NCT02967705

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable chronic-pain

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2016

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

4.8 years

First QC Date

October 20, 2016

Last Update Submit

November 25, 2019

Conditions

Chronic Pain

Keywords

Pain ManagementChronic PainHealth ServicesOccupational Health

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • sickness absence

    6 months before and 6 months after intervention

  • health care contacts

    6 months before and 6 months after intervention

Study Arms (2)

Pain management group

EXPERIMENTAL

6 + 1 meetings 2 hours each

Behavioral: Pain management group

Treatment as usual

NO INTERVENTION

Waiting list - will receive treatment as usual

Interventions

Pain management groupBEHAVIORAL

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

Pain management group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic PainAgnosia

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Helena Miranda, Dr.Med.Sc.

    Helsinki City OHS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project coordinator

Study Record Dates

First Submitted

October 20, 2016

First Posted

November 18, 2016

Study Start

February 20, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

November 26, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share