6 months after intervention
Secondary health care contacts register based, number of contacts to OHS 6 months before and 6 months after intervention
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